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NCT00392327,https://www.clinicaltrials.gov/ct2/show/record/NCT00392327?term=NCT00392327&rank=1,'Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor\r\n* As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued\r\n* All patients with M4 disease are not eligible','A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility\r\n* Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory\r\n* Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred','Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively','Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks','No previous chemotherapy or radiation therapy','Corticosteroids should not be used during chemotherapy administration as an antiemetic','Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John’s wort; the use of these drugs should be avoided with vincristine (vincristine sulfate)','CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy','Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity\r\n* Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin','No other experimental therapy is permitted while on study','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:            \r\n* 0.8 mg/dL (2 to < 6 years of age)\r\n* 1.0 mg/dL (6 to < 10 years of age)\r\n* 1.2 mg/dL (10 to < 13 years of age)\r\n* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)\r\n* 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)','Total bilirubin < 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be < 5 x ULN','Absolute neutrophil count (ANC) >= 1,000/uL','Platelets >= 100,000/uL (untransfused)','Hemoglobin >= 8 g/dl (may be transfused)','Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT00632853,https://www.clinicaltrials.gov/ct2/show/record/NCT00632853?term=NCT00632853&rank=1,'Histologically or cytologically confirmed small cell lung cancer','Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes\r\n* Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible\r\n* Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have a negative thoracentesis\r\n* Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible','Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan','Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) 30610, which must have included carboplatin or cisplatin and etoposide; if a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests prior to starting their first cycle of chemotherapy; additionally, these patients also must have met all of the eligibility criteria prior to receiving the first cycle of chemotherapy; registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 30610','No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for small cell lung cancer (SCLC)','No prior mediastinal or thoracic radiotherapy','Patients with complete surgical resection of disease are not eligible','Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2','No patients that are known to be pregnant or nursing','Granulocytes >= 1,500/ul','Platelet count >= 100,000/ul','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 x ULN','Serum creatinine =< 1.5 times ULN OR calculated creatinine clearance >= 70 mL/min'
NCT00719303,https://www.clinicaltrials.gov/ct2/show/record/NCT00719303?term=NCT00719303&rank=1,'Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis','Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner’s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma','Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy (chemo) or biological therapy','Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution’s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)','Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2','Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen','Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)','Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa)','Patients must complete all pre-entry assessments','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC','Patients with GOG performance grade of 3 or 4','Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus','Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)','Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma','Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago','Patients with a life expectancy of less than one year','Patients with body mass index (BMI) < 20 kg/m^2','Vegan vegetarians','Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue','Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months','Patients who have had surgery for weight loss\r\n* Note: women will not be excluded if their baseline lifestyle assessment indicates a healthy eating and moderate physical activity with the exception of the exclusion criteria above'
NCT00492778,https://www.clinicaltrials.gov/ct2/show/record/NCT00492778?term=NCT00492778&rank=1,'All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma','Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease','Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies','Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done','Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina\r\n* Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible','Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease','Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2','Patients must have an estimated survival greater or equal to 3 months','Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1','Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1','Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min','Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)','Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)','Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)','Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1','Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry','Patients who have met the pre-entry requirements','Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization','Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes','Patients who have received previous vaginal, pelvic, or abdominal irradiation','Patients who received chemotherapy directed at the present recurrence','Patients with septicemia or severe infection','Patients who have circumstances that will not permit completion of this study or the required follow-up','Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy','Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection','Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration','Patients with history of active collagen vascular disease','Patients with GOG performance grade of 3 or 4'
NCT00001337,https://www.clinicaltrials.gov/ct2/show/record/NCT00001337?term=NCT00001337&rank=1,'Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and primary mediastinal B cell lymphoma','Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI)','Any stage for mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL)','No prior systemic chemotherapy; patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome)','Human immunodeficiency virus (HIV) negative','Not pregnant or nursing','In adults: serum creatinine =< 1.5 mg/dl or creatinine clearance > 60 ml/min; and in children serum creatinine (Cr) =< age-adjusted normal\r\n* Age 12-15 years: 1.2 mg/dl\r\n* Age > 15 years: 1.5 mg/dl','Bilirubin < 1.5 mg/dl','Absolute neutrophil count (ANC) > 1000 unless impairment is due to lymphoma or immune-mediated mechanism caused by lymphoma','Platelets > 100,000 unless impairment is due to lymphoma or immune-mediated mechanism caused by lymphoma','No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year; if multi gated acquisition (MUGA) is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%','No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety','No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer','Ability to give informed consent'
NCT00576654,https://www.clinicaltrials.gov/ct2/show/record/NCT00576654?term=NCT00576654&rank=1,'Patients must have histologically or cytologically confirmed diagnosis of malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or for whom CPT-11 treatment would be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin’s and non-Hodgkin’s lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of treatment','Patients enrolled on the expansion portion of the study will consist of two cohorts: those patients who are triple-negative, BRCA-mutant positive and those patients who have triple-negative, non-BRCA mutated breast cancer','Patients enrolled on the dose escalation for intermittent ABT-888 portion of the study must histologically or cytologically confirmed diagnosis of malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or for whom CPT-11 treatment would be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin’s and non-Hodgkin’s lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of treatment','Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines','Patients must have tumors determined to be easily accessible for biopsy (e.g. pleural-based lesions, peripheral lymph nodes, soft tissue metastases, large liver metastases, etc)','Prior chemotherapy is allowed; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment','Prior radiation therapy is allowed; patients must not have received minimal radiation therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation of study treatment; otherwise, patients must not have received radiation therapy (> 5% of their total marrow volume) within 4 weeks prior to the initiation of study treatment; patients who have received prior radiation to 50% or more of their total marrow volume will be excluded','Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Absolute neutrophil count (ANC) >= 1,500/mcL','Platelets (PLT) >= 100,000/mcL','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN); if liver metastases are present, =< 5 x ULN','Bilirubin =< 1.5 x ULN','Creatinine =< 1.5 x ULN OR calculated or measured creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for three months following completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','All patients must provide archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies (NOT required for patients enrolled on the dose escalation for intermittent ABT-888 portion of the study)','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have been administered ABT-888 as part of a single or limited dosing study, such as a phase 0 study, should not necessarily be excluded from participating in this study solely because of receiving prior ABT-888','Patients may not have received any other investigational agents within 4 weeks of study entry','History of allergic reactions attributed to the following: \r\n* Camptothecin derivatives (e.g., topotecan [topotecan hydrochloride], irinotecan, or exatecan [exatecan mesylate]) \r\n* Any ingredients contained within the liquid irinotecan solution (e.g., sorbitol) or\r\n* Any antiemetics or antidiarrheals appropriate for administration with study therapy (e.g., loperamide or dexamethasone)','Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started 1 month prior to enrollment on this study; in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists','Patients with uncontrolled seizures','Patients with known active brain metastases should be excluded from this clinical trial; patients with prior treated brain metastases are allowed, providing that they were not accompanied by seizures and that a baseline brain magnetic resonance imaging (MRI) scan prior to study entry demonstrates no current evidence of brain metastases; all patients with central nervous system (CNS) metastases must be stable for > 3 months after treatment and off steroid treatment prior to study enrollment','Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)','Any patient requiring cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) isoform-inducing drugs (e.g. phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, ketoconazole, St. John’s wort) will be excluded; CYP3A4-inducing drugs should be discontinued at least 2 weeks prior to the first cycle of irinotecan','Uncontrolled intercurrent illness including, but not limited to: \r\n* Ongoing or active infection\r\n* Symptomatic congestive heart failure\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia or\r\n* Psychiatric illness or social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888','Patients who are unable to reliably tolerate and/or receive oral medications'
NCT01012817,https://www.clinicaltrials.gov/ct2/show/record/NCT01012817?term=NCT01012817&rank=1,'PHASE I: Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy definitely capable of extending life expectancy does not exist','PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer','Patients must have received < 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen)','Patients must have measurable disease with at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed topography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments','Absolute neutrophil count >= 1500/mcL','Hemoglobin >= 9.0 g/dL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x the upper limit of normal (ULN)','Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN in the absence of hepatic metastasis; SGPT (ALT) =< 3 x ULN or SGOT (AST) =< 5 x ULN in the presences of hepatic metastasis','Creatinine =< 1.5 x ULN','International normalized ratio (INR) =< 1.4 unless receiving therapeutic doses of coumadin','Partial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN)','Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2','Ability to provide informed consent','Willingness to return to enrolling institution for follow up','Life expectancy >= 12 weeks','Willingness to provide the biologic specimens is required by the protocol; this is part of the mandatory correlative research component; these specimens include:\r\n- PHASE I: peripheral blood for plasma pharmacokinetic analysis and peripheral blood mononuclear cell (PBMC) polymer assessment from 0-24 h after drug administration on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; urine for assessment of ABT-888 renal clearance for 24 h after administration of drugs on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; and a pretreatment peripheral blood sample for possible sequencing of the BRCA1, BRCA2 loci as well as possible pharmacogenomic analysis','Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential only','Able to swallow and absorb the medication','Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy','Prior treatment with a PARP inhibitor or topotecan','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Any of the following prior therapies:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< 6 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration\r\n* Radiation to > 25% of bone marrow \r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to registration; subjects with prostate cancer will be permitted to continue hormone therapy','Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment','New York Heart Association classification III or IV','Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for >= 6 months without requirement for corticosteroids and without seizure activity will be eligible','Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception','Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens','Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive','Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm','Other active malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer','History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias','More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy\r\n* Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen'
NCT00956007,https://www.clinicaltrials.gov/ct2/show/record/NCT00956007?term=NCT00956007&rank=1,'Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS], etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excluded','Clinical stage T1, N1-2 or T2-4a, N0-2, M0 including no distant metastases, based upon the following minimum diagnostic workup:\r\n* General history and physical examination by a radiation oncologist and/or medical oncologist within 8 weeks prior to registration\r\n* Examination by an ear, nose and throat (ENT) or head & neck surgeon, within 8 weeks prior to registration; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is recommended but not required\r\n* Chest x-ray (at a minimum) or chest computed tomography (CT) scan (with or without contrast) or CT/positron emission tomography (PET) of chest (with or without contrast) within 8 weeks prior to registration','Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following “intermediate” risk factors:\r\n* Perineural invasion\r\n* Lymphovascular invasion\r\n* Single lymph node > 3 cm or >= 2 lymph nodes (all < 6 cm) (no extracapsular extension)\r\n* Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins; similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient\r\n* Pathologically confirmed T3 or T4a primary tumor; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient\r\n* T2 oral cavity cancer with > 5 mm depth of invasion','Zubrod performance status 0-1','Absolute granulocyte count (AGC) >= 1,500/mm³','Platelet count >= 100,000/mm³','Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Total bilirubin < 2 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN','Serum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula','Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential','The following assessments are required within 2 weeks prior to the start of registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion','Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control','Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago; patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with primary tumor (T)1-2, nearby lymph nodes (N)0, metastasis (M)0 resected differentiated thyroid carcinoma, who are eligible','Per the operative and/or pathology report, positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery; note: patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient','Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration\r\n* Transmural myocardial infarction within 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients\r\n* Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):\r\n** Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels\r\n** Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)\r\n** Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels\r\n** Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n** Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to cetuximab'
NCT00887146,https://www.clinicaltrials.gov/ct2/show/record/NCT00887146?term=NCT00887146&rank=1,'PRE-REGISTRATION INCLUSION CRITERIA:','United States (US) and Canadian sites:\r\n* This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible','Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review\r\n* Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act [CLIA] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS)\r\n* Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS','REGISTRATION INCLUSION CRITERIA:','Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy','Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study\r\n* Note: mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q','Patients with codeleted low grade gliomas must also be considered “high risk” by exhibiting one or more of the following characteristics:\r\n* Age >= 40 and any surgical therapy\r\n* Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)\r\n* Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)\r\n* Intractable seizures','Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery','Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration','Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration','Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration','Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration','Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only','Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)','Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2','Written informed consent','Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose','Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only)\r\nWillingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient','The following categories are ineligible:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments','History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma are eligible for the study','Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens','Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study','Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy are not eligible; note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm','Other active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, the patient is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brain','History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias','Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis'
NCT00983697,https://www.clinicaltrials.gov/ct2/show/record/NCT00983697?term=NCT00983697&rank=1,'Participant with histologic confirmation of newly diagnosed squamous cell carcinoma (SCC) of the head and neck','Participant with unilateral or bilateral neck dissection planned for care; an N0 neck must be planned to be dissected for the patient to be eligible; the N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned','Participant with confirmed head and neck SCC:\r\n* CT and/or MR imaging has been completed within six (6) weeks prior to enrollment, even if the SCC diagnosis has been made via other methods, and will be submitted to American College of Radiology Imaging Network (ACRIN);\r\n* Simultaneous diagnostic CT with PET will not be excluded, but in such cases PET cannot be used as part of the criteria to define the N0 neck as required for entrance to the trial;\r\n* If sites received CT and/or MR images from institutions other than their own, ACRIN recommends a re-read by a local neuroradiologist to ensure compliance with protocol eligibility requirements','Participant with at least one neck that is clinically N0 as defined by clinical exam (physical exam with CT and/or MRI as the gold standard of the N0 neck); stages T2, T3, or T4. N0–N3, excluding N2c for bilateral disease based on criteria from the American Joint Commission on Cancer','Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);\r\n* These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer','Participant willing to provide a written informed consent','Patient who is pregnant and/or breastfeeding','Patient with sinonasal carcinoma','Patient with tumors in the head and neck that are not SCC','Patient with salivary gland malignancies','Patient with thyroid cancers','Patient with advanced skin cancers','Patient with nasopharyngeal carcinoma','Patient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications','Patient not a candidate for surgery (neck dissection) because of an underlying medical condition','Patient who weighs more than the weight limit for the PET table'
NCT00980954,https://www.clinicaltrials.gov/ct2/show/record/NCT00980954?term=NCT00980954&rank=1,'Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [CT] is recommended, but not required; a negative pre or post-operative PET scan or PET-CT scan of the para–aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection)','Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:\r\n* Positive pelvic nodes\r\n* Positive parametrium\r\n* Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)','No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):\r\n* History/physical examination within 56 days prior to study entry\r\n* Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred) \r\n* Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)','Zubrod performance status 0-1','Absolute neutrophil count (ANC) >= 1,800 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)','White blood cell count >= 4000 cells/mm^3','Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry','Bilirubin =< 1.5 times normal 14 days prior to study entry','Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry','Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry','Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)','Patient must provide study-specific informed consent prior to study entry','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Patients can not have any neuroendocrine histology in pathology','Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable','Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry \r\n* Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol','Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin','Patients who have gross residual disease or distant metastatic disease'
NCT00981656,https://www.clinicaltrials.gov/ct2/show/record/NCT00981656?term=NCT00981656&rank=1,'Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration\r\n* Operable patients whose initial tumor is a primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis; patients who have involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate remain eligible; if the patient’s initial tumor was a high grade stage Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible','Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment (transurethral resection bladder tumor [TURBT] and intravesical bacillus Calmette-Guerin [BCG] immunotherapy) or on initial presentation with a T1 high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in severe, active co-morbidity or because the patient refuses BCG therapy','The participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy','If radiologic evaluation of a lymph node is interpreted as “positive”, this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy; patients with histologically or cytologically confirmed node metastases will not be eligible','Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion','Patient must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy (if necessary) by the joint agreement of the participating urologist, radiation oncologist, and medical oncologist','Appropriate stage for protocol entry, based upon the following minimum diagnostic workup within 60 days prior to registration:\r\n* History/physical examination including weight, performance data, body surface area','Zubrod performance status =< 1','White blood cell count (WBC) >= 4,000/ml','Absolute neutrophil count (ANC) >= 1,800 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 10.0 g/dL (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)','If the patient is to be treated with cisplatin, the serum creatinine should be =< 1.5 mg%','If the patient is to be treated with cisplatin, the serum bilirubin of =< 2.0 mg%','Glomerular filtration rate (GFR) > 25 ml/min (for patients receiving cisplatin, GFR >= 60 ml/min)','Serum pregnancy test for female patients of childbearing potential, =< 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception','Patient must be able to provide study-specific informed consent prior to study entry','Evidence of tumor-related hydronephrosis','Evidence of distant metastases or histologically or cytologically proven lymph node metastases','Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable','A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >= 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT1 that has not been free of disease after treatment for more than a 2 year period','Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT','Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to the study drugs (cisplatin, mitomycin, fluorouracil [5FU]) involved in this protocol'
NCT00980460,https://www.clinicaltrials.gov/ct2/show/record/NCT00980460?term=NCT00980460&rank=1,'Patients must be newly diagnosed with histologically-proven hepatoblastoma','In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP0731 without a biopsy\r\n* Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:\r\n** Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)\r\n** Uncorrectable coagulopathy\r\n* For a patient to maintain eligibility for AHEP0731 when emergent treatment is given, the following must occur:\r\n** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP0731 eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment\r\n** If the patient receives AHEP0731 chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims','Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines','At the time of study enrollment, the patient’s treatment regimen must be identified; if the patient’s primary tumor was resected prior to the day of enrollment and a blood specimen for the determination of serum alpha fetoprotein was not obtained prior to that surgery, the patient will be considered to have alpha fetoprotein of greater than 100 ng/mL for the purpose of treatment assignment; if tumor samples obtained prior to the date of enrollment were not sufficient to determine whether small cell undifferentiated (SCU) histology was present, treatment assignment will be made assuming SCU is not present in the tumor','For patients with stage I or II disease, specimens for rapid central review have been submitted and the rapid central review diagnosis and staging must be available to be provided on the AHEP0731 eligibility case report form (CRF)','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment','Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:\r\n* 1 month to < 6 months: 0.4 mg/dL\r\n* 6 months to < 1 year: 0.5 mg/dL\r\n* 1 to < 2 years: 0.6 mg/dL\r\n* 2 to < 6 years: 0.8 mg/dL\r\n* 6 to < 10 years: 1 mg/dL\r\n* 10 to < 13 years: 1.2 mg/dL\r\n* 13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male) or 1.4 mg/dL (female)','Total bilirubin < 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN for age','Absolute neutrophil count (ANC) > 750/uL','Platelet count > 75,000/uL','Shortening fraction >= 27% by echocardiogram','Ejection fraction >= 47% by radionuclide angiogram (multi gated acquisition scan [MUGA]); Note: the echocardiogram (or MUGA) may be done within 28 days prior to enrollment','Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)','Serum cholesterol level =< 300 mg/dL (7.75 mmol/L)','Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for age','Normal pulmonary function tests (including diffusing capacity of the lungs for carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen); Note: for patients who do not have respiratory symptoms or requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required','Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled','Prothrombin time (PT) < 1.2 x ULN','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met','Patients with stage I or II disease who do not have specimens submitted for rapid central pathology review by day 14 after initial surgical resection','Patients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (eg, radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser]) are not eligible','Patients who have received any prior chemotherapy are not eligible','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anticancer agents are not eligible','Patients who have previously received a solid organ transplant are not eligible','Patients who have an uncontrolled infection are not eligible','Females who are pregnant or breast feeding are not eligible for this study','Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained','Males and females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method','Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy','Patients who are currently receiving enzyme inducing anticonvulsants are not eligible','Patients must not be receiving any of the following potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, azithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, grapefruit juice or St. John’s wort','Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) are not eligible','Patients who are currently receiving angiotensin-converting enzymes (ACE) inhibitors are not eligible','Patients must not have had major surgery within 6 weeks prior to enrollment on the high risk stratum; patients with history of recent minor surgical procedures (vascular catheter placement, bone marrow evaluation, laparoscopic surgery, liver tumor biopsy) will be eligible'
NCT01013649,https://www.clinicaltrials.gov/ct2/show/record/NCT01013649?term=NCT01013649&rank=1,'Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible\r\n* The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)','For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days','Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible','Zubrod performance status 0 or 1','Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)','Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting','Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelets >= 100,000/mm^3','Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)','Post resection serum cancer antigen (CA)19-9 =< 180 units/mL AND prior to any systemic treatment','Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)','Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)','Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)','Negative serum pregnancy test for women of childbearing potential within 14 days of study registration','Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study (or within 31 days prior to day 1 of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead','Signed study-specific informed consent','Consultation, agreement, and documentation in the patient’s chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol','Women of childbearing potential and male participants must practice adequate contraception','Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed','Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely IPMN with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN’s that contain some secondary (minor) foci of adenocarcinoma are also not eligible','Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy','Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligible','Severe, active co-morbidity, defined as follows per time points indicated below (or per time points indicated below prior to the first day of chemotherapy for patients having started chemotherapy prior to first step registration): \r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the 3 months of study registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration','Pregnant or lactating women','Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible'
NCT02085408,https://www.clinicaltrials.gov/ct2/show/record/NCT02085408?term=NCT02085408&rank=1,'Pre-registration: Diagnostic bone marrow and peripheral blood specimens must be submitted for eligibility testing by multiparameter flow cytometry; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) Leukemia Translational Studies Laboratory and reported to the institution','Sexually active males must be strongly advised to use an accepted and effective method of contraception','Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< grade 1','Total bilirubin =< grade 1\r\n* Note: If total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible','Patient must not have a concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes [MDS])','Patient must not have an active, uncontrolled infection','ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:','Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally','ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if >= 70 years of age)','Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts will be excluded','Patients must not have blastic transformation of chronic myelogenous leukemia','Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML\r\n* NOTE: Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine is excluded','Patients may not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis; patients who have received a limited and short-term exposure of ATRA (all trans retinoid acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible','Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible','Patients with a serum creatinine > 1 are eligible if they have a calculated glomerular filtration rate (GFR) of >= 60 ml/min (i.e. class I or class II chronic kidney disease ) using the Modification of Diet in Renal Disease (MDRD) formula\r\n* Note: Daily creatinine and MDRD formula are only for the 1st induction cycle','Cardiac ejection fraction >= 45% or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a two-dimensional (2-D) echocardiogram (ECHO) scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to receiving treatment\r\n* NOTE: when a multi gated acquisition scan (MUGA) or echocardiogram cannot be obtained due to weekend or holiday, then patients may be enrolled provided there is no history of significant cardiovascular disease and a measurement of cardiac ejection fraction will be performed within 5 days of study enrollment','Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture; those with documented CNS involvement will be excluded','Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (> 10^9/l) from peripheral blood','Patients who have received previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine will be excluded','Patients with known human immunodeficiency virus (HIV) infection are excluded','HLA typing should be performed at registration, if possible','Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing','CONSOLIDATION CRITERIA:','NOTE: All patients achieving CR or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit','NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment','Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi','Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant)','Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi','Patients must have an ECOG performance status of 0-2','Patients must have resolved any serious infectious complications related to induction\r\n* NOTE: Patients with an HLA-matched donor and proceeding to transplant will be allowed up to one cycle of consolidation treatment','Any significant medical complications related to induction must have resolved','Patients must have a creatinine and AST =< grade 1','MAINTENANCE CRITERIA:','Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy','Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis','Patients must have an ECOG performance status of 0 -2','Patients must have resolved any serious infectious complications related to consolidation cycle 2','Any significant medical complications related to consolidation cycle 2 must have resolved','Total serum bilirubin =< 1.5 x ULN\r\n* NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible','Serum creatinine =< grade 1','The absolute neutrophil count (ANC) must be > 1000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover','The platelet count must be > 75,000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover','ALLOGENEIC TRANSPLANTATION:','Patients must be > 28 days from the start of induction or re-induction chemotherapy, or from the start of consolidation cycle 1 (if received) and < 90 days following recovery from most recent treatment; and they must have achieved and maintained a response to induction therapy (CR, CRi, or “morphologic disease-free state”)','Patients must have recovered from the effects of induction, re-induction, or consolidation chemotherapy (all toxicities =< grade I with the exception of reversible electrolyte abnormalities), and have no ongoing active infection requiring treatment','Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1','An eligible HLA-identical donor (either related or unrelated) should be available; in sibling donors, low resolution HLA typing (A,B,DR) will be considered sufficient; in the case of unrelated donors, high-resolution class I and II typing (A, B, C, DRB1 and DQ) should be matched at all 10 loci; donors must be willing and able to undergo peripheral blood progenitor mobilization \r\n* HLA-identical sibling (6/6): the donor must be determined to be an HLA-identical sibling (6/6) by serologic typing for class (A, B) and low resolution molecular typing for class II (DRB1)\r\n* Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and –DQB1\r\n* NOTE: for matched donors – will allow select 1 antigen mismatched sibling donors and unrelated donors in accordance with site institutional standard, as long as matched at HLA-A, HLA-B, HLA-C, and DRB1, and with advanced discussion/approval by the Study Chair and the bone marrow transplant (BMT) co-chair','Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance','Patients must have a cardiac ejection fraction of >= 40%, or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a 2-D ECHO scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to allogeneic transplantation','Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease','No known hypersensitivity to Escherichia (E.) coli-derived products','No human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies','Creatinine =< grade 1','Bilirubin =< grade 1\r\n* If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligible','AST =< grade 1'
NCT01042522,https://www.clinicaltrials.gov/ct2/show/record/NCT01042522?term=NCT01042522&rank=1,'Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]','Patients must have newly diagnosed, stage IIA – IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy','Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2','Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control','Patients in the measureable disease cohort must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy','Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1','Platelet greater than or equal to 100,000/mcl','Creatinine no greater than the institutional upper limits of normal','Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)','Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)','Neuropathy (sensory and motor) less than or equal to CTCAE grade 1','No signs of clinically significant hearing loss','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted','Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization','Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted','Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)','Patients with apparent stage I disease who have not undergone a staging procedure','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years','Woman who are pregnant or breastfeeding','Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard'
NCT01096368,https://www.clinicaltrials.gov/ct2/show/record/NCT01096368?term=NCT01096368&rank=1,'Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above','There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met','Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease','Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible','No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment','Pregnant female patients are not eligible for this study','Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained','Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method','Lactating females may not participate unless they have agreed not to breastfeed a child while on this study'
NCT01118026,https://www.clinicaltrials.gov/ct2/show/record/NCT01118026?term=NCT01118026&rank=1,'Histologically documented Hodgkin lymphoma subclassified according to the World Health Organization (WHO) modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system; patients must have clinical stage IA, IB, IIA or IIB; patients with “E” extensions will be eligible if all other criteria have been met; nodular lymphocyte predominant Hodgkin lymphoma is excluded','Patients must have a mediastinal mass > 0.33 maximum intrathoracic diameter on standing posterior-anterior chest x-ray or mass measuring > 10 cm in its largest diameter','No “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse','Patients may have had one cycle only of ABVD prior to enrolling on study; no other prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma is allowed; if patient has had one cycle of ABVD, in order to be eligible to enroll on Cancer and Leukemia Group B (CALGB) 50801, the patient must have had all of the following tests prior to starting the first cycle of ABVD:\r\n* Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multi gated acquisition (MUGA)\r\n* Pulmonary function tests (PFTs) (including diffusing capacity of the lung for carbon monoxide [DLCO]/forced vital capacity [FVC])\r\n* CT scan (neck**, chest, abdomen, pelvis)\r\n* FDG-PET/CT scan\r\n* Chest X-ray, posterior-anterior (PA) & lateral\r\n* Complete blood count (CBC), differential, platelets\r\n* Erythrocyte sedimentation rate (ESR)\r\n* Serum creatinine\r\n* Glucose\r\n* Aspartate aminotransferase (AST)\r\n* Alkaline phosphatase\r\n* Bilirubin\r\n* Lactate dehydrogenase (LDH)\r\n** Patients with a negative FDG-PET/CT scan do not need to have had a dedicated neck CT scan prior to starting the previous cycle of ABVD','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','LVEF by ECHO or MUGA within institutional normal limits unless thought to be disease related; DLCO >= 60% with no symptomatic pulmonary disease unless thought to be disease related','Patients with known human immunodeficiency virus (HIV) must have a CD4 count > 350 and be on concurrent antiretrovirals; patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; an HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk','Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control','Absolute neutrophil count (ANC) >= 1000/uL','Platelet count >= 100,000/uL','Serum creatinine =< 2 mg/dL','Bilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert’s disease','AST =< 2 x upper limit of normal'
NCT01101451,https://www.clinicaltrials.gov/ct2/show/record/NCT01101451?term=NCT01101451&rank=1,'Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy','Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):            \r\n* Positive capillary-lymphovascular space involvement and one of the following:                \r\n** Deep third penetration\r\n** Middle third penetration, clinical tumor >= 2 cm\r\n** Superficial third penetration, clinical tumor >= 5 cm\r\n* Negative capillary-lymphatic space involvement                \r\n** Middle or deep third penetration, clinical tumor >= 4 cm','Absolute neutrophil count (ANC) >= 1,500/mcl','Platelets >= 100,000/mcl','Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min','Bilirubin =< 1.5 x normal','Alkaline phosphate =< 3 x normal','Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal','Gynecologic Oncology Group (GOG) performance status 0, 1, 2','Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery','Patients who have met the pre-entry requirements','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins','Patients with septicemia or severe infection','Patients with intestinal obstruction or gastrointestinal bleeding','Patients with postoperative fistula','Patients with cervix cancer who have received any previous radiation or chemotherapy','Patients whose circumstances do not permit completion of the study or the required follow-up','Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)','Patients with GOG performance status of 3 or 4','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy'
NCT01141231,https://www.clinicaltrials.gov/ct2/show/record/NCT01141231?term=NCT01141231&rank=1,'Able to give informed consent','Must be able to read, write and understand English','Must have a diagnosis of head/neck cancer','Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:\r\n* Grade 0 – None\r\n* Grade 1 – Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)\r\n* Grade 2 – Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)\r\n* Grade 3 – Complete dryness of mouth (no response on stimulation and difficult oral alimentation; intravenous (IV) fluids, pureed diet or tube feedings may be required)\r\n* Grade 4 – Fibrosis','Must have received external beam radiation with curative intent','Must have completed radiotherapy at least 12 months prior to entry','Must have anatomically intact parotid glands and at least one submandibular gland; a focused (head/neck) history and exam conducted by a physician or dentist within the past year is required','Have never had acupuncture for xerostomia','Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2','History of xerostomia, Sjogren’s disease or other illness known to affect salivation prior to head/neck radiation','Suspected or known closure of salivary gland ducts on either side','Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment','Have received any investigational new drug within the past 30 days or planning to receive such during the study period','Active systemic infection or skin infection at or near the acupuncture sites','Receiving chemotherapy during study period'
NCT01366144,https://www.clinicaltrials.gov/ct2/show/record/NCT01366144?term=NCT01366144&rank=1,'Patients must have histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel (i.e., lung, ovarian, breast, melanoma, head and neck, endometrial, urothelial, testicular, esophageal, carcinoma of unknown primary); for indications not listed, eligibility based on disease must be verified by the principal investigator before they are considered','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 8.0 g/dL','Patients with all degrees of renal dysfunction are allowed including patients on hemodialysis; patients with mild to severe hepatic dysfunction are allowed as defined below:','Total bilirubin =< 5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 10 x ULN','For patients with a recently placed biliary stent, patients should have consistent results within a hepatic group from two laboratory readings within 3 days apart, taken at least 10 days following biliary stent placement; for patients with a biliary stent placed over 2 months ago, no obstruction or blockage can have occurred within the last 2 months','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those whose adverse event due to agents administered more than 4 weeks earlier have not resolved or stabilized; patients who have been administered ABT-888 as part of a single or combination, phase 0 or I study, should not necessarily be excluded from participating in this study solely because of receiving prior ABT-888','Patients may not be receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study','Peripheral neuropathy of severity greater than grade 1','Inability to take oral medications on a continuous basis','Evidence of bleeding diathesis','Patients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for at least 3 months and must be off steroid treatment prior to study enrollment','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks may also apply to other agents used in this study','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; however, HIV-positive patients without an acquired immune deficiency syndrome (AIDS)-defining diagnosis who are not receiving agents with the potential for pharmacokinetic (PK) interactions with ABT-888 may be eligible','Patients with both hepatic and renal dysfunction will also be excluded','Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible','Active seizure or history of seizure disorder'
NCT01051635,https://www.clinicaltrials.gov/ct2/show/record/NCT01051635?term=NCT01051635&rank=1,'Patients must have histologically documented (confirmed at the Laboratory of Pathology, National Cancer Institute [NCI]), relapsed solid tumor malignancy or Hodgkin's disease/non-Hodgkin lymphoma that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit','Patients must have measurable or evaluable disease','Patients must have recovered to at least eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01), or therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitors prior to entering the study; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI) discretion, and should have recovered to eligibility levels from any toxicities','Patients must have recovered to at least a grade =< 1 toxicity eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01), or therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitors prior to entering the study; patients must be >= 2 weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase 0 study; patients must be >= 1 month since completion of any prior radiation (>= 2 weeks for palliative radiation therapy); however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy\r\n* Prior therapy with topoisomerase I inhibitors is allowed','The Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60 %)','Life expectancy > 3 months','Absolute neutrophil count (ANC) >= 1,500/uL','Platelet count >= 100,000/uL','Total bilirubin within =< 1.5 normal institutional limits (patients with Gilbert’s syndrome with total bilirubin up to 2.5 mg/dL is allowed)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)','Creatinine < 1.5 x ULN OR creatinine clearance measured >= 60 mL/minute for patients with creatinine levels >= 1.5 x upper limit of normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after discontinuation from the study; women of child bearing potential must have a negative pregnancy test in order to be eligible; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Breastfeeding should be discontinued if the mother is treated with indenoisoquinolines','At the point when tumor biopsies become mandatory (expansion phase only), disease amenable to biopsy and willingness to undergo biopsies or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements outlined','Ability to understand and the willingness to sign a written informed consent document','Patients receiving any other investigational agents','Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 2 months after treatment of the brain metastases, without steroids or anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator','Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, known human immunodeficiency virus (HIV) infection requiring antiretroviral therapy, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'
NCT01222754,https://www.clinicaltrials.gov/ct2/show/record/NCT01222754?term=NCT01222754&rank=1,'Histological confirmation of a high-grade malignant glioma is required; histologic diagnoses include, but are not limited to, anaplastic astrocytoma and glioblastoma multiforme; patients with DIPG are exempt from histologic verification if they have typical MRI findings of DIPG (i.e. hypo- or isointense on T1-weighted imaging, hyperintense on fluid-attenuated inversion recovery [FLAIR] or T2-weighted imaging, epicenter in the pons, > 50% of pons involved) in the face of a typical clinical presentation','Inoperable tumor or residual disease after resection','No prior chemotherapy or radiation therapy for HGG or DIPG is permitted; prior chemotherapy or radiation therapy for treatment of other malignancies is permitted','Able to swallow whole capsules','Patients should have a Karnofsky/Lansky score of greater than or equal to 60; patients who require special assistance due to tumor-related paralysis, but who are out of bed during the day will be considered ambulatory for the purpose of calculating the performance score; patients must be able to communicate any symptoms','Absolute neutrophil count >= 1,000/mcL','Platelets >= 100,000/mcL','Total bilirubin < 1.5 x upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine below age-adjusted maximum limits in the table below OR creatinine clearance >= 60 mL/min/1.73 m^2\r\n* 0.8 mg/dl (patients =< 5 years of age)\r\n* 1.0 mg/dl (patients 5 < age =< 10 years of age)\r\n* 1.2 mg/dl (patients 10 < age =< 15 years of age)\r\n* 1.5 mg/dl (patients > 15 years of age)','Females only:\r\n* Urine or serum pregnancy test negative','No overt renal, hepatic, cardiac or pulmonary disease','Newly diagnosed patients may need to be on steroids due to surgery or control of neurologic symptoms; patients on steroids postoperatively or for control of tumor-related edema are eligible, but attempts to keep patients on the lowest dose necessary to control symptoms should be made','This protocol defines a female of childbearing potential (FCCBP) as a sexually mature female (at least Tanner 2) who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\r\n* Criteria for female children of childbearing potential (FCCBP)\r\n** This protocol defines FCCBP as females who have:\r\n*** Achieved menarche and/or breast development in Tanner stage 2 or greater\r\n*** Has not undergone a hysterectomy or bilateral oophorectomy; \r\n*** Note: amenorrhea following cancer therapy does not rule out childbearing potential\r\n* Criteria for female children not of childbearing potential (FCBCBP)\r\n** This protocol defines FCNCBP as females:\r\n*** Who have not yet experienced menarche or breast development in Tanner stage 2\r\n*** Who have undergone a hysterectomy or bilateral oophorectomy\r\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days and again within 24 hours prior to starting course 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature female (Tanner stage 2) who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure\r\n* Male subjects\r\n** Appropriate male subjects (i.e. those who have reached puberty and are sexually active) will be counseled regarding birth control methods; they must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy\r\n** Appropriate male patients will be given a reproductive risks handout and counseled by a provider; for sexually active patients, the counseling session, consent and counseling checklist will be documented monthly','All patients or their legal guardians (if the patient is < 18 years old) or durable power of attorney (DPA) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study; when appropriate, pediatric patients will be included in all discussions in order to obtain verbal assent','Assignment of DPA to a family member or guardian should be offered to all patients 18 years of age or older','Signed informed consent according to institutional guidelines must be obtained','Patients who have had prior chemotherapy for this tumor','Patients with an HGG that was completely resected with good margins','Patients with a body surface area (BSA) =< 0.4 m^2 are excluded','Patients with a known coagulation disorder are excluded; patients with a first-degree relative with a history of venous thrombosis before age 50 years (yrs) or an arterial thrombosis before age 40 yrs must have the following testing performed prior to enrollment to exclude a heritable disorder; patients with a suspected disorder will be excluded','Patients who have had a thromboembolic event that is not line-related are excluded','Patients with any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy, would compromise a patient's ability to tolerate this therapy or result in inability to assess toxicity; this includes, but is not limited to uncontrolled intercurrent illness including ongoing or active infection, cardiac disease, renal impairment or psychiatric illness/social situations that would limit compliance with study requirements','Patients with a history of toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome are excluded','Patients receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (i.e. thalidomide)','Patients with known hypersensitivity to anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide','Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Patients identified as needing spinal radiation at diagnosis (e.g. spinal metastasis or malignant cells identified on cerebrospinal fluid [CSF] cytology) are excluded'
NCT01386385,https://www.clinicaltrials.gov/ct2/show/record/NCT01386385?term=NCT01386385&rank=1,'Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed)\r\n* Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded','Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form','Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration','Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer','Patients must not have received prior chest radiation therapy for NSCLC','Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study','Patients must have Zubrod performance status 0-1','Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens','Absolute neutrophil count >= 1,500/mcl','Platelets >= 100,000/mcl','Hemoglobin >= 9.0 g/dl','Total bilirubin within institutional upper limit of normal (IULN)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula','Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 1.2 liters/second and/or >= 50% predicted','Patients may not be planning to receive any other investigational agents','Patients must not have more than 10% weight loss in the past 6 months','Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888, carboplatin, paclitaxel or other agents used in study','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients must not currently have a > grade 1 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)','Patients must not have a history of seizures','Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study','Patients must be able to swallow whole capsules','Prestudy history and physical must be obtained within 28 days prior to registration','All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution’s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY:','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation)','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =< (IULN) AND measured of calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count >= 1,500 mcl','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets >= 100,000/mcl','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin >= 9.0 g/dl','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN','REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1'
NCT01381718,https://www.clinicaltrials.gov/ct2/show/record/NCT01381718?term=NCT01381718&rank=1,'Diagnosis of a primary brain tumor treated with at least one of the following:\r\n* Neurosurgical resection of the brain tumor\r\n* Cranial irradiation\r\n* Any chemotherapy to treat the brain tumor','Off-treatment and progression-free for at least 12 months and =< 14 years; treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation, or date of surgery, whichever occurred last','Parent/legal guardian and child > 7 years old able to read English or Spanish','Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations','Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits','Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug\r\n* Childbearing potential is defined as girls who are > Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy\r\n* Urine pregnancy tests are acceptable','Able and willing to sign informed consent/assent','Signed Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization','Off treatment > 14 years','Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < 70)','Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease','Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia, or prolonged corrected QT interval (QTc)','History of stroke or head injury associated with loss of consciousness within 12 months of registration','History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or monoamine oxidase inhibitor (MAO) inhibitors within 30 days of registration','Concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4), hepatic enzyme inducing antiepileptic drugs (EIAEDs), or other drugs known to affect the metabolism of modafinil; examples include, but are not limited to, itraconazole, ketoconazole, doxycycline, rifampin, St. John's wort, phenytoin, phenobarbital, diazepam, and tricyclic antidepressants\r\n* If patients were previously taking EIAEDs, they must be off for > 2 weeks prior to study enrollment','Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of attention-deficit hyperactivity disorder (ADHD) does NOT exclude a child from participation','Participants with known hypersensitivity to modafinil, armodafinil, or any of its components'
NCT01190930,https://www.clinicaltrials.gov/ct2/show/record/NCT01190930?term=NCT01190930&rank=1,'B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932\r\n* Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932','B-ALL patients must have an initial white blood cell count < 50,000/uL','Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible\r\n* Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met','With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932\r\n* Patients receiving prior steroid therapy may be eligible for AALL0932','Patients with central nervous system 3 (CNS3) leukemia\r\n* CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy','B-ALL patients with testicular leukemia are not eligible for AALL0932','For B-LLy patients the following additional exclusion criteria apply:\r\n* T-lymphoblastic lymphoma\r\n* Morphologically unclassifiable lymphoma\r\n* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma\r\n* CNS3-positive disease or testicular involvement\r\n* M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow\r\n* Female patients who are pregnant are ineligible\r\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants\r\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained\r\n* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation'
NCT01231906,https://www.clinicaltrials.gov/ct2/show/record/NCT01231906?term=NCT01231906&rank=1,'Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:\r\n* For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease\r\n* Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic\r\n* Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic\r\n* Tumors arising in the bony skull (extra-dural) are considered to be extracranial','Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist','No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine based on age/gender as follows:\r\n* 1 month to < 6 months: 0.4 mg/dL\r\n* 6 months to < 1 year: 0.5 mg/dL\r\n* 1 to < 2 years: 0.6 mg/dL\r\n* 2 to < 6 years: 0.8 mg/dL\r\n* 6 to < 10 years: 1 mg/dL\r\n* 10 to < 13 years: 1.2 mg/dL\r\n* 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)','Total bilirubin < 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age','Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram','Patients must have no evidence of metastatic disease; metastatic disease:\r\n* Are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken\r\n* Skeletal lesions in adjacent bones (trans-articular)\r\n* Contralateral pleural effusion and contralateral pleural nodules\r\n* Distant lymph node involvement\r\n* Patients with pulmonary nodules are considered to have metastatic disease if the patient has:\r\n** Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing's\r\n** Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not required but if performed and positive indicate metastatic disease','Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible','Patients with pathologic diagnoses other than Ewing sarcoma will be excluded','Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy','Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT01272037,https://www.clinicaltrials.gov/ct2/show/record/NCT01272037?term=NCT01272037&rank=1,'Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/CEP ration < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligible','Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant; (NOTE: the Oncotype DX testing must be completed on the largest lesion)\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)\r\n* Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)','Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND); patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node are not required to undergo full axillary lymph node dissection; this is at the discretion of the treating physician; axillary node evaluation is to be performed per the standard of care at each institution','Patients must not have inflammatory breast cancer and must not have metastatic disease','Patients with a prior diagnosis of contralateral ductal carcinoma in situ (DCIS) are eligible if they underwent a mastectomy or lumpectomy with whole breast radiation; prior partial breast irradiation, including brachytherapy, is not allowed; patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received radiation to that breast are not eligible','Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation); patients must have clear margins from both invasive breast cancer and DCIS (as per local institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowed','Registration of patients who have not yet undergone Oncotype DX screening must occur no later than 56 days after definitive surgery; (for all patients, Step 2 Registration must occur within 84 days after definitive surgery); if the Oncotype DX Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value; a representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX Breast Cancer Assay which will be performed according to the standard commercial process\r\n* If the Oncotype DX Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration; if the Oncotype DX Recurrence Score is already known and is greater than 25, the patient is ineligible','Patients must have a complete history and physical examination within 28 days prior to registration','Patients must have a performance status of 0-2 by Zubrod criteria','Patients must be able to receive taxane and/or anthracycline based chemotherapy','Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration','Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents','Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration','Patients must not be pregnant or nursing; women of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years','The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy; (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment between 14 days prior to and 7 days after Step 1 Registration\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form)','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','STEP 2 REGISTRATION','Recurrence score (RS) by Oncotype DX must be =< 25','Step 2 Registration must take place within 84 days after definitive surgery; patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization','Patients randomized to either arm may also co-enroll in phase III trials that compare local therapies, or compare systemic therapies (such as chemotherapy, if randomized to Arm I of S1007)','The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients at U.S. INSTITUTIONS who consent to participate in the Quality of Life and Economic Substudy must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form after Recurrence Score results and randomized treatment status are known but before treatment has been initiated','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients the appropriate consent form for this registration is the Step 2 Consent'
NCT01275664,https://www.clinicaltrials.gov/ct2/show/record/NCT01275664?term=NCT01275664&rank=1,'Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma\r\n* Stage II, III, or IV disease with optimal (=< 1 cm residual disease) or suboptimal residual disease\r\n* All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, with appropriate tissue for histologic evaluation\r\n* The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual','Patients with the following histologic epithelial cell types are eligible:\r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.) \r\n* However, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist prior to entry \r\n* Patients may have co-existing endometrial cancer so long as the primary origin of invasive tumor is  ovarian or peritoneal for clarification of synchronous primary endometrial cancer','Patients receiving the initial course of chemotherapy including \r\n* Paclitaxel 135 mg/M2 IV over 3 hours on day 1 and \r\n* Cisplatin 75 mg/M2 IP on day 2  OR  \r\n* Paclitaxel 80 mg/m2 IV days 1, 8 and 15 and \r\n* Carboplatin AUC 6 IP on day 1','Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)','Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable)','Patients with a GOG Performance Status of 0, 1, or 2','Patients who are able to read, understand and write English; if FLIE which has been translated into other languages, and validated, becomes available, then patients speaking these languages can be enrolled if translation of the symptom diary can be arranged dependent on availability of suitable translators','Patients who are able to complete the assessments','Patients who are able to comply with the anti-emetic therapy','Patients must have met pre-entry requirements','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients who are known to be hypersensitive to aprepitant, granisetron or any of the components of the patch or to dexamethasone','Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease','Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease','Patients who are pregnant or nursing; to date, no fetal studies in animals or humans have been performed; the possibility of harm to a fetus is likely','Patients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligible','Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard','Patients who, in the opinion of the treating physician, have a medical condition, or currently take medications, which are felt to contraindicate safe or effective administration of the standard three drug anti-emetic regimen used in this study'
NCT01359592,https://www.clinicaltrials.gov/ct2/show/record/NCT01359592?term=NCT01359592&rank=1,'Patients must have biopsy-proven de-novo diffuse large B-cell lymphoma (DLBCL) \r\n* Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible\r\n* Patients with prior or simultaneous diagnosis of indolent lymphoma are not eligible\r\n* Post-transplant lymphoproliferative disorder with DLBCL morphology is ineligible','Patients must have non-bulky stage I or II disease by Ann Arbor classification\r\n* This staging excludes fludeoxyglucose F 18 (FDG)-PET evaluation\r\n* Patients who have stage I or II non-bulky disease based on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible\r\n* Stage and bulk are assigned using measurements obtained prior to biopsy','Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration\r\n* Low-resolution \"localization\" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol\r\n* If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable','Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma            \r\n* Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration','Patients must have either measurable or evaluable limited-stage DLBCL          \r\n* Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible; NOTE: if patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form\r\n* All measurable disease must be assessed within 28 days prior to registration\r\n* Patients with non-measurable disease with or without measurable disease must have all non-measurable disease assessed within 42 days prior to registration','Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration','Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group','Patients must be offered the opportunity to consent to the use of specimens for future research','The lymphoma must express the cluster of differentiation (CD)20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections; a report providing confirmation of CD20 expression must be submitted','Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma','Patients must have a complete history and physical examination within 28 days prior to registration','Zubrod performance status 0-2','The following tests must be performed within 42 days prior to registration either for diagnosis/staging or to obtain baseline values:\r\n* White blood cells (WBC)\r\n* Hemoglobin\r\n* Lactate dehydrogenase (LDH)\r\n* Hepatitis B-surface antigen (Ag) and anti-core antibody (Ab)','Serum creatinine =< 2 x institutional upper limit of normal (IULN), unless due to lymphoma, within 42 day prior to registration','Patients must have aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x IULN, unless due to lymphoma, within 42 days prior to registration','Platelet count >= 100,000 cells/mcL','Absolute neutrophil count (ANC) >= 1,000 cells/mcL within 42 days prior to registration','Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration','Patients must have a cardiac ejection fraction >= institutional lower limit of normal (ILLN) by multi gated acquisition (MUGA) scan or 2-dimensional (D) echocardiogram (ECHO) within 42 days prior to registration','Patients must not be known to be human immunodeficiency virus (HIV)-positive','No other prior malignancy is allowed except for the following:            \r\n* Adequately treated in situ cancers (stage 0)\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Adequately treated stage I or II cancer from which the patient has been in complete remission or\r\n* Any other cancer from which the patient has been disease-free for at least 5 years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period; a woman is considered to be \"of reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','SECOND REGISTRATION (STEP 2)','Patients must have completed 3 cycles of R-CHOP with no evidence of disease progression','Interim PET/CT scans must have been submitted for centralized review','If PET-negative based on the returned results from centralized review, patients must be planning to begin further treatment within 35 days of the start of cycle 3 of R-CHOP; if PET-positive based on the returned results from centralized review, it is important for patients to start IFRT as soon as possible after the end of cycle 3 of R-CHOP; they should be planning to initiate IFRT followed by yttrium-90 ibritumomab tiuxetan within 35 days of the start of cycle 3 of R-CHOP'
NCT01368588,https://www.clinicaltrials.gov/ct2/show/record/NCT01368588?term=NCT01368588&rank=1,'Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:             \r\n* Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)\r\n* Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml\r\n* Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL\r\n* Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure','History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration','Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within 90 days prior to registration            \r\n* Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.5 cm','No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute)\r\n* Equivocal bone scan findings are allowed if plain films (or CT or magnetic resonance imaging [MRI]) are negative for metastasis','Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration','Study entry PSA should not be obtained during the following time frames:             \r\n* 10-day period following prostate biopsy\r\n* Following initiation of hormonal therapy\r\n* Within 30 days after discontinuation of finasteride\r\n* Within 90 days after discontinuation of dutasteride','Zubrod performance status 0-1 (unless otherwise specified)','Within 60 days prior to registration on study: Absolute neutrophil count (ANC) >= 1,500/mm^3','Within 60 days prior to registration on study: Platelets >= 100,000/mm^3','Within 60 days prior to registration on study: Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)','Patient must be able to provide study specific informed consent prior to study entry','Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy not allowed','Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer','Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy','Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)','Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days prior to the date of registration','Use of finasteride within 30 days prior to registration','Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration','Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable','Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients','Patients who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to the hormones involved in this protocol','Patients status post a negative lymph node dissection are not eligible'
NCT01434316,https://www.clinicaltrials.gov/ct2/show/record/NCT01434316?term=NCT01434316&rank=1,'Participants must have histologically confirmed diagnosis of a solid tumor for which no curative therapy exists','Participants must have measurable or evaluable disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Prior chemotherapy is allowed; patients must not have received chemotherapy for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment','Prior exposure to approved receptor tyrosine kinase inhibitors is permitted; at least 5 half-lives must have elapsed since the completion of the kinase inhibitor and the initiation of study treatment','Prior radiation therapy is allowed; patients must not have received any radiation within 3 weeks prior to the initiation of study treatment; patients may not have areas of irradiated marrow exceeding 40% of bone marrow volume','Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies','Prior exposure to ABT888 or other PARP inhibitors is permitted in all cohorts except the cohort evaluating BRCA-mutated PARP inhibitor naive patients, where prior PARP inhibitor treatment will not be permitted; prior exposure to cyclin-dependent kinase inhibitors other than SCH727965 is permitted','Absolute neutrophil count >= 1,500/mm^3','Hemoglobin (Hgb) > 9.0 g/dl','Platelets >= 100,000/mm^3','Total bilirubin < 1.5 mg/dl','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the institutional upper limit of normal; for subjects with known liver metastases, AST and ALT =< 5 times institutional upper limit of normal','Creatinine =< 1.5 times institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal','Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; additionally, if a man suspects that he has fathered a child while taking study agents, he should also inform his treating physician immediately','Eligible patients in the dose escalation phases of the trial must agree to biopsies of normal skin, unless they undergo optional tumor biopsies; the mandatory biopsy requirement can be waived at the discretion of principal investigator in the event of any medical contraindication (e.g. lidocaine allergy); patients enrolled to the expanded cohorts must agree to tumor sampling; patients on anticoagulation must be able to hold warfarin or low molecular weight heparin for a sufficient amount of time to make skin and tumor biopsies safe to perform; PT/INR and PTT should be =< 1.5 times the institutional upper limit of normal prior to performance of skin or tumor biopsies, with values re-checked after the eligibility screen as medically indicated','Patients must be able to swallow pills','Patients enrolling in the BRCA-deficient cohorts must have a documented BRCA1 or BRCA2 germline mutation; alternatively, patients with tumors harboring somatic BRCA mutations may also enroll after discussion with the principal investigator','All patients must agree to provide an archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies; however, patients are not considered ineligible if archival tumor is not available','Ability to understand and the willingness to sign a written informed consent document; subjects must be willing to adhere to dose and visit schedules','Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists','Patients with known active brain metastases are excluded; patients with a history of central nervous system (CNS) metastases that have been treated must be stable with no symptoms for > 3 months after completion of that treatment and off steroid treatment, with image documentation required prior to study enrollment','Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)','Patients who have previously received SCH727965','Patients with other medical conditions judged by the investigator to be clinically relevant in the setting of this study, which may include active infectious processes, intractable emesis, or chronic diarrheal disease','Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888 and SCH727965','Patients with prior seizure history who have experienced a seizure within the three months prior to enrollment are excluded','Subjects with a known allergy to lidocaine','Subjects on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded'
NCT01497444,https://www.clinicaltrials.gov/ct2/show/record/NCT01497444?term=NCT01497444&rank=1,'Cytological or histological confirmed diagnosis of advanced hepatocellular or renal cell carcinoma; HCC patients should not be amenable to treatment with surgery or to orthotopic liver transplant (Phase I)','Patients must have measurable disease (Phase I)','RCC patients only: Tumor progression after receiving standard/approved chemotherapy and/or targeted agent, where there is no approved therapy or for tumors where sorafenib based therapy would be standard therapy (Phase I)','HCC patients only:\r\n* First line (i.e., no prior systemic therapy) or second-line (with prior first-line sorafenib therapy only) advanced HCC \r\n* Child Pugh class A or B7 liver disease \r\n* Prior chemoembolization, radioembolization, radiofrequency ablation (RFA), or other local ablative therapies are permissible if >= 6 weeks from procedure with evidence of progression or new metastatic disease, if applicable (Phase I)','Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1','Absolute neutrophil count (ANC) >= 1200/mm^3','Peripheral platelet count (PLT) >= 75,000/mm^3','Hemoglobin (HgB) > 8.5 g/dL','Bilirubin =< 3.0 x upper limit of normal (ULN)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN\r\n* If subject has HCC or liver metastases =< 5 x ULN) (Phase I); AST and ALT =< 5 x ULN (Phase II)','Creatinine =< 1.5 x ULN','International normalized ratio (INR) =< 1.5 x ULN; patients receiving anti-coagulation therapy are permitted as long as they have a stable INR =< 3.0','Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only','Provide informed written consent','Willing to return to Alliance enrolling institution for follow-up','Life expectancy >= 3 months','Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception for the duration of study participation; men and women should continue to use adequate birth control after the last administration of sorafenib and TH-302 under the guidance of their treating physician','Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens','Receiving any other investigational agent','Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer','Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 100 mmHg on anti-hypertensive medications)','Major surgical procedures, or significant traumatic injury =< 14 days prior to registration or anticipation of need for elective or planned major surgical procedure during the course of the study','New York Heart Association (NYHA) classification III or IV congestive heart failure','Received treatment with radiation therapy or investigational therapy =< 28 days prior to registration','RCC patients only: Having received chemotherapy prior to study entry within 5 half-lives of the agent (as described in the package insert), or 4 weeks prior to registration (whichever is shorter) with resolution of side effects from therapy to =< grade 1','Known central nervous system (CNS) or brain metastasis that are either symptomatic or untreated; Note: patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis\r\n* Note: patients with CNS metastases that have been treated and are stable without symptoms for >= 4 weeks after completion of treatment are eligible','HCC patients only: Cancer potentially amenable to local modalities of therapy or surgical resection (phase I)','Known or suspected allergy or hypersensitivity to any component of TH-302, sorafenib, or any of the sorafenib excipients','Any condition that severely impairs patient’s ability to swallow whole pills','Corrected QT (QTc) interval > 500 msec on baseline electrocardiogram (EKG)','Documented history of prolonged QTc interval =< 6 months prior to registration','Receiving any medication that has documented data or is generally accepted as having increased risk of QT prolongation and/or Torsades de Pointes','Receiving any medications or substances that are inducers or strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 7 days prior to registration\r\n* Use of CYP3A4 inducers are prohibited =< 7 days prior to registration\r\n* Use of CYP3A4 strong or moderate inhibitors are prohibited =< 7 days prior to registration','Fibrolamellar histology HCC, mixed hepatocholangiocarcinoma, hepatic sarcomas and other non-HCC primary liver tumors','History of lobectomy involving > 50% of lobe','Radioembolization within 8 weeks of day 1 dosing of sorafenib','PHASE II REGISTRATION - INCLUSION CRITERIA','Cytological or histological confirmed diagnosis of hepatocellular carcinoma that is locally advanced or metastatic and is not amenable to treatment with surgery or to orthotopic liver transplant (Phase II)','Patients must have measurable disease; must have at least one non-nodal lesion','First line advanced HCC (i.e., no prior systemic therapy)','Child Pugh class A or B7 liver disease','Prior chemoembolization, radioembolization, radiofrequency ablation (RFA) or other local ablative therapies are permissible if >= 6 weeks from procedure with evidence of progression or new metastatic disease, if applicable','Ability to receive intravenous contrast for the purpose of imaging','PHASE II REGISTRATION: EXCLUSION CRITERIA:','Cancer potentially amenable to local modalities of therapy or surgical resection'
NCT01503632,https://www.clinicaltrials.gov/ct2/show/record/NCT01503632?term=NCT01503632&rank=1,'Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required','At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy','Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)','Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine','Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)','Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period','Patient and parent/caregiver must speak English or Spanish','Patients with Down syndrome','Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT01503086,https://www.clinicaltrials.gov/ct2/show/record/NCT01503086?term=NCT01503086&rank=1,'Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT\r\n* Note: COG therapeutic study participation is not required for ACCL10P1 enrollment','Patient enrollment must occur within 4 calendar months following completion of CRT\r\n* Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT','The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT)','The patient must have access to a telephone and phone number where they can be reached','The patient and caregiver must have reading, speaking and listening comprehension of English','Patients with pontine glioma are not eligible','Patients with an estimated survival of less than one year are not eligible','Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible','Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial','Patients with full-scale intelligence quotient (IQ) < 70 per previous testing OR existing diagnosis of/educational classification as a student with an intellectual disability are not eligible','All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution’s policy)','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT01515787,https://www.clinicaltrials.gov/ct2/show/record/NCT01515787?term=NCT01515787&rank=1,'Diagnosis of rectal adenocarcinoma','Radiologically measurable or clinically evaluable disease','Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2','For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality, neoadjuvant chemoradiation followed by curative intent surgical resection','Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon','Clinical stage: T2N1, T3N0, T3N1\r\n* N2 disease is to be estimated as four or more lymph nodes that are >= 10 mm\r\n* Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and either a pelvic magnetic resonance imaging (MRI) or an ultrasound (endorectal ultrasound [ERUS]); if a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Hemoglobin > 8.0 g/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN','Creatinine =< 1.5 times ULN','Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only','Patient of child-bearing potential is willing to employ adequate contraception; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)','Provide informed written consent','Willing to return to enrolling medical site for all study assessments','Clinical T4 tumors','Primary surgeon indicates need for abdominoperineal (APR) at baseline','Evidence that tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)','Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible)','Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years)','Any prior pelvic radiation','Other invasive malignancy =< 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix','Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception','Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens'
NCT01333046,https://www.clinicaltrials.gov/ct2/show/record/NCT01333046?term=NCT01333046&rank=1,'PROCUREMENT: Diagnosis of Hodgkin’s or non-Hodgkin’s lymphoma:\r\n* GROUP A: \r\n** With active disease \r\n*** In second or subsequent relapse\r\n*** In first relapse for indolent lymphoma after first line therapy for relapse\r\n*** Or first relapse if immunosuppressive chemotherapy contraindicated\r\n*** Primary refractory disease or if persistent disease after first line therapy of relapse\r\n** Or multiply relapsed patients in remission who are at a high risk of relapse or the lymphoma is a second malignancy e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL) after failing frontline therapy OR\r\n* GROUP B:\r\n** After autologous or syngeneic stem cell transplant (SCT) (as adjuvant therapy)','PROCUREMENT: Patients with life expectancy >= 6 weeks','PROCUREMENT: Hemoglobin (Hgb) > 8.0 (transfusions allowed)','PROCUREMENT: Patient able to give informed consent','TREATMENT: Diagnosis of Hodgkin’s or non-Hodgkin’s lymphoma:\r\n* GROUP A: \r\n** With active disease \r\n*** In second or subsequent relapse\r\n*** In first relapse for indolent lymphoma after first line therapy for relapse\r\n*** Or first relapse if immunosuppressive chemotherapy contraindicated\r\n*** Primary refractory disease or if persistent disease after first line therapy of relapse\r\n** Or multiply relapsed patients in remission who are at a high risk of relapse or the lymphoma is a second malignancy e.g. a Richter's transformation of CLL after failing frontline therapy OR\r\n* GROUP B:\r\n** After autologous or syngeneic SCT (as adjuvant therapy)','TREATMENT: Patients with life expectancy >= 6 weeks','TREATMENT: Pulse oximetry of > 95% on room air in patients who previously received radiation therapy','TREATMENT: Patients with a Karnofsky/Lansky score of >= 50%','TREATMENT: Bilirubin =< 2 x upper limit of normal','TREATMNET: Aspartate aminotransferase (AST) =< 3 x upper limit of normal','TREATMENT: Hgb > 8.0 g/dL (transfusions allowed)','TREATMENT: Creatinine =< 2 x upper limit of normal for age','TREATMENT: Patients should have been off other investigational therapy for one month prior to entry in this study','TREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab','TREATMENT: Patient able to give informed consent','TREATMENT: Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation','PROCUREMENT: Patients with severe intercurrent infection','PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw)','TREATMENT: Patients with severe intercurrent infection','TREATMENT: Patients receiving systemic corticosteroids','TREATMENT: Pregnant'
NCT01556243,https://www.clinicaltrials.gov/ct2/show/record/NCT01556243?term=NCT01556243&rank=1,'Life expectancy of at least 5 years, excluding diagnosis of breast cancer (comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)','Men are excluded from this study','Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by >= 2 cm of normal breast tissue; foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS); no more than 2 quadrants with biopsy proven breast cancer; Note: the shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained; Note: patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion (s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI); ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only; fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy; patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion','Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:\r\n* An area of atypia > 2 cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC OR\r\n* Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology','Bilateral mammogram =< 90 days prior to date of surgery; Note: for patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment','cN0 or cN1 disease','Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2','Ability to complete questionnaire(s) by themselves or with assistance','Ability to provide written informed consent','Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study; patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution','Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)','Largest single focus of disease > 5 centimeters by either mammogram or MRI or both; Note: measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion','Surgical axillary staging procedure prior to first definitive breast operation; Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted','Clinical or radiographic evidence of metastatic disease','Prior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive)','cNX, cN2, or cN3 disease','Breast implants at time of diagnosis; Note: patients who have had implants previously removed prior to diagnosis are eligible','Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole-breast irradiation (such as connective tissue disorders, lupus, or scleroderma)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)','Treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed); patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy','Planned partial breast radiation','Patients with known breast cancer (BRCA) mutations; patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study','Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer'
NCT01573442,https://www.clinicaltrials.gov/ct2/show/record/NCT01573442?term=NCT01573442&rank=1,'Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of study','Body mass index (BMI) between 18 and 35 kg/m^2','Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy','Must have BOTH estrogen receptor (ER) and progesterone receptor (PR)-positive tumors and BOTH must be >= 26% positive; alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher','Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months','>= 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor, as measured by verbally addressing the following question: please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week\r\n* Note: Patients may, or may not, be taking non-opioid analgesics','Ability to complete questionnaire(s) by themselves or with assistance','Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2','Willing to provide informed written consent','Willing to return to an Alliance enrolling institution for follow-up','Willing to provide blood samples for correlative research purposes','Laboratory values obtained =< 365* days prior to registration:\r\n* Note: Without medical situations that should change these parameters since they were done','Creatinine =< 1.5 x upper limit of normal (ULN)','Hemoglobin > 11 g/dL','White blood cell (WBC) > 3.0','Platelet count > 100,000','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN','Presence of residual or recurrent cancer (locally or metastatic)','Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL','History of coronary artery disease (angina or myocardial infarction)','Patients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapy','Known hypersensitivity to any component of testosterone','Prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops, or local insertion (e.g., intra-articular)\r\n* Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g., for chronic obstructive pulmonary disease), but not within 30 days prior to registration','Receiving any other investigational agent','History of a deep venous thrombosis or a thromboembolism','Concurrent use of the aromatase inhibitor exemestane','Concurrent radiation therapy or chemotherapy','Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen'
NCT01587352,https://www.clinicaltrials.gov/ct2/show/record/NCT01587352?term=NCT01587352&rank=1,'Patients must have metastatic histologically or cytologically confirmed uveal melanoma; (if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma); pathologic confirmation of diagnosis will be performed at Columbia University, Memorial Sloan-Kettering Cancer Center (MSKCC) or Vanderbilt University Medical Center','Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9.0 g/dL not requiring transfusions within the past 2 weeks','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); =< 3 x institutional ULN if the patient has Gilbert's syndrome','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN if no liver metastasis present; =< 5 x institutional ULN if liver metastases are present','Creatinine =< 1.5 mg/dL','Ability to understand and the willingness to sign a written informed consent document','Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of vorinostat administration','Tumor GANQ, GNA11, and BAP1 mutational status must be determined on all patients; if initial testing is performed locally or not available, MSKCC or Columbia University Medical Center (CUMC) patients must consent to provide a tumor block or unstained slides to MSKCC or CUMC for central review of mutational status; if tissue is not available, a pre-treatment biopsy will be necessary for eligibility \r\n* Patients enrolled at Vanderbilt University Medical Center may have GNAQ and GNA11 mutational status determined on a Clinical Laboratory Improvement Act (CLIA)-approved assay at Vanderbilt University Medical Center, CUMC, or MSKCC; tissue must be sent to MSKCC for BAP1 mutational status determination\r\n* The determination of mutational status may be performed retrospectively and will not delay patient treatment on study as long as tissue is available for molecular analysis','Patients may have had any number of prior therapies; at least 3 weeks must have elapsed since the last dose of systemic therapy; at least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator','Patients who are receiving any other investigational agents','Patients with active or untreated brain metastases; treated brain metastases must have been stable for at least 2 months','History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat','Patients receiving histone deacetylase (HDAC) inhibitors or compounds with HDAC inhibitor like activity, such as valproic acid, are ineligible; patients who have received such agents may enroll on this study after a 14-day washout period','Patients on warfarin will be excluded from the trial if they cannot be switched to an acceptable alternative medication (i.e. low molecular weight heparin [LMWH]); prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving vorinostat concomitantly with coumarin-derivative anticoagulants','Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with vorinostat','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy will be eligible unless the cluster of differentiation (CD)4 count is < 200 cells/mm^3 within one month of study enrollment','A second malignancy requiring active therapy','No concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria','Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption','Corrected QT interval (QTc) > 475 milliseconds','Patients who cannot swallow capsules'
NCT01585805,https://www.clinicaltrials.gov/ct2/show/record/NCT01585805?term=NCT01585805&rank=1,'Patients with cytologically or histologically confirmed locally advanced or metastatic pancreas adenocarcinoma with a BRCA1 or 2 or PALB2 mutation confirmed by report from Myriad Genetics (United States of America [USA]); reports from other molecular diagnostic companies can be used to confirm mutations as well; BRCA 1 or 2 or PALB2 mutation can be confirmed locally for all international sites\r\n* For Part I, non-randomized, lead-in portion, patients with a known BRCA 1 or 2 or PALB2 mutation are eligible along with patients who potentially may have a likelihood of having a BRCA mutation (e.g., personal or family history of breast, pancreas, ovary, endometrial, prostate or other likely related malignancy); for Part I, randomized portion, a known BRCA 1 or 2 or PALB2 mutation is required','For Part I (Arms A, B): Patients can have either locally advanced or metastatic pancreas adenocarcinoma for which no prior therapy has been administered for either locally advanced or metastatic disease; prior adjuvant therapy is permissible if gemcitabine or a fluoropyrimidine was administered with or without radiation and if disease recurrence has been documented at least 6 months after completion of adjuvant therapy','For Part II (Arm C): Patients can have either locally advanced or metastatic pancreas adenocarcinoma; up to two prior treatment regimens are permissible (excluding a prior PARP inhibitor) for either localized or metastatic pancreas adenocarcinoma; prior combined chemotherapy and radiotherapy is permissible provided the patient has measurable disease outside the radiation port; prior therapy must have been completed at least 3 weeks prior to starting study therapy','Eastern Cooperative Oncology Group (ECOG) performance status:\r\n* For Part I (Arm A, B): 0-1 (Karnofsky > 70%)\r\n* For Part II (Arm C): 0-2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Hemoglobin >= 9.0 mg/dl','Platelets >= 100,000/mcL','Total bilirubin =< 2 x institutional upper limit of normal','Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase(ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x institutional upper limit of normal unless there is evidence of liver metastases in which case the AST (SGOT)/ALT (SGPT) must be =< 5 x institutional upper limit of normal','Creatinine =< 1.5 x upper limit of normal (ULN)','Measurable disease by RECIST criteria\r\n* For the lead-in, non-randomized portion of Part I, either measurable or evaluable disease is acceptable\r\n* For Part I, randomized portion, measurable disease is required','If a woman is of child-bearing potential a negative blood or urine pregnancy test is required; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier\r\n* For Part I, prior adjuvant therapy with gemcitabine or a fluoropyrimidine therapy is permitted if completed > 6 months prior to recurrence; no prior PARP inhibitor therapy is allowed\r\n* For Part II, no prior PARP inhibitor therapy is permitted; up to two prior treatment regimens are permitted as follows: 1 adjuvant and 1 metastatic; 1 locally advanced and 1 metastatic; or 2 metastatic, or a variation thereof','Patients may not be receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study','For Part I: patients with known contraindications to platinum agents are excluded','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with veliparib; this may also apply to other agents used in this study','Patients with a known active infection, e.g., hepatitis B virus or hepatitis C virus; human immunodeficiency virus (HIV)-positive patients who are otherwise well and who do not have evidence of significant immune compromise are eligible','Patients with active seizure or history of seizure are not eligible','Patients with uncontrolled central nervous system (CNS) metastasis are not eligible; patients with CNS metastases are to be stable for > 3 months after treatment and off steroid treatment prior to study enrollment','Patients with prior malignancy successfully treated who are currently stable and on no active treatment are eligible','Patients who are unable to swallow pills/capsules are ineligible'
NCT01638533,https://www.clinicaltrials.gov/ct2/show/record/NCT01638533?term=NCT01638533&rank=1,'Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor; patients with lymphoma or CLL must have radiologically or clinically evaluable disease, and be refractory to standard therapy as defined by relapse within 6 months of last treatment (see note below); patients with solid tumors must have radiologically or clinically evaluable disease that is metastatic, unresectable, progressive, or recurrent, and for which standard curative measures do not exist or are no longer effective\r\n* Patients with a liver mass, raised alpha-fetoprotein level (>= 500 ng/mL) and positive serology for hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis\r\n* Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with breast, pancreatic, bladder, head and neck cancers, as well as melanoma and other malignancies are eligible\r\n* Note: patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts provided the patients:\r\n** Sign a separate consent form which outlines the lack of efficacy observed in prior studies\r\n** Are consented to the study by a protocol-specified designee who is not their longitudinal oncologist; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts\r\n* Note: as romidepsin is approved for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL), these patients would be eligible WITHOUT the requirement of having ‘relapsed within 6 months of last treatment’','Life expectancy of > 3 months','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Hemoglobin >= 9 g/dL (transfusions and/or erythropoietin are permitted)','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Platelets >= 100 x 10^9/L (or platelet count >= 30 x 10^9 cells/L in patients with lymphoma or CLL if bone marrow disease involvement is documented)','Creatinine =< twice upper limit institutional normal','Patients with abnormal liver function will be eligible and will be grouped according to the criteria below\r\n* Group A (normal hepatic function)\r\n** Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN\r\n* Group B (mild hepatic dysfunction)\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: bilirubin > ULN but =< 1.5 x ULN and any AST\r\n* Group C (moderate hepatic dysfunction)\r\n** Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST\r\n* Group D (severe hepatic dysfunction) \r\n** Bilirubin > 3 x ULN and up to investigators discretion and any AST\r\n* Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test results','Patients with brain metastases who require corticosteroids or non-enzyme inducing anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to enrollment; patients with known brain metastases should have completed brain irradiation (whole brain or gamma knife) more than 4 weeks before starting the protocol; patients on enzyme inducing anticonvulsants are not eligible; note that patients should have had their steroids tapered to low dose (i.e. < 1.5 mg of dexamethasone/day) due to the potential for higher dexamethasone doses to induce CYP3A4','Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis','Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator\r\n* Patients treated with any of the medications prohibited must discontinue their use at least 7 days prior to the first dose of romidepsin; certain other agents that interact with the CYP3A4 system may be used with caution','Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; note: since romidepsin binds to the estrogen receptor, the effectiveness of estrogen containing contraceptives may be reduced','Human immunodeficiency virus (HIV)-positive patients who are not receiving: agents with the potential for PK interactions with romidepsin or hepatotoxic antiretrovirals (nucleoside reverse-transcriptase inhibitors [NRTIs]: abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), dual protease inhibitor (PI)-based regimens except low-dose boosting with ritonavir, atazanavir, indinavir, maraviroc, and nevirapine may be eligible; additionally, the HIV-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3; if the specific cause of hepatic dysfunction is unknown, the patient should be worked up for other viral causes of hepatitis and their eligibility determined after consultation with the principal investigator','Patients who have received prior romidepsin use are eligible','Ability to understand and the willingness to sign a written informed consent document','Patients who have had (prior to entering the study): major surgery and biologic/antibody therapies (including immunotherapies) are not permitted within 4 weeks of romidepsin administration; anti-cancer therapy including chemotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions), and other investigational agents will not be allowed within 14 days or five (5) half-lives (whichever is longer) prior to the first dose of romidepsin (6 weeks for nitrosoureas or mitomycin C); additionally, participants must have recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(ies) of the previous therapy, with the exception of alopecia, unless approved by the principal investigator','Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts only; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts','Patients may not be receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to romidepsin, including cyclic tetrapeptide compounds','Concurrent medications associated with a known risk of corrected QT interval (QTc) prolongation and/or Torsades de Pointes are not allowed within 2 weeks of initiation of study treatment; those medications listed as a possible risk for causing QTc prolongation and Torsades de Pointes will be allowed, although if an alternative medication can be substituted, that would be preferable; granisetron is an acceptable antiemetic on this study, but if a patient must take ondansetron, they may NOT take any other concomitant agents which might impact their QTc','Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted','Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements','Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of romidepsin treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause Torsades de Pointes or may cause a significant prolongation of the QTc\r\n* Note: due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist; if a patient must take ondansetron as their antiemetic, their QTc may NOT be over 450 (no exception for patients with heart block)','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this drug','Warfarin is not permitted'
NCT01775475,https://www.clinicaltrials.gov/ct2/show/record/NCT01775475?term=NCT01775475&rank=1,'Ability to understand and the willingness to provide written informed consent to participate','HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 ribonucleic acid (RNA) viral load > 1,000 copies/mL\r\n* NOTE: the term \"licensed\" refers to a United States (U.S.) Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally\r\n* WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load','Biopsy-proven, systemic DLBCL with a proliferation rate =< 90%, that has been confirmed by an acquired immune deficiency syndrome (AIDS) Malignancy Clinical Trial Consortium (AMC)-approved site pathologist using hematoxylin and eosin (H&E) and immunohistochemical stains; if a hard copy of the pathology report is unavailable at the time of enrollment into the screening segment, a verbal report by the pathologist confirming the diagnosis must be documented in the medical chart; a hardcopy of the pathology report must be available prior to randomization (enrollment into the Treatment Segment); Note: measurable disease is not an entry requirement','Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry; confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry; please reference the AMC-068 Manual of Procedures (MOP) for further instructions on documenting the diagnosis; the site pathologist for non-Hodgkin lymphoma (NHL) must be approved through the AMC's external quality assurance (EQA) process','Participants must have fifteen blank (unstained) slides or a diagnostic tissue block must be available for external quality assurance by the AMC Core Pathology Laboratory','Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 within 7 days of enrollment','Participants must have an estimated life expectancy of > 6 weeks','White blood cells (WBC) >= 3,000 cells/uL (3.0 x 10^9 L) or','Absolute granulocytes >= 1500 cells/uL (1.5 x 10^9 L)','Platelets >= 100,000 cells/uL (75 x 10^9 L); and,','Hemoglobin >= 8 g/dL (5.0 mmol/L)','Patients may enroll with lower hematologic values, if bone marrow involvement is documented; in this case, patients should be transfused to hemoglobin >= 8 g/dL','Estimated creatinine clearance of > 50 ml/min (0.84 mL/s) by the Cockcroft-Gault equation','Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); if secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 uM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 uM/L)','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 times the institutional ULN (unless elevated secondary to lymphomatous involvement of the liver, in which case the AST/ALT must be =< 5 times the institutional ULN)','Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 4 weeks prior to enrollment','All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment','Participants of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception)','Participants must, in the opinion of the investigator, be capable of complying with the protocol','Participants must be able to take oral medications','Participants must have a CD4 count performed within 30 days of enrollment','Inability to provide informed consent','Participants who received any lymphoma directed chemotherapy or radiotherapy with the exception of a single dose of intrathecal chemotherapy given at the time of the diagnostic lumbar puncture (spinal tap); patients who received chemotherapy or radiotherapy for Kaposi’s sarcoma > 2 years prior to study enrollment are allowed as long as the prior treatment did not include doxorubicin in its non-liposomal form; prior exposure to liposomal doxorubicin is allowed; prior exposure to intrathecal therapy given as prophylaxis within 30 days is allowed','Participants who received greater than 10 days of corticosteroids in the preceding 30 days prior to enrollment; physiologic dosing of steroid is 4-5 mg/m^2/day prednisone, 0.03-0.15 mg/kg/day dexamethasone, or 0.5-0.75 mg/kg/day hydrocortisone; contact the AMC Protocol Team for physiologic dosing limits for other corticosteroids','Participants with evidence for central nervous system (CNS) lymphoma on neurological exam and/or with radiographic evidence (if radiographic studies are done) of CNS lymphoma (inclusive of parenchymal, vitreal, or leptomeningeal involvement)','Participants with active infection(s) for which they are receiving drug treatment unless the clinical status is judged to be stable and survival is estimated to be at least 6 weeks','A medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations','Participants with circumstances that will not permit completion of the study or required follow-up; for instance, if travel to and from treatment site is an issue','Pregnant or breastfeeding','Inability to swallow oral medications','Participants with known congestive heart failure (CHF); if known, patients with left ventricular ejection fraction (LVEF) =< 40% are excluded'
NCT01695941,https://www.clinicaltrials.gov/ct2/show/record/NCT01695941?term=NCT01695941&rank=1,'Patients must have histologically confirmed relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma (NHL); patients with evidence of transformation to a high grade histology will not be eligible','Measurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma; baseline scans used for measurement should be obtained within 30 days of registration, and baseline bone marrow biopsy and/or aspiration should be obtained with 90 days of registration','Patients may have received one or more lines of prior chemotherapy with/without rituximab (including high dose therapy plus stem cell transplant which is counted as one regimen); prior bortezomib is allowed; patients must not have received bortezomib in the past 6 months','Patients with human immunodeficiency virus (HIV) who are not receiving cytochrome p450 inhibitors, and who have a minimum of 300+ CD4+ cells/mm^3, an undetectable viral load, and no history of acquired immune deficiency syndrome (AIDS) indicator conditions','Patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration','Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky >= 60%)','Obtained within 30 days of registration: Leukocytes >= 3,000/mcL','Obtained within 30 days of registration: Absolute neutrophil count >= 1,500/mcL','Obtained within 30 days of registration: Platelets >= 75,000/mcL or >= 50,000/mcL with documented bone marrow involvement','Obtained within 30 days of registration: Total bilirubin within normal institutional limits (may be elevated if direct bilirubin normal)','Obtained within 30 days of registration: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 X institutional upper limit of normal','Obtained within 30 days of registration: Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, 3 weeks for rituximab) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, bortezomib or rituximab','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen, or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237','Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237','HIV-positive patients on combination antiretroviral therapy which include cytochrome p450 inhibitors are ineligible; patients with CD4 counts less than 300 CD4+ cells/mm^3 and or a high viral load are ineligible','Grade 2 or greater neuropathy','The following agents are not permitted while patients are taking MLN8237, and should be discontinued at prior to registration if patients are taking them:\r\n* Patients must stop using the proton pump inhibitor (PPI) for at least 4 days prior to the first dose of MLN8237; administration of PPI while on study is not permitted\r\n* Histamine-2 (H2) receptor antagonists are not permitted from the day prior through to the end of MLN8237 dosing, except as required for premedication for rituximab; constant dosing of H2 blockers is not permitted\r\n* Antacid preparations are not permitted for 2 hours before or 2 hours after administration of MLN8237\r\n* Administration of pancreatic enzymes is not permitted at any time while on study\r\n* Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine or St. John's wort is not permitted\r\n* Concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; if bisphosphonate therapy is initiated after study entry, bone lesions will not be considered evaluable for disease response\r\n* Patients must be willing not drive, operate dangerous tools or machinery, or engage in any other potentially hazardous activity that requires full alertness and coordination if they experience excessive sedation; if a patient experiences excessive sedation believed to be related to MLN8237, treatment with MLN8237 should be interrupted\r\n* Patients must be willing to limit alcohol consumption to no more than 1 standard unit of alcohol (12 oz beer [350 mL], 1.5 oz [45 mL] of 80-proof alcohol, or one 6-oz [175 mL] glass of wine) per day during the study and for 30 days from the last dose of MLN8237; minimize the use of agents with central nervous system (CNS) effects\r\n* Benzodiazepine use is discouraged but not prohibited'
NCT01595061,https://www.clinicaltrials.gov/ct2/show/record/NCT01595061?term=NCT01595061&rank=1,'Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva','Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy','Absolute neutrophil count (ANC) >= 1,500/mcl','Platelets >= 100,000/mcl','Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min','Bilirubin =< 1.5 x ULN','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN','Alkaline phosphatase =< 3 x ULN','Patients judged capable of tolerating a radical course of chemoradiation therapy','Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients with a GOG performance status of 0, 1, or 2','Patients with recurrent carcinoma of the vulva regardless of previous treatment','Patients who have received prior pelvic radiation or cytotoxic chemotherapy','Patients with vulvar melanomas or sarcomas','Patients with circumstances that will not permit completion of the study or the required follow-up','Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy'
NCT01602666,https://www.clinicaltrials.gov/ct2/show/record/NCT01602666?term=NCT01602666&rank=1,'Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors located in the suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible; tumors present in the above mentioned locations and with unifocal parenchymal extension are eligible\r\n* Stratum 1(NGGCT): Patients must have one of the following criteria:\r\n** Patients with serum and/or CSF hCGbeta > 100 mIU/mL or any elevation of serum and/or CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective of biopsy results\r\n** Patients with any of the following elements on biopsy/resection are eligible, irrespective of serum and/or CSF hCGbeta and AFP levels: endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCT with malignant GCT elements\r\n* Stratum 2 (Germinoma): Patients must have both serum and CSF markers obtained (unless obtaining CSF is medically contraindicated) and must have one of the following criteria to be eligible:\r\n** Patients with institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) AND hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically contraindicated) (only 1 is required to be elevated) are eligible; no histologic confirmation required\r\n** Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible; no histologic confirmation required\r\n** Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible','All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment; if surgical resection is performed, patients must have pre-operative and post-operative cranial MRI with and without gadolinium; the post-operative brain MRI should be obtained within 72 hours of surgery; if patient has a biopsy only, post-operative cranial MRI is recommended but not required; all patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the spine study is performed for the first time after surgical resection or biopsy, it is recommended to be obtained with and without gadolinium','Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at this time, then it should be performed at least 10 days following surgery before study enrollment; false positive cytology can occur within 10 days of surgery; Note: patients with positive CSF cytology obtained prior to 10 days after surgery may have cytology repeated to determine eligibility','Patients must have CSF tumor markers obtained prior to enrollment unless medically contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first','Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical diagnosis','Peripheral absolute neutrophil count (ANC) >= 1,000/uL','Platelet count >= 100,000/uL (transfusion independent)','Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)','Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:\r\n* 0.8 mg/dL (2 to < 6 years of age) \r\n* 1.0 mg/dL (6 to < 10 years of age)\r\n* 1.2 mg/dL (10 to < 13 years of age) \r\n* 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)\r\n* 1.7 mg/dL (male) and 1.4 mg/dL (female) (>= 16 years of age)','Total bilirubin =< 1.5 times upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN','Patients with seizure disorder may be enrolled if well controlled','Patients must not be in status, coma, or assisted ventilation prior to study enrollment','Patients with mature teratoma or completely resected immature teratoma with normal tumor markers are not eligible','Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible','Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible','Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids','Female patients who are pregnant are ineligible','Lactating females are not eligible unless they have agreed not to breastfeed their infants','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT01622868,https://www.clinicaltrials.gov/ct2/show/record/NCT01622868?term=NCT01622868&rank=1,'Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer','HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)','At least 1 measurable unirradiated parenchymal brain metastasis within 21 days prior to study entry; patients who are to undergo SRS must have no more than 10 brain metastases; there is no limit on number of brain metastases for WBRT; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:\r\n* For a single solitary lesion the size must be >= 10 mm\r\n* For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm\r\n* Patients may also have the following provided the size requirements above are met:\r\n** Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion\r\n** Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion','History/physical examination within 21 days prior to study entry','Karnofsky performance status >= 60 within 21 days prior to study entry','Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)','Absolute neutrophil count (ANC) >= 1,200 cells/mm^3, within 21 days prior to study entry','Platelets >= 70,000 cells/mm^3, within 21 days prior to study entry','Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable), within 21 days prior to study entry','Creatinine < 1.5 times institutional upper limit of normal, within 21 days prior to study entry','Bilirubin < 1.5 times institutional upper limit of normal, within 21 days prior to study entry','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 times institutional upper limit of normal with or without liver metastasis, within 21 days prior to study entry','Patient must provide study specific informed consent prior to study entry','Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry','Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion','Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis','Prior WBRT','Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years','Leptomeningeal disease','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)\r\n* History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry','Grade 2 or greater rash of any cause at time of study entry','Grade 2 or greater diarrhea of any cause at time of study entry'
NCT01649089,https://www.clinicaltrials.gov/ct2/show/record/NCT01649089?term=NCT01649089&rank=1,'Patient must consent for the appropriate surgery','Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade','All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm','Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging','Patients who have met the pre-entry requirements','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2','Patients with stage IA1 disease who are LVSI negative','Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm','Patients with >= stage IB2 disease','Patients with clear cell or neuroendocrine cell types','Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy'
NCT01674140,https://www.clinicaltrials.gov/ct2/show/record/NCT01674140?term=NCT01674140&rank=1,'Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, for whom standard adjuvant endocrine therapy is planned; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/chromosome enumeration probe [CEP] ratio < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligible','Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants\r\n* Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the tumor with the highest recurrence score should be used)','Patients must be high risk by belonging to one of the following risk groups:\r\n* Completion of adjuvant chemotherapy and pathologically negative lymph nodes, and a tumor measuring >= 2 cm in greatest diameter, and an Oncotype DX recurrence score > 25 (completed as standard of care) or a MammaPrint assay (completed as standard of care) in the high-risk category; patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative \r\n* Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX recurrence score > 25, MammaPrint assay in the high-risk category (completed as standard of care), or tumor tissue with pathological grade III following local practice; if Oncotype DX is done, then RS must be > 25, similarly if the MammaPrint assay is performed it has to be high-risk; if the test is not done, but the patient has grade III disease then the patient is eligible and Oncotype DX or MammaPrint does not need to be performed\r\n* Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes\r\n* Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined after chemotherapy\r\n* NOTE: patients who receive both the neoadjuvant and adjuvant chemotherapy may be registered in the neoadjuvant therapy risk group, provided they meet all the criteria above for that risk group\r\n* NOTE: in the lymph node positive groups, at least one metastasis >= 2.0 mm must be present; patients with micrometastases as the only nodal involvement (pN1mi) are eligible and will be categorized as node-negative','Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins\r\n* Patients who had breast-conserving surgery must have completed whole breast radiation; use of regional nodal basin radiation will be at the discretion of the investigator according to institutional guidelines\r\n* Patients with >= 4 positive lymph nodes must have completed breast/chest wall and nodal basin radiation therapy according to standard of care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients\r\n* Patients must be registered at least 21 days after completion of radiation therapy and must have recovered (=< grade 1) from any of the effects of radiation','Patients must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND)\r\n* For patients with 1-3 positive lymph nodes, sentinel node biopsy alone is allowed provided that the patient completed either whole breast or chest wall radiation and the primary tumor is < 5 cm\r\n* All patients with >= 4 positive lymph nodes must have completed ALND (with or without prior sentinel node biopsy)','Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer','Patients must not be receiving or planning to receive trastuzumab; concurrent bisphosphonate therapy is allowed; patients must not have prior exposure to mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors (rapamycin, everolimus, temsirolimus, deforolimus); patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study','Absolute neutrophil count (ANC) >= 1,500/mL within 28 days prior to registration','Hemoglobin >= 9 g/dL within 28 days prior to registration','Platelet count >= 100,000/mL within 28 days prior to registration','Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome) within 28 days prior to registration','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 1.5 x institutional upper limit of normal (IULN) within 28 days prior to registration','Alkaline phosphatase =< 1.5 x IULN within 28 days prior to registration','Serum creatinine level =< IULN within 28 days prior to registration','Fasting cholesterol =< 300 mg/dL and triglycerides =< 2.5 x IULN obtained within 28 days prior to registration; patients may be on lipid lowering agents to reach these values','Patients must have a complete history and physical examination within 28 days prior to registration','Patients must have a performance status of 0-2 by Zubrod criteria','Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia','Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)','Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed','Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline cluster of differentiation (CD)4 count is > 500 cells/mm^3 AND not taking anti-retroviral therapy; patients with known hepatitis are not eligible unless there is a known negative hepatitis panel; (exception: previous history of hepatitis A infection that is not currently active is allowed); patients must not have any known uncontrolled underlying pulmonary disease','Patients must be able to take oral medications; patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)','Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette–Guerin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment','Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or CYP3A4 inducers','No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy and barrier contraceptive devices; however, if at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures','Patients must have pre-treatment blood and tissue specimens submitted for translational medicine as outlined; with patient consent, residuals will be banked for future research','Patients (at National Cancer Institute [NCI] Community Oncology Research Program [NCORP] Institutions only) must be offered the opportunity to participate in the S1207-E01 Behavioral and Health Outcomes study (BAHO); NOTE: patients who have already started endocrine therapy are eligible for the BAHO study','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT01668719,https://www.clinicaltrials.gov/ct2/show/record/NCT01668719?term=NCT01668719&rank=1,'Patients must have newly diagnosed active multiple myeloma (MM); except where otherwise indicated below that assessment is required within 14 days, all tests for establishing baseline disease status must be completed within 28 days prior to registration for patients with no prior therapy, or within 28 days prior to initiation of first Induction course for patients with prior therapy','For the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):\r\n* Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as myeloma prognostic risk score [MyPRS] score, Signal Genetics, Inc) AND/OR\r\n* Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by fluorescence in-situ hybridization (FISH) or cytogenetics AND/OR\r\n* Primary plasma cell leukemia (defined by either >= 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count) AND/OR\r\n* Serum lactate dehydrogenase (LDH) >= 2 x institutional upper limit of normal (IULN) AND/OR\r\n* 1q21 amplification by FISH analysis AND/OR\r\n* High risk by the SKY92 signature','Patients with non-secretory MM or known amyloidosis are not eligible','Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)','Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =< 14 days and total treatment dose was =< 360 mg','Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1','Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 without growth factor support','Platelet count >= 70,000 cells/mm^3 for patients who have bone marrow plasmacytosis < 50%; or >= 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50%','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)','Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.5 x IULN','Creatinine clearance (CrCL) >= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration','Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation); patients with documentation of, or clinical signs or symptoms consistent with, CNS involvement of MM must have a lumbar puncture that is negative for CNS involvement of MM; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration; note that monitoring of CNS involvement and treatment with intrathecal therapy is recommended during protocol treatment','Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:\r\n* Cluster of differentiation (CD)4 cells >= 500/mm^3\r\n* Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART\r\n* No zidovudine or stavudine as part of cART\r\n* Patients who are HIV+ and do not meet all of these criteria are not eligible for this study','Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture','Patients must have Zubrod performance status =< 2','Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load < 800,000 IU/L within 28 days prior to registration','Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)','Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled >= grade 3 cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration','Uncontrolled diabetes: a glycated hemoglobin (Hg A1C) > 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months','Uncontrolled blood pressure and hypertension: systolic blood pressure (SBP) > 140 mm Hg or diastolic blood pressure (DBP) > 90 mm Hg within 14 days prior to registration; patients are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study); all blood pressure measurements within the 14 days prior to registration and on day 1 of cycle 1 must be SBP =< 140 and DBP =< 90; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure','Patients must have history and physical examination within 28 days prior to registration','Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol','Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days prior to registration; (Note: that pregnancy testing is also required within 24 hours prior to treatment on cycle 1, day 1); furthermore, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patients must be offered participation in banking of specimens for future research; with the patient’s consent, specimens (serum and bone marrow biopsy core) must be submitted to the repository; patient consent must be obtained before specimens are submitted','Patients must be registered to the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)™ program and must be willing and able to comply with the requirements of the Revlimid REMS™ program','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT01711541,https://www.clinicaltrials.gov/ct2/show/record/NCT01711541?term=NCT01711541&rank=1,'PHASE I:','Patients who are treatment naïve, high risk, stage IVa/IVb (all other sites) and histologically proven squamous cell carcinoma of the head and neck (SCCHN) with no definitive evidence of metastatic disease, excluding patients with oropharynx human papillomavirus (HPV)-positive tumors; in summary, those patients eligible are newly diagnosed and treatment naive: \r\n* Stage IVa-b squamous cell carcinoma other than oropharyngeal cancer (OPC), or\r\n* Oropharyngeal cancer (OPC) HPV-negative, stage IVa-b','PHASE II:','Patients who are treatment naïve, high risk, stage IVa/IVb (all other sites) histologically proven SCCHN with no definitive evidence of metastatic disease; in summary, those patients eligible are:\r\n* Stage IVa-b SCCHN other than OPC, or\r\n* OPC, HPV-negative, IVa-b, or\r\n* OPC, HPV positive, with greater than 10 pack-year smoking history and N2b-N3 disease','PHASE I AND II:','Patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria; i.e., patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan magnetic resonance imaging (MRI), or calipers by clinical exam','Eastern Cooperative Oncology Group (ECOG) performance status 0-1','Patients must be able to swallow the drug','Ability to understand and the willingness to sign a written informed consent document','Leukocytes >= 3,000/mm^3','Absolute neutrophil count >= 1,500/mm^3','Platelets >= 100,000/mm^3','Total bilirubin =< 1.5 institutional upper limit of normal (ULN)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x institutional ULN as calculated by Cockcroft-Gault','Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN as calculated by Cockcroft-Gault','Patients who are receiving any other investigational agents are not eligible','Patients with active seizure or a history of seizure are not eligible','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study, including Cremophor, carboplatin, paclitaxel, cisplatin, 5-fluorouracil, hydroxyurea, or any compounds of similar chemical or biologic composition are not eligible','Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of ABT-888 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) are not eligible to participate in this study','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible to participate in the study','Pregnant women are not eligible to participate in this study; NOTE: women of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; \r\n* Breastfeeding should be discontinued if the mother is treated with ABT-888','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are not eligible','Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent are not eligible to participate in this study; topical or inhaled corticosteroids are allowed','Patients with other malignancies within the past 2 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin or surgically treated early stage solid tumors are ineligible to participate in this study'
NCT01711554,https://www.clinicaltrials.gov/ct2/show/record/NCT01711554?term=NCT01711554&rank=1,'Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines','Patients must have high-risk neuroblastoma','Patients must have at least ONE of the following:\r\n* Recurrent/progressive disease at any time prior to enrollment - regardless of response to frontline therapy\r\n* Refractory disease: persistent sites of disease (after less than a partial response to frontline therapy, following a minimum of 4 cycles of induction therapy) AND patient has never had a relapse/progression\r\n* Persistent disease: persistent disease after achieving at least a partial response to frontline therapy after a minimum of 4 cycles of induction therapy and patient has never had a relapse/progression','Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below):\r\n* Bone disease\r\n** At least one metaiodobenzylguanidine (MIBG) avid bone site or diffuse MIBG uptake\r\n*** For recurrent/progressive or refractory disease a biopsy is not required regardless of number of MIBG avid lesions\r\n*** For persistent disease, if patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1-2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at the time of enrollment (bone marrow, bone, or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of >= 3 then no biopsy is required for eligibility\r\n** If a tumor is known to be MIBG non-avid, then a patient must have at least one fludeoxyglucose (FDG)-positron emission tomography (PET) avid bone site present at the time of enrollment with biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma obtained at any time prior to enrollment and two weeks subsequent to most recent prior therapy\r\n* Any amount of neuroblastoma tumor cells in the bone marrow based on routine morphology (with or without immunocytochemistry) in at least one sample from bilateral aspirates and biopsies\r\n* At least one soft tissue lesion that meets the criteria for a TARGET lesion as defined by:\r\n** SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter >= 10 mm, or for lymph nodes >= 15 mm on short axis; lesions meeting size criteria will be considered measurable\r\n** In addition to size, a lesion needs to meet ONE of the following criteria:\r\n*** MIBG avid; for patients with persistent disease only: if a patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1-2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of >= 3 then no biopsy is required for eligibility\r\n*** FDG-PET avid (only if tumor is known to be MIBG non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one FDG-PET avid site present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy\r\n*** Non-avid lesion (both MIBG and FDG-PET non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non-avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy','Patients with prior progressive disease who do not meet criteria above, are eligible as long as they have not been off treatment for > 3 months prior to enrollment on NANT 2011-04','Patients must have a life expectancy of at least 6 weeks','Lansky (=< 16 years) or Karnofsky (> 16 years) score of at least 50','Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment','Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study\r\n* Myelosuppressive chemotherapy: must have received last dose at least 2 weeks prior to protocol therapy; this includes cytotoxic agents given on a low dose metronomic regimen\r\n* Biologic (anti-neoplastic agent) (includes retinoids): must have received last dose at least 7 days prior to protocol therapy\r\n* Monoclonal antibodies: must have received last dose at least 7 days or 3 half-lives, whichever is longer, prior to protocol therapy','Radiation: \r\n* Patients must not have received radiation (small port) for a minimum of two weeks prior to protocol therapy\r\n* Except for patients with a history of progressive disease, patients whose only site(s) of disease have been radiated are eligible if at least one lesion meets at least one of the criteria listed in sites of disease above\r\n* A minimum of 12 weeks prior to start of protocol therapy is required following large field radiation therapy (i.e. total body irradiation, craniospinal, whole abdominal, total lung, > 50% marrow space)\r\n* A minimum of 6 weeks must have elapsed prior to start of protocol therapy for other substantial bone marrow radiation','Stem Cell Transplant (SCT): \r\n* Patients are eligible 6 weeks after date of autologous stem cell infusion following myeloablative therapy (timed from first day of protocol therapy)\r\n* Patients are not eligible post allogeneic stem cell transplant\r\n* Patients who have received an autologous stem cell infusion to support non-myeloablative therapy (such as 131 iodine [I]-MIBG) are eligible at any time as long as they meet the other criteria for eligibility','A minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapy','Prior anti-disialoganglioside (GD2) antibody, isotretinoin, or lenalidomide therapy:\r\n* Patients who have received prior anti-GD2 antibody therapy are eligible if they did not have tumor relapse/progression while receiving this therapy\r\n* Patients who have received either isotretinoin or lenalidomide are eligible, but not if they have received the two agents concomitantly','All cytokines or hematopoietic growth factors must be discontinued a minimum of 7 days prior to protocol therapy','Patients must not be receiving any other anti-cancer agents or radiotherapy at the time of study entry or while on study','Absolute phagocyte count (APC = neutrophils and monocytes): >= 1000/mm^3','Absolute neutrophil count: >= 750/mm^3','Platelet count: >= 50,000/mm^3, transfusion independent (no platelet transfusions within 1 week)','Hemoglobin >= 8.0 (may transfuse)','Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria; patients with marrow disease are not evaluable for hematologic toxicity','Age-adjusted serum creatinine =< 1.5 x normal for age or creatinine clearance or glomerular filtration rate (GFR) >= 60 cc/min/1.73 m^2\r\n* Age 1 month to < 6 months: 0.4 mg/dL for males and 0.4 mg/dL for females\r\n* Age 6 months to < 1 year: 0.5 mg/dL for males and 0.5 mg/dL for females\r\n* Age 1 to < 2 years: 0.6 mg/dL for males and 0.6 mg/dL for females\r\n* Age 2 to < 6 years: 0.8 mg/dL for males and 0.8 mg/dL for females\r\n* Age 6 to < 10 years: 1.0 mg/dL for males and 1.0 mg/dL for females\r\n* Age 10 to < 13 years: 1.2 mg/dL for males and 1.2 mg/dL for females\r\n* Age 13 to < 16 years: 1.5 mg/dL for males and 1.4 mg/dL for females\r\n* Age >= 16 years: 1.7 mg/dL for males and 1.4 mg/dL for females','=< grade 2 hematuria (criteria applicable only for dose levels that include isotretinoin) and =< grade 2 proteinuria','Total bilirubin =< 1.5 x upper limit of normal for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x upper limit of normal (note that for ALT, the upper limit of normal is defined as 45 U/L)','Sinusoidal obstruction syndrome (SOS) if present, must be stable or improving clinically','Cardiac function:\r\n* Normal ejection fraction (>= 55%) documented by either echocardiogram or radionuclide multi gated acquisition scan (MUGA) evaluation; OR \r\n* Normal fractional shortening (>= 27%) documented by echocardiogram','No dyspnea at rest','Serum triglyceride =< 300 mg/dL (applicable only for dose levels that include isotretinoin) (note that a non-fasting triglyceride value could be obtained, if this is > 300 mg/dL then a fasting triglyceride should be obtained and patient will be eligible if the fasting level is =< 300 mg/dL)','=< grade 2 hypercalcemia (applicable only for dose levels that include cis retinoic acid [RA])','Skin toxicity =< grade 1','All post-menarchal females must have a negative beta-human chorionic gonadotropin (HCG); males and females of reproductive age and childbearing potential must use effective contraception for the duration of their participation; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10–14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy','Patients with other ongoing serious medical issues must be approved by the study chair prior to registration','Quantitative serum b-HCG must be negative in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnant or breast-feeding women will not be entered on this study','Breast feeding women are not eligible','Patients who have an active or uncontrolled infection are excluded','Patients with a paraben allergy cannot take isotretinoin preparations containing this compound (i.e. Accutane, Sotret) but are eligible if they can take an alternate preparation without paraben; (applicable only for entry onto dose levels receiving isotretinoin)','Patients with a history of venous or arterial thrombosis personally before the age of 40 years unless associated with a central line','Patients with a history of prior central nervous system (CNS) metastases or skull lesions with intracranial extension will be required to have a head computed tomography (CT) or magnetic resonance imaging (MRI) at study entry demonstrating no active CNS metastases; patients with skull metastases with associated intracranial soft tissue masses will remain eligible','Inability to swallow lenalidomide capsules whole; capsules of 13-isotretinoin may be opened','Patient declines participation in NANT 2004-05; unless the institution has been granted special exemption from mandatory enrollment on NANT 2004-05 by the NANT Operations Center'
NCT01781468,https://www.clinicaltrials.gov/ct2/show/record/NCT01781468?term=NCT01781468&rank=1,'Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month','>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion','Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial','Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician','Ability to complete questionnaire(s) by themselves or with assistance','Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3','Provide informed written consent','Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)','Stable dose of corticosteroid >= 14 days prior to registration','Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception','History of hypersensitivity to other psychostimulants','History of steroid psychosis','History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report','Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed','Anticipating surgery, history of hypothyroidism, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or clinical depression per physician discretion','Active or a history of Tourette’s syndrome or tic disorder','History of or active glaucoma','History of intractable epilepsy, or uncontrolled seizure disorder','Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:\r\n* History of myocardial infarction\r\n* Unstable angina\r\n* Left ventricular hypertrophy\r\n* Mitral valve prolapse syndrome','Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong inhibitors of CYP3A4:\r\n** > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance\r\n** Indinavir (Crixivan)\r\n** Nelfinavir (Viracept)\r\n** Atazanavir (Reyataz)\r\n** Ritonavir (Norvir)\r\n** Clarithromycin (Biaxin, Biaxin XL)\r\n** Itraconazole (Sporanox)\r\n** Ketoconazole (Nizoral)\r\n** Nefazodone (Serzone)\r\n** Saquinavir (Fortovase, Invirase)\r\n** Telithromycin (Ketek)\r\n* Moderate Inhibitors of CYP3A4\r\n** > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance\r\n** Aprepitant (Emend)\r\n** Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE)\r\n** Fluconazole (Diflucan)\r\n** Grapefruit juice\r\n** Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM)\r\n** Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)','Receiving any medications or substances that are inducers of CYP3A4; use of the following inducers are prohibited =< 7 days prior to registration\r\n* Inducers of CYP3A4 \r\n** Efavirenz (Sustiva)\r\n** Nevirapine (Viramune)\r\n** Carbamazepine (Carbatro, Epitol, Equetro, Tegretol, Tegretol-XR)\r\n** Modafinil (Provigil)\r\n** Phenobarbital (Luminal)\r\n** Phenytoin (Dilantin, Phenytek)\r\n** Pioglitazone (Acto)\r\n** Rifabutin (Mycobutin)\r\n** Rifampin (Rifadin)\r\n** St. John’s wort'
NCT01805076,https://www.clinicaltrials.gov/ct2/show/record/NCT01805076?term=NCT01805076&rank=1,'Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded; for patients enrolled after receipt and completion of neoadjuvant chemotherapy, the clinical stage must be determined based on pre-chemotherapy assessment','Patients must have either:\r\n* Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry [IHC] staining) and HER-2 negative breast cancer OR\r\n* ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors\r\n* HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines:\r\n** HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH\r\n** HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH\r\n* For patients enrolling after neoadjuvant therapy, the ER, PR, and HER2 markers are based on assessment prior to initiating neoadjuvant treatment','No patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS)','No patients with bilateral breast cancer','No patients with known deleterious mutations in breast cancer (BRCA) genes','No history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed','Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible','No patients scheduled to receive partial breast irradiation following breast conserving surgery','Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram; women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial; for patients who have neoadjuvant therapy, eligibility for BCT is determined at completion of therapy; repeat mammogram +/- ultrasound (US) will be required at completion of neoadjuvant chemotherapy to determine eligibility for BCT','No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed can be enrolled; for patients with multifocal or multicentric disease enrolled after completion of neoadjuvant chemotherapy, histologic confirmation of multifocality/multicentricity must have been completed before initiation of chemotherapy','Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):\r\n* No history of untreatable claustrophobia\r\n* No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* No history of sickle cell disease\r\n* No contraindication to intravenous contrast administration\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30\r\nmL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration\r\n* Weight lower than that allowable by the MRI table','No prior MRI of study breast within the 12 months prior to registration','Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential','Signed study-specific informed consent prior to registration'
NCT01730937,https://www.clinicaltrials.gov/ct2/show/record/NCT01730937?term=NCT01730937&rank=1,'Patients must have an HCC diagnosis (initial, recurrent, progressive and/or refractory to other therapies) by at least one criterion listed below =< 360 days prior to study entry\r\n* Pathologically (histologically or cytologically) proven diagnosis of HCC\r\n* At least one solid liver lesion or vascular tumor thrombosis (involving portal vein, inferior vena cava [IVC] and/or hepatic vein) > 1 cm with arterial enhancement and delayed washout on multi-phasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis\r\n* For patients whose CURRENT disease is vascular only: enhancing vascular thrombosis (involving portal vein, IVC and/or hepatic vein) demonstrating early arterial enhancement and delayed washout on multi-phasic CT or MRI, in a patient with known HCC (diagnosed previously < 720 days)','Patients must have measureable hepatic disease and/or presence of vascular tumor thrombosis (involving portal vein, IVC and/or hepatic vein) which may not be measureable as per Response Evaluation Criteria in Solid Tumors (RECIST) on liver CT or MRI, within 28 days PRIOR TO STUDY ENTRY','Appropriate for protocol entry based upon the following minimum diagnostic workup:\r\n* History/physical examination including examination for encephalopathy, ascites, weight, height, and blood pressure within 14 days prior to study entry\r\n* Assessment by radiation oncologist and medical oncologist or hepatologist who specializes in treatment of HCC within 28 days prior to study entry\r\n* Pre-randomization scan (REQUIRED for all patients): Within 28 days prior to study entry, CT scan chest/abdomen/pelvis or positron emission tomography (PET) CT chest/abdomen/pelvis with multiphasic liver CT or multiphasic liver magnetic resonance (MR) scan (MRI of abdomen and pelvis with contrast with CT chest) is permitted','Zubrod performance status 0-2 within 28 days prior to study entry','Absolute neutrophil count (ANC) >= 1,500 cells/mm^3; obtained within 14 days prior to study entry','Platelets >= 60,000 cells/mm^3; obtained within 14 days prior to study entry','Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable); obtained within 14 days prior to study entry','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 6 times upper limit of normal (ULN); obtained within 14 days prior to study entry','Serum creatinine =< 1.2 x ULN or creatinine clearance >= 60 mL/min; obtained within 14 days prior to study entry','Patients must have Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 28 days prior to study entry','Child-Pugh score A within 14 days prior to study entry','Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of radiation therapy (RT) and for at least 28 days following the last dose of sorafenib (whichever is later)','Unsuitable for resection or transplant or radiofrequency ablation (RFA)','Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) or drug eluting beads (DEB) for any of the following reasons, as described by Raoul et al (2011):\r\n* Technical contraindications: arteriovenous fistula, including surgical portosystemic shunt or spontaneous portosystemic shunt\r\n* Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion\r\n* Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease\r\n* Presence of extrahepatic disease\r\n* No response post TACE (or DEB) or progressive HCC despite TACE; prior TACE or DEB is allowed but must be > 28 days from study entry\r\n* Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be > 28 days from study entry\r\n* Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age > 80 years, tumor > 10 cm, > 50% replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage)','Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria','Patient must be able to provide study-specific informed consent prior to study entry','Prior invasive malignancy (except non-melanomatous skin cancer and T1 renal cell carcinoma) unless disease free for a minimum of 2 years (note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Prior sorafenib use > 60 days and/or grade 3 or 4 sorafenib related toxicity; note that prior chemotherapy for HCC or a different cancer is allowable','Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields','Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration\r\n* Transmural myocardial infarction within the last 6 months prior to study entry\r\n* Unstable ventricular arrhythmia within the last 6 months prior to study entry\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\r\n* Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry\r\n* Bleeding within 28 days prior to study entry due to any cause, requiring transfusion\r\n* Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted\r\n* Known bleeding or clotting disorder\r\n* Uncontrolled psychotic disorder','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Maximal diameter of any one hepatocellular carcinoma > 15 cm','Total sum of maximum diameters of each definite parenchymal hepatocellular carcinomas within the liver or maximum diameter of a single conglomerate HCC > 20 cm','More than 5 discrete intrahepatic parenchymal foci of definite HCC','Direct tumor extension into the stomach, duodenum, small bowel or large bowel','Measureable common or main branch biliary duct involvement with HCC','Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm','Prior liver transplant','Human immunodeficiency virus (HIV) positive with CD4 count < (350) cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= (350) cells/microliter, and no known detectable viral load, at the time of study entry; note also that HIV testing is not required for eligibility for this protocol'
NCT01349881,https://www.clinicaltrials.gov/ct2/show/record/NCT01349881?term=NCT01349881&rank=1,'STEP 0: REGISTRATION (Optional)','Patients with a primary colon or rectal cancer resection who are potentially eligible for S0820 may be pre-registered at Step 0; patients registered to Step 0 will appear on an institutional patient tracking report; patients registered to Step 0 are not registered to the S0820 protocol; to participate in S0820, patients must be registered to Step 1 after patient is consented and evaluation of eligibility; patients registered to S0820 at Step 0 continuing to Step 1 registration must use the same Southwest Oncology Group (SWOG) patient identification (ID) for registration to S0820 Step 1','STEP 1: REGISTRATION','Patients must have a history of stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy; adjuvant chemotherapy and radiation therapy (RT) treatment must have been completed at least 30 days prior to registration','Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection); the definition of resection does not include endomucosal resection (EMR); patients that have received total proctocolectomy are ineligible\r\n* In addition to segmental resections, the following types of procedures are allowed: polypectomy: for Tis (stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:\r\n** Single specimen, completely removed\r\n** Clear margins\r\n** None of the following must be present:\r\n*** Moderate or poor differentiation\r\n*** Lymphovascular invasion\r\n*** Perineural invasion\r\n* Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if National Comprehensive Cancer Network (NCCN) criteria for transanal excision are met, as stipulated here:\r\n** < 30% circumference of bowel\r\n** < 3 cm in size\r\n** Margin clear (> 3 mm)\r\n** Mobile, nonfixed\r\n** Within 8cm of anal verge\r\n** T1 only\r\n** Endoscopically removed polyp with cancer\r\n** No lymphovascular invasion or perineural invasion\r\n** Well to moderately differentiated\r\n** No evidence of lymphadenopathy on pretreatment imaging\r\n***When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used; TEM for more proximal lesions may be technically feasible','Patients must be registered between 180 days and 465 days (inclusive) of primary resection; patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and computed tomography (CT) scans* of chest, abdomen and pelvis (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration); patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed\r\n* CT scan is for high risk patients, as per National Comprehensive Cancer Network (NCCN) guidelines and at the discretion of the treating physician\r\n* NOTE: magnetic resonance imaging (MRI) evaluation is an acceptable alternative to CT scans for eligibility purposes','Patients must not have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery, or New York Heart Association class III or IV heart failure; patients must not have known uncontrolled hyperlipidemia (defined as low-density lipoprotein cholesterol [LDL-C] >= 190 mg/dL or triglycerides >= 500 mg/dL) within the last 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration','Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease','Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration; patients with hearing loss > 40 dB in any of the five tested frequencies (250 Hertz [Hz], 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones; Note: sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study','Patients must not have known hypersensitivity to eflornithine or sulindac or the excipients byproducts; patients must not have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal antiinflammatory drugs (NSAIDs)','Patients must not have documented history of gastric/duodenal ulcer within the last 12 months; participant must not currently be on treatment for gastric/duodenal ulcer or be experiencing symptoms at study entry; patients with gastroesophageal reflux disease (GERD) are eligible, however, and these patients may receive over-the-counter histamine-2 (H2) antagonists; proton-pump inhibitors, or other prescription-based treatment for GERD','Patients must have a Zubrod performance status of 0-1','Patients must not be expecting to receive radiation or additional chemotherapy','Patients must not be receiving or plan to receive concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; (NSAID use may not exceed 10 days per month); patients may receive daily aspirin for cardiovascular prophylaxis as long as acetylsalicylic acid (ASA) is =< 100 mg per day or =< two 325 mg tablets per week','Patients must have the ability to swallow oral medication','Patients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registration','Total white blood cells (WBC) >= 4.0 x 10^3/mcL','Platelets >= 100,000/mcL','Hemoglobin > 11.0 g/dL','Serum bilirubin =< 2.0 mg/dL','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x IULN (institutional upper limit of normal)','Serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration','No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA','Patients must be offered the option to participate in submission of specimens for banking for future translational medicine studies','Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis','Patients must be offered the option to participate in the Diet and Lifestyle Substudy','REGULATORY CRITERIA','Individuals must not currently be participating in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only; patients must also agree not to join such a trial while participating in this study','All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT01789684,https://www.clinicaltrials.gov/ct2/show/record/NCT01789684?term=NCT01789684&rank=1,'SITE INCLUSION CRITERIA:','Providing surgical treatment for newly diagnosed breast cancer patients','Minimum provider participation requirements met; this includes participation in the study intervention of a minimum of the following: Site Coordinator and Site Clinician Investigator/study champion','Site Coordinator identification and contact with as many as possible of the site’s relevant healthcare providers and staff regarding participation in the study intervention; relevant providers may include physicians, nurse practitioners, physician assistants, patient navigators, nurses and other staff who interact directly with breast cancer patients','PATIENT INCLUSION CRITERIA:','Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including in situ and invasive cancer, stages 0 – III; pathologic confirmation of diagnosis is required','Able to read and write in English or Spanish','SITE EXCLUSION CRITERIA:','On-site genetics professionals as defined by the Commission on Cancer','PATIENT EXCLUSION CRITERIA:','Any previous diagnosis of cancer except for non-melanoma skin cancer','Stage IV breast cancer','Received HBOC genetic counseling or mutation testing prior to diagnosis; if the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible','The SunCoast Community Clinical Oncology Program (CCOP) Research Base does not exclude patients who are participating in other investigational studies; refer to the local Institutional Review Board (IRB) guidelines'
NCT01863550,https://www.clinicaltrials.gov/ct2/show/record/NCT01863550?term=NCT01863550&rank=1,'STEP I: Patients must be diagnosed with symptomatic standard-risk multiple myeloma (SR-MM) as defined by all of the following (except gene expression profile [GEP]70 status if unknown):\r\n* No evidence of t(14;16) by fluorescence in situ hybridization (FISH) testing on bone marrow or not available\r\n* No evidence of t(14:20) by FISH testing on bone marrow or not available\r\n* No evidence of deletion 17p by FISH testing on bone marrow\r\n* FISH should be from within 90 days of registration\r\n** NOTE: If the FISH result states that no immunoglobulin heavy chain (IgH) abnormality is present, both t(14;16) and t(14;20) can be considered negative; in addition, if the patient has a t(11;14) or t(4;14) translocation present, they can be considered negative for t(14;16) and t(14;20); if testing for t(14;16) or t(14;20) could not be performed for lack of sufficient material or non-availability of the probe in the test panel, patients can be enrolled on the study\r\n* Standard Risk GEP70 signature within the past 90 days (only if GEP has been done and results are available)\r\n** NOTE: GEP testing is NOT a requirement for the study; if the test has been done, patients found to have a GEP70 status of high-risk will not be eligible\r\n* Serum lactate dehydrogenase (LDH) =< 2 x upper limit of normal (ULN) within the past 28 days\r\n* No more than 20% circulating plasma cells on peripheral blood smear differential or 2,000 plasma cells/microliter on white blood cell (WBC) differential of peripheral blood within the past 90 days\r\n** NOTE: This is NOT the plasma cell % from the marrow aspirate','STEP I: Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:\r\n* >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis\r\n* >= 200 mg/24 hours (hrs) of monoclonal protein on a 24 hour urine protein electrophoresis\r\n* Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)\r\n* Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)\r\n* Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay are required to be performed within 28 days prior to randomization; a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response\r\n** NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr; please note that if both serum and urine M-components are present, both must be followed in order to evaluate response\r\n** NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL; measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr','STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization)','STEP I: Untransfused platelet count >= 75,000 cells/mm^3 (obtained within 28 days prior to randomization)','STEP I: Absolute neutrophil count >= 1000 cells/mm^3 (obtained within 28 days prior to randomization)','STEP I: Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior to randomization)','STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)','STEP I: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 2.5 times the upper limit of normal (obtained within 28 days prior to randomization)','STEP I: Patients must have received no more than one cycle (4 weeks or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma; they should not have been exposed to lenalidomide, bortezomib or carfilzomib for treatment of symptomatic myeloma; prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts that meet the study requirements','STEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted','STEP I: Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months','STEP I: Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome','STEP I: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (performance status [PS] 3 allowed if secondary to pain)','STEP I: Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible','STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0','STEP I: Patients must not have active, uncontrolled infection','STEP I: Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation','STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months','STEP I: Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast are not excluded)','STEP I: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide throughout the entire duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; female subjects must agree to use contraception or abstinence for 30 days after last dose of carfilzomib\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months','STEP I: Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 28 days after stopping lenalidomide; male subjects must also agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from lenalidomide; male subjects must be willing to use condoms for 90 days after discontinuation of carfilzomib','STEP I: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women','STEP I: Human immunodeficiency virus (HIV) infection is not excluded; known HIV positive patients must meet the following criteria:\r\n* Cluster of differentiation (CD)4 cell count >= 350/mm^3\r\n* No history of acquired immune deficiency syndrome (AIDS)-related illness\r\n* Not currently prescribed zidovudine or stavudine','STEP I: Patient enrolling to this study must agree to register to the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist','STEP II: Patients must have complete induction without experiencing progression or patients must have received at least 6 cycles on Arm A and 4 cycles on Arm B but stopped induction therapy due to adverse events','STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy','STEP II: Patients must not have received any non-protocol therapy outside of the assigned induction therapy including stem cell transplant','STEP II: ECOG performance status 0, 1, or 2 (PS 3 allowed if secondary to pain)','STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or less','STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II)','STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II)','STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II)','STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II)','STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)','STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II)','STEP II: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide throughout the entire duration of study treatment, and for 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months','STEP II: Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 28 days after stopping lenalidomide; male subjects must also agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from lenalidomide; males must agree to use contraception and agree to not donate sperm for at least 90 days after the last day of carfilzomib','STEP II: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women','STEP II: Patient enrolling to this study must agree to register to the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist'
NCT01749397,https://www.clinicaltrials.gov/ct2/show/record/NCT01749397?term=NCT01749397&rank=1,'Histologically confirmed epithelial ovarian, primary peritoneal or fallopian tube malignancy that is metastatic and for which standard curative measures do not exist','Disease confined to the intraperitoneal and retroperitoneal cavity; Note: nodal disease below the diaphragm, implants adherent to the surface of the liver or intrahepatic lesions will not be exclusionary; patients remain eligible if all intrahepatic tumor is debulked or ablated by the time treatment is initiated','EXPANSION PHASE ONLY: Evaluable or measurable disease with the largest nodule measuring less than 5 cm in greatest dimension by radiographic imaging after debulking procedure','Candidate for and willingness to have a surgically placed intraperitoneal catheter and tissue acquisition at the time of port placement; note: if an intraperitoneal catheter is already in place, a tumor biopsy will still be required; a guided core-needle biopsy is sufficient in these cases','Able to swallow and absorb the medication','Obtained =< 7 days prior to registration: Absolute neutrophil count (ANC) >= 1500/mm^3','Obtained =< 7 days prior to registration: Platelets (PLT) >= 100,000/mm^3','Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Obtained =< 7 days prior to registration: Creatinine =< 1.5 x institutional ULN','Obtained =< 7 days prior to registration: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional ULN','Obtained =< 7 days prior to registration: Hemoglobin (Hgb) > 9.0 mg/dl','Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2','Ability to provide informed written consent','Life expectancy >= 12 weeks','Women of childbearing potential only: negative pregnancy test done =< 7 days prior to registration','Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy; note: patients with recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube will be allowed, if the investigator believes the study treatment is a better alternative to initiation platinum-based chemotherapy, such as patients with a prior platinum allergy or low volume disease for whom platinum-based therapy is deferred until a later date','More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other ‘targeted’ agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Any of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) =< 28 days prior to registration\r\n* Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy','Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment','Significant cardiovascular disease defined as congestive heart failure (New York Heart Association class III or IV cardiac disease), angina pectoris requiring nitrate therapy or recent myocardial infarction (=< 6 months prior to registration)','Metastatic disease outside the intraperitoneal cavity and retroperitoneum, intrahepatic lesions, or pleural effusions; significant ascites precluding catheter placement; exception: intrahepatic lesions removed or planning to be removed during the debulking procedure','Any of the following:\r\n* Nursing women\r\n* Pregnant women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception (non-barrier method)','Immunocompromised patients (other than that related to the use of corticosteroids) with the exception of patients known to be human immunodeficiency virus (HIV) positive and have a cluster of differentiation 4 (CD4) count > 400 and do not require antiretroviral therapy','Receiving any other investigational agent that would be considered a treatment for the primary neoplasm','Other active malignancy =< 1 year prior to registration\r\n* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer'
NCT01806129,https://www.clinicaltrials.gov/ct2/show/record/NCT01806129?term=NCT01806129&rank=1,'Female patients presenting with initial diagnosis of any type of cancer','Patients must not have initiated chemotherapy or radiation prior to registration to this study','Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of any method','Patients must be pre-menopausal patients within the reproductive age range','Please note, pre-menopausal will be defined as women meeting the following criteria:\r\n* Patients not currently on hormonal contraception with the presence of menses in the past 6 months\r\n* If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23 mlU/mL\r\n* If age < 47 years and on hormonal contraception then patient will be eligible regardless of menstrual history\r\n* If age >= 47 years and on hormonal contraception then FSH confirmed < 23 mIU/mL','Pregnant women are eligible to participate in this study','Patients must have the cognitive ability to participate in the study'
NCT01586403,https://www.clinicaltrials.gov/ct2/show/record/NCT01586403?term=NCT01586403&rank=1,'Patients must have a diagnosis of metastatic melanoma which is measurable either clinically or radiologically','Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines','Patients must have a performance status of 0 or 1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) scale','The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time','Patients’ melanoma must be positive for both tyrosinase and human leukocyte antigen (HLA)-A2 per Loyola University Medical Center pathologic review from fine needle aspiration (FNA)/core/excisional biopsy of lesion','Cardiac ejection fraction >= 50% as determined by screening echocardiogram','Patients that have undergone treatment with anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) antibody must have at least 3 months from last dose of CTLA-4 antibody before they can be enrolled into this study','The patients BRAF mutation status at position 600 must be known prior to enrollment; patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have been offered an approved BRAF inhibitor or MEK inhibitor therapy and refused','Patients treated with prior Interleukin-2 will be allowed to be in this study','Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable','ECOG performance status of 2 or greater','Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior six months that was not controlled with surgery or radiotherapy','Patients taking steroids for disease control or pain management','Patients must not be pregnant or nursing because of the potentially harmful effects of these agents on a developing fetus; women/men of reproductive potential must have agreed to use an effective contraceptive method','Patients whose BRAF V600E mutation status is unknown, have the BRAF V600E mutation and are responding to a BRAF inhibitor or MEK inhibitor therapy, or have the BRAF V600E mutation and have not been offered the option of receiving a BRAF inhibitor or MEK inhibitor therapy for the treatment of their melanoma','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years','Patients that have undergone Tyrosinase immunotherapy','Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy','Absolute neutrophil count < 1.5 x 10^9/L','Platelet count < 100 x 10^9/L','Serum bilirubin > 1.5 x upper limit of normal (ULN)','Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 x ULN','Serum alkaline phosphatase (ALP) > 2 x ULN','Serum Albumin < 2.5 g/dL','International Normalized Ratio (INR) > 1.5','Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (< 50mL/min)','Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics','Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound healing, ulcer or bone fracture)','Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start','Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)','Known hypersensitivity to any of the components of the study drugs','Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'
NCT01755195,https://www.clinicaltrials.gov/ct2/show/record/NCT01755195?term=NCT01755195&rank=1,'Patients must have histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable and for which standard treatment that prolongs survival does not exist or is no longer effective','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients are allowed prior VEGFR-tyrosine kinase inhibitor (TKI); patients will be stratified based on prior VEGFR-TKI therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky > 70%)','Life expectancy > 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 times upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Hemoglobin >= 9 g/dL','Serum albumin >= 2.8 g/dL','Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis','Urine protein/creatinine ratio (UPCR) =< 1','Serum phosphorus calcium, magnesium and potassium >= lower limit of normal (LLN)','Subjects must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the average of three BP readings at the time of enrollment is =< 140/90 mmHg','Patients must be able to swallow whole tablets; tablets must not be crushed or chewed','Women of child-bearing potential and men must agree to use adequate contraception; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s); sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used','Ability to understand and the willingness to sign a written informed consent document','Patients who have had anticancer therapy, including kinase inhibitors or any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to baseline from adverse events (except alopecia and other non-clinically significant adverse events [AEs]); patients who have received prior cabozantinib or inhibitors of c-MET or HGF are ineligible','The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment','The subject has received radiation therapy within 4 weeks (=< 2 weeks for palliative radiation therapy)','Patients with active brain metastases or carcinomatous meningitis or epidural disease are excluded from this clinical trial; subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation who are asymptomatic and have remained stable for 4 weeks and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility','Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of cabozantinib will be determined following review of their cases by the principal investigator; patients who are taking enzyme-inducing anticonvulsant agents are not eligible','Patients with refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that could interfere with absorption','Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib','Strong inhibitors and inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be avoided whenever possible or switched to alternatives; subjects requiring chronic concomitant treatment of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort) are not eligible for this study','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted (please note that there may be cases in which patients on study require anticoagulation for deep vein thrombosis [DVT]/pulmonary embolism [PE] management; this does not necessitate taking the patient off study)','The subject has experienced any of the following\r\n* Clinically-significant gastrointestinal bleeding within 3 months before the first dose of study treatment; the participant must be maintained on a prophylactic regimen for management of an upper gastrointestinal (GI) bleeding event with no evidence of recurrence and/or endoscopic confirmation of resolution of the source of a lower GI bleed\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment','The subject has radiographic evidence of cavitating pulmonary lesion(s)','The subject has tumor invading or encasing any major blood vessels','The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib','The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: \r\n* Cardiovascular disorders including: \r\n** Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening \r\n** Concurrent uncontrolled hypertension defined as sustained BP > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment \r\n** Any history of congenital long QT syndrome \r\n** Any of the following within 6 months before the first dose of study treatment: \r\n*** Unstable angina pectoris \r\n*** Clinically-significant cardiac arrhythmias \r\n*** Stroke (including transient ischemic attack [TIA], or other ischemic event) \r\n*** Myocardial infarction \r\n*** Thromboembolic event requiring therapeutic anticoagulation (note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)\r\n* Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: \r\n** Any of the following within 28 days before the first dose of study treatment\r\n*** Intra-abdominal tumor/metastases invading GI mucosa \r\n*** Active peptic ulcer disease\r\n*** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis \r\n*** Malabsorption syndrome \r\n** Any of the following within 6 months before the first dose of study treatment: \r\n*** Abdominal fistula \r\n*** Gastrointestinal perforation \r\n*** Bowel obstruction or gastric outlet obstruction \r\n*** Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment\r\n* Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy \r\n* Other clinically significant disorders such as: \r\n** Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment \r\n** History of organ transplant, including allogeneic bone marrow transplant \r\n** Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment \r\n** History of major surgery as follows:\r\n*** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications \r\n*** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications \r\n** In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery','The subject is unable to swallow tablets','The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before enrollment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard','The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee','The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment','Patients should not have any clinical evidence of an active infection at the time of enrollment'
NCT01767194,https://www.clinicaltrials.gov/ct2/show/record/NCT01767194?term=NCT01767194&rank=1,'Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e., > 2 x upper limit of normal [ULN]), at the time of initial diagnosis','For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:\r\n* First episode of recurrent disease following completion of aggressive multi-drug frontline therapy\r\n* First episode of progressive disease during aggressive multi-drug frontline therapy\r\n* Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, etc.)','Patients must have at least ONE of the following:\r\n* Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan obtained within 3 weeks prior to study entry; measurable is defined as >= 10 mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose (FDG) uptake on positron emission tomography (PET) scan\r\n* MIBG scan obtained within 3 weeks prior to study entry with positive uptake at a minimum of one site; this site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction\r\n* Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma; biopsy is not required for patients who have new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy\r\n* Note: Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease','At least 14 days must have elapsed since completion of myelosuppressive therapy','At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid','No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions; however, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response; lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma; palliative radiation is allowed to sites that will not be used to measure response during this study','Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions as long as hematologic and other eligibility criteria have been met','Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met','Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible','Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days of entry on this study; seven days must have elapsed since administration of a short acting myeloid growth factor','Peripheral absolute neutrophil count (ANC) >= 750/uL','Platelet count >= 75,000/uL (transfusion independent)','Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and platelet count criteria are met but are not evaluable for hematological toxicity','Creatinine clearance or estimated radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or','A serum creatinine =< upper limit of normal (ULN) based on age/gender as follows:\r\n* Age 1 month to < 6 months: 0.4 for males, 0.4 for females\r\n* Age 6 months to < 1 year: 0.5 for males, 0.5 for females\r\n* Age 1 to < 2 years: 0.6 for males, 0.6 for females\r\n* Age 2 to < 6 years: 0.8 for males, 0.8 for females\r\n* Age 6 to < 10 years: 1 for males, 1 for females\r\n* Age 10 to < 13 years: 1.2 for males, 1.2 for females\r\n* Age 13 to < 16 years: 1.5 for males, 1.4 for females\r\n* Age >= 16 years: 1.7 for males, 1.4 for females','Total bilirubin =< 1.5 x ULN for age AND','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L); for the purpose of this study, the ULN for SGPT is 45 U/L','Adequate central nervous system function defined as:\r\n* Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of study enrollment\r\n* Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsants\r\n* CNS toxicity =< grade 2','Shortening fraction of >= 27% by echocardiogram (ECHO) OR','Ejection fraction >= 50% by ECHO or gated radionuclide study','Adequate coagulation defined as:\r\n* Prothrombin time (PT) =< 1.2 x upper limit of normal','Adequate pulmonary function defined as:\r\n* No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry; normal pulmonary function tests in patients who are capable of cooperating with testing (including diffusion capacity of the lung of carbon monoxide [DLCO]) are required if there is a clinical indication for determination; for patients who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT required','Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study; female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study','Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study','Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment; patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions; the use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency','Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, valproic acid, or carbamazepine for at least 7 days prior to study enrollment; patients receiving non-enzyme inducing anticonvulsants such as gabapentin or levetiracetam will be eligible','Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma','Patients with symptoms of congestive heart failure are not eligible','Patients must not have >= grade 2 diarrhea','Patients must not have uncontrolled infection','Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of the anti-GD2 therapy are not eligible','Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible'
NCT01089101,https://www.clinicaltrials.gov/ct2/show/record/NCT01089101?term=NCT01089101&rank=1,'Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration','All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration','Patients must start therapy within 7 calendar days of registration','Laboratory values must be no older than seven (7) days prior to the start of therapy; if a test that is repeated after registration and prior to therapy is outside the limits for eligibility, it must be rechecked within 48 hours prior to the start of therapy; if laboratory values still fail to meet eligibility criteria, the patient may not receive protocol therapy','All patients must meet the following inclusion and exclusion criteria; NO EXCEPTIONS WILL BE GIVEN','Participant is willing to sign a screening consent and provide pre-trial tumor material for BRAF testing (both for BRAF V^600E mutation and BRAF KIAA1549 fusion assessments)\r\n* All patients who are candidates for enrollment in stratum 5 based on their tumor histology must be pre-screened\r\n* Screening may be applied to potential stratum 1 and 2 patients','Patients whose prior BRAF testing was performed at another lab (Clinical Laboratory Improvement Amendments [CLIA]/College of American Pathologist [CAP] certified or otherwise) must send additional tumor material to Brigham and Women's Hospital (BWH) for confirmation; however, to preserve available tumor material, patients whose tumor material has previously undergone BRAF analysis at the Lindeman and Ligon Labs at Brigham and Women’s Hospital using the same procedures as described in this protocol, will not be required to submit additional tumor material for analysis; these patients must have both the BRAFV600E mutation and BRAF KIAA1549 fusion assessments done and if only one test was previously conducted; additional tissue will be required for the second test','Patient must have one of the following: \r\n* For stratum 5: non NF-1 associated low grade glioma (LGG) (other than pilocytic astrocytoma or optic pathway glioma) \r\n* For stratum 1 or 2: non NF-1, non-optic pathway pilocytic astrocytoma; note: all patients with non NF-1 associated optic pathway glioma with or without tissue must be enrolled on stratum 4','Patients with sporadic (non NF-1 associated), histologically diagnosed progressive, recurrent or refractory non-optic pathway pilocytic astrocytoma who have pre- treatment tumor tissue available for BRAF analysis','NF-1 patients with radiographic evidence of a progressive, recurrent or refractory low grade glioma, with or without pre-treatment tumor tissue','Patients with progressive, recurrent or refractory optic pathway glioma, with or without pre-treatment tumor tissue','Patients with histologically diagnosed progressive, recurrent or refractory non NF-1 associated LGG (other than pilocytic astrocytoma or optic pathway glioma); these patients must have BRAF aberrations as documented by the Lindeman and Ligon Labs at Brigham and Women’s Hospital using the same procedures','Patients will be assigned to one of 6 strata prior to enrollment; all BRAF assessments used for stratification below must be done at the Lindeman and Ligon Labs at Brigham and Women’s Hospital using the same procedures as described in this protocol; assessments for both BRAF V^600E mutation and BRAF KIAA1549 fusion are required for patients who will enroll on strata 1, 2 and 5 \r\n* Stratum 1: patients with non NF-1 associated progressive, recurrent or refractory pilocytic astrocytoma with pre-trial tumor material available and with a BRAF aberration i.e. BRAFV^600E mutation and/or BRAF KIAA1549 fusion as determined by IHC and FISH, respectively; patients with optic pathway glioma are excluded\r\n* Stratum 2: patients with non NF-1 associated progressive, recurrent or refractory pilocytic astrocytoma with pre-trial tumor material available and without a BRAF aberration i.e. BRAF^V600E mutation and/or BRAF KIAA1549 fusion as determined by IHC and FISH, respectively; patients with optic pathway glioma are excluded\r\n* Stratum 3: patients with neuro-fibromatosis 1 (NF-1) associated progressive, recurrent or refractory low grade glioma (World Health Organization [WHO] grade I & II), with or without tissue\r\n* Stratum 4*: patients with non-NF1 associated progressive, recurrent or refractory optic pathway glioma with or without tissue available for BRAF evaluation\r\n* Stratum 5: patients with non NF-1 associated progressive, recurrent or refractory low grade glioma other than pilocytic astrocytoma or optic pathway glioma with a documented BRAF aberration identified in pre-trial tumor material\r\n* Stratum 6: patients with non-NF-1 associated progressive, recurrent or refractory low grade glioma (other than optic pathway glioma [OPG]) with tissue available for BRAF analyses who cannot be classified into stratum 1, 2 or 5 due to inadequate tissue quality, assay failure, etc\r\n**Clarification: Stratum 4 was specifically designed for patients with hypothalamic/optic pathway gliomas; the intent is that if there is any optic chiasm invasion regardless of where the tumor is originating from (chiasm vs. hypothalamus vs. other location), the patient should be enrolled on Stratum 4, regardless of whether the tumor has been biopsied or not; obviously, there are some tumors that include part of the hypothalamus and clearly do NOT include the chiasm at all; in these situations, and if the tumor is a biopsy proven pilocytic astrocytoma, these patients should be enrolled on Stratum 1 or 2 (depending upon BRAF status)','Patients must have bi-dimensionally measurable disease defined as at least one lesion that can be accurately measured in at least two planes in order to be eligible for this study','Patients must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry','Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if nitrosourea','Patient must have received their last dose of the biologic agent >= 7 days prior to study registration\r\n* For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration','Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration','Radiation: patients must have:\r\n* Had their last fraction of local irradiation to primary tumor >= 12 months prior to registration; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression\r\n* Had their last fraction of craniospinal irradiation (> 24 Gy) > 3 months prior to registration','Corticosteroids: patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration','Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations','Patients must have a body surface area (BSA) >= 0.55 m^2','Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration','Patients must be able to swallow capsules','Karnofsky performance scale (KPS for > 16 years [yrs.] of age) or Lansky performance score (LPS for =< 16 years of age) >= 60 assessed within two weeks prior to registration','Absolute neutrophil count >= 1,000/uL (unsupported), within 14 days of registration and within 7 days of the start of treatment','Platelets >= 100,000/L (unsupported), within 14 days of registration and within 7 days of the start of treatment','Hemoglobin >= 8 g/dL (may be supported), within 14 days of registration and within 7 days of the start of treatment','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal for age, within 14 days of registration and within 7 days of the start of treatment','Total bilirubin < 1.5 times upper limit of normal for age, within 14 days of registration and within 7 days of the start of treatment','Albumin >= 3 g/dL, within 14 days of registration and within 7 days of the start of treatment','Serum sodium and potassium within the institutional limits of normal, within 14 days of registration and within 7 days of the start of treatment','Serum calcium and magnesium above the institutional lower limit of normal, within 14 days of registration and within 7 days of the start of treatment','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73m^2 or a serum creatinine based on age as follows, within 14 days of registration and within 7 days of the start of treatment:\t\t\t\r\n* =< 5 years: 0.8 mg/dL\r\n* > 5 years but =< 10 years: 1 mg/dL\r\n* > 10 years but =< 15 years: 1.2 mg/dL\r\n* > 15 years: 1.5 mg/dL','Left ventricular ejection fraction (LVEF) >= 55%','Corrected QT (QTc) interval =< 450 msecs','Hypertension:\r\n* Patients, 3-17 years of age must have a blood pressure that is =< 95th percentile for age, height and gender at the time of registration\r\n** The normal blood pressure by height, age and gender tables can be accessed in the Generic Forms section of the Pediatric Brain Tumor Consortium (PBTC) members’ webpage\r\n* Patients who are >= 18 years of age must have a blood pressure that is < 140/90 mm of Hg at the time of registration\r\n* Note: if a blood pressure (BP) reading prior to registration is above the 95th percentile for age, height and gender it must be rechecked and documented to be =< the 95th percentile for age, height and gender prior to patient registration','Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for four weeks after dosing with AZD6244 ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle','Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines','Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), likely interfere with the study procedures or results','Patients who are receiving any other anticancer or investigational agents','Patients with uncontrolled seizures','Previous mitogen-activated protein kinase kinase (MEK) inhibitor use such as PD-0325901; CI1040; AS73026; GDC 0973; ARRY43182; GSK110212','Prior treatment with a BRAF inhibitor such as vemurafenib or dabrafenib (previous treatment with sorafenib is allowed)','Patients with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) that meets New York Heart Association (NYHA) class II or above','Required use of a concomitant medication that can prolong the QT interval','History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244','ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY','Patients must have recurrence or progression of their low-grade glioma after coming off treatment with AZD6244 on PBTC-029 or PBTC-029B, with or without having received additional anti-tumor therapy following discontinuation of AZD6244; the progression must be unequivocal and sufficient to warrant re-treatment in the opinion of the investigator; progression will be defined as either progressive disease (PD) that meets the study definitions of progressive disease by MRI or vision deterioration thought to be related to tumor in patients with optic pathway tumors','Patients must have received treatment on PBTC-029 or PBTC-029B for a minimum of 12 courses with at least stable disease, or had a sustained response (partial response [PR]/ complete response [CR]) but remained on treatment < 12 courses','Patients must have bi-dimensionally measureable disease defined as at least one lesion that can be accurately measured in at least two planes','Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to registration on the Re-treatment Study or at least six weeks if a nitrosourea\r\n* Biologic agent: Patient must have received their last dose of the biologic agent >= 7 days prior to study registration; for biologic agents and monoclonal antibody treatment, at least three half-lives must have elapsed prior to registration\r\n* Other investigational agents (not fitting into one of the above specified categories): patients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment\r\n* Radiation: Patients must have:\r\n** Had their last fraction of local irradiation to the primary tumor >= 12 months prior to registration; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression;\r\n** Had their last fraction of craniospinal irradiation (> 24Gy) > 3 months prior to registration\r\n* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration\r\n* Growth factors: Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations'
NCT01872975,https://www.clinicaltrials.gov/ct2/show/record/NCT01872975?term=NCT01872975&rank=1,'The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines','The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1','Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan','Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted','Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing','Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible','Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen','For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: it is preferred that all intended chemotherapy be administered in the neoadjuvant setting','Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated','At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:\r\n* Axillary node dissection\r\n* Sentinel node biopsy alone provided that at least 2 sentinel lymph nodes are removed; removal of at least 3 sentinel lymph nodes and use of dual tracer for lymphatic mapping are strongly recommended or\r\n* Sentinel node biopsy followed by axillary node dissection\r\nNote: patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an National Cancer Institute (NCI) Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study','Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible','Patient who have undergone either a total mastectomy or a lumpectomy are eligible; (patients who have had a nipple-sparing mastectomy are eligible)','For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)','For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor','The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days','The patient must have recovered from surgery with the incision completely healed and no signs of infection','If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved','Definitive clinical or radiologic evidence of metastatic disease','T4 tumors including inflammatory breast cancer','Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone','N2 or N3 disease detected clinically or by imaging','Patients with histologically positive axillary nodes post neoadjuvant therapy','Patients with microscopic positive margins after definitive surgery','Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)','Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)','History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization','Any radiation therapy for the currently diagnosed breast cancer prior to randomization','Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization','Prior breast or thoracic radiation therapy (RT) for any condition','Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma','Pregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)','Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up','Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements'
NCT01771107,https://www.clinicaltrials.gov/ct2/show/record/NCT01771107?term=NCT01771107&rank=1,'HIV positive; documentation of HIV-1 infection by means of any one of the following:\r\n* Documentation of HIV diagnosis in the medical record by a licensed health care provider;\r\n* Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider;\r\n* HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;\r\n* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay\r\n* NOTE: A “licensed” assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies','Histologic diagnosis of CD30-positive classical HL as defined by the 2008 World Health Organization (WHO) Classification of Hematological diseases; nodular lymphocyte predominant Hodgkin lymphoma is not eligible','Stage II, III or IV disease as defined by the Ann Arbor Staging System','Participants must have previously untreated HIV-classical HL (cHL), with the exception of up to 14 consecutive days of steroids, emergency radiation, or 1 prior cycle of cyclophosphamide to reduce tumor burden and improve hyperbilirubinemia in the setting of lymphoma related liver involvement','Normal baseline cardiac ejection fraction >= 50%','Serum creatinine of =< 1.5 mg/dL; if creatinine > 1.5 mg/dL, creatinine clearance must be >= 60 mL/minute','Absolute neutrophil count (ANC) >= 1000/uL','Platelets >= 75,000/uL unless related to bone marrow involvement by HIV-cHL','Total bilirubin must be < 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert’s syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established','Female participants must have a negative pregnancy test within 1 week of enrollment and all participants must agree to use two reliable methods of contraception simultaneously if conception is possible during the study and for 6 months after stopping treatment; should a woman subject become pregnant or suspect she is pregnant while the subject is participating in this study, she should inform her treating physician immediately; the participant will then be removed from protocol therapy; participants who father a child while participating in the study will be permitted to continue with the protocol; the participant, however, is required to notify the investigator if he fathers a child','Ability to understand and the willingness to sign a written informed consent document','Karnofsky performance status > 30% (given the aggressiveness of this disease and the often severely debilitated nature of the patients at initial presentation)','Measurable or non-measurable (evaluable) tumor parameter(s); non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy','Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible','CD4 count >= 50 cells/ul','Participants are required to be on antiretroviral regimens that are in accordance with the current International Acquired Immune Deficiency Syndrome (AIDS) Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), cobicistat, didanosine (Videx or Videx EC), or similar potent cytochrome P450 (CYP)3 inhibitors are prohibited; in order to be eligible, participants taking zidovudine or ritonavir, or cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation; changes to HAART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.); participants must be on HAART at least 7 days prior to therapy','Negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy; all participants will be required to be screened for hepatitis B; per Infectious Disease Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antigen antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen [HBsAg]+, hepatitis B core [HBcore]+, hepatitis B surface antibody [HBsAB]-) will be required to be on anti-hepatitis B therapy during the study in order to be eligible; patients will be permitted to enroll in the study provided normal liver function tests and no evidence of cirrhosis; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; however all patients who present with acute hepatitis B or show normal transaminases and are hepatitis B virus HBsAg surface protein antigen (HBsAg) positive (+) and immunoglobulin M (IgM)+ for hepatitis core antigen will not be eligible for trial enrollment','Patients diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests','Participants must discontinue use of the following agents within 7 days prior to therapy\r\n* Strong CYP3A4 inhibitors that treat HIV\r\n* Other strong CYP3A inhibitors\r\n* Moderate CYP3A4 inhibitors should be used with caution but are not excluded; if 2 moderate CYP3A4 inhibitors are used concurrently, one must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy\r\n* P-glycoprotein inhibitors\r\n* If patients are taking any of these excluded medications, they must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy\r\nAll concomitant medications must be reviewed by the study chair or co-chair prior to enrollment by email; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of','Patients with prior anthracycline therapy will be excluded','Female participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women','Medical illness unrelated to HL, which in the opinion of the study physician will preclude administration of chemotherapy safely; this includes patients with uncontrolled infection (including opportunistic), chronic renal failure, myocardial infarction (MI) within the past 6 months, unstable angina, or cardiac arrhythmias other than chronic atrial fibrillation, or second malignancy requiring active treatment','Prior malignancy within 2 years before enrollment other than curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi’s sarcoma (KS); participants with prior malignancies must have completed all therapy at least 2 years before enrollment with no evidence of disease since therapy completion','Grade 2 or greater peripheral neuropathy','Evidence of progressive multifocal leukoencephalopathy (PML) identified on the pretreatment magnetic resonance imaging (MRI)','Central nervous system disease','Patients with history of John Cunningham (JC) virus identified in the cerebrospinal fluid (CSF) or previous history of PML will be excluded from the study','Cirrhosis secondary to any cause will be excluded'
NCT01220583,https://www.clinicaltrials.gov/ct2/show/record/NCT01220583?term=NCT01220583&rank=1,'Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: \r\n* Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma\r\n* High-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma\r\n* High-grade acinic cell carcinoma or high-grade (> 30% solid component) adenoid cystic carcinoma\r\n* Patients with diagnoses such as \"undifferentiated or poorly differentiated carcinoma\", \"carcinoma-ex pleomorphic adenoma\", \"carcinoma not otherwise specified (NOS)\" and others should be considered for this trial','Surgical resection with curative intent within 8 weeks prior to registration','Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (=< 1 mm) or microscopically positive surgical margin (American Joint Committee on Cancer [AJCC], 7th edition); patients must be free of distant metastases based upon the following minimum diagnostic workup:\r\n* History/physical examination within 8 weeks prior to registration\r\n* Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast computed tomography (CT) imaging of the chest is required; positron emission tomography (PET)/CT is acceptable','Zubrod performance status 0-1','Absolute neutrophil count (ANC) >= 1,800 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Serum creatinine < 2.0 mg/dl','Total bilirubin < 2 x the institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN','Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential','Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment','All patients must have a Medical Oncology evaluation within 4 weeks prior to registration','Patients must be deemed able to comply with the treatment plan and follow-up schedule','Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review','Patients with residual macroscopic disease after surgery','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol\r\n* Pre-existing >= grade 2 neuropathy\r\n* Prior organ transplant','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Significant pre-existing hearing loss, as defined by the patient or treating physician'
NCT01824836,https://www.clinicaltrials.gov/ct2/show/record/NCT01824836?term=NCT01824836&rank=1,'Patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:\r\n* >= 60 years of age; or\r\n* < 60 years of age and amenorrheic for >= 12 months prior to day 1 if uterus/ovaries are intact; or\r\n* < 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone [FSH] and estradiol within institutional standard for postmenopausal status); or\r\n* < 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or\r\n* < 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or\r\n* Prior radiation castration with amenorrhea for at least 6 months','NOTE: use of luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin) is not allowed','Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast','Patients must have completed planned local therapy (i.e., definitive surgery and radiation therapy) and adjuvant chemotherapy for breast cancer prior to registration; in addition, any prior local therapy and adjuvant chemotherapy should be completed prior to participant completion of baseline Patient Reported Outcomes (PRO) instruments (i.e., Health Assessment Questionnaire [HAQ], PROMIS Physical Function, Functional Assessment of Cancer Therapy [FACT] Breast and Endocrine Symptoms [ES], etc.) and collection of optional blood for banking for future research','NOTE: concomitant treatment with ongoing trastuzumab (Herceptin) or other targeted/biologic agents is allowed; concomitant treatment with any other type of chemotherapy or hormonal therapy is not allowed','Patients must not have received prior AI therapy with exemestane, letrozole, or anastrozole as preoperative/adjuvant therapy or for prevention of breast cancer; prior tamoxifen is allowed','Plan to treat with anastrozole for at least 12 months','Eastern Cooperative Oncology Group (ECOG) performance status between 0-2','Patients must be disease-free of other prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; prior early stage breast cancers are also allowed as long as prior treatment did not include aromatase inhibitors','Patients must not be currently taking (or have taken in the past 6 months) medication for active, chronic conditions, including rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles; this includes analgesic medications or medications being taken with the purpose of treating pain or that may have an effect on pain (e.g. anti-depressants for help with pain or neuropathy, corticosteroid shots for arthritis); (Note: patients taking daily low dose aspirin are allowed to participate in this trial)','Patients must not have a prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years','Patients must have worst pain rated as no worse than 3 out of 10 on the following question (i.e., a pain score of 0, 1, 2, or 3): “In the past week, how much pain have you had on a scale of 0 to 10, where 0 equals no pain and 10 means the worst pain you can imagine; \" NOTE: this question regarding patient’s pain should be completed within one week prior to registration; this question may be asked orally prior to consent up to 7 days prior to registration; the response will be recorded on the registration checklist','Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician'
NCT01810913,https://www.clinicaltrials.gov/ct2/show/record/NCT01810913?term=NCT01810913&rank=1,'Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx','Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible','Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)','Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;\r\n* Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation\r\n* Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave\r\n* Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement','Zubrod performance status of 0-1 within 14 days prior to registration','Absolute granulocyte count (AGC) >= 1,500 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration','Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula','Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential','The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion','Patients with feeding tubes are eligible for the study','Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control','Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago','Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible','Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration\r\n* Transmural myocardial infarction within 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients','Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):','Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels','Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)','Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels','Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels','Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to cetuximab'
NCT01817075,https://www.clinicaltrials.gov/ct2/show/record/NCT01817075?term=NCT01817075&rank=1,'TRANSPLANT PATIENTS: all patients undergoing planned allogeneic transplant (both malignant and non-malignant diagnoses)','ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional >= 3 months or are on or will be on a chemotherapy regimen for < 3 months and then proceed to transplant (allogeneic or autologous stem cell rescue) during the 3-month study period','Patients undergoing allogeneic transplant must have, or be scheduled to have, an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central catheter [PICCs], etc.) and/or non-tunneled percutaneously inserted central catheter (PICC) that is expected to remain in place for an additional >= 3 months','Patients with acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional >= 3 months','All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional >= 3 months','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met','Patients with a previous or current line infection are ineligible until 14 days after the completion of antibiotics','Patients with only totally implanted CVCs or ports are ineligible','Patients with a known allergy or hypersensitivity to CHG are ineligible','Patients with chronic, severe, generalized skin breakdown (such as generalized blistering, burns, severe graft versus host disease [GVHD] with open sores, etc.) are ineligible','Patients currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study','Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim [TMP]/sulfamethoxazole [SMX]) or encapsulated organisms (penicillin) are eligible','Patients receiving sorafenib at the time of enrollment and those who are scheduled to receive sorafenib as part of a treatment plan are ineligible','Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment and those who are scheduled to receive antimicrobial locks in the CVC as part of a treatment plan are ineligible','Patients previously enrolled on this trial are ineligible','Females who are pregnant or breastfeeding are ineligible'
NCT00978250,https://www.clinicaltrials.gov/ct2/show/record/NCT00978250?term=NCT00978250&rank=1,'Patients must have histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, or breast cancer whose disease has progressed after at least one line of standard therapy','Patients with solid tumors (non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, and breast cancer) must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; patients with the above tumor types whose disease is limited to the skin are eligible at the discretion of the principal investigator (PI) and must have a physical exam with documentation of skin lesion(s) by color photography, including a ruler to estimate the size of the lesion(s)','Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment','Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least six weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the PI’s discretion, and should have recovered to eligibility levels from any toxicities','Karnofsky performance status >= 60%','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin < 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; =< 5 X upper limit of normal (ULN) for patients with liver metastases','Creatinine < 1.5 institutional upper limit of normal OR','Creatinine clearance >= 60 mL/min for patients with creatinine levels above 1.5 x institutional upper limit of normal','Pregnant women will be excluded from this trial; nursing women are also excluded; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 3 months after completion of study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she or her partner should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients should not be receiving any other investigational agents','Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to: active or uncontrolled infection, immune deficiencies or confirmed diagnosis of human immunodeficiency virus (HIV) infection, active infection with hepatitis B or hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements','History of allergic reactions attributed to fluoropyrimidines (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine'
NCT01822496,https://www.clinicaltrials.gov/ct2/show/record/NCT01822496?term=NCT01822496&rank=1,'Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC','Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)','Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible','Patients must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm)','Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy','If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible','The institution’s pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments (CLIA) certified lab documents presence of known “sensitive” mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon 19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement; either the primary tumor or the metastatic lymph node tissue may be used for testing of mutations','The institution’s pre-enrollment biomarker screening at a CLIA certified lab documents absence of T790M mutation in the EGFR TK domain','Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination, including recording of pulse, blood pressure (BP), weight, and body surface area, within 45 days prior to registration\r\n* Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to mid-thighs) within 30 days prior to registration; PET/CT must be negative for distant metastasis\r\n* CT scan with contrast of the chest and upper abdomen to include liver and adrenals (unless medically contraindicated) within 30 days prior to registration\r\n* Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with contrast, if MRI medically contraindicated) within 30 days prior to registration','Zubrod performance status 0-1 within 14 days prior to registration','Absolute neutrophil count (ANC) >= 1,000 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) within 14 days prior to registration','Bilirubin within normal institutional limits within 14 days prior to registration','Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential','Patient must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Atelectasis of the entire lung','Contralateral hilar node involvement','Exudative, bloody, or cytologically malignant effusions','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to the study drug(s) involved in this protocol'
NCT01822509,https://www.clinicaltrials.gov/ct2/show/record/NCT01822509?term=NCT01822509&rank=1,'Histologically or cytologically confirmed hematologic malignancy','The following malignancies will be considered eligible if progressive or persistent:\r\n* Chronic lymphocytic leukemia (CLL)\r\n* Non-Hodgkin lymphoma (NHL)\r\n* Hodgkin lymphoma (HL)\r\n* Multiple myeloma (MM)\r\n* Acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL])\r\n* Myelodysplastic syndrome (MDS)\r\n* Myeloproliferative neoplasms (MPN)\r\n* Chronic myeloid leukemia (CML)','Life expectancy of greater than 3 months','Must have undergone allogeneic hematopoietic stem cell transplantation (HSCT) (regardless of stem cell source)','Must have baseline donor T cell chimerism of >= 20%','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert’s disease or disease-related hemolysis, then =< 3.0 x ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN','Creatinine =< 1.5 x institutional ULN','Prednisone dose =< 5 mg/day and off all other systemic immunosuppressive medications for at least 4 weeks prior to study entry','Ability to understand and the willingness to sign a written informed consent document','Participants who have had anti-tumor therapy or other investigational agents within 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C), or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration','Patients with prior history of or active severe (grade 3 or 4) acute graft-versus-host disease (GVHD)','Patients with a history of prior treatment with ipilimumab, anti-programmed cell death protein 1 (PD 1) antibody, or cluster of differentiation (CD)137 agonist therapy are ineligible for the ipilimumab arm, but are eligible for the nivolumab arm','Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to registration','Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis); patients with Hashimoto’s thyroiditis are eligible to go on study','Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded','Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study or within 23 weeks after the last dose of study drug, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for at least 31 weeks after completion of ipilimumab or nivolumab administration'
NCT01822522,https://www.clinicaltrials.gov/ct2/show/record/NCT01822522?term=NCT01822522&rank=1,'Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration','Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal','Creatinine =< 1.5 x ULN','Creatinine clearance >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal','Hemoglobin >= 9 g/dL','Serum albumin >= 2.8 g/dL','Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis','Urine protein/creatinine ratio (UPCR) =< 1','Serum phosphorus >= lower limit of normal (LLN)','Calcium >= LLN','Magnesium >= LLN','Potassium >= LLN','A cluster of differentiation (CD)4+ lymphocyte count > 50/mcL will be required within 2 weeks of study participation','Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 12 consecutive months; note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason','Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of cabozantinib administration; sexually active participants (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 6 months after the last dose of study drug(s), even if oral contraceptives are also used; all participants of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 6 months after the last dose of study drug','Participating participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued','Ability to understand and the willingness to sign a written informed consent document','Participants must in the opinion of the investigator be capable of complying with this protocol','Prior treatment with cabozantinib (XL184)','The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment','The participant has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 4 weeks or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; note: participants with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents','The participant has received any other type of investigational agent within 28 days before the first dose of study treatment','The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)','The participant has a primary brain tumor','The participant has active brain metastases or epidural disease; participants with brain metastases previously treated with whole brain radiation or radiosurgery or participants with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; participants with treated brain metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2 weeks of registration, though non-enzyme inducing anticonvulsive drugs such as levetiracetam are allowed; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for participants with known brain metastases is required to confirm eligibility','The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment','The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted','The participant requires chronic concomitant treatment with the following strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers OTHER than antiretroviral agents: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, primidone, modafinil, and other enzyme inducing anti-convulsant drugs (EIACD), and St. John’s wort; use of efavirenz or etravirine is permitted for participants considered for the CYP3A4-inducer based antiretroviral therapy (ART) regimen arm (Stratum B) of the trial; the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product','The participant requires concomitant treatment with the following inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Gastrointestinal (GI): cimetidine, aprepitant\r\n* Hepatitis C: boceprevir, telaprevir\r\n* Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids); use of any of anti-retrovirals (delavirdine) or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) is permitted; specifically, ritonavir and cobicistat is permitted for participants considered for the CYP3A4-inhibitor based ART regimen arm (Stratum A) of the trial; as part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product','The participant has experienced any of the following:\r\n* Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment','The participant has radiographic evidence of cavitating pulmonary lesion(s)','The participant has tumor invading or encasing any major blood vessels','The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\r\n* Cardiovascular disorders including:\r\n** Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n** Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n** Any history of congenital long QT syndrome\r\n** Any of the following within 6 months before the first dose of study treatment:\r\n*** Unstable angina pectoris\r\n*** Clinically-significant cardiac arrhythmias\r\n*** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n*** Myocardial infarction\r\n*** Thromboembolic event requiring therapeutic anticoagulation (note: participants with a venous filter [e.g. vena cava filter] are not eligible for this study)\r\n* Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n** Any of the following within 28 days before the first dose of study treatment\r\n*** Active peptic ulcer disease\r\n*** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n*** Malabsorption syndrome\r\n** Any of the following within 6 months before the first dose of study treatment:\r\n*** Abdominal fistula\r\n*** Gastrointestinal perforation\r\n*** Bowel obstruction or gastric outlet obstruction\r\n*** Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment','Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy','Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment; participants with HIV infection will be eligible provided they meet the criteria; participants with known hepatitis B infection should be screened for active disease prior to study participation; participants with known hepatitis C infection must not be actively receiving treatment for the infection\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n* In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery','The participant is unable to swallow tablets that are whole (do not crush or chew or administer via nasogastric [NG]-tube)','The participant has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (ECGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the participant meets eligibility in this regard','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib (XL184)','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib'
NCT01244737,https://www.clinicaltrials.gov/ct2/show/record/NCT01244737?term=NCT01244737&rank=1,'Subjects may be enrolled at one of three time points in the clinical course of disease:\r\n* Study 1 (New Diagnosis): \r\n** Pediatric patients with newly diagnosed primary central nervous system tumors undergoing surgical resection/biopsy within 21 days or who, within the prior 21 days, have undergone resection/biopsy with substantial residual (greater than half as assessed by the surgeon) tumor\r\n* Study 2 (Possible Tumor Recurrence): \r\n** Pediatric patients with a history of treated primary central nervous system tumor, in whom standard imaging has raised concern for tumor recurrence; tumor tissue for histological analysis must be available from a biopsy/resection planned within the next 21 days or from a prior resection/biopsy if no current biopsy material is available\r\n* Study 3 (Response to Therapy): \r\n** Pediatric patients with a primary central nervous system tumor who will be starting a new regimen (standard or experimental) of chemotherapy within 21 days, have not received radiation therapy during the past six months, and who will not be receiving radiation therapy during the first two cycles of chemotherapy','Patients should be capable of achieving imaging without the need for sedation or anesthesia','Karnofsky performance status >= 50 for patients >= 12 years of age; for children < 12 years of age, the Lansky play scale >= 50% can be substituted','Signed informed consent by subject (age >= 18 years) or by parent/guardian (subject age < 18 years); information will be provided to potential subjects and their parents/guardians (as appropriate) by oral discussion with opportunity for question and answer and the written informed consent document; subjects less than 18 years of age capable of giving assent will be included in these discussions and will be asked for written assent on the same document as the parents/guardians give consent; if feasible, both parents (or guardians) will be included in these discussions and will be asked to sign the written consent document; if a second parent or guardian is unavailable, this will be explained in writing on the written consent document; if subjects age 18 years or older are unable to provide informed consent, then they will not be enrolled in this study','Patients receiving glucocorticoids and/or anti-seizure medications are eligible for this study','Clinically active infection; an active infection may alter the biodistribution of 18F-FLT','Known pregnancy or breast feeding; pregnant women are excluded as the effects of 18F-FLT on the fetus are not known, and there is the potential for teratogenic or abortifacent effects; within 48 hours prior to a PET scan, a pregnancy test will be obtained in all female participants of child bearing potential to confirm non-pregnant status; because there is an unknown, but potential, risk of adverse effects in nursing infants, breastfeeding should be discontinued before the mother receives 18F-FLT','Serious intercurrent medical illness','Patients requiring emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging'
NCT01841723,https://www.clinicaltrials.gov/ct2/show/record/NCT01841723?term=NCT01841723&rank=1,'Histologically confirmed diagnosis of hairy cell leukemia or variant according to World Health Organization (WHO) criteria','Hemoglobin < 11 g/dL','Platelet count < 100,000/mL','Absolute neutrophil count < 1,000/mL','Progressive or symptomatic splenomegaly or hepatomegaly','Enlarging lymphadenopathy >= 2 cm','Absolute lymphocyte count > 5,000/mL','Disease related constitutional symptoms consisting of unexplained weight loss exceeding 10% of body weight over the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue, fevers > 100.5 degrees Fahrenheit (F) or night sweats for greater than 2 weeks without evidence of infection','Patients with classic hairy cell leukemia may receive therapy under the following conditions: \r\n* After at least 1 prior purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine), or\r\n* Relapsed or de novo disease if deemed medically unfit for therapy with a purine nucleoside analog\r\n** Both previously treated and previously untreated patients with variant hairy cell leukemia will be eligible','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 months','Creatinine =< 2.0 mg/dL, and/or creatinine clearance (estimated glomerular filtration rate [GFR] [Cockcroft-Gault]) >= 30 mL/min','Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless disease related or due to Gilbert’s disease)','Aspartate aminotransferase (AST) =< 3.0 x ULN (unless disease related)','Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN','Partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN','Patients will be eligible without respect to baseline peripheral blood cell counts if they otherwise meet inclusion criteria','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry; female patients who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >=1 year; or history of hysterectomy; or history of bilateral tubal ligation; or history of bilateral oophorectomy); female patients of childbearing potential must have a negative serum pregnancy test upon study entry; male and female patients who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition as ibrutinib','Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor; therefore, any medications or substances that are strong inhibitors of CYP3A4/5 should be discontinued; patients unable to change these medications must be excluded from participation','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of study drug','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ibrutinib','Human immunodeficiency virus (HIV)-positive patients will be eligible unless they have been previously diagnosed with an acquired immune deficiency syndrome (AIDS)-defining illness','Patients who require anticoagulation with warfarin (Coumadin) or who have taken warfarin within 28 days prior to enrollment are not eligible due to a potential increased risk of hemorrhage; patients who are currently taking vitamin K antagonists are also ineligible for this study','Patients requiring daily corticosteroids at a prednisone equivalent of >= 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg per day of prednisone or equivalent), the discontinuation or dose reduction should be done at least 7 days prior to first dose','Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor','Major surgery within 4 weeks of first dose of study drug','A history of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening, and felt to be at low risk for recurrence by the treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of disease','Currently active clinically significant cardiovascular disease such as: uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification or history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to first dose with study drug','Patient is unable to swallow capsules, or has disease significantly affecting gastrointestinal function or resection of the stomach or small bowel, or symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction','History of stroke or intracranial hemorrhage within 6 months prior to enrollment','Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; PCR positive patients will be excluded','Concurrent systemic immunosuppressant therapy other than corticosteroids (e.g., cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drug','Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug','Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia','Known bleeding disorders (e.g., von Willebrand’s disease) or hemophilia','Unwilling or unable to participate in all required study evaluations and procedures','Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute [NCI]/Child Pugh classification)'
NCT01849146,https://www.clinicaltrials.gov/ct2/show/record/NCT01849146?term=NCT01849146&rank=1,'Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; if above the institutional upper limit of normal but =< 3 times institutional upper limit of normal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must be able to provide written informed consent','Patients must have magnetic resonance imaging (MRI) within 21 days of starting treatment','Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use two birth control methods (either two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment','Patients must be able to swallow whole capsules','PHASE I PATIENTS:','Must have histologically proven glioblastoma','Must have recovered from the immediate post-operative period','Patients going on Arm 1 or combination dose cohort must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed','Patients going on Arm 2 must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study; patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity (except lymphopenia) attributed to the temozolomide; Arm 2 patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed','INTRATUMORAL DRUG DISTRIBUTION STUDY PATIENTS:','Patients must have prior histologically proven glioblastoma that is progressive or recurrent following radiation therapy +/- chemotherapy','Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers','Patients must have measurable contrast-enhancing progressive or recurrent glioblastoma by MRI within 21 days of starting treatment; patient must be able to tolerate MRIs','Patients may have an unlimited number of prior therapy regimens','Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., Tarceva, hydroxychloroquine, bevacizumab, etc.)','Patients receiving any other investigational agents are ineligible','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or AZD1775 (MK-1775) are ineligible; the AZD1775 (MK-1775) investigator brochure and the temozolomide package insert can be referenced for more information','Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol; patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of AZD1775 (MK-1775)','Patients may not be on drugs known to be moderate or potent inhibitors/inducers of CYP3A4, sensitive substrates of CYP3A4, or substrates of CYP3A4 with narrow therapeutic windows','Patients may not be on anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH)','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD1775 (MK-1775)','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT01901094,https://www.clinicaltrials.gov/ct2/show/record/NCT01901094?term=NCT01901094&rank=1,'Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition','No inflammatory breast cancer','No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix','All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy\r\n* Note: Biopsy of intramammary nodes does not fulfill eligibility criteria','Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy\r\n* Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled','Patients must have completed all chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes\r\n* Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist','Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial','All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy\r\n* Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility','No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy','No neoadjuvant radiation therapy','No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy','No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed','No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis','No history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowed','Patients must not be pregnant or nursing\r\n* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential','Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1','INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA','Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy','A minimum of 1 sentinel node and a maximum of 6 total nodes (sentinel + non-sentinel) are identified and excised by the surgeon; patients who do not have an identifiable sentinel lymph node will not proceed to registration/randomization','At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment\r\n* Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)\r\n* Note: If on final pathology, more than 8 lymph nodes are seen pathologically, then the patient should discontinue study\r\n* Axillary lymph node dissection (ALND) is not to be performed prior to registration/randomization','POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA','For cases where ALND has not been performed and one of the following is true: 1) intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive lymph node (sentinel or non-sentinel) with metastasis greater than 0.2 mm OR 2) lymph node (sentinel or non-sentinel) considered negative on intra-operative evaluation was found to be positive on final pathology (with metastasis greater than 0.2 mm)','Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy; negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink','At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified on final pathology (for cases where intra-operative evaluation was not performed, or was negative and completion dissection was not performed)','Among the minimum of 1 and the maximum of 6 lymph nodes (sentinel + non-sentinel) identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised; \r\n* Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)','For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization'
NCT01851369,https://www.clinicaltrials.gov/ct2/show/record/NCT01851369?term=NCT01851369&rank=1,'Phase I: histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist','Phase II: histologically confirmed colorectal adenocarcinoma post at least two lines of therapy, NSCLC post at least two lines of therapy, or granulosa cell ovarian cancer post at least one line of therapy; patients must have measurable disease','Patients enrolling in the expansion cohorts must have disease amenable to biopsy and be willing to undergo pre-and post-treatment biopsies','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Phase I), =< 1 (Phase II)','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Hemoglobin >= 10 g/dL without transfusion within 4 days prior to enrollment','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; 5.0 x ULN in cases of liver metastases','Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration','Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks (or 5 half-lives, whichever is shorter) prior to entering the study (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted','Patients must be able to swallow whole tablets or capsules; nasogastric or gastrostomy tube (G-tube) administration is not allowed','Ability to understand and the willingness to sign a written informed consent document and to undergo tumor biopsies in the expansion phase','Patients who are actively receiving any other investigational agents','Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= 4 weeks without requiring steroid and anti-seizure medications are eligible to participate','Phase II only: No other prior malignancies are allowed except for the following:\r\n* Adequately managed stage 0 (carcinoma in situ), I, or II basal cell or squamous cell carcinoma from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease-free for three years\r\n* Adequately managed stage I or II well differentiated thyroid or prostate cancer is also eligible, wherein the patient is not required to be in complete remission','Phase II only: patients with colorectal cancer with known microsatellite instability (MSI)-high disease who have previously been treated with immunotherapy or who have refused treatment with immunotherapy','History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or TMZ','Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','HEALTHY VOLUNTEER BLOOD DONORS','Age > 18 years','Hemoglobin >= 12 g/dL','No history of bleeding problems; not taking aspirin or any medication that may affect erythrocyte biochemistry','Willingness to sign the healthy volunteer informed consent form'
NCT01935934,https://www.clinicaltrials.gov/ct2/show/record/NCT01935934?term=NCT01935934&rank=1,'Patients must have histologically or cytologically confirmed metastatic endometrial cancer; eligible histologies for the experimental cohort are: endometrioid or serous; eligible histologies for the exploratory cohort are: carcinosarcoma, clear cell, mixed, adenosquamous and any other rare sub-type of endometrial cancer','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam and >= 15 mm in short axis for nodal lesions; patients must have radiographic evidence of disease progression following the most recent line of treatment','Prior therapy: Eligible subjects must have had 1 line of systemic cytotoxic treatment; this may be adjuvant therapy with documented progression within 12 months of completion, or 1 line of cytotoxic therapy for metastatic disease; NOTE: eligible patients are allowed up to 2 lines of systemic cytotoxic treatment, of which only 1 line is allowed for metastatic disease; the acceptance of progression within 12 months of adjuvant is part inclusion to not require patient to re-challenge with chemotherapy (chemo) if they progressed soon after adjuvant therapy; prior hormonal therapy for metastatic/recurrent disease is also allowed; prior targeted therapy not directed against cMET or vascular endothelial growth factor (VEGF) pathways is allowed','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1.5 x 10^9/L','Platelets >= 100 x 10^9/L','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 X institutional upper limit of normal','Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Hemoglobin >= 90 g/L','Serum albumin >= 28 g/L','Lipase < 2.0 x ULN; no radiologic/clinical evidence of pancreatitis','Urine protein/creatinine ratio (UPCR) =< 1','Serum phosphorus, calcium, magnesium and potassium >= lower limit of normal (LLN)','Women of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopausal is defined as amenorrhea >= 12 consecutive months; note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason','Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; sexually active subjects must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)','Patients must consent to analysis on archival tissue; if archival sample is not available, a sufficient tumor biopsy can be performed a minimum of 28 days prior to start of treatment if felt to be clinically reasonable','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g., cytokines or antibodies) or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose of study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Prior treatment with cabozantinib','The subject has received radiation therapy:\r\n* To bone metastasis within 14 days before the first dose of study treatment \r\n* To any other site(s) within 28 days before the first dose of study treatment','The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment','The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment','The subject has received any other type of investigational agent within 28 days before the first dose of study treatment','The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from related toxicity to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)','Any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer','Patients with known brain metastases should be excluded from this clinical trial','The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN =< 7 days before the first dose of study treatment','Therapeutic anticoagulation with warfarin, antiplatelet agents (e.g., clopidogrel), thrombin, or Factor Xa inhibitors is not allowed; therapeutic anticoagulation with low molecular weight heparin (LMWH) is allowed as well as prophylactic anticoagulation using low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and LMWH','The subject requires chronic concomitant treatment of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort)','The subject has experienced any of the following:\r\n* Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment','The subject has tumor in contact with, invading or encasing any major blood vessels','The subject has evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib','The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\r\n* Cardiovascular disorders including:\r\n** Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n** Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n** Any history of congenital long QT syndrome\r\n** Any of the following within 6 months before the first dose of study treatment:\r\n*** Unstable angina pectoris\r\n*** Clinically-significant cardiac arrhythmias\r\n*** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n*** Myocardial infarction\r\n*** Thromboembolic event requiring therapeutic anticoagulation (note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)','Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following within 28 days before the first dose of study treatment\r\n** Intra-abdominal tumor/metastases invading GI mucosa\r\n** Active peptic ulcer disease,\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment','Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy','Other clinically significant disorders such as:\r\n* Active uncontrolled infection requiring intravenous systemic treatment within 14 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n*** In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery','The subject is unable to swallow tablets','The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms =< 7 days before the first dose of study treatment','The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee','History of allergic reactions attributed to compounds of similar chemical or biologic composition to XL184','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with XL184','Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT01881867,https://www.clinicaltrials.gov/ct2/show/record/NCT01881867?term=NCT01881867&rank=1,'Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)','Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment','Assessable disease with a positive bone scan and/or measurable disease on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis','Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy','No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 days','Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment','Absolute neutrophil count (ANC) >= 1500/uL','Bilirubin < 1.5 x upper limit of normal (ULN)','Hemoglobin >= 10 g/dL','Platelets >= 100,000/mcL','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN','Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation','Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists or s/p orchiectomy)','Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky performance status of >= 80%','Life expectancy of at least 6 months','Prior local radiation therapy must be completed at least 30 days prior to enrollment and the patient must have recovered from all toxicity','Prior “systemic” radiopharmaceuticals (strontium, samarium, radium 223 dichloride) must be completed >= 8 weeks prior to enrollment','Patients must agree to use 2 methods of adequate contraception for the duration of study participation, and for four months after discontinuing therapy','Ability to understand and the willingness to sign a written informed consent document','Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed','Prior investigational immunotherapy','Prostate cancer pain requiring regularly scheduled narcotics','Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression','Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable); systemic corticosteroids must be discontinued for at least 30 days prior to first CYT107 injection','Known central nervous system metastases','Documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion','History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less','Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves','Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)','Concurrent or prior malignancy except for the following: \r\n* Adequately treated basal or squamous cell skin cancer\r\n* Adequately treated stage I or II cancer from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease-free for 5 years','Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder; HIV-positive patients on combination antiretroviral therapy are ineligible','Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness','Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of CYT107 hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea','History of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107','Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment','Active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)','Patients who have received hepatotoxic drugs less than 7 days prior to enrollment','Patients who have received prior biologic agents less than 30 days prior to enrollment','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients who have a history of any hematopoietic malignancy','History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume [FEV] > 60% of predicted for height and age required in patients with prolonged smoking history or symptoms of respiratory dysfunction)'
NCT01534598,https://www.clinicaltrials.gov/ct2/show/record/NCT01534598?term=NCT01534598&rank=1,'Patients must have histologically documented solid tumors whose disease has progressed on standard therapy that is known to be associated with a survival advantage or have disease for which there is no known standard therapy','Patients must have measurable or evaluable disease','Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is being enrolled prior to patient enrollment','Patients must have completed any chemotherapy, radiation therapy, biologic therapy, or major surgery >= 4 weeks prior to enrollment (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study, at the discretion of the principal investigator; patients must have recovered to eligibility levels from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous (IV) bisphosphonate treatment prior to study entry may continue this treatment','Karnofsky performance status >= 60%','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 X institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal; =< 5 X upper limit of normal (ULN) for patients with liver metastases','Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels above 1.5 X institutional upper limit of normal','Pregnant women are excluded from this trial; nursing women are also excluded; women of childbearing potential must agree to either abstain from sexual intercourse or use two forms of acceptable birth control, including one barrier method, for 4 weeks prior to study entry, for the duration of study participation, and for 3 months after completion of study; men must use a latex condom every time they have sexual intercourse during therapy and for 3 months after study completion, even if they have had a successful vasectomy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she or her partner should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients should not be receiving any other investigational agents','Ability to swallow liquids','Willingness to provide blood and urine samples, and biopsy samples if on the expansion phase of the study, for research purposes; for the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or archival tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of archival tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements','Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known human immunodeficiency virus (HIV) infection requiring protease inhibitor therapy, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 2 months after treatment of the brain metastases; patients should be on stable doses of anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator','History of allergic reactions attributed to fluoropyrimidine (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine','Malabsorption syndrome or other conditions that would interfere with intestinal absorption'
NCT01897012,https://www.clinicaltrials.gov/ct2/show/record/NCT01897012?term=NCT01897012&rank=1,'Patients must have histologically or cytologically confirmed Hodgkin lymphoma, Burkitt’s lymphoma, double-hit lymphoma, other c-Myc positive B-cell lymphoma, diffuse large-B cell lymphoma including those patients with history of transformed follicular lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma','Patients must have at least one 1.5 cm bidimensional measurable lesion','Relapsed or refractory after at least 1 front-line therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Absolute neutrophil count >= 1,500/mcL','Platelets >= 75,000/mcL','Direct bilirubin =< 1 mg/dL','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine =< 2 x institutional upper limits of normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of MLN8237 plus romidepsin administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 plus romidepsin administration','Ability to understand and the willingness to sign a written informed consent document','According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration; these guidelines may change pending results from an ongoing food effects study','Patients who have had chemotherapy, radiation therapy, or other investigational agents within 3 weeks prior to entering study, 6 weeks for nitrosoureas or mitomycin','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines, or romidepsin; agents that alter gastric pH may change MLN8237 absorption are not permitted; proton pump inhibitors need to be stopped 4 days prior to the first dose of MLN8237; histamine-2 (H2) receptor antagonists are not permitted from the day prior (day -1) through to the end of MLN8237 dosing; antacid preparations are not permitted for 2 hours before or 2 hours after administration of MLN8237','Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine, or St. John’s wort is not permitted; concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; bisphosphonate therapy may not be initiated after study entry','Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trial','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237 and/or romidepsin','Ejection fraction (EF) < 40% or myocardial infarction (MI) within the past 3 months; known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237','Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed','Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel; treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study; patients must be cautiously co-medicated with agents that cause corrected QT interval (QTc) prolongation and agents that are strong or moderate enzyme inhibitors during the study'
NCT01896999,https://www.clinicaltrials.gov/ct2/show/record/NCT01896999?term=NCT01896999&rank=1,'PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)','Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted','Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease','Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab','Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)','Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2','Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by a diagnostic quality computed tomography (CT) scan; patients must use the same imaging modality (CT or PET/CT) throughout the study','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air','Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration','Absolute neutrophil count (ANC) >= 1500/mcL (1.5 x 10^9/L) obtained within 2 weeks prior to registration','Platelets >= 75,000/mcL (75 x 10^9/L) obtained within 2 weeks prior to registration','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) obtained within 2 weeks prior to registration','Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registration','Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min obtained within 2 weeks prior to registration','No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response','Patient must have no current or prior history of central nervous system (CNS) involvement','All prior therapy must have been completed at least 21 days prior to enrollment; no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed','No history of Steven’s Johnson’s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy','Human immunodeficiency virus (HIV) positive patients are allowed on this study if they have a CD4 count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded','Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed\r\n* Replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to initiation of study treatment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study\r\n* Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible','Patients must not have grade 2 or greater peripheral sensory neuropathy','Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia','Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab','Patients must not have a serious medical or psychiatric illness likely to interfere with study participation','Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration','Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment','Patients registering to Arms D, E, F, G, H, I, X, Y must not currently be smoking tobacco or other substances and must not have smoked within the past 6 months','RANDOMIZED PHASE II (ARMS K AND L): Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted','RANDOMIZED PHASE II (ARMS K AND L): Patients must have relapsed after first line chemotherapy; may have relapsed after autologous stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; patient must not have received a prior allogeneic stem cell transplant','RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab','RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)','RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2','RANDOMIZED PHASE II (ARMS K AND L): Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study','RANDOMIZED PHASE II (ARMS K AND L): Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 24 hours prior to enrollment to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','RANDOMIZED PHASE II (ARMS K AND L): Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','RANDOMIZED PHASE II (ARMS K AND L): Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air','RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration','RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L), obtained within 2 weeks prior to registration','RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L), obtained within 2 weeks prior to registration','RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN), obtained within 2 weeks prior to registration','RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registration','RANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min, obtained within 2 weeks prior to registration','RANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response','RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement','RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed','RANDOMIZED PHASE II (ARMS K AND L): No history of Steven’s Johnson’s syndrome, TENs syndrome, or motor neuropathy','RANDOMIZED PHASE II (ARMS K AND L): HIV positive patients are eligible provided they meet the other protocol criteria including the following:\r\n* Long term survival expected were it not for the cHL\r\n* HIV viral loads undetectable by standard clinical HIV testing\r\n* Willing to adhere to effective combination antiretroviral therapy','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of steroid medication for at least 2 weeks prior to initiation of therapy are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation','RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration','RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment','RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents','RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a history of or evidence of cardiovascular risks including any of the following:\r\n* QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec at baseline \r\n* History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration\r\n* History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multigated acquisition scan (MUGA)\r\n* Intra-cardiac defibrillator\r\n* History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy'
NCT01902173,https://www.clinicaltrials.gov/ct2/show/record/NCT01902173?term=NCT01902173&rank=1,'PHASE I PORTION ELIGIBILITY CRITERIA','Patients must have BRAF^V600 mutant metastatic cancer irrespective of the histology or prior therapy; BRAF^V600 mutant status must be documented by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory may also be accepted','Patients must have locally advanced unresectable stage IIIC or metastatic stage IV cancer with either progression to prior therapy or a newly diagnosed cancer that does not have an available treatment with curative intent','Patients must have a complete physical examination and medical history within 28 days prior to registration','Patients must have measurable or non-measurable disease; all measurable lesions must be assessed (by physical examination, computed tomography [CT], or magnetic resonance imaging [MRI] scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)','All patients must undergo a CT or MRI of the brain within 42 days prior to registration; patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e. not requiring corticosteroids) at the time of registration will be eligible','Patients may have received prior systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens); all adverse events associated with prior treatment must have resolved to =< grade 1 prior to registration','Patients progressing on a prior BRAF inhibitor-based therapy will be eligible, as are patients nave to BRAF inhibitor therapy; resistance to BRAF inhibitor-based therapy will be defined as progressive disease by RECIST 1.1 criteria while receiving therapy with a BRAF inhibitor (vemurafenib or dabrafenib, alone or in combination with a mitogen-activated protein kinase [MEK] inhibitor); this may be innate resistance (patients who never achieved a tumor response while on BRAF inhibitor therapy) or acquired resistance (progression after having a tumor response to BRAF inhibitor therapy); there will not be a period of break between progression on the prior BRAF inhibitor-based therapy and the start of dabrafenib, trametinib and GSK2141795','Patients may have received prior surgery (for both the primary and stage IV disease); all adverse events associated with prior surgery must have resolved to =< grade 1 prior to registration','Patients may have received prior radiation therapy; all adverse events associated with prior radiation therapy must have resolved to =< grade 1 prior to registration','Patients must be willing to submit blood for pharmacokinetics; sites must order S1221 pharmacokinetic (PK) kit immediately after registration; the Southwest Oncology Group (SWOG) patient identification (ID) number must be provided on the S1221 PK Kit request form','Patients must have available and be willing to submit baseline tissue taken at the time of disease progression to prior BRAF inhibitor-based therapy (either fresh frozen [preferred], or paraffin-embedded tumor blocks) OR must have a site of disease that can be biopsied within this study for translational medicine studies; tissue may be from an archival biopsy or a new biopsy after the patient has been registered to the protocol; since patients are referred to this protocol after progression on prior BRAF inhibitor-based therapy, the biopsy taken at the time of progression will be used as the baseline biopsy for this study; patients must be willing to submit plasma and whole blood for translational medicine studies','Patients must have Zubrod performance status =< 1','Absolute neutrophil count (ANC) >= 1,200/ul','Platelets >= 100,000/ul','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert’s syndrome)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)','Serum albumin >= 2.5 g/dL','Serum creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance >= 50 mL/min','Patient must have a left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days prior to registration','Patients must not have a corrected QT (QTc) interval >= 480 msecs within 28 days prior to registration','Patients must not have a history of acute coronary syndromes (including unstable angina), myocardial infarction within 6 months, coronary angioplasty, or stenting within the past 24 weeks; class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; or history of known cardiac arrhythmias (such as atrial fibrillation) unless it has been stably controlled for > 30 days prior to registration; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; subjects with moderate valvular thickening are not eligible','Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration','Patients with human immunodeficiency virus (HIV) are eligible if they are not on antiviral agents and have adequate cluster of differentiation (CD)4 counts (>= 500 mm^3)','Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range','At the time of registration, patients must not be receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); patients must not be planning to use herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)','Women of childbearing potential must have a negative pregnancy test within 14 days of registration','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; hormonal contraception is not allowed; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, previously diagnosed type 1 diabetes mellitus/type 2 diabetes, psychiatric illness/social situations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements; patients must not have any evidence of mucosal or internal bleeding; patients must not have a history of pneumonitis or interstitial lung disease; patients must not have received any major surgery within four weeks prior to registration','Patients must not have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection','Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib or other agents used in this study including dimethyl sulfoxide (DMSO)','Patients must be able to retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels; patients who have feeding tubes can enroll in the study provided that the capsules do not need to be modified','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','Patients must have a serum albumin >= 2.5 g/dL within 28 days prior to registration','Patients with known history or current evidence of retinal vein occlusion (RVO) are not eligible:\r\n* History of RVO, or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)\r\n* Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO such as:\r\n** Evidence of new optic disc cupping\r\n** Evidence of new visual field defects\r\n** Intraocular pressure > 21 mmHg\r\n** NOTE: Ophthalmic exam is required for all patients; exam must be obtained within 28 days prior to registration','Patients must not have uncontrolled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg which cannot be controlled by anti-hypertensive therapy)','PHASE II PORTION ELIGIBILITY CRITERIA','Patients must have histologically confirmed melanoma with BRAF^V600 mutation; patients must have stage IIIC or stage IV disease','Patients must have received prior BRAF inhibitor therapy (e.g. dabrafenib, vemurafenib) within 56 days prior to registration; prior trametinib therapy is permitted; patients are not required to interrupt BRAF or MEK inhibitor therapy prior to the initiation of three agent combination therapy on study','Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)','Patients must have Zubrod performance status =< 2','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: Prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility'
NCT01953588,https://www.clinicaltrials.gov/ct2/show/record/NCT01953588?term=NCT01953588&rank=1,'Eastern Cooperative Oncology Group (ECOG) performance status 0-2','Postmenopausal, verified by: \r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards','Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy','Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node\r\nPrimary tumor must be:\r\n* Palpable\r\n* Its largest tumor diameter is > 2.0 cm by physical examination or by radiological assessment\r\n* Bi-dimensional measurement by tape, ruler or caliper technique must be provided\r\n** Note:\r\n*** Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible\r\n*** Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible; if the other lesions have been biopsied (biopsy not required) they must meet the estrogen receptor/human epidermal growth factor receptor 2 (ER/HER2) eligibility requirements; research biopsies and Ki67 assessment and radiological measures are to be performed on the dominant breast lesion','Invasive breast cancer is estrogen receptor (ER) positive with an Allred score of 6, 7 or 8 by local institution standard protocol; if an Allred score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible; if ER positivity is =< 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred score to determine eligibility','Invasive breast cancer is human epidermal growth factor receptor 2 (HER2) negative; a patient is considered to have HER2 negative breast cancer if one of the following if one of the following applies: \r\n* 0 or 1+ by immunohistochemistry (IHC) and in situ hybridization (ISH) not done\r\n* 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2\r\n* 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2','Documentation of mammogram and ultrasound (including ductal carcinoma in situ [DCIS] and invasive cancer) of the diseased breast performed within 56 days prior to registration; mammogram for the unaffected contralateral breast is required within 12 months prior to registration','Absolute neutrophil count (ANC) > 1,000/mm^3','Platelet count > 100,000/mm^3','Total bilirubin < 1.5 x upper limits of normal (ULN)','Creatinine < 1.5 x ULN','Serum alanine aminotransferase (ALT) < 2.5 x ULN','Tissue acquisition: patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies','Premenopausal status','Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)','An excisional biopsy of this breast cancer','Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration','Tumor ER Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0','Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted','Clinical or radiographic evidence of metastatic disease; metastatic workup is not required, but is recommended for patients with clinical stage III disease; Note: isolated ipsilateral supraclavicular node involvement is permitted','Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion','Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry','History of invasive breast cancer or contralateral DCIS'
NCT01912625,https://www.clinicaltrials.gov/ct2/show/record/NCT01912625?term=NCT01912625&rank=1,'Patients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligible','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Prior thoracic radiation allowed only if there is minimal to no overlap with the treatment area estimated at the time of consultation, and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Life expectancy of greater than 6 months','Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Hemoglobin >= 9 g/dL','Platelets >= 100 x 10^9/L','Albumin >= 2.5 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (any G12, G13, Q61) confirmed by Clinical Laboratory Improvement Act (CLIA)-certified testing','The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis','History of another malignancy\r\n* Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above','History of interstitial lung disease or pneumonitis','Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to either carboplatin or paclitaxel','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','History or current evidence/risk of retinal vein occlusion (RVO)','History or evidence of cardiovascular risk including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < LLN\r\n* A QT interval corrected for heart rate using the Bazett’s formula corrected QT (QTcB) >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to registration are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Known cardiac metastases','Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)','HIV-positive patients on combination antiretroviral therapy are ineligible','Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)'
NCT01925131,https://www.clinicaltrials.gov/ct2/show/record/NCT01925131?term=NCT01925131&rank=1,'Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt’s leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded','Patients must have evidence of acute leukemia in their peripheral blood or bone marrow; patients must have >= 5% blasts in the peripheral blood or bone marrow within 14 days prior to registration; at least >= 20% of those blasts must be CD22-positive (surface) based on local immunophenotyping and histopathology','Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine','For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria:\r\n* Patient is in second salvage or more and B1931022 has been considered and ruled out as a treatment option; OR\r\n* Patient was treated on the standard of care arm of B1931022 and failed therapy','Patients may have received prior allogeneic transplant or autologous transplant; however, patients with prior allogeneic bone marrow transplant will be eligible only if both of the following conditions are met:\r\n* The transplant must have been performed >= 90 days prior to registration\r\n* The patient must not have >= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD within 14 days prior to registration','Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least one second or third generation tyrosine kinase inhibitor','Patients must not have received prior treatment with inotuzumab ozogamicin; previous treatment with other anti-CD22 antibodies must have been completed at least 90 days prior to registration','Patients must have Zubrod performance status 0-2','Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration; Food and Drug Administration (FDA)-approved tyrosine kinase inhibitors may also be administered until 1 day prior to start of study therapy (cycle 1 [C1], day 1 [D1])\r\n* All drug-related toxicities must have resolved to =< grade 2','Patients must not have a systemic bacterial, fungal, or viral infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)','Patients must not have any other serious concurrent disease or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would put the patient at undue risk of undergoing therapy','Patients must not have active central nervous system (CNS) involvement (by clinical evaluation); patients with previous documented history of CNS involvement of acute leukemia, or with clinical signs or symptoms consistent with CNS involvement of acute leukemia, must have a lumbar puncture which is negative for CNS involvement of acute leukemia; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture before registration; note that treatment with intrathecal therapy is recommended during protocol treatment but CNS analysis during treatment is not required','Patients must have a peripheral blast count < 25,000/uL within 2 days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown)','Patients must have serum creatinine =< 2 x institutional upper limits of normal (IULN) within 7 days prior to registration','Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated)','Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration','Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN within 7 days prior to registration','Patients with a history of a serious allergic or anaphylactic reaction to humanized monoclonal antibodies are not eligible','Patients must not have a history of chronic or active hepatitis B or C infection; patients must have negative hepatitis B and C serologies performed within 28 days prior to registration','Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome','Patients must not have a cardiac ejection fraction < 45% or the presence of New York Heart Association stage III or IV heart failure within 14 days prior to registration; either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) may be used to determine ejection fraction','Patients must not have a myocardial infarction within 6 months prior to registration','Patients must not have a history of clinically significant arrhythmia, prolonged corrected QT (QTc) interval, or unexplained syncope not thought to be vasovagal in nature within 6 months prior to registration','Patients must not have a screening corrected QT using Fridericia's formula (QTcF) interval > 500 milliseconds (by Fridericia calculation) based on the average of triplicate electrocardiogram (EKG) performed within 7 days prior to registration; note that triplicate EKG is required at other time points','Patients must not have a history of chronic liver disease (or cirrhosis)','Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:\r\n* CD4+ cells >= 350/mm^3 (nadir)\r\n* Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART\r\n* No zidovudine or stavudine as part of cART\r\nPatients who are HIV+ and do not meet all of these criteria are not eligible for this study','Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration','Patients must have complete history and physical examination within 28 days prior to registration','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Prior malignancy other than acute leukemia is allowed, provided it is in remission and there is no plan to treat the malignancy at the time of registration','Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S1312; specimens must be submitted to the site's preferred Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory; reports of the results must be submitted as described; note that cytogenetics are required at other time points','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','Patients planning to enroll in this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation'
NCT00942877,https://www.clinicaltrials.gov/ct2/show/record/NCT00942877?term=NCT00942877&rank=1,'Patients must have histologically confirmed alveolar soft part sarcoma; pathology should be confirmed at the Laboratory of Pathology, National Institutes of Health','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan','Patients must have metastatic alveolar soft part sarcoma that is not curable by surgery; patients who have surgically resectable tumors with metastasis will be considered on a case-by-case basis','Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion, and should have recovered to eligibility levels from any toxicities','Any degree of prior treatment is allowed, including other anti-angiogenic treatments (e.g., vascular endothelial growth factor receptor 2 [VEGFR2] inhibitors or bevacizumab); patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery','Body surface area (BSA) >= 1.04 m^2','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 for adults, Karnofsky performance status >= 50% for pediatric patients > 10 years of age, and Lansky performance status >= 50 for pediatric patients =< 10 years of age','Life expectancy of greater than 8 weeks','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin < 1.5 X institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal','Creatinine within normal limits based on age as follows:\r\n* Age (years): maximum serum creatinine (mg/dL)\r\n** =< 5: 0.8 mg/dL\r\n** 5 < age =< 10: 1.0 mg/dL\r\n** 10 < age =< 15: 1.2 mg/dL\r\n** > 15: 1.5 mg/dL\r\nOR creatinine clearance >= 60 mL/min for adults or >= 60 mL/min/1.73m^2 for children with creatinine levels above institutional upper limit of normal','Corrected QT interval (QTc) must be < 500 msec','Pediatric patients: normal left ventricular function with ejection fraction > 55% or shortening fraction >= 27%','Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity of pharmacokinetics (PK) of AZD2171 will be determined following review of their case by the principal investigator; efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications one week prior to starting therapy','Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients should not be receiving any other investigational agents','Prior therapy with anti-angiogenic agents is permitted','Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to: active or uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements','Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine)','Patients who are unable to swallow tablets','Mean QTc > 500 msec (with Bazett’s correction) in screening electrocardiogram or history of familial long QT syndrome','Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD2171','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Adult patients with hypertension not controlled by medical therapy (hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management); pediatric patients must have blood pressure (BP) within normal limits (WNL) for age; NOTE: blood pressure within the upper limit of normal is defined as: blood pressure =< the 95th percentile for age, height, and gender, and not be receiving medication for treatment of hypertension'
NCT01273155,https://www.clinicaltrials.gov/ct2/show/record/NCT01273155?term=NCT01273155&rank=1,'Patients (except those with hepatocellular carcinoma) must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor or lymphoma that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective; patients with hepatocellular carcinoma do not require biopsy confirmation; a liver mass with raised alpha-fetoprotein level (>= 500 ng/mL), consistent radiographic changes, and serology and viral deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) measurements consistent with chronic hepatitis will be sufficient to identify hepatocellular carcinoma without the need for pathologic confirmation of the diagnosis; patients with hepatocellular carcinoma must still, however, have disease that has failed standard therapy; having chronic hepatitis B or C will not exclude patients from participating','No radiation, major surgery, chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C); >= 2 weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a subtherapeutic dose of drug is administered) at the principal investigator (PI)’s discretion; patients must have recovered to at least eligibility levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Serum creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal, as determined by a measured 24-hour creatinine clearance','Patients with abnormal liver function will be eligible and will be grouped according to the criteria described; patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes','Patients with biliary obstruction for which a stent has been placed are eligible, provided the stent has been in place for at least 10 days prior to the first dose of belinostat and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis','For patients with hepatocellular carcinoma secondary to hepatitis B or C, test results should be indicative of chronic viral hepatitis infection:\r\n* Patients with hepatitis B\r\n** Antibodies: Hepatitis B surface antigen (HepBsAg) and hepatitis B core antibody (HepBcAb) should be elevated and hepatitis B surface antibody (HepBsAb) and hepatitis Be antibody (HepBeAb) low, indicating chronic infection; if the pattern is different from this, please notify the PI\r\n** Viral load: COBAS TaqMan test measuring hepatitis B virus (HBV) DNA is reduced in chronic phase hepatitis B; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms\r\n* Patients with hepatitis C\r\n** Antibodies: Anti-hepatitis C virus (HCV) testing-specific tests used will be based on the site’s standard procedure for identifying hepatitis C\r\n** Viral load: HCV-RNA should be relatively constant in chronic phase of disease, though the level is typically higher than in the acute phase; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms','Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to enrollment; patients with known brain metastases should have had brain irradiation (whole brain or gamma knife) more than 4 weeks before starting the protocol; note that patients should have had their steroids tapered to low dose (i.e., < 1.5 mg of dexamethasone/day)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Prior therapy with belinostat','Patients may not be receiving any other investigational agents','Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to belinostat, including hydroxamate compounds or arginine','Patients should not have taken valproic acid, another histone deacetylase (HDAC) inhibitor, for at least 2 weeks prior to enrollment','Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with belinostat','Having chronic hepatitis B or C will not exclude patients from participating if they are otherwise eligible; however, requiring treatment with interferon is an exclusion; patients must be stable without having received interferon in at least 4 weeks','Human immunodeficiency virus (HIV) positive patients who are not on retroviral therapy will not be excluded from cohort 1, the normal liver function cohort\r\n* HIV positive patients who are not on retroviral therapy will be excluded from cohorts 2-4','HIV-positive patients on combination antiretroviral therapy are ineligible','Patients with significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of frequency adjusting medication for atrial fibrillation is allowed, if stable medication for at least last month prior to initiation of belinostat treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/corrected QT (QTc) interval, e.g., repeated demonstration of a QTc interval > 450 msec; long QT syndrome; concomitant use of drugs known to prolong the QT interval and/or cause Torsades de Pointes is not allowed during the study or within 2 weeks of study entry; these drugs should also be avoided for up to 4 weeks following discontinuation of study treatment; drugs that may be associated with Torsades de Pointes but lack substantial evidence will be allowed at the discretion of the PI (although it is preferable to substitute an alternate medication), and patients will be closely monitored'
NCT01273168,https://www.clinicaltrials.gov/ct2/show/record/NCT01273168?term=NCT01273168&rank=1,'Patients with the following types of histologically documented solid tumors:\r\n* Estrogen receptor (ER) positive (+)/progesterone receptor (PR)+, ER+/PR negative (-), or ER-/PR+ breast cancer\r\n* Gynecologic tumors (endometrial, ovarian, uterine, fallopian tube, peritoneal, etc.)\r\n* Desmoid tumors\r\n* Tumors that are ER+ or PR+ by immunohistochemistry (including low-level expression) such as non-small cell lung, colorectal, and prostate','Patients with breast cancer must have had at least one prior chemotherapy regimen for metastatic disease; additionally, patients with breast cancer must have received prior tamoxifen and/or aromatase inhibitor therapy (if post-menopausal) with at least one hormonal regimen in the metastatic setting; patients with HER2+ breast cancer must have progressed after at least one prior HER2-directed regimen (trastuzumab, lapatinib) for metastatic disease\r\n* All other patients must have disease that has progressed following at least one line of standard therapy; prior therapy with tamoxifen is allowed','Patients enrolled based on tumor ER/PR status must have ER/PR status confirmed by the Laboratory of Pathology, National Institutes of Health (NIH); ER/PR status will be determined on a metastatic site, if possible; otherwise, the original site or available tissue will be acceptable','Patients must have recovered to at least eligibility levels following any display of adverse events and/or toxicity due to prior chemotherapy or biologic therapy; they must not have had hormonal therapy, chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C, or 7-hydroxystaurosporin [UCN-01]); patients must be >= 2 weeks since any prior administration of study drug in a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion; patients must be >= 4 weeks since any prior radiation or major surgery; however, patients receiving bisphosphonates or therapeutic anticoagulation are eligible for this trial','The Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy > 3 months','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Total bilirubin within =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine < 1.5 x upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels >= 1.5 x upper limit of normal','Women of childbearing potential and men must agree to use adequate non-hormonal contraception (barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after discontinuation from the study; women of childbearing potential must have a negative pregnancy test in order to be eligible; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued if the mother is treated with Z-endoxifen','Every effort should be made to switch patients taking drugs that are known to be sensitive substrates of these enzymes to other medications 1 week prior to starting therapy; if a patient’s medication cannot be switched, the patient’s eligibility will be determined following a review of their case by the principal investigator','Ability to understand and the willingness to sign a written informed consent document','Patients receiving any other investigational agents','Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 3 months after treatment of the brain metastases, without steroids or anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator','Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, stroke/cerebrovascular accident within the past 6 months, or psychiatric illness/social situations that in the investigator’s opinion would make it undesirable for the patient to participate in the trial, or which would jeopardize compliance with the protocol','Patients with untreated spinal cord metastases or metastases close to vital organs (as determined by the principal investigator) are excluded','Patients with a history of deep vein thrombosis must be on anti-coagulation therapy prior to enrollment; patients requiring prophylactic anti-coagulation are eligible'
NCT01362803,https://www.clinicaltrials.gov/ct2/show/record/NCT01362803?term=NCT01362803&rank=1,'PHASE I: >= 3 years and =< 18 years of age at the time of study enrollment, if able to swallow whole capsules','PHASE II: >= 2 and =< 18 years; body surface area (BSA) >= 0.55 m^2, and able to swallow whole capsules','Patients with NF1 and inoperable PN defined as PN that cannot be surgically completely removed without risk for substantial morbidity due to encasement of, or close proximity to vital structures, invasiveness, or high vascularity of the PN; the PN has to cause (stratum 1) or have the potential to cause (stratum 2) significant morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or are significantly disfiguring, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions; patients will be enrolled into stratum 1 or 2 based on PN related morbidity; histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a PN is clinically suspected; a PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches; a spinal PN involves two or more levels with connection between the levels or extending laterally along the nerve; in addition to PN, all study subjects must have either positive genetic testing for NF1 or have at least one other diagnostic criterion for NF1 listed below (National Institutes of Health [NIH] Consensus conference):\r\n* Six or more café-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1','Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable','PHASE II: Measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the NCI Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as “typical PN” versus “nodular PN” versus “solitary nodular PN prior to enrollment','Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity\r\n* Patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* There will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, peginterferon alfa-2b (Peg-Intron), sorafenib, imatinib, or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the PN; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 before entering this study\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healing','Patients > 16 years of age must have a Karnofsky performance level of >= 70%, and children =< 16 years old must have a Lansky performance of >= 70%; patients who are wheelchair bound because of paralysis secondary to a plexiform neurofibroma should be considered ambulatory when they are up in their wheelchair; similarly, patients with limited mobility secondary to need for mechanical support (such as an airway PN requiring tracheostomy or continuous positive airway pressure [CPAP]) will also be considered ambulatory for the purpose of the study','Absolute neutrophil count >= 1500/ul','Hemoglobin >= 9 g/dl','Platelets >= 100,000/ul','Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) within =< 3 x upper limit of normal','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 ml/min/1.73 m^2 or a normal serum creatinine based on age described in the table below:\r\n* Age: =< 5 years; maximum serum creatinine: 0.8 mg/dL\r\n* Age: 5 < age =< 10 years; maximum serum creatinine: 1.0 mg/dL\r\n* Age: 10 < age =< 15 years; maximum serum creatinine: 1.2 mg/dL\r\n* Age: > 15 years; maximum serum creatinine: 1.5 mg/dL','Normal ejection fraction (echocardiogram [ECHO] or cardiac MRI) >= 53% (or the institutional normal; if a range is given then the upper value of the range will be used); corrected QT (QTC) or Fridericia's correction formula (QTcF) =< 450 msec','Adequate blood pressure defined as:\r\n* A blood pressure (BP) =< the 95th percentile for age, height, and gender measured; adequate blood pressure can be achieved using medication for treatment of hypertension','Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < 18 years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patient’s research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained','Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated','Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study, as these may affect selumetinib metabolism','Pregnant or breast-feeding females are excluded; pregnancy tests must be obtained prior to enrollment for all females of childbearing potential as per institutional standards (at National Institutes of Health [NIH] subjects 9 years and older or those showing pubertal development); males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; abstinence is an acceptable method of birth control','PHASE I: Patients who anticipate the need for surgical intervention within the first three cycles (3 months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable','Use of an investigational agent within the past 30 days','Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy','Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) will be excluded; patients with HIV who have adequate cluster of differentiation (CD)4 count, not requiring antiretroviral medication will not be excluded','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study','Inability to swallow capsules, since capsules cannot be crushed or broken','Inability to undergo MRI and/or contraindication for MRI examinations following the MRI protocol; prosthesis or orthopedic or dental braces that would interfere with volumetric analysis of target PN on MRI','Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption','Prior treatment with selumetinib or another specific mitogen-activated protein kinase (MEK)1/2 inhibitor (unless the subject meets criteria for re-treatment)','Evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy','Supplementation with vitamin E greater than 100% of the daily recommended dose; any multivitamin containing vitamin E must be stopped prior to initiation of therapy','Patients not achieving adequate blood pressure in spite of antihypertensive therapy for control of blood pressure','Cardiac function:\r\n* Known inherited coronary disease\r\n* Symptomatic heart failure (New York Heart Association [NYHA] class II-IV prior or current cardiomyopathy, or severe valvular heart disease)\r\n* Prior or current cardiomyopathy\r\n* Severe valvular heart disease\r\n* History of atrial fibrillation','Ophthalmologic conditions:\r\n* Current or past history of central serous retinopathy\r\n* Current or past history of retinal vein occlusion\r\n* Known intraocular pressure (IOP) > 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of IOP); patients with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma may be eligible after discussion with the study chair\r\n* Subjects with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility\r\n* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal PN (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study','Known severe hypersensitivity to selumetinib or any excipient of selumetinib or history of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib','Recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access','Any unresolved chronic toxicity with CTCAE grade >= 2, from previous anti-NF1 therapy, except for alopecia','Clinical judgement by the investigator that the patient should not participate in the study','While not an exclusion criterion, unless considered clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medication; in particular, patients should avoid medications that are known to either induce or inhibit the activity of hepatic microsomal isoenzymes CYP1A2, CYP2C19 and CYP3A4'
NCT01391962,https://www.clinicaltrials.gov/ct2/show/record/NCT01391962?term=NCT01391962&rank=1,'Patients must have histologically confirmed metastatic alveolar soft part sarcoma that is not curable by surgery; diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment','Patients must show evidence of objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1 on scans within the 6 month period immediately preceding enrollment; both scans used to determine disease progression should have been obtained within this 6-month period','Patients with newly diagnosed, unresectable, metastatic, and measurable ASPS who show clinical evidence of disease progression (including history and increasing physical symptoms) will also be eligible; on-study documentation will include a physician’s rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan','Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients who have had prior monoclonal antibody therapy must have completed that therapy at least 3 half-lives of the antibody or 6 weeks ago; patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center principal investigator (PI) after consultation with a cardiologist and if screening echocardiogram is normal','Patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the coordinating center PI’s discretion, and should have recovered to eligibility levels from any toxicities','Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery','Patients age 16-17 years are eligible only if they have a body surface area (BSA) >= 1.7 m^2 or weigh >= 60 kg','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total serum bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal','Corrected QT interval (QTc) < 480 msec (with Bazett’s correction) in screening electrocardiogram','The following groups of patients are eligible after consultation with a cardiologist and at the coordinating center PI’s discretion, provided they have New York Heart Association class II (NYHA) cardiac function on baseline echocardiogram (ECHO)/multigated acquisition scan (MUGA):\r\n* Those with a history of class II heart failure who are asymptomatic on treatment\r\n* Those with prior anthracycline exposure greater than a cumulative dose of 350 mg/m^2\r\n* Those who have received central thoracic radiation that included the heart in the radiotherapy port','Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the BP reading prior to enrollment is no greater than 140/90 mmHg','Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal','Strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors are not permitted within 7 days before and during the study, and strong CYP3A4 inducers are not permitted within 12 days before and during the study; every effort should be made to switch patients taking such agents or substances to other medications 1 week prior to starting therapy, particularly patients with brain metastases who are taking enzyme-inducing anticonvulsant agents; patients who require potent CYP3A4 inducers or inhibitors and cannot switch medications must have their case reviewed by the coordinating center PI and may be enrolled only after discussion with and agreement from the coordinating center PI; eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics (PK) of cediranib will be determined following review of their case by the coordinating center PI','Women of childbearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months following study drug discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Patients who are nursing infants: breastfeeding should be discontinued if the mother is treated with the study agents','Ability to understand and the willingness to sign a written informed consent document','Patients must be able to swallow whole tablets and capsules','Patients must not have received prior treatment with any vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed','Patients may not be receiving any other investigational agents','Major surgery within 4 weeks prior to entry into the study, or a surgical incision that is not fully healed','History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation','Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible','Warfarin and its derivatives are not allowed; patient can be receiving low molecular weight heparin if clinically indicated','Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow, retain, and/or absorb the drug are excluded','Patients with any of the following conditions are excluded: serious or non-healing wound, ulcer; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment; coronary/peripheral artery bypass graft or stenting within the past 12 months; or cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months','Greater than 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart or 24-hour urine protein of > 1 g; patients with < 2+ proteinuria are eligible following initial determination by urinalysis within 1 week prior to enrollment and do not need the urinalysis repeated','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT01572493,https://www.clinicaltrials.gov/ct2/show/record/NCT01572493?term=NCT01572493&rank=1,'Patients must have histologically confirmed (by the National Cancer Institute [NCI] Pathology Department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are associated with minimal patient survival benefit (as defined the Lymphoid Malignancies Branch physicians or if the patient refuses standard of care treatment); enrollment of patients with tumors that can be safely biopsied is encouraged','Patients must have evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan','Patients must have recovered to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 from toxicity of prior chemotherapy or biologic therapy and must not have had prior chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, 8 weeks for 7-hydroxystaurosporine [UCN-01])','Patients on bisphosphonates for any cancer or on hormone therapy for prostate cancer will not need to discontinue this therapy to be eligible; however, patients with prostate cancer will need to have metastatic prostate cancer that has progressed despite hormonal therapy; castrate testosterone levels occur within hours after castration and within 2 to 3 weeks of a luteinizing hormone-releasing hormone agonist; the current standard is to continue androgen suppression despite progressive disease','Diffusing capacity of the lung for carbon monoxide (DLCO)/alveolar volume (VA) and forced expiratory volume in 1 second (FEV-1.0) >= 60% of predicted on pulmonary function tests','Serum creatinine of =< 1.5 X the upper limit of normal','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x the upper limit of normal','Absolute neutrophil count >= 1,500/mm^3','Platelets >= 100,000/mm^3','Karnofsky performance status >= 70% or Eastern Cooperative Oncology Group (ECOG) =< 1','Subjects with inactive central nervous system (CNS) metastasis are eligible; inactive CNS metastasis is defined as: no signs of cerebral edema after successful definitive treatment of brain metastases (surgical resection, whole brain irradiation, stereotactic radiation therapy, or a combination of these) with stable or improved radiographic appearance on magnetic resonance imaging (MRI) scan at least 1 month after completion of treatment','Patients who have received any systemic corticosteroid therapy within 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent','Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines, monoclonal antibodies or major surgery in the 4 weeks prior to the start of the study','Life expectancy of less than 3 months','Patients with more than 30% replacement of hepatic parenchyma by tumor or any history of drug related hepatic encephalopathy','History of complex ventricular or supraventricular arrhythmias','Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, or hepatitis C infection','A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B virus surface antibody [HBsAb] positive and hepatitis B virus core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion','A positive hepatitis C serology is an exclusion criterion','Concurrent anticancer therapy (including other investigational agents), with the exception of hormone therapy for prostate cancer','Active CNS metastases','History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible)','History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte antigen 4 [CTLA-4]) therapy that has been completely resolved for more than 4 weeks','Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of treatment)','Cognitive impairment, history of medical or psychiatric disease, other uncontrolled intercurrent illness, active substance abuse, or social circumstances, which in the view of the principal investigator (PI), would preclude safe treatment or the ability to give informed consent'
NCT01748825,https://www.clinicaltrials.gov/ct2/show/record/NCT01748825?term=NCT01748825&rank=1,'Patients must have histologically confirmed solid tumors for which all standard therapy known to prolong survival have failed or for which standard therapies do not exist','Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Expansion Arm A), for the 6-patient breast cancer gene (BRCA)-mutation expansion arm, patients must have measurable disease; however, tumor biopsies are optional; for Expansion Arm B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements','Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study or >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky > 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin > 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the treatment with the study drug, and for 2 months after the last dose of AZD1775; male patients who are involved in the study must agree to avoid procreative and unprotected sex (i.e., by using acceptable forms of contraception) and must not donate sperm during the study and for 3 months after the last dose of AZD1775; where the female partner is pregnant or not using effective birth control, men should be advised to abstain while in the study and for 3 months after the last dose of AZD1775; female partners, who are of child-bearing potential, of men participating in clinical studies of AZD1775 will also be required to use effective contraceptive measures while their partner is on study drug and for 3 months thereafter; male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study should they wish to father children while on AZD1775 or during the 3 months after stopping AZD1775','Breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug','Patients must be able to swallow whole tablets or capsules; nasogastric or gastrostomy tube (G-tube) administration is not allowed; any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed','Ability to understand and the willingness to sign a written informed consent document','Patients with prostate cancer can continue to receive treatment with gonadotropin releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on therapy','Patients who are receiving any other investigational agents','Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= 4 weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator','Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of AZD1775 will be determined following review by the principal investigator','Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4, or CYP3A4 substrates need to be reviewed by the principal investigator; continuation of such medications will be at the discretion of the principal investigator; concomitant use of aprepitant or fosaprepitant is prohibited; as grapefruit and Seville oranges are known to contain moderate inhibitors of CYP3A4, these fruits or their products (including marmalade, juice, etc.) should be avoided while taking AZD1775; the use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study; herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study','Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy are ineligible'
NCT01827384,https://www.clinicaltrials.gov/ct2/show/record/NCT01827384?term=NCT01827384&rank=1,'TUMOR BIOPSY SEQUENCING: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survival','TUMOR BIOPSY SEQUENCING: Patient must have tumor amenable to percutaneous or excisional skin biopsy and be willing to undergo a tumor biopsy or biopsy samples (formalin-fixed paraffin-embedded [FFPE] blocks) collected on another study or from a procedure performed due to medical necessity may be acceptable if collected within 6 months prior to registration on MPACT and providing that the patient has not received any investigational or targeted treatment since that time','TUMOR BIOPSY SEQUENCING: Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan','TUMOR BIOPSY SEQUENCING: Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment, denosumab, or similar agents areare eligible to participate and may continue this treatment; patients with prostate cancer may continue luteinizing hormone-releasing hormone (LHRH) agonists or antagonists','TUMOR BIOPSY SEQUENCING: Karnofsky performance status >= 70%','TUMOR BIOPSY SEQUENCING: Life expectancy > 3 months','TUMOR BIOPSY SEQUENCING: Absolute neutrophil count >= 1,000/uL (mcL)','TUMOR BIOPSY SEQUENCING: Platelets >= 100,000/uL (mcL)','TUMOR BIOPSY SEQUENCING: Total bilirubin < 1.5 x institutional upper limit of normal','TUMOR BIOPSY SEQUENCING: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','TUMOR BIOPSY SEQUENCING: Creatinine < 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels >= 1.5 x institutional upper limit of normal','TUMOR BIOPSY SEQUENCING: Women of childbearing potential and men must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study; breastfeeding should be discontinued while the patient is on this trial and for 30 days following last dose of study drug','TUMOR BIOPSY SEQUENCING: Patients with history of central nervous system (CNS) metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for 4 weeks will be eligible; enzyme-inducing anticonvulsants are contraindicated','TUMOR BIOPSY SEQUENCING: Ability to understand and the willingness to sign a written informed consent document (subjects with impaired decision-making capacity are not eligible)','TUMOR BIOPSY SEQUENCING: Women who are pregnant or breastfeeding','TUMOR BIOPSY SEQUENCING: Patients who are receiving any other investigational agents; patients on other trials will be eligible as long as they are no longer receiving study treatment','TUMOR BIOPSY SEQUENCING: Patients with uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the past 6 months, invasive fungal infections, or active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e., quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) are not eligible to participate; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated','TUMOR BIOPSY SEQUENCING: Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease) are excluded; subjects with Crohn’s disease or a partial or complete small bowel obstruction are also excluded, as are any patients who cannot swallow tablets or capsules whole; tablets or capsules must not be crushed or chewed; nasogastric or gastrostomy tube (G-tube) administration is not allowed','TUMOR BIOPSY SEQUENCING: Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','TUMOR BIOPSY SEQUENCING: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use','TREATMENT: Patient must have predefined targeted mutation in tumor biopsy','TREATMENT: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy or for which no standard therapy exists that has been shown to prolong survival','TREATMENT: Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan','TREATMENT: Any prior therapy, radiotherapy, or major surgery must have been completed >= 3 weeks (> 6 weeks for nitrosoureas or mitomycin C) or 5 half-lives of the agent (whichever is shorter) prior to enrollment on protocol, and the participant must have recovered to eligibility levels from prior toxicity; radiofrequency ablation (RFA) of localized lesions should have been performed >= 2 weeks prior to treatment','TREATMENT: Patients who have had prior treatment with any of the other investigational agents or combinations on this protocol are eligible but will not receive the same investigational agent (everolimus or trametinib) or combination (AZD1775/combination or veliparib/temozolomide); instead, patients will receive an investigational agent or combination prospectively identified to work on a different target in their tumor’s mutation/aberrant pathway','TREATMENT: Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment, denosumab, or similar agents are eligible to participate and may continue this treatment; patients with prostate cancer may continue LHRH agonists or antagonists','TREATMENT: Karnofsky performance status >= 70%','TREATMENT: Absolute neutrophil count >= 1,000/uL (mcL)','TREATMENT: Platelets >= 100,000/uL (mcL)','TREATMENT: Total bilirubin < 1.5 x institutional upper limit of normal','TREATMENT: AST (SGOT)/ALT (SGPT) =< 3 x institutional upper limit of normal','TREATMENT: Creatinine < 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels >= 1.5 x institutional upper limit of normal','TREATMENT: Life expectancy > 3 months','TREATMENT: Women of childbearing potential and men must agree to use highly effective contraception (see list below) prior to study entry, for the duration of study participation, and for 3 months after completion of study\r\n* Total abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); (for female subjects on the study, the vasectomized male partner should be the sole partner for that subject)\r\n* Use of a combination of any two of the following (a+b or a+c or b+c):\r\n** Use of oral, injected, implanted or other hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* In case of use of oral contraception, women should have been stable on the oral agent before taking study treatment\r\n* Sexually active males must use a condom during intercourse','TREATMENT: Breastfeeding should be discontinued while the patient is on this trial and for 30 days following last dose of study drug','TREATMENT: Patients with melanoma and known v-raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutations must have received and progressed on specific BRAF inhibitor therapy','TREATMENT: Patients with non-small cell lung cancer (NSCLC) must have previously been tested for the presence of epidermal growth factor receptor (EGFR) mutations, and, if detected, should have received and progressed on EGFR tyrosine kinase inhibitor (TKI) therapy','TREATMENT: Patients with ovarian cancer and breast cancer gene (BRCA) mutations must have received specific poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy; if these patients have other mutations of interest, they will be eligible to receive agents based on that mutation','TREATMENT: Patients with metastatic breast cancer and BRCA mutations must have received specific PARP inhibitor therapy; if these patients have other mutations of interest as defined in the protocol, they will be eligible to receive agents based on that mutation','TREATMENT: Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib dimethyl sulfoxide (DMSO), its excipients, or DMSO, are ineligible to receive treatment with trametinib DMSO','TREATMENT: Patients with a history or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED) or predisposing factors to RVO or RPED (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes), are ineligible to receive treatment with trametinib DMSO; visible retinal pathology (as assessed by ophthalmic exam) that is considered a risk factor for RVO or RPED includes evidence of new optic disc cupping or new visual field defects, or intraocular pressure > 21 mm Hg','TREATMENT: Patients with a history of seizures are not eligible to receive veliparib, but patients with a history of CNS metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for >= 4 weeks will be eligible for other study agents; enzyme inducing anticonvulsants are contraindicated','TREATMENT: Patients who have received prior carboplatin or AZD1775 (MK-1775) would not be excluded unless the two drugs were administered in combination; patients who have received prior carboplatin in combination with AZD1775 (MK-1775) would still be eligible to receive other study treatment regimens based on identified genetic mutation(s), other than carboplatin plus AZD1775 (MK-1775)','TREATMENT: Patients who have had prior treatment with any PARP inhibitor in combination with temozolomide are ineligible to receive treatment with veliparib on this study; patients who have received prior temozolomide or PARP inhibitor with or without other chemotherapy/targeted agent aside from temozolomide should not be excluded solely because of receiving prior PARP inhibitor or temozolomide, unless it was in combination; patients who have received temozolomide with a PARP inhibitor in the past are eligible to participate but will not receive veliparib with temozolomide on study; such patients are eligible to receive other treatment regimens on study based on identified genetic mutations','TREATMENT: Patients who have received prior everolimus or other mechanistic target of rapamycin (mTOR) inhibitors or those with known intolerance or hypersensitivity to other rapamycin analogs (e.g., sirolimus, temsirolimus) would not be eligible to receive everolimus on study; if these patients have mutations of interest in pathways other than the phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (pI3K) pathway, they will be eligible to receive agents based on that mutation','TREATMENT: Patients who have received prior mitogen-activated protein kinase kinase (MEK) inhibitors would not be eligible to receive trametinib DMSO on study; if these patients have mutations of interest in pathways other than the rat sarcoma (RAS) pathway, they will be eligible to receive agents based on that mutation','TREATMENT: Patients with current or a history of interstitial lung disease, known severely impaired lung function (spirometry and carbon monoxide diffusing capability test (DLCO) 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air) or non-infectious pneumonitis will not be assigned treatment with everolimus or trametinib DMSO; symptoms should have resolved and course of antibiotics been completed for patients with a history of infectious pneumonitis to be eligible','TREATMENT: For patients on everolimus, fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: in case one or both of these thresholds are exceeded, the patient can receive everolimus on study only after initiation of appropriate lipid lowering medication with follow up documentation of values below the above cut-off','TREATMENT: Patients with known hypersensitivity reaction to dacarbazine are ineligible to receive temozolomide','TREATMENT: Women who are pregnant or breastfeeding','TREATMENT: Patients who are receiving any other investigational agents; patients on other trials will be eligible as long as they are no longer receiving study treatment','TREATMENT: Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients who have a history of seizures are not eligible to receive veliparib, but patients who have either not had seizures or who have been on stable doses of anti-seizure medicine and had no seizures for 4 weeks will be eligible for other study agents; enzyme-inducing anticonvulsants are contraindicated','TREATMENT: Patients with uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the past 6 months, invasive fungal infections, or active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) are not eligible to participate; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated','TREATMENT: Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease) are excluded; subjects with Crohn's disease or a partial or complete small bowel obstruction are also excluded, as are any patients who cannot swallow tablets or capsules whole; tablets or capsules must not be crushed or chewed; nasogastric or G-tube administration is not allowed','TREATMENT: HIV-positive patients on combination antiretroviral therapy are ineligible','TREATMENT: Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics (i.e., cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP450], P-glycoprotein [PgP]) of any of the study drugs will be determined following review of their cases by the principal investigator (PI); patients on strong and moderate cytochrome P450 system inducers or inhibitors are ineligible; every effort would be made to switch patients off medications that are known substrates of CYP450; if it is medically important for the patient to remain on such medications, these patients can still be eligible to participate based on PI discretion','TREATMENT: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use','TREATMENT: Patients who have poorly controlled diabetes (defined as fasting blood glucose of > 160 mg/dL (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) and glycated hemoglobin (HgA1c) > 8% are ineligible to receive treatment with everolimus on study; patients with fasting blood glucose > 160 mg/dL may be eligible if the HgA1c < 8%, per PI discretion','TREATMENT: Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib DMSO, its excipients, or DMSO, are ineligible to receive treatment with trametinib DMSO','TREATMENT: Patients requiring chronic treatment with corticosteroids or other immunosuppressive agents are ineligible to receive everolimus (topical or inhaled corticosteroids are allowed)','TREATMENT: Patients who have received live attenuated vaccines within 1 week of the start are ineligible to receive everolimus','TREATMENT: Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for > 3 years'
NCT01922076,https://www.clinicaltrials.gov/ct2/show/record/NCT01922076?term=NCT01922076&rank=1,'Patients with newly diagnosed DIPGs, defined as tumors with a pontine epicenter and diffuse involvement of the pons, are eligible without histologic confirmation\r\n* Patients with brainstem tumors that do not meet these criteria or are not considered to be typical intrinsic pontine gliomas will only be eligible if the tumors are biopsied and proven to be an anaplastic astrocytoma, glioblastoma, gliosarcoma, diffuse midline glioma with histone H3 K27M mutation, or anaplastic mixed glioma; patients with pilocytic astrocytoma, fibrillary astrocytoma, gangliogliomas, or other mixed gliomas without anaplasia are not eligible\r\n* Patients with disseminated disease are not eligible, and magnetic resonance imaging (MRI) of spine must be performed if disseminated disease is suspected by the treating physician\r\n* Enrollment must be no later than 28 days after the date of radiographic diagnosis or surgery, whichever is the later date','Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must not have received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG; prior dexamethasone and/or surgery are allowed','Peripheral absolute neutrophil count (ANC) >= 1000/mm^3','Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* 0.8 mg/dL (3 to < 6 years of age)\r\n* 1.0 mg/dL (6 to < 10 years of age)\r\n* 1.2 mg/dL (10 to < 13 years of age)\r\n* 1.5 mg/dL (male) or 1.4 mg/dl (female) (13 to < 16 years of age)\r\n* 1.7 mg/dL (male) or 1.4 mg/dl (female) (>= 16 years of age)','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 units per liter (U/L); for the purpose of this study, the ULN for SGPT is 45 U/L','Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase [AST] =< 3 x ULN = 150 U/L; for the purpose of this study, the ULN for SGOT is 50 U/L','Serum albumin >= 2 g/dL','Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled','Corrected QT interval (QTc) =< 480 msec','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women may not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; negative serum or urine pregnancy test within 3 days prior to enrollment','Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive methods as follows: fertile females of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation; male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for 3 months after treatment stops','Patients receiving corticosteroids are eligible for this trial','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients must not currently be receiving enzyme inducing anticonvulsants','Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause Torsades De Pointes; if possible, alternative agents should be considered; patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available','Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of CYP3A4, sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant or fosaprepitant as an antiemetic is prohibited due to early drug interaction data demonstrating increased exposure to AZD1775; the use of hydroxymethylglutary (HMG) coenzyme-A (Co-A) inhibitors such as atorvastatin is prohibited','Herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng; patients should stop using these herbal medications 7 days prior to study enrollment','Any known hypersensitivity or contraindication to the components of the study drug AZD1775','Patients must not receive metformin for at least 5 days prior to enrollment and for the duration of study treatment','Patients must be able to swallow capsules; nasogastric or gastrostomy feeding (G) tube administration is not allowed','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial','Major surgical procedures =< 28 days of beginning study treatment, or minor surgical procedures (including ventriculoperitoneal [VP] shunt placement or stereotactic biopsy of the tumor) =< 7 days; no waiting period required following port-a-cath or other central venous access placement','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT01964300,https://www.clinicaltrials.gov/ct2/show/record/NCT01964300?term=NCT01964300&rank=1,'Patient must have a histologically verified diagnosis of craniopharyngioma\r\n* Stratum 1: patients with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who have not received radiation therapy; patients with unresectable craniopharyngiomas, (i.e. residual measurable disease following surgical resection) will be enrolled at the time of progression\r\n* Stratum 2: patients with progressive or recurrent craniopharyngiomas following radiation therapy; the patient must be at least 6 months post irradiation to be eligible','All patients must have measurable residual disease defined as tumor measurable in two perpendicular diameters on magnetic resonance imaging (MRI); measurements are required for both the solid and cystic components','Subjects must have recovered from the acute toxicities of all prior therapy before entering this study; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0, unless otherwise specified in the inclusion and exclusion criteria','Myelosuppressive chemotherapy:\r\n* Subjects must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks if nitrosourea','Subjects must have received their last dose of investigational or biologic agent >= 7 days prior to study registration\r\n* In the event that a subject has received an investigational or biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to registration\r\n* If the investigational or biologic agent has a prolonged half-life (>= 7 days) then at least three (3) weeks must have elapsed prior to registration','Subjects must have completed at least 3 half-life periods from the last dose of monoclonal antibody prior to registration \r\n* Note: a list of half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) website under Generic Forms and Templates','Stratum 1: patients must not have received radiation therapy','Stratum 2: patients must have received radiation therapy, which may include gamma knife or phosphorus-32 (P32)\r\n* More than 6 months from the time of enrollment if the recurrence is predominantly solid\r\n* More than 12 months from the time of enrollment if the recurrence is predominantly cystic','At least 7 days since the completion of therapy with a hematopoietic growth agent (filgrastim, sargramostim, and erythropoietin) and 14 days for long-acting formulations','Karnofsky performance scale (KPS for >= 16 years [yrs] of age) or Lansky performance score (LPS for < 16 years of age) >= 60 assessed within two weeks prior to registration','Minimum weight 20 kilograms is required to be eligible for the study since the minimum injection volume of SYLATRON is 0.05 ml, 20 mcg, subcutaneously (SQ) as suggested by Merck','Absolute neutrophil count (ANC) >= 1000/ul (unsupported)','Platelets >= 100,000/ul (unsupported)','Hemoglobin (Hg) >= 8g/dL (unsupported)','Alanine aminotransferase (ALT) =< 2.5 x the upper limit of institutional normal','Total bilirubin =< x 1.5 upper limit of institutional normal','Serum creatinine =< 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2\r\n* =< 0.6 mg/dL (1 to < 2 years of age)\r\n* =< 0.8 mg/dL (2 to < 6 years of age)\r\n* =< 1.0 mg/dL (6 to < 10 years of age)\r\n* =< 1.2 mg/dL (10 to < 13 years of age)\r\n* =< 1.4 mg/dL (females >= 13 years of age)\r\n* =< 1.5 mg/dL (males 13 to < 16 years of age)\r\n* =< 1.7 mg/dL (males >= 16 years of age)','Patients must have evidence of radiographic progression as defined below:\r\n* Stratum 1: defined as >= 25% increase in the product of the greatest perpendicular diameters of the tumor as a whole (solid and cystic component) AND >= 0.4 cm increase in each of at least two dimensions of the tumor as a whole OR any new or worsening neurologic/vision deficit in conjunction with a lesser change in the solid or cystic component\r\n* Stratum 2: \r\n** For patients more than 6 months following radiation therapy (RT) (including radiosurgery or P32), progression is defined as a >= 25% increase in the product of the greatest perpendicular diameters of the solid component AND >= 0.4 cm increase in each of at least two dimensions of the solid component\r\n** For patients more than 12 months following RT (including radiosurgery or P32), progression is defined as >= 25% increase in each of the product of the greatest perpendicular diameters of the solid tumor AND >= 0.4 cm increase in each of at least two dimensions of the solid tumor; patients demonstrating predominantly cystic progression more than 12 months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least 4 weeks apart OR re-accumulation of the cyst following one or more cyst aspirations; patients with progressive neurologic signs and/or symptoms associated with isolated cyst formation or progression are eligible if the neurologic signs and/or symptoms do not improve within 4 weeks of cyst aspiration','Female subjects of childbearing potential must not be pregnant or breast-feeding; female subjects of childbearing potential must have a negative serum or urine pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of therapy)','Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study','Ability to understand and the willingness to sign a written informed consent document','Stratum 1 patients: must not have had > 3 surgical debulking procedures/resections','Patients may not have received prior interferon, either systemic or intra-cystic','Patients must not have evidence of metastatic tumor or other cancer','Patients must not be on steroids other than for physiologic replacement','Patients must not have a severe psychiatric illness, including major depression or any previous suicide attempts','Patients must not be on phenytoin, warfarin or methadone','Patients must not have known hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Steven-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other products component','Subjects with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy'
NCT02004275,https://www.clinicaltrials.gov/ct2/show/record/NCT02004275?term=NCT02004275&rank=1,'Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed','Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true:\r\n* Measurable disease:\r\n** Serum M-protein >= 1.0 g/dL (>= 0.5 g/dL for IgA or IgM myeloma) and/or\r\n** Urine M-protein >= 200 mg/24 hours and/or\r\n** Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio\r\n* For non-measurable disease:\r\n** Baseline marrow burden of myeloma of at least 30%','Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease)\r\n* Lenalidomide-refractory disease is defined as disease progression on or progression within 60 days of the last dose of a lenalidomide-based treatment; patients should have received at least 2 cycles of a lenalidomide-based regimen to be evaluable for refractoriness; examples: 1) progression on lenalidomide maintenance therapy after initial induction +/- consolidation; 2) initial response followed by progression on continuous lenalidomide-dexamethasone +/- elotuzumab or daratumumab','Pomalidomide naive disease','Proteasome inhibitor naive or sensitive disease; proteasome inhibitor sensitive disease is defined as a PR or better to prior proteasome inhibitor-based therapy that is maintained for >= 60 days from the last dose of the proteasome inhibitor\r\n* A patient who receives induction therapy with lenalidomide, bortezomib and dexamethasone and achieves a PR or better but subsequently progresses on continued lenalidomide or lenalidomide-dexamethasone would be eligible provided the progression occurs 60 days or more after discontinuation of the bortezomib; similarly, ixazomib exposure is allowed provided they meet the definition of proteasome inhibitor sensitive disease','1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)','Allogeneic stem cell transplantation is allowed provided the patient is >= 1 year from transplant at time of registration, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, and no evidence of active infection','No other chemotherapy or radiation therapy within 14 days prior to registration','No investigational therapy within 14 days prior to registration','No major surgery within 28 days prior to registration','No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria','No platelet transfusions within 7 days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time','A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\r\n* Women of childbearing potential:\r\n** Must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mlU/ml no more than 14 days prior to registration and must agree to repeat this test within 24 hours of starting pomalidomide\r\n** Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide\r\n** Must agree to ongoing pregnancy testing\r\n** Must agree to not become pregnant or breast feed a child during treatment on this protocol\r\n* Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy\r\n* Note: All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','Absolute neutrophil count (ANC) >= 1.0 x 10^9/L','Platelet count >= 50 x 10^9/L','Calculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection','Total bilirubin < 1.5 x upper limits of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limits of normal (ULN)','Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria','Patients cannot have:\r\n* Central nerve system involvement\r\n* Primary refractory multiple myeloma, where primary refractory multiple myeloma is defined as disease that is nonresponsive – patients who have never achieved a minimal response (MR) or better – with any therapy over the course of their disease; it includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD)\r\n* Primary or secondary plasma cell leukemia\r\n* Light-chain (AL) amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome\r\n* Known active hepatitis C based on:\r\n** +hepatitis C virus (HCV) antibody (confirmed)\r\n** +HCV RNA\r\n** Liver disease with history of positive serology\r\n** Note: patients with a prior history of hepatitis C that has been successfully eradicated with antiviral therapy are eligible\r\n* Known hepatitis B surface antigen positivity\r\n* Previous hypersensitivity to any of the components of the study treatment\r\n* Prior history of erythema multiforme with thalidomide or lenalidomide treatment','=< grade 2 peripheral neuropathy','Adequate cardiac function, defined as:\r\n* No electrocardiogram (EKG) evidence of acute ischemia\r\n* No EKG evidence of active, clinically significant conduction system abnormalities\r\n* No EKG evidence of > grade 2 (> 480 ms) corrected QT (QTc) prolongation \r\n* Prior to study entry, any EKG abnormality at screening not felt to put the patient at risk has to be documented by the investigator as not medically significant\r\n* No uncontrolled angina or severe ventricular arrhythmias\r\n* No clinically significant pericardial disease\r\n* No history of myocardial infarction within 6 months prior to registration\r\n* No class 3 or higher New York Heart Association congestive heart failure','No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 within 14 days prior to registration\r\n*Note: Ixazomib is a substrate of CYP3A4 and CYP1A2','Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:\r\n* No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness\r\n* Cluster of differentiation (CD)4+ cells nadirs > 350/mm^3 within 28 days prior to registration\r\n* Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3 within 28 days prior to registration\r\n* Note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patient must have measurable disease or non-measurable disease after progression on pomalidomide + dexamethasone, defined as one or more of the following holding true:\r\n* Measurable disease:\r\n** Serum M-protein >= 0.5 g/dL and/or\r\n** Urine M-protein >= 200 mg/24 hours and/or\r\n** Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio\r\n* For non-measurable disease:\r\n** Marrow burden of myeloma of at least 30%','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): \r\n* Women of childbearing potential:\r\n** Must have a negative serum or urine pregnancy test within 72 hours prior to re-registration\r\n** Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide\r\n** Must agree to ongoing pregnancy testing\r\n** Must agree to not become pregnant or breast feed a child during treatment on this protocol\r\n* Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy\r\n* Note: All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status 0-2','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Absolute neutrophil count (ANC) >= 1.0 x 10^9/L','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Calc. creatinine clearance >= 30 mL/min\r\n* Calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN)','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy','RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2\r\n* Note: Ixazomib is a substrate of CYP3A4 and CYP1A2'
NCT01940809,https://www.clinicaltrials.gov/ct2/show/record/NCT01940809?term=NCT01940809&rank=1,'Study participants must have histologically or cytologically confirmed unresectable or metastatic malignant melanoma','Study participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Study participants must have completed any prior treatment at least 3 weeks prior to treatment on this protocol; prior treatments may have included chemotherapy however may not have included BRAF or MEK inhibitors or immunotherapies (interleukin-2, ipilimumab, anti-programmed death [PD]1 antibodies etc.) excluding vaccine therapy; prior treatment with interferon in the adjuvant setting is allowed, though prior treatment with ipilimumab in the adjuvant setting is not; prior radiation therapy is allowed though must have included no more than 3000 centigray (cGy) to fields including substantial marrow','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Absolute neutrophil count (ANC) >= 1.2 x 10^9/L','Hemoglobin >= 9 g/dL','Platelets >= 100 x 10^9/L','Albumin >= 2.5 g/dL','Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO)','Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (lab); if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided','Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency','Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed) for the duration of study participation, and for at least 2 weeks after treatment with dabrafenib or for 6 months after dabrafenib in combination with trametinib; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 (except alopecia) at the time of randomization','Ability to understand and the willingness to sign a written informed consent document','Prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study','Study participants with a history of prior treatment with BRAF or MEK inhibitors','Study participants who had prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\r\n* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Study participants who have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study','Study participants with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody and/or anti-PD-1 antibody','Study participants with brain metastases are excluded unless these have been definitively treated and are radiographically stable for at least 1 month; the study participant must also demonstrate a stable physical exam and must have discontinued systemic steroids for treatment of edema related to brain metastases or treatment for over 7 days','Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO)','Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)','Patients with history of rat sarcoma (RAS) mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility','History or evidence of cardiovascular risks including any of the following:\r\n* QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec\r\n* History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to randomization\r\n* History or evidence of current class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Intra-cardiac defibrillators\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy','Any condition which in the investigator’s opinion makes the subject unsuitable for study participation','History of retinal vein occlusion (RVO)','History of interstitial lung disease or pneumonitis'
NCT01947023,https://www.clinicaltrials.gov/ct2/show/record/NCT01947023?term=NCT01947023&rank=1,'Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective','Patients must have measurable and histologically or cytologically confirmed thyroid cancer with a BRAF V600E or V600K (c. 1799 T to A and c.1799_1800TG>AA) mutation that is not considered curable by surgery; confirmation will be done at Memorial Sloan Kettering (MSK); only tumors with a BRAFV600E or BRAFV600K mutation will be eligible for the clinical study; BRAF status will be assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; BRAF status may also be tested with any Food and Drug Administration (FDA)-approved test (such as Cobas 4800 BRAF V600 Mutation Test)','The tumor is considered to be radioactive-iodine refractory by any of the following criteria:\r\n* Total lifetime dose of radioactive iodine > 600 mCi\r\n* Absent or insufficient radioactive iodine uptake in either all lesions or an index lesion which has never been resected or received external beam radiation therapy as documented on a radioactive iodine scan (insufficient uptake must be confirmed by either an endocrinologist or nuclear medicine physician)\r\n* Progression of disease (by imaging or thyroglobulin) within 6 months of radioactive iodine treatment\r\n* Fludeoxyglucose F 18 (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= 3) on a FDG-positron emission tomography (PET) scan','No recent treatment for thyroid cancer as defined as:\r\n* No radioactive iodine therapy is allowed if given < 3 months prior to initiation of this protocol therapy; a diagnostic study using < 10 mCi of radioactive iodine (RAI) is not considered radioactive iodine therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy','Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or Karnofsky\r\n>= 60%','Life expectancy of greater than 2 months','Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Absolute neutrophil count (ANC) >= 1.2 x 10^9/L, within 2 weeks of the first dose of study treatment','Hemoglobin >= 9 g/dL, within 2 weeks of the first dose of study treatment','Platelets >= 100 x 10^9/L, within 2 weeks of the first dose of study treatment','Bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome, within 2 weeks of the first dose of study treatment','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN, within 2 weeks of the first dose of study treatment','Blood creatinine =< 1.5 mg/dL (if blood creatinine is > 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft and Gault method or using a 24 hour urine collection for creatinine; creatinine clearance must be > 50 mL/min), within 2 weeks of the first dose of study treatment','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PT/INR/PTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding (e.g., deficiency of factor XII), within 2 weeks of the first dose of study treatment','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO), within 2 weeks of the first dose of study treatment','Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study treatment','Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed) for the duration of study participation, and for at least 2 weeks after treatment with dabrafenib; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patient must agree to allow 3 separate biopsies of any malignant lesion; biopsies do not need to be done if:\r\n* Tumor is not considered accessible by either the investigator or the person performing the biopsy (it is determined the risk is too high due to location near vital organs or too great of a risk of an adverse event)\r\n* Patient is on anticoagulation and it would be unsafe to temporarily hold the anticoagulation\r\n* Consent of the principal investigator (PI) not to have a biopsy done\r\n* A minimum of 8 subjects must participate in the biopsy part of the study','Prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study','Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded; it is important to regularly consult a frequently-updated list of these agents; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\r\n* Prohibited: strong inducers of CYP3A or CYP2C8\r\n** Antibiotics: rifamycin class agents (e.g., rifampin, rifabutin, rifapentine)\r\n** Anticonvulsant: carbamazepine, oxcarbazepine phenobarbital, phenytoin, s-mephenytoin\r\n** Miscellaneous: bosentan, St. John’s wort\r\n* Prohibited: strong inhibitors of CYP3A or CYP2C8\r\n** Antibiotics: clarithromycin, telithromycin, troleandomycin\r\n** Antidepressant: nefazodone\r\n** Antifungals: itraconazole, ketoconazole, posaconazole, voriconazole\r\n** Hyperlipidemia: gemfibrozil\r\n** Antiretroviral: ritonavir, saquinavir, atazanavir\r\n** Miscellaneous: conivaptan','Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia; in specific cases, will be allowed with permission from the principal investigator','Human immunodeficiency virus (HIV)-positive patients on antiviral drugs and/or cluster of differentiation (CD)4 count is inadequate (< 500); if neither condition exists, HIV-positive patients are eligible','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)','Presence of an invasive malignancy other than the study indication under this trial within 3 years of study enrollment except for carcinoma in situ CIS, squamous cell carcinomas of the skin, or basal cell carcinoma of the skin; a diagnosis of an invasive malignancy within 3 years is allowed if both the cure rate is felt to be > 80% and there has been no evidence of disease in the past year','Patients with a history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however if the results of previous RAS testing are known, they must be used in assessing eligibility','Brain metastases that are symptomatic or requiring corticosteroids (except inhaled); subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks','History or evidence of cardiovascular risks including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to randomization\r\n* History or evidence of current class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Intra-cardiac defibrillators\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy','Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO)','Medical or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with dabrafenib'
NCT01988571,https://www.clinicaltrials.gov/ct2/show/record/NCT01988571?term=NCT01988571&rank=1,'Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma stage I-IV; (patients should have a > 2 year life expectancy)','Scheduled to receive chemotherapy with an anthracycline (doxorubicin [doxorubicin hydrochloride] or epirubicin [epirubicin hydrochloride])','Patients that are receiving or have received chemotherapy regimens are allowed','Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment','Able to hold breathe for 10 seconds','Eastern Cooperative Oncology Group (ECOG) 0 or 1','Patients with breast implants are usually permitted to have an magnetic resonance imaging (MRI); check with the MRI technician to confirm','It is recommended the lipid profile be drawn fasting >= 8 hrs; serum lipid profile: total cholesterol/high-density lipoprotein (HDL)/low-density lipoprotein (LDL)/triglycerides (LDL levels prior to chemotherapy must be =< 190 mg/dl), within 30 days prior to enrollment\r\n* If labs are drawn non-fasting and LDL levels are >= 190 mg/dl the lipid profile should be repeated fasting to determine eligibility','Alanine aminotransferase level (ALT) =< 3 x the upper limit of normal (ULN), within 30 days prior to enrollment','Aspartate aminotransferase level (AST) =< 3 x ULN, within 30 days prior to enrollment','Total bilirubin =< 2.0, within 30 days prior to enrollment','Thyroid stimulating hormone (TSH) =< 1.5 times ULN, within 30 days prior to enrollment','Creatinine kinase =< 2.5 x the ULN, within 30 days prior to enrollment','It is recommended glucose be drawn fasting >= 8 hrs; glucose < 126 (diabetics 40–75 years of age are not eligible), within 30 days prior to enrollment\r\n* If glucose is >= 126 the glucose should be repeated fasting to determine eligibility','Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin','40 to 75 years of age with diabetes per American College of Cardiology (ACC)/American Heart Association (AHA) ACC/AHA 2013 guidelines','Significant ventricular arrhythmias (> 20 premature ventricular contractions [PVCs]/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response','Current use of statin therapy','Current or history of hepatic dysfunction','Uncontrolled hypothyroidism','Recent extended history of constant-recurrent substance abuse or another medical condition that might compromise safety or the successful completion of the study','Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices','Current use of the following cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4) inhibitors are not allowed: boceprevir, clarithromycin, cyclosporine (oral), darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, gemfibrozil, grapefruit juice > 1 liter per day, itraconazole, lopinavir plus ritonavir, nelfinavir, saquinavir plus ritonavir, telaprevir, tipranavir plus ritonavir','Current use of rifampin and digoxin','Unable to provide informed consent','Symptomatic claustrophobia','Pregnant or breast feeding; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence [not having sex], oral contraceptives, intrauterine device [IUD], Depo-Provera, tubal ligation, or vasectomy of the partner [with confirmed negative sperm counts] in a monogamous relationship [same partner]); an acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; women who are currently breast-feeding are not eligible for this study','Breast patients with tissue expanders are not allowed with the exception of tissue expanders made of material that are MRI compatible; check with the MRI technician to confirm'
NCT01993810,https://www.clinicaltrials.gov/ct2/show/record/NCT01993810?term=NCT01993810&rank=1,'Histologically or cytologically proven diagnosis of non-small cell lung cancer','Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist \r\n* Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible\r\n* Patients who refuse surgery are eligible\r\n* Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible\r\n* Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible','Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination within 30 days prior to registration including resting heart rate;\r\n* Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration\r\n* Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration; \r\n* Forced expiratory volume in one second (FEV1) >= 0.8 liter or >= 35% predicted with or without bronchodilator within 90 days prior to registration;\r\n** Patients who meet the criterion above without oxygen (O2), but who need acute (started within 10 days prior to registration) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable','Zubrod performance status 0-1 within 30 days prior to registration','Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 obtained within 30 days prior to registration','Platelets >= 100,000 cells/mm^3 obtained within 30 days prior to registration','Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable), obtained within 30 days prior to registration','Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) within 30 days prior to registration\r\n* It is highly recommended but not required that SGOT or SGPT be =< 1.5 upper limit of normal','Total bilirubin =< 1.5 within 30 days prior to registration\r\n* It is highly recommended but not required that total bilirubin be =< 1.5 upper limit of normal','Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula','Peripheral neuropathy =< grade 1 at the time of registration','Patients with non-malignant pleural effusion are eligible\r\n* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:\r\n** When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative\r\n** Exudative pleural effusions are excluded, regardless of cytology\r\n** Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible','Patients must have measurable or evaluable disease','Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration','Women of childbearing potential and male participants must practice adequate contraception','Patient must provide study-specific informed consent prior to study entry','Prior invasive malignancy unless disease free for a minimum of 3 years; however, skin cancer and in situ carcinomas of the breast, oral cavity, cervix, and other organs and are permissible','Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received, other than patients who have recurrent disease following resection','Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy; note that prior chemotherapy for a different cancer is allowable','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;\r\n* Transmural myocardial infarction within the last 6 months;\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration;\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol','Unintentional weight loss > 10% within 30 days prior to registration','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception'
NCT02054741,https://www.clinicaltrials.gov/ct2/show/record/NCT02054741?term=NCT02054741&rank=1,'INCLUSION CRITERIA FOR PHYSICIANS','Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study','INCLUSION CRITERIA FOR PATIENTS','Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed','Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other\r\n* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (> 50%) will be allowed; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment\r\n* Patients who are receiving approved cancer treatment in combination with radiation are eligible\r\n* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met','Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits\r\n* The plan for treatment should be for at least 3 months at time of study enrollment; the treatment can stop earlier during the study at the discretion of the physician and patient (e.g., due to progression as noted through imaging, toxicity, or patient preference)','Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy','Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit; if the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll','Participant has adequate understanding of the English language','EXCLUSION CRITERIA FOR PATIENTS','Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible','Presence of symptomatic brain metastases at time of study consent process; patients with history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment'
NCT01946789,https://www.clinicaltrials.gov/ct2/show/record/NCT01946789?term=NCT01946789&rank=1,'Patients must have histologically or cytological confirmed malignancy in the following disease groups: melanoma that is metastatic or unresectable, non-small cell lung carcinoma, renal cell carcinoma, sarcoma, colon carcinoma, non-Hodgkin lymphoma, squamous cell head and neck carcinoma, or cutaneous squamous cell carcinoma, for which standard curative or palliative measures do not exist or are no longer effective; the primary site may be cutaneous or unknown, but mucosal and ocular primaries are excluded\r\n* Note: patients with non-small lung cancer must have had prior epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) testing; patients with sensitizing mutations in EGFR or ALK rearrangements should have been treated with prior targeted agents and have had progression or discontinued due to toxicity from these agents','For cohort 3 only, patients must be able to safely undergo pre and post-treatment biopsy, i.e., at least one readily accessible lesion or palpable lymph node metastasis arising from any solid tumor cancer or lymphoma\r\n* NOTE: this may include cutaneous and subcutaneous tumors using injection by palpation or ultrasound guidance\r\n* NOTE: the target lesion must be >= 1.5 cm on its longest diameter, be at least 5 mm thick, and have distinct borders\r\n* NOTE: deep seated lesion(s) that are deemed hazardous to inject or lesion(s) close to vital structures that might be impinged with tumor swelling are excluded as targeted tumor\r\n* NOTE: cohort 3 should be selected for patients with injectable cutaneous lesion(s), unless the patient elects not to receive IT injection and/or undergo pre and post-treatment biopsies','Prior therapy requirements:\r\n* At least one prior therapy using an agent with the potential for prolonged remission (generally includes interleukin-2, checkpoint-blocking antibodies, or adoptive cell therapy)\r\n* At least 4 weeks from last dose of prior chemotherapy or immunomodulator therapy with resolution of the acute toxicities; for patients coming off molecularly-targeted therapy, at least 2 weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria\r\n* At least 2 weeks from completion of prior radiation therapy with no residual radiation toxicities\r\n* At least 4 weeks from last dose of prior investigational therapy with recovery to meet baseline eligibility criteria\r\n* Not receiving any current anticancer therapy\r\n* Note: any patient whose tumors carry a B-Raf proto-oncogene, serine/threonine kinase (BRAF) v600 mutation should either be excluded, or may be included after experiencing progression following treatment with BRAF inhibitor regimen or if they consent and agree to forgo Food and Drug Administration (FDA)-approved therapies that increase median survival','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Both men and women of all races and ethnic groups are eligible for this trial','Life expectancy of greater than 6 months','Leukocytes >= 3,000/mcL','Absolute lymphocytes count >= 500/mcL','Absolute neutrophil count >= 1,000/mcL (without hematopoietic growth factors)','Platelets >= 100,000/mcL (without transfusion)','Hemoglobin >= 10 g/dL (may be transfused but must be stable without clinical evidence of ongoing blood loss or hemolysis)','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR','Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','No history of severe chronic obstructive pulmonary disease (COPD) or emphysema or interstitial lung disease currently on home supplemental oxygen; patients with NSCLC with stable COPD or emphysema not requiring supplemental oxygen are eligible','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 4 months after the completion of ALT-803 administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy, targeted therapy, or radiotherapy, and have not recovered from acute toxicity to their pretreatment baseline or to a grade 1 level within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study \r\n* Note: patients with chronic residual prior therapy-related toxicity (e.g. vitiligo, alopecia, low grade neuropathy), or in the consensus opinion of the Cancer Immunotherapy Trials Network (CITN)/Cancer Therapy Evaluation Program (CTEP) investigators would not impact the safety of the patient or the integrity of the study, are not excluded\r\n* Note: for resolution of autoimmune toxicity from prior immune therapy, patients must be off steroids for at least 30 days without relapse of autoimmune toxicity, or it must be at least 30 days from their last dose of infliximab or related immunosuppressive therapy without relapse of autoimmune toxicity','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial; previously treated brain metastases, neurologically stable, and no ongoing or anticipated need for steroid therapy are eligible','Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant lung disease or psychiatric illness/social situations that would limit compliance with study requirements; patient who, in the clinical judgment of the investigator, have underlying risk factors for cardiac disease should be excluded or undergo clearance stress-based cardiac function testing; the pre-treatment corrected QT interval (QTc) must be < 500 msec','Patients with thyroid disease should be excluded unless euthyroid on suppressive or replacement therapy','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ALT-803','Human immunodeficiency virus (HIV)-positive patients','Positive hepatitis C serology or active hepatitis B infection','Active bacterial or fungal infection; all prior infections must be resolved following optimal therapy','Chronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapy','Immunosuppressive therapy within 30 days prior to initiation of protocol therapy','Inability to home monitor blood pressure','Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria or serious arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmias requiring chronic therapy)'
NCT01989585,https://www.clinicaltrials.gov/ct2/show/record/NCT01989585?term=NCT01989585&rank=1,'PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression','Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a Clinical Laboratory Improvement Act [CLIA]-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective\r\n* If test at CLIA-certified lab used a non-Food and Drug Administration (FDA) approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Prior therapy is allowed; for patients enrolled in the Phase II portion of the study, patients may have received prior immunotherapy (including high-dose IL-2, ipilimumab, nivolumab, and other anti-PD1/PDL1 antibodies) or chemotherapy; however prior navitoclax, BRAF inhibitor and/or MEK inhibitor therapy will not be allowed','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1 x 10^9/L','Hemoglobin >= 9 g/dl (patients may be transfused to this level)','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)','Serum creatinine =< 1.5 mg/dL OR creatinine clearance >= 50 mL/min/1.73 m^2','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO)','Patients must have a corrected QT (QTc) interval of less than 480 msec','Women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed) prior to study entry, for the duration of study participation, and for 4 months after completion of study drug administration; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency','Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Ability to understand and the willingness to sign a written informed consent document; if a patient has impaired decision-making capacity, a legally authorized representative, patients will be allowed to participate','PHASE I SUBJECTS ONLY: Patients must not have received prior navitoclax, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression; in the phase II portion of the study','Patients who have had immunotherapy, chemotherapy or radiotherapy within 14 days prior to the first dose of navitoclax, or prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to first dose of dabrafenib and/or trametinib; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment; biologics will not be allowed within 30 days prior to, or during, navitoclax administration','Prior navitoclax, BRAF inhibitor, and MEK inhibitor is prohibited; (exceptions for Phase I are described above)','Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study','Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks','History of allergic reactions attributed to compounds of similar chemical or biologic composition to navitoclax, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with the study drugs','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; it is not necessary to conduct HIV testing at screening; patients who are HIV-positive with undetectable viral loads, not on interacting antiretroviral therapy, and have CD4 counts above 300/mm^3 may be eligible after discussion with the principal investigator','History of another malignancy; exception: patients who have been disease-free for 3 years (depending upon tumor type studied or clinical setting, 3 or 5 years can be used; e.g., for advanced melanoma and pancreatic studies 3 years is more appropriate due to aggressiveness of the disease, while 5 years can be more appropriate for prostate or ovarian cancer or adjuvant setting when life expectancy is longer), or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the CTEP medical monitor if unsure whether second malignancies meet the requirements specified above; exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility','History of interstitial lung disease or pneumonitis','History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):\r\n* History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)\r\n* Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mmHg','History or evidence of cardiovascular risk including any of the following:\r\n* A QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec on screening electrocardiography (ECG)\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study','Known history of hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); it is not necessary to conduct HBV and HCV testing at screening','Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding','Subject has a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug','A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency','Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomization','The following concomitant medications are not allowed during navitoclax administration: clopidogrel, ibuprofen, tirofiban, warfarin, and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* Anticoagulants or antiplatelet agents except for low-dose, 81 mg aspirin','Caution should be exercised when dosing navitoclax concurrently with cytochrome P450, family 2, subfamily C, peptide 8 (CYP2C8) and cytochrome P450, family 2, subfamily C, peptide 9 (CYP2C9) substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin; when possible, investigators should switch to alternative medications or monitor the patients closely; cytochrome P450, family 3, subfamily A (CYP3A) inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration','Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of permeability-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded; below are a few examples of the agents:\r\n* Strong inducers of CYP3A or CYP2C8:\r\n** Antibiotics: rifamycin class agents (e.g., rifampin, rifabutin, rifapentine)\r\n** Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, s-mephenytoin\r\n** Miscellaneous: bosentan, St. John's wort\r\n* Strong inhibitors of CYP3A or CYP2C8\r\n** Antibiotics: clarithromycin, telithromycin, troleandomycin\r\n** Antidepressants: nefazodone\r\n** Antifungals: itraconazole, ketoconazole, posaconazole, voriconazole\r\n** Hyperlipidemia: gemfibrozil\r\n** Antiretroviral: ritonavir, saquinavir, atazanavir\r\n** Miscellaneous: conivaptan'
NCT01979536,https://www.clinicaltrials.gov/ct2/show/record/NCT01979536?term=NCT01979536&rank=1,'Newly diagnosed patients with histologically proven ALCL (International Classification of Diseases for Oncology [ICD-0] code: 9714/3)','Disease must be cluster of differentiation (CD)30 positive','Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)','Patients must have stage II, III, or IV disease','Patients must have a life expectancy of >= 8 weeks','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for ALT is 45 U/L','If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made','Shortening fraction of >= 27% by echocardiogram, or','Ejection fraction of >= 50% by radionuclide angiogram','Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air unless current dysfunction is due to the lymphoma in which case the patient is eligible','Patients with central nervous system (CNS) disease are not eligible','Patients with disease limited to the skin are not eligible, regardless of how wide-spread','Patients with stage I disease are not eligible','Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible','Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated','Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL','Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal','Lactating females are not eligible unless they have agreed not to breastfeed their infants','Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment','Patients with Down syndrome are not eligible','Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible','Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed','CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed','CYP3A4 inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, ritonavir, and St. John’s wort are not eligible; the topical use of these medications (if applicable) is allowed','Patients that are known to be positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date','Patients who weigh < 10 kg are not eligible'
NCT02003222,https://www.clinicaltrials.gov/ct2/show/record/NCT02003222?term=NCT02003222&rank=1,'PRE-REGISTRATION','Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution\r\n* NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WBC AND BLAST COUNT BEFORE BLOOD ONLY IS SUBMITTED\r\n* NOTE: Hydroxyurea can be given for up to 5 days prior to initiation of protocol therapy for control of leukocyte count and/or other symptoms or signs; corticosteroids can be given after pre-registration to the protocol and submission of baseline marrow and blood samples for control of leukocyte count and/or other symptoms or signs prior to initiation of protocol therapy if needed; if corticosteroids are given prior to pre-registration, contact the study chair as the patient may still be eligible to participate','INDUCTION ELIGIBILITY CRITERIA-STEP 1','New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible','Mature B ALL (Burkitt’s-like leukemia) is excluded from enrollment in this trial; pre-study bone marrow biopsy and aspirate must be completed =< 1 week prior to registration','Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations','Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood; FISH testing for common B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETS-variant gene 6 [ETV6]/runt-related transcription factor 1 [RUNX1]), t(1;19) (pre-B-cell leukemia homeobox 1 [PBX1]/transcription factor 3 [TCF3]), +4,+10,+17, (centromeric [Cen]4/Cen10/Cen17), t(11q23;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]), deletion (del)(9p) (cyclin-dependent kinase inhibitor 2A [CDKN2A]/Cen9), and t(14;var) (immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial','Patient must not have a concurrent active malignancy for which they are receiving treatment','Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration','Serum creatinine < 2 mg/dl; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration','Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet','Patient must not have intercurrent organ damage or medical problems that will jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)','Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria:\r\n* No history of acquired immune deficiency syndrome (AIDS)-related complications other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low\r\n* Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia\r\n* Patient must have serum HIV viral load of < 200 copies/mm^3\r\n* Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy\r\n* Patient must not be receiving protease inhibitors or once daily formulations containing cobicistat, stavudine, or on regimens containing stavudine or zidovudine\r\n* It is recommended to utilize a regimen of the integrase inhibitor, dolutegravir, combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine','Patient must not have an antecedent hematologic disorder','Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia','Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia; Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalities','Patient must have a normal cardiac ejection fraction by pretreatment multigated acquisition scan (MUGA) or echocardiogram within 4 weeks prior to registration (resting ejection fraction >= 40% or >= 5% increase with exercise), shortening fraction by echocardiogram >= 24%, or to within the normal range of values for the institution','Patient must not have an active uncontrolled infection','Women must not be pregnant or breast-feeding and must not become pregnant or breastfeed during protocol therapy and for at least 3 months after protocol therapy; woman of childbearing potential must abstain from sexual activity or be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Men who have a female partner of childbearing potential must be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; men who have a pregnant partner must be willing to use a condom during sexual activity throughout protocol therapy and for 3 months after the last dose of protocol-specified therapy','ECOG performance score 0-3','Patient must have given written informed consent','POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)','ECOG performance status 0-2','Patients must have achieved a CR or CRi','Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi','Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia','Patients must have resolved any serious infectious complications related to induction','Any significant medical complications related to induction must have resolved','Obtained =< 48 hours prior to registration: Serum creatinine =< 2.0 mg/dl','Obtained =< 48 hours prior to registration: Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3','Obtained =< 48 hours prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)','RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3','Patients must have an ECOG performance status of 0-2','Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy','Patients must have resolved any serious infectious complications related to therapy','Any significant medical complications related to therapy must have resolved','Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomization','Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomization','Bone marrow aspirates must be submitted for centralized minimal residual disease (MRD) assessment performed by the ECOG-ACRIN Leukemia Translational Research Laboratory','MRD results will be reported to the submitting institution\r\n* NOTE: FOR MRD ASSESSMENTS, AN ASPIRATE FROM A SEPARATE BONE MARROW ASPIRATION SITE MUST BE SUBMITTED (THE NEEDLE CAN BE RE-DIRECTED THROUGH THE SAME SKIN PUNCTURE SITE); ONLY SUBMIT ASPIRATES FROM THE FIRST PULL OF AN ASPIRATION SITE FOR MRD TESTING; DO NOT SUBMIT SAMPLES FROM THE SECOND OR THIRD PULL OF THE SAME ASPIRATION SITE \r\n* In B-lineage ALL, MRD levels in peripheral blood or from a dilute marrow aspiration can be 300% lower, on average, than those in bone marrow at a given time point; submitting a first pull from a separate aspiration site will ensure that MRD determinations used in randomization and trial interpretation are accurate\r\n** NOTE: failure to submit bone marrow aspirates will result in a major violation at the time of an audit','CRITERIA FOR ALLOGENEIC TRANSPLANTATION','A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)','Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3','Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance','CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status of 0-3','CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM aspirate and biopsy','CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapy','CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolved'
NCT01896869,https://www.clinicaltrials.gov/ct2/show/record/NCT01896869?term=NCT01896869&rank=1,'Have histologically proven adenocarcinoma of the pancreas; patients with mixed histology will be excluded','Have stable metastatic pancreatic cancer after receiving 8-12 doses of FOLFIRINOX (measurable disease is not required)','Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky > 60%)','Life expectancy of greater than 3 months','White blood cells (WBC) >= 3500/uL','Absolute neutrophil count (ANC) >= 1500/uL','Platelets >= 90 x 10^3/uL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for patients with documented liver metastases)','Creatinine =< 2.0 x ULN','Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential','Ability to understand and the willingness to sign a written informed consent document','Oxygen saturation on room air > 92 % by pulse oximetry; (patients on intermittent or continuous supplemental oxygen are not allowed)','Patients in whom histologic diagnosis is not consistent with ductal adenocarcinoma such as adenosquamous, squamous cell, colloid, islet cell, serous or mucinous cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma, intraductal oncocytic papillary neoplasms (IOPN), osteoclast-like giant cell tumors, acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumors, undifferentiated small cell carcinoma and non-epithelial tumors (sarcomas, gastrointestinal [GI] stromal tumor, lymphoma)','Patients who have adenocarcinomas of the ampulla, distal bile duct, and duodenum','Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement','Patients who have been off of FOLFIRINOX more than 70 days prior to treatment on study','Patients who have had prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX); prior radiation is allowed; chemotherapy for non-metastatic disease is allowed','Patients with a history of prior treatment with ipilimumab, anti-programmed cell death 1 (PD1) antibody, cluster of differentiation (CD)137 agonist or anti-CD 40 antibody','Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab/vaccine)','Patients who are receiving any other investigational agents','Patients who have received any of the following concomitant therapy: interleukin (IL)-2, interferon; immunosuppressive agents; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses)','Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the protocol chair, following discussion with the study sponsor and Cancer Therapy Evaluation Program (CTEP)','Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody','Patients with known brain metastases should be excluded from early clinical trials','Patients with radiographic ascites that is apparent on physical exam or requiring medical intervention (medication or procedures) in the 2 months prior to enrollment','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or obscure the interpretation of adverse events (AEs)','Patients with a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide (DMSO), fetal bovine serum, or trypsin (porcine origin)','Patients with chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded','WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product','Women who are pregnant or breastfeeding','Women with a positive pregnancy test on enrollment or prior to investigational product administration','Sexually active fertile men not using effective birth control if their partners are WOCBP'
NCT02065687,https://www.clinicaltrials.gov/ct2/show/record/NCT02065687?term=NCT02065687&rank=1,'Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma\r\n* Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:\r\n** Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)','Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI','Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2','Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl','Platelets greater than or equal to 100,000/mcl','Creatinine less than 1.4 mg/dl','Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN','Alkaline phosphatase less than or equal to 2.5 x ULN','Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma','Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy','Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy','Patients must be able to swallow and retain orally-administered medication','Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study','Patients must NOT be taking metformin or have been on metformin in the past 6 months','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study','Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)'
NCT02059499,https://www.clinicaltrials.gov/ct2/show/record/NCT02059499?term=NCT02059499&rank=1,'HIV-positive; documentation of HIV-1 infection by means of any one of the following: \r\n* Documentation of HIV diagnosis in the medical record by a licensed health care provider\r\n* Documentation of receipt of antiretroviral therapy (ART) (at least two different medications) by a licensed health care provider (documentation may be a record of an ART prescription in the participant’s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant’s name)\r\n* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL\r\n* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay\r\nNOTE: A “licensed” assay refers to a United States (U.S.) Federal Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies','Biopsy-proven HSIL (anal intraepithelial neoplasia 2 [AIN2] with a positive p16 stain, AIN 2-3, or AIN3) of the anal canal at either the squamocolumnar junction or distal anus, documented within 60 days prior to enrollment, but not less than 7 days prior to randomization','HSIL comprising 2 or more lesions, or anal HSIL in at least 2 octants, or anal HSIL that has recurred or is persistent after prior ablative treatment\r\nNote: HSIL should be in the anal canal at either the squamocolumnar junction or distal anus on HRA at screening or randomization; the extent of HSIL should be based on available biopsy results and visual appearance','Anal HSIL lesions are visible at randomization and no lesions are suspicious for invasive cancer','Ability to understand and willing to provide informed consent','Participants must, in the opinion of the Investigator, be capable of complying with the requirements of this protocol including self-administration of study treatment','Karnofsky performance status (KPS) of >= 70% or Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Cluster of differentiation (CD)4 count >= 200 within 120 days prior to enrollment or plasma HIV-1 RNA < 200 copies/mL within 120 days prior to randomization','For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to randomization for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to randomization','Absolute neutrophil count (ANC) > 750 cells/mm^3 within 90 days prior to randomization','Hemoglobin >= 9.0 g/dL within 90 days prior to randomization','Platelet count >= 75,000/mm^3 within 90 days prior to randomization','History of anal cancer','Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of HSIL at any point, use of intra-anal or topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of condyloma within 6 months prior to randomization or perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5% within 6 months prior to randomization','Extensive concurrent perianal or lower vulvar HSIL or condyloma requiring a different treatment modality than the study treatment, or treatment that cannot be deferred in observation arm, per examining provider','Condyloma occupying more than 50% of the circumference of the anal canal or that obscures a satisfactory exam','Ongoing use of anticoagulant therapy other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) that places the participant at increased bleeding risk in the opinion of the site investigator','Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 14 days prior to randomization','Malignancy requiring systemic therapy; Note: Kaposi sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy','Concurrent systemic corticosteroids, cytokines, and immunomodulatory therapy (e.g. interferons)','Participants who received investigational agents, other than investigational antiretroviral agents for HIV, within the 4 weeks before randomization, unless approved by the study chair','Treatment for anal or perianal HSIL, low-grade squamous intraepithelial lesion (LSIL) or condyloma within 4 months of randomization; please note that infrared coagulation (IRC) or electrocautery of a biopsy site to stop bleeding does not constitute treatment','Female participants who are pregnant or breastfeeding; women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization; all women of childbearing potential must be willing to comply with an acceptable birth control regimen to prevent pregnancy while receiving treatment and for 3 months after treatment is discontinued as determined by the Investigator; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; (note: a woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives)'
NCT02029950,https://www.clinicaltrials.gov/ct2/show/record/NCT02029950?term=NCT02029950&rank=1,'Patients must have histologically or cytologically confirmed: \r\n* Pathologically confirmed intermediate or poor risk newly diagnosed AML (subtypes M0, 1, 2, 4-7), but excluding newly diagnosed core-binding factor (CBF) (t(8;21) or M4eo subtype (inv(16) or t(16;16) AMLs and acute promyelocytic leukemia (acute promyelocytic leukemia [APL], M3)\r\n* MDS with high risk features as defined by intermediate (INT)-2 or high International Prognostic Scoring System (IPSS) score with > 10% blasts in the bone marrow\r\n* Chronic myelomonocytic leukemia-2 (CMML-2) defined as having > 10% blasts (including promonocytes) in the bone marrow or 5-19% blasts (including promonocytes) in the peripheral blood','Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for treatment of MDS or myeloproliferative neoplasm (MPN) (e.g. azacitidine, decitabine, histone deacetylase inhibitors, tyrosine kinase inhibitors, hematopoietic growth factors, interferon, lenalidomide, thalidomide) will be eligible for this trial as long as immunomodulatory drugs (e.g. lenalidomide, thalidomide) have not been used in the past 3 months','Patients must be off all non-cytotoxic chemotherapies or biologic agents (e.g. azacitidine, decitabine, histone deacetylase inhibitors, tyrosine kinase inhibitors, hematopoietic growth factors, interferon, but excluding hydroxyurea and cyclophosphamide) for at least 2 weeks prior to starting induction chemotherapy','Patients must be off radiation therapy or chemotherapy 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting induction chemotherapy','All adverse events (excluding alopecia, acne, rash) due to agents administered more than 2 weeks earlier should recover to =< grade 1; patients with hematologic malignancies are expected to have hematologic abnormalities at study entry; these abnormalities which are thought to be primarily related to the underlying leukemia, are not considered to be toxicities (adverse events [AE]) and do not need to resolve to =< grade 1','Patients with therapy-related AML or MDS should have not received prior cumulative anthracycline (daunorubicin equivalent) lifetime dose > 450 mg/m^2','Cytoreduction allowed: \r\n* Hydroxyurea, corticosteroids, leukapheresis can be used prior to start of induction chemotherapy\r\n* Cyclophosphamide up to dose 50-60 mg/kg is allowed for cytoreduction, but must be given at least 7+/- 2 days before start of induction chemotherapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)','Total bilirubin < 2.0 mg/dL unless due to Gilbert’s disease, hemolysis or leukemia','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 × institutional upper limit of normal unless due to leukemic infiltration','Creatinine =< 2.0 mg/dL','Left ventricular ejection fraction >= 45%','Female who is able to become pregnant must have a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide; female who is able to become pregnant must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective and one additional effective method at the same time; female who is able to become pregnant must agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with female who is able to become pregnant even if they had vasectomy for the duration of study participation, and 28 days after completion of pomalidomide administration; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure while taking pomalidomide; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document; consent will be obtained by day 14 of AcDVP-16 induction regimen','Known human immunodeficiency virus (HIV) infected patients (HIV testing will not be performed as a part of screening) on combination antiretroviral therapy are eligible for inclusion; the use of zidovudine is not allowed','Patients who are receiving any other investigational agents or who have received pomalidomide in the past','Patients with known active central nervous system leukemia should be excluded from this clinical trial; patient receiving intrathecal chemotherapy prophylaxis should not receive pomalidomide for >= 3 days after administration','History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide (e.g. lenalidomide, thalidomide) or other agents used in study','The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs in the past','Uncontrolled intercurrent illness including, but not limited to, active and uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, mental deficits, psychiatric illness or history or social situations that would limit compliance with study requirements; patients with infection under active treatment and controlled with antibiotics are eligible','Any other medical condition that in opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events)','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with pomalidomide','Known positive patients for infectious hepatitis, type A, B, C','Active graft-versus-host disease (GVHD) following allogeneic stem cell transplant for non-AML condition (ex. MDS, MPN, lymphoid malignancy, aplastic anemia) requiring ongoing use of immunosuppressants'
NCT02015104,https://www.clinicaltrials.gov/ct2/show/record/NCT02015104?term=NCT02015104&rank=1,'Patients must have histologically confirmed localized high grade (G3) transitional cell carcinoma (urothelial carcinoma) of the bladder that is stage Ta, T1, and/or carcinoma in situ (CIS) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) 90 days prior to study entry; this can be obtained at an outside hospital prior to entry into the study or at the NCI; however, all outside pathology specimens will require that the formalin-fixed paraffin embedded tissues be re-read by the Laboratory of Pathology, NCI; for patients enrolled at collaborating trial sites, diagnosis must be confirmed by the Department of Pathology at the institution where the patient is enrolled on the trial; pathology can also be reviewed by the Laboratory of Pathology at the NCI if the participating trial site prefers another pathologic evaluation','Patients have failed at least one previous induction course of intravesical BCG, defined as histologically confirmed persistent or relapsing tumor present on post-BCG endoscopic evaluation; all BCG failures will be considered for inclusion into the study, including BCG-refractory, -resistant, and -relapsing; for the purposes of the study, “BCG-refractory” and “BCG-resistant” subjects will be considered to have “BCG-persistent” disease','Patients who are not currently candidates for radical cystectomy (e.g. patient refuses surgery, comorbidities preclude major surgery, etc.)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Absolute neutrophil count >= 1,500/mcL','Platelets >= 50,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Estimated glomerular filtration rate (GFR) (calculated using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) >= 30 mL/min/1.73 sq.m.','Computerized tomography (CT) urogram or magnetic resonance imaging (MRI) urogram; if urogram protocol not available or contrast allergy/poor renal function preclude such imaging, then noncontrast CT or MRI of the abdomen/pelvis within 45 days of study entry will suffice','Chest x-ray negative for metastatic disease','Ability of patient to understand and the willingness to sign a written informed consent document','Previous pelvic radiation for bladder or prostate cancer if performed < 12 months prior to enrollment into the study','Patients who are receiving any other concurrent investigational agents (patients are eligible to enroll 4 weeks after completion of prior agent)','Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; there will be at least a 3 week delay from the time of a previous bladder biopsy/transurethral resection of bladder tumor (TURBT) to allow for adequate bladder healing prior to enrollment','Patients with a history of encephalitis, multiple sclerosis, or seizures within the last year (from seizure disorder or brain metastasis) should be excluded from this clinical trial','History of allergy or untoward reaction to prior vaccination with vaccinia virus','Patients should have no evidence of being immunocompromised as listed below:\r\n* Human immunodeficiency virus positivity\r\n* Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; patients with endocrine disease that is controlled by replacement therapy including thyroid disease and adrenal disease and vitiligo may be enrolled\r\n* History of splenectomy','Uncontrolled intercurrent illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, active second malignancy other than a cancer that has been successfully treated resulting in a high likelihood of long-term survival (e.g. completely resected basal cell or squamous cell carcinoma of the skin, stage 1 renal cell carcinoma treated with partial nephrectomy, treated low risk prostate cancer, etc.), inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis), active diverticulitis, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vaccines; patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately','Concurrent use of systemic steroids, except for physiologic doses of systemic steroids for replacement or local (topical, nasal, or inhaled) steroid use; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed; although topical steroids are allowed, steroid eye-drops are contraindicated','Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)','Medical conditions which, in the opinion of the investigators, would jeopardize the patient or the integrity of the data obtained','Serious hypersensitivity reaction to egg products','Chronic hepatitis infection, including B and C','Clinically significant cardiomyopathy or cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled angina','Previous intolerance to BCG intravesical therapy suggested by development of systemic BCG infection in the past and/or grade 4 or greater adverse effect by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0','Patients unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day 1 vaccination: (a) children =< 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczematoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV)'
NCT02070549,https://www.clinicaltrials.gov/ct2/show/record/NCT02070549?term=NCT02070549&rank=1,'Patients must have a histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative treatments do not exist or are no longer effective\r\n* Hepatocellular carcinoma (HCC) patients are not required to have histologically or cytologically confirmed malignancy, patients are considered eligible based on tumor markers and/or imaging assessment\r\n* Patients with the following tumor types will be excluded from the normal and mild cohorts:\r\n** Pancreatic cancer patients\r\n** Colorectal cancer patients \r\n** BRAF V600E melanoma patients who have failed BRAF inhibitors\r\n*** Note: Patients with pancreatic cancer, colorectal cancer, and BRAF V600E melanoma patients who have failed BRAF inhibitors are allowed to enroll in the moderate and severe cohorts provided the patients: 1) sign a separate consent form which outlines the extremely limited activity observed in prior studies, and 2) are consented to the study by a protocol-specified designee who is not their longitudinal oncologist','All patients must have completed any prior chemotherapy, targeted therapy, radiotherapy (unless palliative doses which must be discussed with study principal investigator), surgery, anti-angiogenic therapy or interferon >= 28 days before study entry','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 5.04 (CTCAE v5.04) grade =< 1 (except alopecia) at the time of enrollment','Absolute neutrophil count (ANC) >= 1.2 x 10^9/L','Hemoglobin >= 9 g/dL','Platelets >= 75 x 10^9/L','Serum creatinine =< 1.5 mg/dL (=< 133 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Proteinuria =< +1 on dipstick or =< 1 gram/24 hours','Prothrombin time (PT) =< 1.5 x institutional upper limit of normal (ULN)','International normalized ratio (INR) =< 1.5 x institutional ULN','Partial thromboplastin time (PTT) =< 1.5 x institutional ULN','Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition scan (MUGA)','Patients with active hemolysis should be excluded','No distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes','Patients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:\r\n* Group A: Normal hepatic function\r\n** Bilirubin =< ULN\r\n** Aspartate aminotransferase (AST) =< ULN\r\n* Group B: Mild hepatic dysfunction\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: ULN < bilirubin =< 1.5 x ULN and any AST\r\n* Group C: Moderate hepatic dysfunction\r\n** 1.5 x ULN < bilirubin =< 3 x ULN and any AST\r\n* Group D: Severe hepatic dysfunction\r\n** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients’ group assignment being altered if different to registration test results','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','History of another malignancy\r\n* Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above','History of interstitial lung disease or pneumonitis','Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 28 days prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrollment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study; patients previously treated with v-raf murine sarcoma (RAF) and/or mitogen-activated protein kinase (MEK) inhibitors are excluded from the study; multikinase antiangiogenic tyrosine kinase inhibitors such as regorafenib, sorafenib, sunitinib, etc. whose primary mechanism of action is not RAF inhibition, are allowed; if there are any questions, please contact study's principal investigator','Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib or excipients or to dimethyl sulfoxide (DMSO)','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (Note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','History or current evidence/risk of retinal vein occlusion (RVO)','History or evidence of cardiovascular risk including any of the following:\r\n* LVEF < LLN\r\n* A QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Patients with intra-cardiac defibrillators \r\n* Known cardiac metastases','Active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)','Patients with known human immunodeficiency virus (HIV) infection are eligible if not on antiviral agents and cluster of differentiation (CD)4 counts are adequate (>= 500)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','The study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)','HIV-positive patients on combination antiretroviral therapy are ineligible','Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk'
NCT02079740,https://www.clinicaltrials.gov/ct2/show/record/NCT02079740?term=NCT02079740&rank=1,'Patients must have histologically- or cytologically-confirmed diagnosis of KRAS or NRAS mutation-positive malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective; patients must have activating mutations affecting codons 12, 13, 61, or 146 as determined in a Clinical Laboratory Improvement Amendments (CLIA)-certified lab to be eligible for this study','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm by chest x-ray or as >= 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Participants must have received at least one line of prior systemic chemotherapy and must have experienced documented radiographic progression or intolerance on this therapy','Paired pre-treatment and post-treatment biopsies are required for all patients on Part 1 and first 15 patients in Part 2; participants must have available archival tumor tissue (at least 20 unstained slides); if archival tissue is not available or is found not to contain tumor tissue, a fresh biopsy is required; if a patient is having a tumor biopsy, less than 20 unstained slides are acceptable with approval of the principal investigator (PI); biopsies will only be performed in a given patient if they are not deemed to involve unacceptable risk based on the sites of disease and other concurrent medical conditions','Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Life expectancy of greater than 3 months','Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v 4) grade =< 1 (except alopecia) at the time of enrollment; this requirement to return to =< grade 1 does not apply to immune checkpoint inhibitor related endocrinopathies (e.g. thyroiditis, hypophysitis, etc.) that necessitate hormone replacement therapy including, but not limited to levothyroxine, cortisol, and testosterone; CTCAE v5.0 will be utilized beginning April 1, 2018','Leukocytes >= 3,000/mcL','Absolute neutrophil count (ANC) >= 1,200/mcL (subjects may be treated with hematopoietic growth factors to achieve or maintain this level)','Hemoglobin >= 9 g/dL','Platelets >= 100 x 10^9/L','Albumin >= 2.5 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULN','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)','Women of child-bearing potential and men with a female partner of child bearing potential must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and up to 4 months following completion of therapy:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 4 months following completion of therapy','Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; the potential hazard to the fetus should be explained to the patient and partner (as applicable)','Ability to understand and the willingness to sign a written informed consent document','History of another malignancy; exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or any carcinoma in situ and/or patients with indolent second malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements','History of interstitial lung disease or pneumonitis','Any major surgery, extensive radiotherapy (> 15 days of treatment), chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to first dose of study treatment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to first dose of study treatment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study drug(s) and during the study','Patients with known brain metastases should be excluded from this clinical trial; exception: patients with brain metastases will be allowed on study if they have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO), or to compounds of similar chemical or biologic composition to navitoclax','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* The following concomitant medications are not allowed during navitoclax administration: warfarin, clopidogrel (Plavix), ibuprofen, tirofiban (Aggrastat), and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor','Caution should be exercised when dosing navitoclax concurrently with cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin and warfarin; when possible, investigators should switch to alternative medications or monitor the patients closely (particularly in the case of medications that have a narrow therapeutic window such as warfarin; use of warfarin is specifically prohibited while on study); cytochrome P450, family 3, subfamily A (CYP3A) inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; patient instructions and information of possible drug interactions will be given to all patients upon enrollment in this study','History or current evidence/risk of retinal vein occlusion (RVO)','History or evidence of cardiovascular risk including any of the following:\r\n* Left ventricle ejection fraction (LVEF) < LLN\r\n* A QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to enrollment are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Known cardiac metastases\r\n* Patients with intra-cardiac defibrillators','Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding','Subject has a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug','Subject has a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months)','Pregnant women or nursing mothers'
NCT02095132,https://www.clinicaltrials.gov/ct2/show/record/NCT02095132?term=NCT02095132&rank=1,'Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)','Part A: Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors','Part B: Patients with relapsed or refractory neuroblastoma','Part C: Patients with relapsed or refractory medulloblastoma or CNS PNET','Part D: Patients with relapsed or refractory rhabdomyosarcoma','Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment if enrolling on dose levels 1-5; patients must have a body surface area >= 0.46 m^2 at the time of study enrollment if enrolling on dose level 0','Part A: Patients must have either measurable or evaluable disease','Part B: Patients must have either measurable disease or must be evaluable for MIBG response without evidence of Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesions; patients with neuroblastoma in bone marrow only are not eligible','Part C: Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)','Part D: Patients must have measurable disease for Part D','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy','At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)','At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair','At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair','At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines','>= 21 days must have elapsed from infusion of lase dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1','At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow radiation, including therapeutic doses of Iobenguane (MIBG)','Stem cell Infusion without TBI: no evidence of active graft vs host disease and at least 84 days must have elapsed after transplant or stem cell infusion','Patients previously treated with irinotecan are eligible for this study','For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm^3','For patients with solid tumors without known bone marrow involvement: platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','For patients with solid tumors without known bone marrow involvement: hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity for Part A, the dose escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: 0.6 mg/dL\r\n* Age 2 to < 6 years: 0.8 mg/dL\r\n* Age 6 to < 10 years: 1 mg/dL\r\n* Age 10 to < 13 years: 1.2 mg/dL\r\n* Age 13 to < 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females)\r\n* Age >= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females)','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Serum albumin >= 2 g/dL','Correct QT interval (QTc) =< 480 msec; Note: Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause torsades de pointes; if possible, alternative agents should be considered; patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available','Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled','Nervous system disorders (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) resulting from prior therapy must be =< grade 2','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Tissue blocks or slides must be sent if available, with exclusions; if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment','Patients must be able to swallow capsules','Pregnant or breast-feeding women may not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal','Males or females of reproductive potential may not participate unless they have agreed to use an effective double barrier contraceptive method for the entire duration of protocol therapy and for 3 months (males) and 1 month (females) after study drug discontinuation','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant as an antiemetic is prohibited; caution should be exercised with concomitant administration of AZD1755 (MK-1775) and agents that are sensitive substrates of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), 2C9 and 2C19, or substrates of this enzyme with narrow therapeutic ranges, as well as agents that are inhibitors or substrates of permeability glycoprotein (P-gp)','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollment','Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients with a history of allergic reaction to irinotecan, cephalosporins or a severe penicillin allergy are not eligible','Patients unable to swallow capsules whole are not eligible; nasogastric or gastric (G) tube administration is not allowed'
NCT02097225,https://www.clinicaltrials.gov/ct2/show/record/NCT02097225?term=NCT02097225&rank=1,'Patients must have histologically confirmed, BRAF-mutant (V600E/K) solid tumor (molecularly confirmed using Cobas assay or a comparable Food and Drug Administration [FDA]-approved assay) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy, and for which standard curative measures do not exist or are no longer effective\r\n* If test at Clinical Laboratory Improvement Act (CLIA)-certified laboratory (lab) used a non-FDA approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Prior therapy is allowed; patients may have received any number of prior lines of therapy, including treatment with a BRAF and/or MEK inhibitor','All prior anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE version 5.0; National Cancer Institute [NCI], 2017) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents)','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,200/mcL','Hemoglobin >= 9 g/dl (patients may be transfused to this level)','Platelets >= 100,000/mcL','Total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Prothrombin time (PT) < 1.3 x upper limit of normal (ULN)','International normalized ratio (INR) < 1.3 x ULN','Partial thromboplastin time (PTT) < 1.3 x ULN','Serum creatinine =< 1.5 mg/dL OR creatinine clearance >= 50 mL/min/1.73 m^2','Potassium > 3 and < 5.5 mEq/L','Magnesium > 1.2 and < 2.5 mEq','Left ventricular >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) ejection fraction','Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to use effective contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed) from 14 days prior to randomization, throughout the treatment period, and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency','Ability to understand and the willingness to sign a written informed consent document','Able to swallow and retain oral medication, and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1; patients are permitted to be on dabrafenib and trametinib standard of care at start of therapy without wash-out period prior to day 1 of cycle 1; dosing will change to protocol determined dose levels on day 1 of cycle 1','Patients must not have received prior HSP90 inhibitor therapy','Patients who are receiving any other investigational agents; patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to randomization','Patients with history of activating RAS mutation positive tumors regardless of interval from current study; however, patients may have concurrent BRAFV600 and RAS mutations in the tumor to be treated with protocol therapy','Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 4 weeks (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks','History of known immediate or delayed hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to AT13387, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued prior to the mother being treated with the study drugs','Patients known to be human immunodeficiency virus (HIV)-positive patients and on combination antiretroviral therapy are ineligible','History of another malignancy other than the study indication under this trial within 5 years of study enrollment; does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, or other in situ cancers\r\n* Exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility','History of interstitial lung disease or pneumonitis','History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED):\r\n* History of RVO or RPED, or predisposing factors to RVO or RPED (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)\r\n* Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm mercury (Hg)','History or evidence of cardiovascular risk including any of the following:\r\n* An average of the three most recent QT intervals corrected for heart rate using the Bazett’s formula QTcB >= 460 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* Prior placement of an implantable defibrillator\r\n* History of or identification on screening imaging of intracardiac metastases','No known active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV); patients with chronic or cleared HBV infection and HCV infection are eligible','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded'
NCT02152982,https://www.clinicaltrials.gov/ct2/show/record/NCT02152982?term=NCT02152982&rank=1,'Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status','Sufficient tissue available for central pathology review and MGMT methylation status evaluation','Patients who have had a local MGMT testing that is unmethylated are not allowed to participate','Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson','Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma','Absolute neutrophil count (ANC) >= 1500 cells/mm^3 within 14 days prior to study registration','Platelets >= 100,000 cells/mm^3 within 14 days prior to study registration','Creatinine =< 1.5 x upper limit of normal (ULN) within 14 days prior to study registration','Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert’s disease','Alanine aminotransferase (ALT) =< 3 x ULN within 14 days prior to study registration','Aspartate aminotransferase (AST) =< 3 x ULN within 14 days prior to study registration','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible','Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible','Prior treatment:\r\n* Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist\r\n* Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation therapy; the only exception is the Optune device (NovoTTF-100A), which may be started any time after end of radiation therapy up through the initiation of Cycle 1; intent to use Optune must be declared at registration for stratification','Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who: \r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)','Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration','Comorbid conditions: patients are unable to participate due to the following:\r\n* Generalized or partial seizure disorder that is uncontrolled at the time of registration; the definition of controlled generalized seizures is patients must be on a stable dose of anti-seizure medication and without generalized seizures for at least 10 days prior to registration; the definition of controlled partial seizures is patients must be on a stable dose of anti-seizure medication for at least 10 days prior to registration; patients with occasional breakthrough partial seizures are allowed at treating physician’s discretion\r\n* Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration\r\n* Known history of prolonged QT syndrome','No history of major surgery =< 14 days prior to registration'
NCT02101775,https://www.clinicaltrials.gov/ct2/show/record/NCT02101775?term=NCT02101775&rank=1,'Patients must have histologically or cytologically confirmed epithelial ovarian, primary peritoneal and fallopian tube carcinoma; all histologic subtypes of epithelial ovarian cancer are eligible, but only patients with high grade serous ovarian cancer will be considered for the statistical analysis; non-high grade serous cancers will be allowed in an exploratory cohort','Patients must be platinum-resistant (platinum-free interval < 6 months) or have platinum-refractory disease as per Gynecologic Cancer Intergroup Committee (GCIC) criteria; disease progression has to be radiologic or clinical; biomarker progression with CA125 after a platinum based regimen would not be sufficient evidence of disease progression; the patients must have had radiological progression to that regimen','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','There is no limitation in the number of prior lines of therapy','Patients must have completed any prior chemotherapy, radiotherapy or major surgery at least 4 weeks before receiving study treatment; ongoing toxicities related to treatment must be =< grade 1 and patients with grade 2 alopecia or peripheral neuropathy can also be included; palliative radiation to < 10% of bone marrow is permissible if completed within one week of commencing study treatment as long as the toxicities secondary to palliative radiotherapy are limited to grade 1; the lesions that have received radiation treatment immediately before will be excluded as target lesions; previously irradiated lesions can be considered as targeted lesions, as long as there is prove of radiological progression','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 90 g/L\r\n* Blood transfusions are allowed at any time during the screening, treatment or follow-up period, according to the center recommendations','Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)','Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert’s syndrome','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal (5 x if liver metastases)','Creatinine =< 1.5 × institutional upper limit of normal OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional limit of normal','Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction\r\n* Note: patients can have a history of prior bowel obstruction, provided the patient is not having symptoms of bowel obstruction at the time of enrolment and the bowel obstruction is not anticipated to recur during the participation in the study','Patients must have disease amenable to biopsy and must be willing to undergo a paired biopsy for correlative analyses (the first biopsy within 28 days prior to start of treatment and the second biopsy while on treatment)','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\r\n* Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 12 consecutive months; Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason','Ability to understand and the willingness to sign a written informed consent document','Patients who previously received gemcitabine for the treatment of recurrent disease','Patients who are receiving any other investigational agents','Patients with clinically or radiologically unstable brain metastases are excluded from this clinical trial\r\n* Note: patients with stable brain metastases after treatment, for at least 3 months prior to enrolling on this trial, could participate in the study; patients should be off, or on a stable dose of steroids','History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD 1775 (MK-1775) or gemcitabine','Patients taking the following prescription or non-prescription drugs or other products (i.e. grapefruit juice) are ineligible: sensitive cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrates, CYP3A4 substrates with a narrow therapeutic index, moderate to potent inhibitors/inducers of CYP3A4; patients would be eligible if the medications can be discontinued two weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication','Pregnant and breastfeeding women are excluded from this study','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, congestive heart failure, symptomatic congestive heart failure, unstable angina pectoris, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease or cerebrovascular disease with previous stroke, or psychiatric illness/social situations that would limit compliance with study requirements'
NCT02143726,https://www.clinicaltrials.gov/ct2/show/record/NCT02143726?term=NCT02143726&rank=1,'Patients must have 10 representative hematoxylin and eosin (H&E) stained thyroid tissue slides OR tumor block available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; CT must be performed within 28 days of registration','Radioactive iodine (RAI)-refractory disease defined as 1 or more of the following:\r\n* Patients who have received greater than 600 mCi of radioactive iodine in their lifetime OR\r\n* RAI-avid metastatic lesion which remained stable in size or progressed despite RAI treatment within 9 months of RAI treatment OR\r\n* 10% or more increase in serum thyroglobulin (on thyroid-stimulating hormone [TSH]-suppression) within 9 months of RAI treatment OR\r\n* Index metastatic lesion non-RAI avid on a diagnostic RAI scan OR\r\n* Presence of fluorodeoxyglucose (FDG) avid metastatic lesions on positron emission tomography (PET)/CT scan (standardized uptake values [SUV]max > 5 of any single lesion)','Progressive disease defined by RECIST criteria =< 14 months','Patients must have metastatic disease or locally advanced unresectable disease','Prior treatment:\r\n* Patients may have received prior radiation therapy to index lesions >= 28 days prior to registration on this protocol if there has been documented progression by RECIST criteria; prior radiation therapy to the non-index lesions is allowed if >= 28 days prior to registration on this protocol\r\n* Prior RAI therapy is allowed if >= 90 days prior to registration on this protocol and evidence of progression (as defined above) has been documented in the interim (a diagnostic study using < 10 mCi of RAI is not considered RAI therapy)\r\n* Prior chemotherapy is allowed if >= 28 days prior to registration on this protocol\r\n* Patient may have received any number of prior lines of therapy\r\n* No prior use of sorafenib or an mammalian target of rapamycin (mTOR) (including phosphoinositide 3-kinase [PI3k] or protein kinase B [AKT]) inhibitor for the treatment of thyroid cancer','No history of major surgery =< 28 days of registration','No history of intracranial brain metastasis','No history of any of the following =< 6 months of registration:\r\n* Myocardial infarction or unstable angina\r\n* New York Heart Association grade III or greater congestive heart failure \r\n* Cerebrovascular accident \r\n* Grade 3 or 4 peripheral ischemia\r\n* Grade 3 or 4 thromboembolic event','No history of the following:\r\n* Child Pugh class B or C liver disease\r\n* “Chronic active” hepatitis defined as: \r\n** Hepatitis B surface antigen (HBsAg) > 6 months\r\n** Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B\r\n** Persistent or intermittent elevation in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels\r\n** Liver biopsy showing chronic hepatitis with moderate or severe necroin?ammation','No history of gastrointestinal fistula or gastrointestinal perforation < 90 days of registration','No known history of prolonged QT syndrome','No grade 3 or 4 hypertension (systolic blood pressure [BP] > 160 and or diastolic BP > 100) that cannot be controlled with medication prior to registration','Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment\r\n* Patients requiring anticoagulation must be on stable dose of medication prior to registration','Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Eligible patients must have histopathologically confirmed Hürthle cell thyroid cancer by central review','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 mg/dL OR calculated (calc.) creatinine clearance >= 30 mL/min','Total bilirubin =< 1.5 x upper limits of normal (ULN)','Serum glutamic oxaloacetic transaminase (SGOT) (AST) =< 2.5 x ULN','Fasting serum cholesterol =< 300 mg/dL','Fasting triglyceride =< 2.5 x ULN'
NCT02154490,https://www.clinicaltrials.gov/ct2/show/record/NCT02154490?term=NCT02154490&rank=1,'SCREENING/PRE-SCREENING REGISTRATION:','Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed','Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these criteria are:\r\n* Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV) and must have progressed during or following their most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), the prior systemic therapy must have been a platinum-based chemotherapy regimen and disease progression on the platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; for patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab)\r\n* Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV or recurrent disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab); patients on first-line platinum-based treatment are eligible upon receiving cycle 1, day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted','Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume\r\n* The local interpreting pathologist must review the specimen\r\n* The pathologist must sign the S1400 Local Pathology Review Form confirming tissue adequacy prior to screening/pre-screening registration\r\n* Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker profiling and c-MET IHC; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment; patients must agree to have any tissue that remains after NGS testing retained for the use of the translational medicine (TM) studies (if such TM studies are defined) within any sub-study the patient is enrolled in','Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; EGFR/ALK testing is not required prior to registration and is included in the Foundation Medicine Incorporated (FMI) testing for screening/prescreening','Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration','Patients must also be offered participation in banking for future use of specimens','Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','United States (U.S.) patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN survey ancillary study; NOTE: Patients enrolled to S1400 prior to revision #12 are not eligible for the S1400GEN survey ancillary study; study physicians will provide participants with a hard copy of the survey (at the time of informed consent) to improve tracking and comprehension during the interview','SUB-STUDY REGISTRATION:','Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible','Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy','Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; patients must not have received any radiation therapy within 14 days prior to sub-study registration','Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to sub-study registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to sub-study registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration','Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration','Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study registration','Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable','Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study registration','Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study registration','Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration','Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN','Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)','Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration','Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration','Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia','Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection','Patients with a known history of human immunodeficiency virus (HIV) seropositivity:\r\n* Must have undetectable viral load using standard HIV assays in clinical practice\r\n* Must have cluster of differentiation (CD)4 count >= 400/mcL\r\n* Must not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis)\r\n* Must not be newly diagnosed within 12 months prior to sub-study registration','Prestudy history and physical exam must be obtained within 28 days prior to sub-study registration','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','As part of the OPEN registration process the treating institution’s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the system','Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.'
NCT02101788,https://www.clinicaltrials.gov/ct2/show/record/NCT02101788?term=NCT02101788&rank=1,'Patients with the following tumors are included in the study:\r\n* Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)\r\n* Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)','At least 4 weeks must have elapsed since the patient underwent any major surgery (eg. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]); there is no restriction on MINOR procedures: (eg. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy)','Patients must have documented low-grade serous carcinoma; confirmation must occur by prospective pathology review prior to study entry; the prospective pathology review can be done on tissue from the recurrent carcinoma or from original diagnostic specimen','All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI; all imaging studies must be performed within 28 days prior to registration','Prior therapy\r\n* Patients must have recurred or progressed following at least one platinum-based chemotherapy regimen\r\n* Patients may have received an unlimited number of prior therapy regimens\r\n* Patients may not have received all of the five choices in the “standard therapy” arm\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Any other prior therapy directed at the malignant tumor, including chemotherapy and radiation therapy, must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 28 days prior to registration','Women of childbearing potential (i.e. patients whose reproductive organs remain in place and who have not passed menopause) and men must agree to use a highly effective method of contraception (e.g. hormonal, intrauterine device or; abstinence*) prior to study entry, during the study participation, and for six months after the last dose of the drug; women of child-bearing potential must have a negative pregnancy test within 14 days prior to randomization, cannot be breast-feeding, and must agree to use a highly effective form of contraception throughout the treatment period and for 6 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; * abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the patient','Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information','Patients must have a GOG performance status of 0 or 1','Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome, bowel obstruction, or major resection of the stomach or bowel','All prior treatment-related toxicities must be CTCAE v4 grade =< 1 (except alopecia) at the time of randomization','Patients must have a left ventricular ejection fraction >= lower limit of normal by echocardiogram (ECHO) or multigated acquisition scan (MUGA)','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Bilirubin =< 1.5 times upper limit of normal','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times upper limit of normal','Albumin >= 2.5 g/dL','Prothrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normal','Neutrophil count >= 1.5 x 10^9/L','Platelet count >= 100 x 10^9/L','Hemoglobin >= 9.0 g/dL','If letrozole is selected as the control therapy, patients must be postmenopausal, either following bilateral oophorectomy or at least 5 years after spontaneous menopause; patients within 5 years of spontaneous menopause or who have had a hysterectomy without bilateral oophorectomy must have postmenopausal luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels; patients on hormone replacement therapy (HRT) must agree to withdrawal of hormone therapy before letrozole is started','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib or standard of care agent','If patients have had a potential index lesion radiated, it must have progressed post radiation therapy to be used as a measurable eligibility lesion','Patients may not have received prior MEK, v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), or v-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor therapy','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Patients may not be receiving any other anti-cancer or investigational agents\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','Patients with known leptomeningeal or brain metastases or spinal cord compression should be excluded from this clinical trial','Patients with a bowel obstruction or any other gastrointestinal condition that might affect absorption of the oral drug should be excluded; this would include patients with inability to swallow and retain orally-administered medication, malabsorption syndrome, or those with a major resection of the stomach or bowels','Patients with a history of interstitial lung disease or pneumonitis','Patients with a previous or current malignancy at other sites should be excluded, with the exception of:\r\n* Curatively treated local tumors such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin\r\n* Tumors for which no relapse has been observed within 5 years','Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications','Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO), or to Cremophor EL (polyoxyethylated castor oil); please note, exclusion for Cremophor is unnecessary unless paclitaxel is the only agent available and the patient randomizes to the conventional therapy option','Patients with a history or evidence of cardiovascular risk, including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN)\r\n* Bazett's corrected QT (QTcB) >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias\r\n* Exception: Subjects with controlled atrial fibrillation for > 30 days prior to randomization are eligible\r\n* History of (within 6 months prior to randomization) acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting\r\n* History or evidence of current >= class II congestive heart failure as defined by New York Heart Association (NYHA)\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Patients with intra-cardiac defibrillators or permanent pacemakers\r\n* Known cardiac metastases','Patients with a history or current evidence/risk of retinal vein occlusion (RVO)','Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures','Patients who require use of a concomitant medication that can prolong the QT interval','Women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)'
NCT02101853,https://www.clinicaltrials.gov/ct2/show/record/NCT02101853?term=NCT02101853&rank=1,'First relapse of B-ALL, allowable sites of disease include isolated bone marrow, combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular; extramedullary sites are limited to the CNS and testicles','No waiting period for patients who relapse while receiving standard maintenance therapy','Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study','Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy (methotrexate strongly preferred) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status','Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur','Stem cell transplant or rescue: patient has not had a prior stem cell transplant or rescue','Patient has not had prior treatment with blinatumomab','With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse)','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 1 to < 2 years: =< 0.6 mg/dL\r\n* 2 to < 6 years: =< 0.8 mg/dL\r\n* 6 to < 10 years: =< 1 mg/dL\r\n* 10 to < 13 years: =< 1.2 mg/dL\r\n* 13 to < 16 years: =< 1.5 mg/dL (males) and =< 1.4 mg/dL (females)\r\n* >= 16 years: =< 1.7 mg/dL (males) and =< 1.4 mg/dL (females)','Direct bilirubin < 3.0 mg/dL','Shortening fraction of >= 27% by echocardiogram, or','Ejection fraction of >= 50% by radionuclide angiogram','All patients and/or their parent or legal guardian must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met','Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible','Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible','Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible','Patients with B-lymphoblastic lymphoma (B-LL) are not eligible','Patients with known optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement','Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome','Patients with known human immunodeficiency virus (HIV) infection','Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and etoposide phosphate (Etopophos)','Lactating females who plan to breastfeed','Patients who are pregnant; pregnancy test is required for female patients of childbearing potential','Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation','Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved)','Patients with uncontrolled seizure disorder are not eligible; (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs remain eligible)'
NCT02101905,https://www.clinicaltrials.gov/ct2/show/record/NCT02101905?term=NCT02101905&rank=1,'Patients must have histologically proven World Health Organization (WHO) grade IV glioblastoma/ gliosarcoma or WHO grade III glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, mixed anaplastic oligoastrocytoma, anaplastic ependymoma) which is progressive or recurrent following radiation therapy +/- chemotherapy','Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to tolerate MRIs','Patients may have an unlimited number of prior therapy regimens','Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents\r\n* 4 weeks from the last treatment with bevacizumab\r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)','Patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:\r\n* Expectation that the surgeon is able to resect at least 500 mg of tumor from enhancing tumor and 100 mg from non-enhancing tumor with low risk of inducing neurological injury','Patient tumor sample must have evidence of EGFR gene amplification by fluorescence in situ hybridization (FISH) using a Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay','Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment)','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 × institutional upper limit of normal','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment','Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with corrected (QTC) =< 470 msec','Patients must be able to provide written informed consent','Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of lapatinib administration','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Patients must be able to swallow medication by mouth, either tablets or dispersed tablets in solution','Patients may not be receiving any other investigational agents','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib are ineligible; the lapatinib Investigator Brochure can be referenced for more information','Patients with prior therapy with EGFR inhibitors are ineligible; patients with prior EGFRvIII vaccine are eligible if recurrent tumor is positive for EGFR gene amplification','Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol; patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of lapatinib','Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction','Patients must not have evidence of significant intracranial hemorrhage','Patients with uncontrolled intercurrent illness including, but not limited to, hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lapatinib','Human immunodeficiency virus (HIV)-positive patients on strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors are ineligible','Patients who have acute or currently active/requiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)','Patients receiving P-glycoprotein (P-gp) inhibitors are ineligible','Patients who are receiving a drug that has a risk of QTc prolongation if QTc is >= 460 msec. are ineligible'
NCT02135042,https://www.clinicaltrials.gov/ct2/show/record/NCT02135042?term=NCT02135042&rank=1,'Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx','Sites are required to complete Step 1 registration before submitting specimens for EBV DNA analysis\r\n* Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration\r\n* For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs within 28 days prior to Step 1 registration: that test result can be used for eligibility without the need for re-testing; to use this test result for eligibility, the central lab must enter the test result through the pathology portal','Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:\r\n* History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration\r\n* Evaluation of tumor extent with one of the following combinations required within 28 days prior to registration:\r\n** Magnetic resonance imaging (MRI) of the nasopharynx and neck; or computed tomography (CT) of the nasopharynx and neck with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement). \r\n** MRI of the nasopharynx and positron emission tomography (PET)/CT (with contrast) of the neck\r\n*** Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist\r\n* To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:\r\n** A CT scan with contrast of the chest and abdomen (required), and the pelvis (optional), or a total body PET/CT scan (non-contrast PET/CT is acceptable)\r\n** A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)','Zubrod performance status 0-1 within 21 days prior to registration','Absolute neutrophil count (ANC) >= 1,500 cells/mm^3, within 21 days prior to registration','Platelets >= 100,000 cells/mm^3, within 21 days prior to registration','Hemoglobin >= 8.0 g/dl, within 21 days prior to registration (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), within 21 days prior to registration','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN, within 21 days prior to registration','Alkaline phosphatase =< 1.5 x institutional ULN, within 21 days prior to registration','Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula, within 21 days prior to registration','Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential','Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment','Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay','Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed','>= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)','Severe, active co-morbidity, defined as follows:\r\n* Major medical or psychiatric illness, which in the investigator’s opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy\r\n* Unstable angina and/or uncontrolled congestive heart failure\r\n* Myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to the study drug(s) involved in this protocol','Patients with undetectable pre-treatment plasma EBV DNA'
NCT02135419,https://www.clinicaltrials.gov/ct2/show/record/NCT02135419?term=NCT02135419&rank=1,'HIV positive; documentation of HIV-1 infection by means of any one of the following:\r\n* Documentation of HIV diagnosis in the medical record by a licensed health care provider;\r\n* Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (documentation may be a record of an ART prescription in the participant’s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant’s name; receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis [PrEP] regimen alone [e.g., Truvada], which is exclusionary);\r\n* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;\r\n* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay\r\n* NOTE: A “licensed” assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies','Biopsy-proven anal HSIL at baseline (anal intraepithelial neoplasia [AIN]2 with a positive cyclin-dependent kinase inhibitor 2A [p16] stain, AIN2-3, or AIN3)','At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study','For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to enrollment for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to enrollment','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Life expectancy of greater than 5 years','Absolute neutrophil count: >= 750/mm^3 within 90 days before enrollment','Platelets: >= 75,000/mm^3 within 90 days before enrollment','Hemoglobin >= 9.0 g/dL within 90 days before enrollment','Women of childbearing potential (FCBP) must have a negative urine pregnancy test within 7 days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator','Men randomized to the treatment arm should not father a baby while receiving topical treatment during this study; men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment','Participant is willing to be randomized and able to comply with the protocol','Clinician is comfortable that cancer has adequately been ruled out and is willing to follow the participant for up to 5 years without treatment of the HSIL','Participant is unable to provide informed consent','Participants who received any other chronic (defined as more than 50% of the time in the last 6 months) systemic immunomodulatory agents (replacement doses of steroids for adrenal insufficiency are permitted or treatment with prednisone =< 5 mg/day); receipt of investigational agents within the 4 weeks before randomization enrollment, other than investigational antiretroviral agents for HIV and investigational or approved agents for hepatitis C, are also exclusionary','History of anal cancer, penile, vulvar, vaginal, or cervical cancer, or signs of any of these malignancies at baseline; participants with prior carcinoma in situ will not be considered to have prior cancer for eligibility purposes','Treatment or removal of HSIL less than 6 months prior to randomization','Participant has symptoms related to HSIL and would benefit more from immediate treatment than from entry into the study and potential for randomization to active monitoring arm','Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL','Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy','Warts so extensive that they preclude the clinician from determining the extent and location of HSIL','Participant plans to relocate away from the study site to a location that does not have an Anal Cancer/HSIL Outcomes Research (ANCHOR) study site during study participation'
NCT02255461,https://www.clinicaltrials.gov/ct2/show/record/NCT02255461?term=NCT02255461&rank=1,'Patients with retinoblastoma protein (Rb1) positive recurrent, progressive or refractory central nervous system (CNS) tumors','Histologically confirmed Rb1 positive primary recurrent, progressive, or refractory central nervous system tumors; patients with low grade gliomas are excluded','Formalin fixed paraffin embedded tumor tissue (preferably from current recurrence) must be available to assess Rb1 protein status prior to enrollment; only patients with recurrent diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for Rb1 protein status confirmation','Patients must have measurable disease (in 2-dimensions) on magnetic resonance imaging (MRI) scan of brain and/or spine to assess preliminary evidence of response','Body surface area (BSA):\r\n* Patients enrolled on dose level 1 (50 mg/m^2) must have BSA >= 1.20 m^2\r\n* Patients enrolled on dose level 2 (75 mg/m^2) must have BSA >= 0.93 m^2\r\n* Patients enrolled on dose level 3 (95 mg/m^2) must have BSA >= 0.70 m^2','Patients must have received no more than 2 prior chemotherapy regimens and/or focal radiotherapy for their brain tumor and fully recovered from the acute treatment related toxicities of all prior therapies prior to entering this study; for those acute baseline adverse events attributable to prior therapy, patients must meet organ function criteria','Chemotherapy: patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study enrollment in the study or at least six (6) weeks for those receiving nitrosourea','Biologic therapy: patients should have received their last dose of biologic agent >= 7 days prior to enrollment; in the event the patient has received another biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to enrollment; if the investigational or biologic agent has a prolonged half-life then at least three (3) weeks interval is required','Radiotherapy: patients must have had their last fraction of: \r\n* Focal irradiation > 2 weeks prior to enrollment','Corticosteroids: patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment; it is recommended that patients be off all steroid therapy or receive the least dose that will control their neurologic symptoms','Growth factors: all colony forming growth factor(s) have been discontinued for at least one week prior to enrollment (filgrastim, sargramostim, and erythropoietin); for patients on long acting growth factors, the interval should be two weeks','Patients with neurological deficits that are stable for a minimum of one week prior to registration','Patients must be able to swallow capsules','Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of enrollment must be >= 60','Absolute neutrophil count >= 1,000/mm^3','Platelets >= 100,000/mm^3 transfusion independent (no platelet transfusion one week prior to enrollment)','Hemoglobin >= 8 g/dl','Total bilirubin =< 1.5 times upper limit of institutional normal (ULN) for age','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal for age','Serum albumin >= 3 g/dL','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 1 to < 2 years: 0.6 (male), 0.6 (female)\r\n* 2 to < 6 years:\t0.8 (male), 0.8 (female)\r\n* 6 to < 10 years: 1 (male), 1 (female)\r\n* 10 to < 13 years: 1.2 (male), 1.2 (female)\r\n* 13 to < 16 years: 1.5 (male), 1.4 (female)\r\n* >= 16 years: 1.7 (male), 1.4 (female)','Female patients of childbearing potential must have a negative serum pregnancy test at the time of enrollment','Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study','Patient and/or guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines','Patients with any clinical significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) that is likely to interfere with the study procedures or results','Patients with low grade gliomas and Rb1 negative tumors','Patients who have received any of the following:\r\n* > 2 chemotherapy regimens\r\n* Myeloablative chemotherapy with stem cell rescue\r\n* Craniospinal irradiation','Patients with corrected QT (QTc) interval of > 450 msec or those on medications known to prolong QTc interval','Prior treatment on a CDK inhibitor','Patients who are receiving drugs that are strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)','Patients who are receiving any other investigational therapy','Patients who require enzyme inducing anti-convulsants to control seizures','Patients with cataracts on ophthalmologic examination'
NCT02101944,https://www.clinicaltrials.gov/ct2/show/record/NCT02101944?term=NCT02101944&rank=1,'Patient must have relapsed or refractory myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria for symptomatic myeloma (although new or worsening end organ damage is not required to be eligible) as defined below:\r\n* Presence of clonal bone marrow plasma cells\r\n* Presence of serum and/or urinary measurable monoclonal protein or light chains\r\n* Evidence of any end organ damage criteria listed below (at any time) attributed to the patient’s myeloma:\r\n** Hypercalcemia: serum calcium > 11.5 mg/dL or\r\n** Renal insufficiency: serum creatinine > 2 mg/dL\r\n** Anemia > 2 g/dL below the lower limit of normal or a hemoglobin value < 10 g/dL\r\n** Bone lesions: lytic lesions, severe osteopenia or pathologic fractures','Patients must have measurable disease defined as any of the following:\r\n* Serum monoclonal protein >= 500 mg/dL by protein electrophoresis \r\n* > 200 mg of monoclonal protein in the urine on screening 24-hour electrophoresis \r\n* Serum immunoglobulin free light chain >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio','Patients must have been previously treated with an immunomodulatory drug (IMiD) and proteasome inhibitor, must be refractory to carfilzomib defined as progression on or within 2 months of a carfilzomib-containing therapy, and must be progressing','Prior autologous and/or allogeneic transplant is permitted although transplant must have occurred greater than 90 days prior to registration','Both men and women of all races and ethnic groups are eligible for this study','Prior radiation is permitted; however, at least 2 weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all radiation-associated toxicities to no greater than grade 1 at the time of registration','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) is required for eligibility; those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible','Absolute neutrophil count (ANC) >= 1000/uL','Platelet count >= 75,000 and transfusion independent','Total bilirubin < 1.5 mg/dL','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the institutional upper limit of normal','Ability to understand and the willingness to sign a written informed consent document','Patients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals during the days of reolysin treatment and for two days after','Patients must not have known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections','Systolic cardiac function will be assessed at screening if clinically indicated by history and physical; only patients with left ventricular ejection fraction (LVEF) >= 50% will be eligible for enrollment','Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting 28 days prior to starting the study until at least 90 days following discontinuation of the trial therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Patients must agree not to donate blood, sperm/ova during the course of taking protocol therapy and for at least 4 weeks after stopping treatment','Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment','Patients who are receiving any other therapeutic investigational agents','Patients previously treated on clinical trial with reolysin','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued','Patients with a \"currently active\" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation','Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS) syndrome','Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug'
NCT02032823,https://www.clinicaltrials.gov/ct2/show/record/NCT02032823?term=NCT02032823&rank=1,'Provision of informed consent prior to any study specific procedures','* For patients who underwent initial surgery and received adjuvant chemotherapy\r\n** Triple negative breast cancer (TNBC) patients must have been axillary node-positive (>= pN1, any tumor size) or axillary node negative (pN0) with invasive primary tumor pathological size > 2 cm (>= pT2)\r\n** Estrogen receptor (ER) and/or progesterone receptor (PgR) positive/human epidermal growth factor receptor (HER) 2 negative patients must have had >= 4 pathologically confirmed positive lymph nodes\r\n* For patients who underwent neoadjuvant chemotherapy followed by surgery\r\n** TNBC patients must have residual invasive breast cancer in the breast and/or resected lymph nodes (non-pathological complete response [pCR])\r\n** ER and/or PgR positive/HER2 negative patients must have residual invasive cancer in the breast and/or the resected lymph nodes (non-pCR) AND a clinical pathologic stage (CPS) & estrogen receptor status nuclear grade (EG) score >= 3','Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the two following phenotypes:\r\n* TNBC defined as:\r\n** ER and PgR negative defined as immunohistochemistry (IHC) nuclear staining < 1%\r\n** HER2 negative (not eligible for anti-HER2 therapy) defined as:\r\n*** IHC 0, 1+ without in situ hybridization (ISH) OR \r\n*** IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR \r\n*** ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)\r\n* ER and/or PgR positive, HER2 negative breast cancer defined as:\r\n** ER and/or PgR positive defined as IHC nuclear staining >= 1%; AND\r\n** HER2 negative (not eligible for anti-HER2 therapy) defined as:\r\n*** IHC 0, 1+ without ISH OR\r\n*** IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR\r\n*** ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)','Patients with multifocal or multicentric invasive disease are eligible as long as all the lesions for which HER2 characterization is available are HER2 negative','Patients with synchronous bilateral invasive disease are eligible as long as all the lesions assessed for HER2 on both sides are negative','In both the above cases, the lesion considered at highest risk for recurrence based on the investigator's discretion will be used for eligibility determination','Documented germline mutation in BRCA1 or breast cancer 2, early onset (BRCA2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); local germline (g)BRCA testing results, if available, will be used for establishing eligibility; if local gBRCA testing results are not available, central testing will be provided for those patients who otherwise appear to be eligible','Completed adequate breast surgery defined as:\r\n* The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ with the exception of the posterior margin if this margin is the pectoralis major fascia or the anterior margin if this is the dermis; patients with resection margins positive for lobular carcinoma in situ are eligible\r\n* Patients with breast conservation must have adjuvant radiotherapy; patients having mastectomy may have adjuvant radiotherapy according to local policy and/or international guidelines','Completed adequate axilla surgery defined as:\r\n* ADJUVANT CHEMOTHERAPY PATIENTS:\r\n** Sentinel lymph node biopsy alone if negative or if lymph node(s) only contain micrometastases (=< 2.0 mm) OR \r\n** Positive sentinel lymph node biopsy followed by axillary nodal dissection or radiotherapy as per local guidelines OR\r\n** Axillary dissection\r\n* NEOADJUVANT CHEMOTHERAPY PATIENTS:\r\n** Sentinel lymph node biopsy performed before neoadjuvant chemotherapy:\r\n*** If negative or if lymph node(s) only contain micrometastases (=< 2.0 mm), additional axillary surgery is not required\r\n*** If positive, axillary node dissection or axillary nodal radiotherapy should follow completion of neoadjuvant chemotherapy\r\n** Sentinel lymph node biopsy performed after neoadjuvant chemotherapy:\r\n*** If negative, additional axillary surgery not mandated\r\n*** If positive (micrometastases are regarded as positive), additional axillary surgery is required unless the patient is enrolled in a phase III multicenter clinical trials proposing radiotherapy as alternative treatment of the axilla; the trial must be pre-approved by the OlympiA Executive Committee\r\n** Axillary dissection','Completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both; prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed; (for neoadjuvant patients all chemotherapy should be delivered prior to surgery; no further cycles of chemotherapy post-surgery are allowed)','Hemoglobin >= 10.0 g/dL measured within 28 days prior to randomization','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L measured within 28 days prior to randomization','Platelet count >= 100 x 10^9/L measured within 28 days prior to randomization','Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomization','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN measured within 28 days prior to randomization','Alkaline phosphatase (ALP) =< 2.5 x ULN measured within 28 days prior to randomization','Patients with screening ALT/AST or ALP above institutional upper limit of normal should have liver ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) at any time point between diagnosis of current breast cancer and randomization; screening bone scan is required if ALP and/or corrected calcium level are above the institutional upper limit; (note positron emission tomography [PET]/CT scan may be used as an alternative imaging technique)','Serum or plasma creatinine =< 1.5 x ULN measured within 28 days prior to randomization','Eastern Cooperative Oncology Group (ECOG) performance status 0-1','Women who are not postmenopausal or have not undergone a hysterectomy must have documented negative pregnancy test within 28 days prior to randomization\r\n* Postmenopausal is defined as one or more of the following: \r\n** Age >= 60 years (yrs)\r\n** Age < 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment\r\n** Follicle-stimulating hormone (FSH) and plasma estradiol levels in the post menopausal range for women under 60\r\n** Radiation-induced oophorectomy with last menses > 1 year ago\r\n** Bilateral oophorectomy\r\n* Female patients of childbearing potential who are sexually active must agree, with their partners, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 1 month after the last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse; male patients must agree, with their partners who are sexually active and of childbearing potential, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse','Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations','Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary tumor, mandatory\r\n* NOTE: for adjuvant patients this refers to the surgical specimen; for neoadjuvant patients, both the pre-treatment core biopsy and the surgical specimen with residual disease are requested but only one is mandatory; if the surgery tumor blocks are available, but cannot be submitted, sites may submit a portion of invasive tumor from the original block, either by taking at least one core of at least 3 mm in diameter, or by splitting the original block in two parts, and re-embedding one in a new block for central submission; if blocks containing pre-neoadjuvant treatment core biopsies are available but cannot be submitted, sections mounted on glass slides prepared from the block can be provided; if tumor sample can't be provided as requested above or if it's not available, approval by study team for patient's entry into the trial is required','Patient should be randomized in the trial ideally within a maximum of 8 weeks of completion of their last treatment (surgery, chemotherapy or radiotherapy), but in no case longer than 12 weeks','Involvement in the planning and/or conduct of the study','Patients who do not have deleterious or suspected deleterious gBRCA1 and/or 2 mutations but only have BRCA1 and/or BRCA2 mutations that are considered to be non-detrimental (e.g., “variants of uncertain clinical significance” or “variant of unknown significance” or “variant, favor polymorphism” or “benign polymorphism” etc.)','Previous randomization in the present study','Evidence of metastatic breast cancer; patient considered at high risk of having disseminated disease (i.e. those with locally advanced disease, clinical N2-3 or pathological N1-3 with the exception of pN1a in adjuvant patients) should have a CT/MRI scan of the thorax/abdomen/pelvis or any other area as clinically indicated and a bone scan or a CT scan with bone windows at any point between diagnosis of the current breast cancer and randomization to rule out metastatic breast cancer; (note PET/CT scan may be used as an alternative imaging technique and precludes the need for bone scan); patients with screening ALT/AST or ALP above institutional upper limit of normal should have liver ultrasound, CT or MRI at any time point between diagnosis of current breast cancer and randomization; screening bone scan is required if ALP and/or corrected calcium level are above the institutional upper limit; (note PET CT scan may be used as an alternative imaging technique)','Exposure to an investigational product within 30 days or five half-lives (whichever is the longer) prior to randomization','Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment','Patients with second primary malignancy, EXCEPTIONS are: \r\n* Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma\r\n* Other solid tumors and lymphomas (without bone marrow involvement) diagnosed >= 5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied','Resting electrocardiogram (ECG) with corrected QT (QTc) > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome; if ECG demonstrates QTc > 470 msec, patient will be eligible only if repeat ECG demonstrates QTc =< 470 msec','Patients receiving systemic chemotherapy within 3 weeks prior to randomization','Patients receiving adjuvant radiotherapy within 2 weeks prior to randomization','Concomitant use of known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir','Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy','Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML','Major surgery within 2 weeks prior to randomization: patients must have recovered from any effects of any major surgery','Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on high resolution computed tomography scan or any psychiatric disorder that prohibits obtaining informed consent','Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication','Pregnant or breastfeeding women','Patients with known active hepatitis B or C','Patients known to be human immunodeficiency virus (HIV) positive with one or more of the following:\r\n* Baseline cluster of differentiation (CD)4 count of < 250 cells/mm^3\r\n* History of acquired immune deficiency syndrome (AIDS) indicator conditions\r\n* Anti-retroviral therapy with any potent CYP3A4 inhibitor','Previous allogeneic bone marrow transplant','Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing (packed red blood cells and platelet transfusions are acceptable)'
NCT02176967,https://www.clinicaltrials.gov/ct2/show/record/NCT02176967?term=NCT02176967&rank=1,'Patients must be:\r\n* < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or\r\n* < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma','Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients','Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology','Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index\r\n* “Favorable” genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above\r\n* “Unfavorable” genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)\r\n* Only patients with MYCN non-amplified tumors are eligible for this study','Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin\r\n* Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma\r\n* No prior tumor resection or biopsy','Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes\r\n* Group A1:\r\n** > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR\r\n** Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR\r\n** < 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter\r\n* Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter.','Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise\r\n* No prior tumor resection, tumor biopsy ONLY\r\n* Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1','Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma','No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed','Patients with MYCN amplified tumors are not eligible','Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure','Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02152137,https://www.clinicaltrials.gov/ct2/show/record/NCT02152137?term=NCT02152137&rank=1,'Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC)','Patients must have measurable disease','Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)','Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1','There is no limit to the number of prior lines of treatment a patient has received','No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration','No prior taxane therapy =< 6 months, except as a radiosensitizer','No history of the following:\r\n* Class III or IV congestive heart failure (CHF)\r\n* Grade 3 or 4 thromboembolic event =< 6 months\r\n* Pericardial effusion =< 12 months (any grade)\r\n* Pericardial involvement with tumor\r\n* Grade 2 or higher pleural effusion =< 6 months','No current symptomatic, untreated, or uncontrolled brain metastases present','No major surgery =< 14 days prior to registration','No grade 2 or higher neuropathy','No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations','Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required','Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible','Patients with known hypersensitivity to any TZD oral agents are not eligible','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/min','Bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)','Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:\r\n* Psychiatric illness which would prevent the patient from giving informed consent\r\n* Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\r\n* Patients with a “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer\r\n* Patients who cannot swallow oral formulations of the agent(s)\r\n* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\r\n* Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)'
NCT02379416,https://www.clinicaltrials.gov/ct2/show/record/NCT02379416?term=NCT02379416&rank=1,'Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; 5.0 x ULN in patients with liver metastases','Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration','Patients must have completed radiation therapy or major surgery >= 3 weeks, or biologic therapy or chemotherapy >= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted','Corrected QT interval using Fridericia's formula (QTcF) interval of > 450 msec at study entry; congenital long QT syndrome','Sensory/motor neuropathy >= grade 2','Patients who are receiving any other investigational agents','Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= 4 weeks without requiring steroid and anti-seizure medication are eligible to participate','History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs','Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT02206334,https://www.clinicaltrials.gov/ct2/show/record/NCT02206334?term=NCT02206334&rank=1,'Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic\r\n* NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)','Primary tumor site without progression at registration','All metastases not resected must be amenable to SBRT','The patient must meet ONE of the three following criteria:\r\n* 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR\r\n* 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR\r\n* 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed','Evaluation by a radiation oncologist within 45 days prior to study registration','Evaluation by a medical oncologist within 45 days prior to study registration','The following imaging workup to document metastases within 45 days prior to study registration: \r\n* Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT','History/physical examination within 45 days prior to study registration','Zubrod performance status =< 2 within 45 days prior to study registration','Age >= 18 years','Absolute neutrophil count (ANC) >= 500 cells/mm^3','Platelets >= 50,000 /mm^3','Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 3 x upper limit of normal (ULN)','Patient must provide study specific informed consent prior to study entry','For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration','Progression of primary tumor site (breast, prostate, or lung) at time of registration','Metastases with indistinct borders making targeting not feasible','Known brain metastases','Prior palliative radiotherapy to metastases','Metastases located within 3 cm of the previously irradiated structures:\r\n* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)\r\n* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)\r\n* Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)\r\n* Primary tumor irradiated with SBRT\r\n* Metastasis irradiated with SBRT','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration\r\n* Transmural myocardial infarction within the last 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration\r\n* Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease\r\n* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol\r\n* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)','Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment'
NCT02112916,https://www.clinicaltrials.gov/ct2/show/record/NCT02112916?term=NCT02112916&rank=1,'T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231','Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV \r\n* Note: a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or > 25% in the bone marrow; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory\r\n* For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be accepted','All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:\r\n* Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility\r\n* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or\r\n* 600 cGy of chest irradiation, if medically necessary\r\n** Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment','Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity','Uncontrolled seizure disorder','Diagnosis of Down syndrome (Trisomy 21)','Patients who are pregnant; a pregnancy test is required for female patients of childbearing potential','Lactating females who plan to breastfeed','Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation','Patient has hypersensitivity to bortezomib, boron, or mannitol','Serious medical or psychiatric illness likely to interfere with participation in this clinical study','Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib'
NCT02115282,https://www.clinicaltrials.gov/ct2/show/record/NCT02115282?term=NCT02115282&rank=1,'Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of >= 1% cells will be considered positive; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)','Patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)','Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved\r\n* NOTE: Where baseline imaging has already been performed =< 6 weeks prior to study randomization, repeat imaging may not be required','Pre/peri- and postmenopausal women and all men are eligible for this trial; postmenopausal is defined as:\r\n* Age >= 55 years and one year or more of amenorrhea\r\n* Age < 55 years and one year or more of amenorrhea, with estradiol < 20 pg/ml\r\n* Age < 55 with prior hysterectomy but intact ovaries, with estradiol < 20 pg/ml\r\n* Prior bilateral oophorectomy\r\nNOTE: Women who do not fit the criteria for being postmenopausal as above are deemed pre-or peri-menopausal; pre/perimenopausal women and all men can enroll provided they agree to receive concomitant luteinizing hormone-releasing hormone (LHRH) agonist; pre/perimenopausal women must have commenced treatment with LHRH agonist at least 4 weeks prior to randomization; if patients have received alternative LHRH agonist prior to study entry, they must switch to goserelin for the duration of the trial','Sexually active males and pre/perimenopausal women must agree to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study =< 2 weeks prior to randomization\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Patients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases; patients with leptomeningeal disease are not eligible','Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\r\n* NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment for that cancer','Patients must meet at least one of the following criteria:\r\n* Disease progression any time after non-steroidal aromatase inhibitor (AI) use in the advanced disease setting\r\n* Relapse while on or within =< 12 months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease\r\n* NOTE: In either setting, treatment with any prior endocrine therapy must be completed >= 2 weeks prior to course 1 day 1 (C1D1) of study treatment with the exception of exemestane which is permitted in the advanced disease setting within =< 4 weeks immediately prior to C1D1; prior adjuvant exemestane is allowed if the disease free interval is > 12 months from the discontinuation of exemestane; prior faslodex, everolimus, palbociclib or other cyclin-dependent kinase (CDK) inhibitor (e.g. ribociclib, abemaciclib) use are allowed and must have been completed >= 2 weeks prior to C1D1; failure to adhere to this washout guideline will result in a protocol violation','Patients may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization','Patients may be treated with bone modifying agents such as bisphosphonates or RANK-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change','Prior radiotherapy must in general have been completed >= 2 weeks prior to randomization and patients must have recovered from the toxicity of the radiation\r\n* NOTE: Patients may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as sites of measurable or non-measurable disease outside the radiation therapy port are available to follow','Patients must NOT receive concurrent anti-cancer therapy or investigational agent unless specified in protocol','Patients must NOT be receiving valproic acid, an histone deacetylase (HDAC) inhibitor, and may not have previously received any HDAC inhibitor prior to enrollment (e.g. valproic acid, entinostat, vorinostat) unless discussed with the study chair; patients must not have received prior HDAC therapy for the treatment of their malignancy','Patients must have no known allergies to exemestane, entinostat, or medications that have a benzamide structure (e.g., tiapride, remoxipride, clebropride)','Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infection','Patients must have recovered from all clinically relevant adverse events to grade 1 or baseline due to previous agents administered (except alopecia)','Patients must have adequate hematologic, liver and renal function =< 28 days prior to randomization\r\n* NOTE: It is preferred that laboratory values for eligibility be assessed after the last dose of prior treatment, especially in cases where most-recent treatment prior to study entry is chemotherapy','Hemoglobin (HgB) >= 9.0 g/dL','Platelet count >= 100,000/mcL','Absolute neutrophil count >= 1,500/mcL','Creatinine =< 2.0 mg/dL','Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert’s syndrome)','Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 x institutional upper limit normal','Known human immunodeficiency virus (HIV)-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3','Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1','Patients must have a life expectancy >= 12 weeks','Patients must be able to swallow tablets'
NCT02116777,https://www.clinicaltrials.gov/ct2/show/record/NCT02116777?term=NCT02116777&rank=1,'Age:\r\n* Phase 1 (Part A)\r\n** Patients must be > than 12 months and =< 21 years of age at the time of study enrollment\r\n* Phase 2 (Part B and Part C)\r\n** Patients must be > than 12 months and =< 30 years of age at the time of study enrollment','Body surface area (for Parts A, B and C): \r\n* Patients must have a body surface area (BSA) of >= 0.42 m^2 at the time of study enrollment','Diagnosis: \r\n* Phase 1 (Part A)\r\n** Solid tumors (Part A1): patients with relapsed or refractory solid tumors including central nervous system (CNS) tumors without bone marrow involvement are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\r\n** Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) (Part A2): patients with relapsed or refractory Ewing sarcoma or peripheral PNET without bone marrow involvement will be eligible for Part A2 if there are no available slots on Part A1; these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling, or at the starting dose level (dose level 1) if dose escalation has not yet occurred; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Phase 2 (Part B)\r\n** Ewing sarcoma or peripheral PNET: patients with relapsed or refractory Ewing sarcoma or peripheral PNET are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Phase 2 (Part C)\r\n** Acute lymphoblastic leukemias (ALL): patients must have 2nd or greater relapse of pre-B ALL or T-cell ALL; patients may not have refractory disease\r\n** Patients with ALL must have had histologic verification of the malignancy at the most recent relapse, including immunophenotyping to confirm diagnosis','Disease status: \r\n* Phase 1 (Part A):\r\n** Patients must have either measurable or evaluable disease \r\n* Phase 2 (Part B):\r\n** Ewing sarcoma or peripheral PNET: patients must have measurable disease\r\n* Phase 2 (Part C):\r\n** Acute lymphoblastic leukemias (ALL): patients with ALL must have an M3 marrow with or without extramedullary site of relapse OR an M2 bone marrow with an extramedullary site of relapse; patients with CNS 3 status are not eligible for enrollment','Therapeutic options: patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients who have received prior therapy with a temozolomide-based regimen are eligible; Note: patients who have progressed on a poly adenosine diphosphate ribose polymerase (PARP) inhibitor and temozolomide regimen are not eligible for Part A of the study','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy:\r\n** Solid tumors (Part A and Part B): at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Acute lymphoblastic leukemias (ALL) (Part C):\r\n*** Patients with leukemia who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study\r\n*** Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy, with the exception of hydroxyurea\r\n*** Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of BMN 673\r\n*** Note: patients with leukemia are permitted to receive intrathecal chemotherapy, including methotrexate or cytarabine; intrathecal therapy should be restricted to days 15 and 22 of each 28 day cycle \r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; patients with prior total body irradiation (TBI), craniospinal XRT and/or >= 50% radiation of the pelvis are not eligible\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion','PARP inhibitor exposure:\r\n* Part A: Patients who have received prior therapy with a PARP inhibitor, with the exception of BMN 673, are eligible; however, patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible\r\n* Part B and Part C: Patients who have previously been exposed to a PARP inhibitor are not eligible','For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm^3','For patients with solid tumors without known bone marrow involvement: platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','For patients with solid tumors without known bone marrow involvement: hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)','All patients enrolled on Part A of the study must be evaluable for hematologic toxicity','Patients on Part B of the study with known bone marrow metastatic disease will be eligible for the study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Patients on Part C with acute lymphoblastic leukemia: platelet count >= 20,000/mm^3 (may receive platelet transfusions); these patients must not be known to be refractory to red cell or platelet transfusion','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a maximum serum creatinine (mg/dL) based on age/gender as follows:\r\n* 1 to < 2 years: 0.6 \r\n* 2 to < 6 years: 0.8 \r\n* 6 to < 10 years: 1 \r\n* 10 to < 13 years: 1.2 \r\n* 13 to < 16 years: 1.5 for males, 1.4 for females\r\n* >= 16 years: 1.7 for males, 1.4 for females','Patients on Part A and Part B: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Patients on Part A and Part B: serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Patients on Part A and Part B: serum albumin >= 2 g/dL','Patients on Part C with ALL: bilirubin (sum of conjugated + unconjugated) =< 1.5 x ULN for age','Patients on Part C with ALL: SGPT (ALT) =< 225 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Patients on Part C with ALL: serum albumin >= 2 g/dL','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','For patients enrolling on Part B: tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the Study Chair must be notified prior to enrollment','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy); patients with acute lymphoblastic leukemia may receive intrathecal therapy','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients must be able to swallow capsules whole','Patients who have an uncontrolled infection are not eligible','For Part C (Phase 2): recurrent ALL patients with CNS 3 status are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients with prior TBI, craniospinal XRT and/or those with >= 50% radiation of the pelvis are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients with known hypersensitivity to temozolomide or dacarbazine are not eligible','Phase 1 (Part A): patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible','Phase 2 (Part B and Part C): patients who have previously been exposed to a PARP inhibitor are not eligible','Phase 1 (Part A): patients with known bone marrow involvement are not eligible'
NCT02211755,https://www.clinicaltrials.gov/ct2/show/record/NCT02211755?term=NCT02211755&rank=1,'Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =<1.5 x institutional upper limit of normal (IULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration','Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 3 weeks prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted','Cardiac function within institutional normal limits on echocardiogram','Sensory/motor neuropathy >= grade 2','Corrected QT (QTc) interval (Fridericia formula) > 450 msec for men or > 470 msec for women at study entry; history of congenital long QT syndrome','Patients who are receiving any other investigational agents','Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for >= 4 weeks without requiring steroid and anti-seizure medication, are eligible to participate','History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs; patients who have previously received either clofarabine or bortezomib will be excluded','Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded; breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Both men and women of all races and ethnic groups are eligible for this trial'
NCT02200042,https://www.clinicaltrials.gov/ct2/show/record/NCT02200042?term=NCT02200042&rank=1,'Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis within 90 days of registration; patients with an adenocarcinoma suggestive of a pancreaticobiliary primary with radiographic findings consistent with an intrahepatic cholangio-carcinoma are eligible','Patient must have 1 lesion with a maximum AXIAL diameter of 12 cm; up to 3 satellite lesions are permitted; satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (GTV) are permitted; the satellite lesions are NOT included in the AXIAL diameter measurement; regional lymph node involvement within the porta hepatis (as medial as superior mesenteric vein [SMV] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. fludeoxyglucose F 18 [FDG] avid)','Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination within 30 days prior to registration \r\n* Assessment by medical oncologist who specializes in treatment of IHC within 30 days of registration \r\n* Pre-randomization scan (REQUIRED for all patients): computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan within 30 days prior to registration; if CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen and pelvis is permitted','Zubrod performance status 0-1 within 30 days prior to registration','Absolute neutrophil count (ANC) >= 1,500 cells/m^3','Platelets >= 100,000 cells/mm^3','Total bilirubin < 2.5 mg/dl','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 5.0 X institutional upper limit of normal','Albumin >= 2.5 mg/dl','Creatinine within normal institutional limits or creatinine clearance >= 60mL/min/1.73 m^2 for subject with creatinine levels above institutional normal','Hemoglobin >= 9.0 g/dl; (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)','Patient must provide study specific informed consent prior to study entry','Negative beta human chorionic gonadotropin (bHCG) within 14 days prior to study entry if patient is pre or perimenopausal','Multiple lesions that don’t meet the criteria as satellite lesions','Extrahepatic metastases or malignant nodes beyond the periportal region; celiac, pancreaticoduodenal and para-aortic nodes > 2 cm are ineligible; note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm','Maximum diameter exceeding 12 cm (maximum diameter does not include satellite lesion)','Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry','Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields','Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time','Direct tumor extension into the stomach, duodenum, small bowel or large bowel','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible)','Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable','Currently receiving other anti-cancer agents','Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin','Prior surgery for the IHC; (liver resection is not allowed)','Prior allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine (gemcitabine hydrochloride) or cisplatin','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration\r\n* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol\r\n* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Grade 3 or higher peripheral neuropathy'
NCT02177695,https://www.clinicaltrials.gov/ct2/show/record/NCT02177695?term=NCT02177695&rank=1,'Patients must have histologically proven urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded','Patients must have stage cT2-T4a N0 M0 disease; clinical T stage is based on the transurethral resection of bladder tumor (TURBT) sample and imaging studies; patients must undergo cystoscopy and TURBT as part of the staging procedure within 56 days prior to registration; to exclude non-bulky/low-risk tumors and ensure adequate tissue for assessment, subjects must have documented muscle invasion with at least one of the following:\r\n* Disease measuring at least 5 mm on cross-sectional imaging or by endoscopic assessment; bladder thickening on imaging without definable tumor is not adequate; pathology verification of >= 0.5 cm of viable tumor (longest diameter) from the biopsy sample and represented on the submitted slides is also acceptable\r\n* The presence of tumor-associated hydronephrosis','Patients must have staging scans with abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) scan and CT scan or x-ray of the chest within 56 days prior to registration; if alkaline phosphatase is above the treating institution’s upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration','Patients must have a Zubrod performance status of 0 or 1','Patients must not have received previous systemic cytotoxic chemotherapy for urothelial carcinoma','Patients must not have received previous systemic anthracycline (intravesical anthracycline is allowed)','Patients must not have peripheral neuropathy >= grade 2','Patients must not have presence of class III or IV heart failure, according to New York Heart Association classifications, or a known left ventricular ejection fraction of less than 50%; Note: left ventricular ejection fraction (LVEF) evaluation by echocardiogram or multi-gated acquisition scan (MUGA) is not required prior to registration','Patients must not have a clinically relevant hearing impairment > grade 2','Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration; use the modified Cockcroft-Gault formula','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert’s disease)','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x institutional ULN','Absolute neutrophil count (ANC) >= 1,500/mcL','Hemoglobin >= 9 g/dL','Platelets >= 100,000/mcL','Patients must not be known to have hypersensitivity to cisplatin, gemcitabine (gemcitabine hydrochloride), doxorubicin (doxorubicin hydrochloride), vinblastine (vinblastine sulfate), methotrexate or filgrastim/pegfilgrastim','Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol','Prestudy history and physical must be obtained within 28 days prior to registration','Patients must not be pregnant or nursing; women/men of reproductive potential must agree to use an effective contraceptive method during and for 6 months after completing protocol treatment; a negative pregnancy test (either serum or urine) is required within 7 days prior to registration; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible','Patients must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of 20 (10 micron) slides of formal-fixed paraffin embedded (FFPE) tissue, with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides; the diagnostic TURBT sample must have been obtained within 56 days prior to registration; all sections should be placed on \"plus\" slides, as is the standard procedure in most pathology units','Patients must consent, if residual tumor is present at the time of cystectomy, to the submission of 20 (10 micron) unstained slides with 2 (5 micron) slides at the start and stop of the series (total of 22 unstained slides)','Patients must consent to have voided urine (40-50 mL) submitted prior to initiating chemotherapy (pre-treatment) and after chemotherapy prior to surgery (post-treatment)','Patients must consent to whole blood (2 x 10 mL) submitted prior to initiating chemotherapy','Patients must agree to participate in the translational medicine studies','Patients must be offered the opportunity to participate in the ultra pure Circulating Tumor Cells (upCTCs) study','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any study-related procedures in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of Institutional Review Board approval for this study has been entered in the system'
NCT02190279,https://www.clinicaltrials.gov/ct2/show/record/NCT02190279?term=NCT02190279&rank=1,'Platelet count > 50,000/mm^3','Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2','Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed','ARM I ONLY: For patients with presumed localized disease (any T, N0, M0), a multiparametric MRI (standard of care at the National Institutes of Health [NIH] Clinical Center) must be performed within 4 months of the 18F-DCFBC injection with findings suggestive for prostate cancer and a prostate lesion at least 6 mm or greater; must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging','ARM II ONLY: For patients status post radiation therapy for prostate cancer, any PSA increase from post radiation therapy nadir OR','ARM II ONLY: For patients status post prostatectomy, a PSA >= 0.2 ng/ml','ARM II ONLY: Nonspecific or no evidence for disease on standard imaging modality','ARM III ONLY: Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality; if only soft tissue metastasis, one lesion must measure at least 6 mm or greater; patients must have confirmation of prostate cancer prior to 18F-DCFBC imaging\r\n* Note: a patient who is eligible for one arm, subsequently may cross-over into a different arm','Subjects for whom participating would significantly delay the scheduled standard of care therapy','Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results','Subjects with severe claustrophobia unresponsive to oral anxiolytics','Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures','Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry','Serum creatinine > 2 times the upper limit of normal','Total bilirubin > 2 times the upper limit of normal','Liver transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) greater than 3 times the upper limit of normal'
NCT02133183,https://www.clinicaltrials.gov/ct2/show/record/NCT02133183?term=NCT02133183&rank=1,'Patients must have histologically proven glioblastoma or gliosarcoma which is progressive or recurrent following radiation therapy +/- chemotherapy','Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent glioblastoma or gliosarcoma by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to tolerate MRIs','Patients may have had treatment for no more than 2 prior relapses','Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy or mitomycin C\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent except bevacizumab/vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 6 weeks from bevacizumab/VEGFR inhibitors','Patients must be undergoing surgery that is clinically indicated as determined by their care providers','Patients must be eligible for surgical resection according to the following criteria:\r\n* Part 1 Patients: Expectation that the surgeon is able to resect at least 350 mg of tumor from enhancing tumor and at least 350 mg from non-enhancing tumor with low risk of inducing neurological injury\r\n* Part 2 Patients: Expectation that the surgeon is able to resect at least 1000 mg from enhancing tumor and at least 350 mg from non-enhancing tumor with low risk of inducing neurological injury','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Fasting serum glucose =< 130 MG/DL','HbA1c =< 7.0%','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal','Creatinine =< institutional upper limit of normal OR','Creatinine clearance >= 50 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must be able to provide written informed consent','Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, prior to study entry, for the duration of study participation, and through 90 days (or longer, as mandated by local labeling [e.g. USPI, SmPC, etc.]) after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and through 120 days after the last dose of study drug','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Patients must be able to swallow whole capsules','Patients enrolled in Part 2 must have at least 20 (preferably 40) slides of archival tumor tissue from a prior surgery demonstrating GBM; patients enrolled in Part 1 will not be required to have archival tissue','Patients with controlled diabetes are allowed on study; controlled diabetes is defined as < 130 ml/dL for the sake of this study','Patients receiving any other investigational agents are ineligible','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) are ineligible','Patients may not have had prior treatment with mTOR, peptidase inhibitor 3, skin-derived (PI3) kinase or Akt inhibitors','Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol; patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of MLN0128 (TAK-228)','Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction','Patients must not have evidence of significant intracranial hemorrhage','Patients with a history of any of the following within the last 6 months prior to study entry are ineligible:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism','Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are ineligible','Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) are ineligible','Patients with known diabetes mellitus which is poorly controlled (defined as hemoglobin A1c [HbA1c] > 7%) are ineligible; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion have been met','Patients who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228) are ineligible; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)','For weekly MLN0128 (TAK-228) dose cohorts, patients taking proton pump inhibitors (PPIs) are ineligible unless these patients are able to switch to a histamine (H2) blocker and/or antacid','Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are ineligible','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this agent','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Subjects taking strong CYP3A4 and CYP2C19 inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 (TAK-228) metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the study doctor should be consulted'
NCT02249949,https://www.clinicaltrials.gov/ct2/show/record/NCT02249949?term=NCT02249949&rank=1,'Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained myxoid liposarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility','Measurable disease','Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment\r\n* There is no limit to the number of prior lines of treatment a patient has received\r\n* No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less','No history of the following:\r\n* Class III or IV congestive heart failure (CHF)\r\n* Pericardial effusion =< 12 months (grade 3 or 4)\r\n* Pericardial involvement with tumor\r\n* Grade 2 or higher pleural effusion =< 6 months','No symptomatic, untreated, or uncontrolled brain metastases present','Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)','Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible','Patients with known hypersensitivity to any TZD oral agents are not eligible','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','Absolute neutrophil count (ANC) >= 1,000/mm^3','Platelet count >= 75,000/mm^3','Creatinine =< 1.5 mg/dL x upper limits of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min','Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN; for subjects with liver metastases, SGOT (AST) and SGPT (ALT) < 5 x the upper normal limit of institution's normal range is allowed','Eligible patients must have histopathologically confirmed myxoid liposarcoma with confirmation of DDIT3 rearrangement'
NCT02143401,https://www.clinicaltrials.gov/ct2/show/record/NCT02143401?term=NCT02143401&rank=1,'For Dose Escalation Cohort: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective','For Dose Expansion Cohort: HCC patients only: HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria; all of the following criteria must be met or a biopsy is required:\r\n* Known cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\r\n* Hypervascular liver masses > 2 cm, and either serum alpha-fetoprotein (AFP) > 400 ng/ml\r\n* AFP > three times normal and doubling in value in the antecedent 3 months\r\n* In the expansion cohort, prior treatment with sorafenib as first-line therapy allowed','Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Targeted therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrow','HCC patients only: prior regional treatments for liver metastasis are permitted including:\r\n* Selective internal radiation therapy such as brachytherapy, cyber knife, radiolabeled microsphere embolization, etc.\r\n* Hepatic artery chemoembolization\r\n* Hepatic artery embolization\r\n* Hepatic artery infusional chemotherapy\r\n* Radiofrequency ablation\r\n* NOTE: patients must be >= 4 weeks from treatment and show progressive measurable/evaluable disease in the liver after regional therapy or must have measurable disease outside the liver','HCC patients only: Child Pugh class A or B7 liver disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of > 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL (patients may be treated with hematopoietic growth factors to achieve or maintain this level)','Hemoglobin >= 9.0 g/dL','International normalized ratio (INR) =< 1.4','Platelets >= 100,000/mm^3','Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert’s syndrome may have direct bilirubin > 2.5 x ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 times the ULN','Able to swallow and retain oral medication','Negative serum pregnancy test =< 7 days prior to registration for women of childbearing potential\r\n* NOTE: women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months)','Ability to understand and the willingness to sign a written informed consent document','Willing to provide tissue samples for correlative research purposes','Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v 4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia','Receiving any other investigational agents =< 28 days prior to registration','Known brain metastases (even if treated)','Known portal hypertension or history of variceal bleeding','Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 90 mmHg on anti-hypertensive medications)','History of allergic reactions attributed to compounds of similar chemical or biologic composition to navitoclax or sorafenib','Current use of anticoagulation; NOTE: use of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter is allowed','Corrected QT (QTc) interval > 480 msec on baseline electrocardiogram (EKG)','Documented history of prolonged QTc interval =< 6 months prior to registration','Receiving any medications that prolong the QTc and have a known risk for Torsades de pointes; providers should use caution with drugs with possible increased risk for Torsades de pointes; NOTE: patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-lives of the medication','Current use of certain concomitant medications due to mechanistic-based platelet toxicities from navitoclax: clopidogrel, ibuprofen, tirofiban and other anticoagulants, drugs or herbal supplements that effect platelet function; NOTE: antiplatelet use is prohibited during the use of navitoclax; subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the principal investigator in conjunction with the medical monitor','Current use of strong CYP3A inhibitors such as ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, and clarithromycin are prohibited; NOTE: moderate inhibitors of CYP3A4 should be used with caution; navitoclax is a moderate inhibitor of CYP2C8 and a strong inhibitor of CYP2C9; caution should be exercised when dosing navitoclax concurrently with CYP2C8 and CYP2C9 substrates; common CYP2C8 substrates include paclitaxel, statins and repaglinide; CYP2C9 substrates include celecoxib, phenytoin and warfarin; when possible, investigators should switch to alternative medications or monitor the patients closely','Concurrent use of strong CYP3A4/5 inducers such as carbamazepine, phenytoin, rifampin, and St. John’s wort are prohibited','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Any of the following: \r\n* Pregnant women\r\n* Nursing women \r\n* Women of childbearing potential who are unwilling to employ adequate contraception; NOTE: should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and up to 90 days following completion of therapy:\r\n** Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration) \r\n** Vasectomized male subject or vasectomized partner of female subjects\r\n** Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion\r\n** Intrauterine device (IUD)\r\n** Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n** Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy','Human immunodeficiency virus (HIV)-positive patients on highly active antiretroviral therapy (HAART) are excluded','Underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding','Recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding =< 1 year prior to the registration','History of cardiovascular disease (e.g., myocardial infraction [MI], thrombotic or thromboembolic event in the last 6 months)'
NCT02143414,https://www.clinicaltrials.gov/ct2/show/record/NCT02143414?term=NCT02143414&rank=1,'Registration Step 1 – Induction/Re-Induction:','Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients with Burkitt's (L3) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have relapsed or refractory diagnoses\r\n* NOTE: Relapsed/refractory Ph-positive patients or Ph-like patients with dasatinib-sensitive mutations or kinase fusions who have previous exposure to either dasatinib or another 2nd or 3rd generation TKI will begin protocol therapy with Cohort 2: re-induction cycle 1','Patients must have a diagnosis of Philadelphia chromosome negative ALL or Ph chromosome positive ALL by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR); patients will be registered to receive treatment in either Cohort 1 (ph-) or Cohort 2 (Ph+ or Ph-like DSMKF) based on these results; diagnostic specimens must be submitted to the site’s local Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory and results of tests (cytogenetics, FISH or PCR) must confirm Ph status prior to registration; if not already known, breakpoint cluster region- abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) status (p190 or p210) must be evaluated in Ph-positive patients by PCR\r\n* For Cohort 2, Ph-like testing is not required specifically for this study; however, to be registered to Cohort 2 under the Ph-like DSMKF criterion, the patient must have a known or presumed activating Ph-like signature and dasatinib-sensitive mutation or kinase fusion, such as: ABL1, ABL2, colony stimulating factor 1 receptor (CSF1R), platelet derived growth factor receptor beta (PDGFRB), platelet derived growth factor receptor alpha (PDGFRA), or fibroblast growth factor receptor (FGFR)s that was otherwise identified as part of normal standard of care; prior to registering any patients with a known or presumed activating Ph-like signature and dasatinib-sensitive mutations or kinase fusions (DSMKF) treating physicians must confirm eligibility with the study chairs via email; the study chairs must respond via email with confirmation of patient eligibility prior to patient registration','All newly diagnosed patients must have evidence of ALL in their marrow or peripheral blood with at least 20% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; all relapsed/refractory patients (Cohort 2) must have at least 5% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; for relapsed/refractory patients, pathology and cytogenetics reports (both from time of original diagnosis) must be submitted at time of registration; if a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage; for ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell or mixed B/T cell); appropriate marker studies including cluster of differentiation (CD)19 (B cell), must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers (myeloid cells) should be determined; the blood/bone marrow sample for these assays must be obtained within 28 days prior to registration; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible','Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by cerebrospinal fluid (CSF) analysis, or other significant CNS abnormalities','Patients must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration; patients with CNS3 are excluded from the trial; patients with CNS1 or CNS2 will be eligible, but will be monitored for CNS involvement; note that intrathecal methotrexate administered during the pre-study lumbar puncture may count as the first dose of intrathecal therapy required as part of the study','Cohort I, Ph-negative Patients Only','Patients must not have received any prior chemotherapy, radiation therapy, or other therapy for the treatment of ALL (other than those noted below) and must not be receiving any immunosuppressive therapy; patients may not have received any prior investigational therapy within 28 days prior to registration; patients must not have received any monoclonal antibody therapy within 42 days of registration; patients may have received the following within any time prior to registration: low dose chemotherapy-including: cyclophosphamide 1 g/m^2, oral 6-mercaptopurine, or oral methotrexate (other low dose chemotherapy may be allowable, however any other options not listed here should be confirmed with the study chairs), TKI therapy, steroids, hydroxyurea, leukapheresis, intrathecal chemotherapy or vincristine (vincristine sulfate)','In the event that the patient’s bone marrow blast count is >= 50% blasts, patients may be registered but should receive steroids for 3-5 days in order to reduce tumor burden prior to blinatumomab administration, as follows\r\n* Prephase treatment with dexamethasone (10-20 mg/m^2) for 3-5 days is required for patients with bone marrow blasts >= 50%, peripheral blood blasts 15,000/uL or higher, or elevated lactate dehydrogenase (LDH) suggesting rapidly progressive disease per investigator opinion\r\n** Pre-treatment should conclude at least 24 hours prior to the first dose of blinatumomab (although additional dexamethasone is automatically given as a pre-med prior to the first dose); at the time of first infusion of blinatumomab, the absolute peripheral blast count should be < 25,000/uL\r\n** Note: For the purposes of the study, day 1 of the cycle will be the first day of blinatumomab administration','It is preferred, but not required, that corticosteroids and hydroxyurea should start only after all diagnostic samples have been obtained; however, if the patient was previously on corticosteroids and/or hydroxyurea, this is allowable provided that the patient still has measurable disease at time of the bone marrow aspirate\r\n* Corticosteroids and/or hydroxyurea, as well as any of the other therapies mentioned (with the exception of IV cyclophosphamide), may continue to be administered, at physician discretion, until 1 day prior to blinatumomab administration\r\n** IV cyclophosphamide must be discontinued at least 7 days prior to blinatumomab administration','Patients must not be candidates for allogeneic hematopoietic stem cell transplant; NOTE: Subjects up to age 70 years who are considered fit for allogeneic hematopoietic stem cell transplant, should be considered for enrollment on E1910, in order to avoid competing with that study; if a patient is considered unfit for intensive chemotherapy at the time of initial diagnosis, but subsequently achieves a complete remission (CR), then it will be left to the treating physician’s discretion to consider hematopoietic stem cell transplant (HSCT)','Patients must have complete history and physical examination within 28 days prior to registration','Patients must have a Zubrod performance status of 0-2','Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration','Patients must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration','Patients must have total bilirubin =< 2.0 x IULN within 14 days prior to registration','Patients must have alkaline phosphatase =< 2.5 x IULN within 14 days prior to registration','Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)','Patients must not have Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 neuropathy (cranial, motor or sensory) within 14 days prior to registration','Patients known to be positive for HIV (the human immunodeficiency virus) may be eligible, providing they meet the following additional criteria within 28 days prior to registration:\r\n* No history of acquired immune deficiency syndrome (AIDS)-defining conditions\r\n* CD4 cells > 350 cells/mm^3\r\n* If on antiretroviral agents, must not include zidovudine or stavudine\r\n* Viral load =< 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or =< 25,000 copies HIV mRNA/mm^3 if not on cART\r\n* Highly active antiretroviral therapy (HAART) regimens are acceptable providing they have only weak P450A4 interactions','Patients must not have any known autoimmune disease','Patients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registration','Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patients must have the following tests within 28 days prior to registration to obtain baseline measurements:\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients)\r\n* Neurologic assessment','Patients must have specimens submitted for blinatumomab immunogenicity assessment; collection of pretreatment specimens must be completed within 28 days prior to registration to S1318; specimens must be submitted to LabConnect','Cohort 2, Ph-positive and Ph-like DSMKF Patients Only','Patients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration, with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1); IV cyclophosphamide may be administered at doses of 1 g/m^2 or less until up to 7 days prior to registration','For patients 65-69 years of age, patient must be deemed not suitable for standard intensive induction chemotherapy at the discretion of the local investigator, or must have refused standard intensive chemotherapy','Patients must not have active pericardial effusion, ascites or pleural effusion of any grade based on chest x-ray and echocardiogram within 28 days prior to registration; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion =< grade 2 or pleural effusion =< grade 1','Patients must have ejection fraction >= 45% based on echocardiogram performed within 28 days prior to registration','Patients must have QTcF (by Fridericia calculation) < 480/msec based on electrocardiogram (EKG) performed within 28 days prior to registration','Patients must not be receiving any proton pump inhibitors at the time of registration','Patients must agree to have specimens submitted for blinatumomab immunogenicity testing if subsequently moved to a blinatumomab containing treatment regimen on protocol','Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 28 days prior to registration to S1318; specimens must be submitted to the site’s preferred CLIA-approved cytogenetics laboratory; BCR-ABL status must be verified in Ph-positive patients by FISH, cytogenetics, and/or PCR prior to enrollment; if a patient is Ph-positive, PCR for both p190 and p210 must be sent','Patients must be offered participation in specimen submission for future research; with patient’s consent, specimens must be submitted as outlined','ALL PATIENTS: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','ALL PATIENTS: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','Registration Step 2 – Post-Remission Therapy:','COHORT 1 PH-NEGATIVE PATIENTS ONLY: Patients must have achieved CR or CRi within 2 cycles of induction/re-induction with blinatumomab\r\n* NOTE: day 1 of post-remission = day 43 of the preceding cycle (+/- 3 days)','COHORT 2 PH-POSITIVE AND PH-LIKE DSMKF PATIENTS ONLY: Newly diagnosed Ph+, newly-diagnosed Ph-like DSMKF, and relapsed/refractory Ph+ patients without prior dasatinib or other 2nd or 3rd generation TKI therapy, must have achieved CR or CRi within 1 cycle of induction with dasatinib/prednisone, or within 2 cycles of re-induction with blinatumomab; relapsed/refractory Ph+ or Ph-like DSMKF patients with prior dasatinib or other 2nd or 3rd generation TKI therapy must have achieved CR or CRi within 2 cycles of re-induction therapy with blinatumomab\r\n* NOTE: day 1 of post-remission = day 85 of the preceding induction cycle (+/- 3 days), or day 43 of the preceding re-induction cycle (+/- 3 days) as applicable','Serum creatinine =< 1.5 mg/dl within 14 days prior to registration','AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration','Total bilirubin =< 2.0 x IULN within 14 days prior to registration','Absolute neutrophil count (ANC) >= 750/mcl within 28 days prior to registration','Platelets >= 50,000/mcl within 28 days prior to registration','Patients must be registered to Step 2 within 28 days after count recovery; (Note: there is no maximum allotted time period for count recovery, providing patient remains in CR or CRi)','All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2','Registration Step 3 – Maintenance: Patients must have documented CR or CRi within 28 days prior to registration; note that bone marrow examination is only required if there are clinical signs/symptoms of progression; if progression is a concern due to the length of the time for count recovery, a bone marrow examination is recommended','Registration Step 3 – Maintenance: Patients must have serum creatinine =< 1.5 mg/dl within 14 days prior to registration','Registration Step 3 – Maintenance: Patients must have AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration','Registration Step 3 – Maintenance: Patients must have total bilirubin < 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration','Registration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by ANC >= 750/mcl within 28 days prior to registration','Registration Step 3 – Maintenance: Patients must have adequate marrow function as evidenced by platelets >= 75,000/mcl within 28 days prior to registration','Registration Step 3 – Maintenance: All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2'
NCT02179086,https://www.clinicaltrials.gov/ct2/show/record/NCT02179086?term=NCT02179086&rank=1,'PRIOR TO STEP 1 REGISTRATION','A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively; the residual enhancing tumor and/or resection cavity must have a maximal diameter of 5 cm or less; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate\r\n* The postoperative brain MRI should be obtained within 72 hours of resection; if it is not obtained within 72 hours post-resection, then an MRI obtained 2 weeks or longer after surgery is required and can be utilized to ensure maximal diameter of residual tumor and/or resection cavity is 5 cm or less\r\n* For cases where a gross total resection of enhancing tumor is performed, but postoperative surgical cavity is NOT identifiable, the patient will be excluded from the trial','Tumor tissue must be available for submission for central pathology review\r\n* Timing requirements:\r\n** If MGMT has been assessed locally by LabCorps or MD Anderson Cancer Center Molecular Diagnostics Lab (MDACC-MDL):\r\n*** Tissue for central pathology review and central MGMT assessment and the official LabCorps or MDACC-MDL MGMT result must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 40\r\n*** The site’s local MGMT report from LabCorp or MDACC-MDL will then be used to stratify the patient; a post-stratification MGMT central review will be performed, but step 2 registration and protocol treatment can proceed without central review of MGMT\r\n*** Patients whose tissue for central pathology review and official LabCorps or MDACC-MDL MGMT result cannot be received by NRG Oncology Biospecimen Bank on or before 40 calendar days after surgery may NOT enroll on this trial\r\n** If MGMT has not been assessed locally by LabCorps or MDACC-MDL:\r\n*** Tissue for central pathology review and central MGMT assessment must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 30\r\n*** Central MGMT analysis will be performed at MDACC-MDL and used for patient stratification; results will be conveyed to NRG Oncology within 10 business days of receipt of the tissue\r\n*** Patients who have not had local MGMT assessment by LabCorps or MDACC-MDL and whose tissue for central pathology review cannot be received by NRG Oncology Biospecimen Bank on or before 30 calendar days after surgery may NOT enroll on this trial\r\n* Tissue Requirements:\r\n** Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; in total, at least 1 cubic centimeter of tissue composed primarily of tumor must be present\r\n** Submission of an accompanying hematoxylin and eosin H&E slide(s) is MANDATORY\r\n** Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy and cavitronic ultrasonic surgical (CUSA) techniques are not allowed','The tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)','Patients must provide study-specific informed consent prior to step 1 registration','PRIOR TO STEP 2 REGISTRATION','Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration','Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient quantity for central analysis of MGMT status','History/physical examination within 28 days prior to step 2 registration','The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration','Documentation of steroid doses within 28 days prior to step 2 registration','Karnofsky performance status >= 70 within 28 days prior to step 2 registration','Complete blood count (CBC)/differential obtained within 28 days prior to step 2 registration','Absolute neutrophil count (ANC) >= 1,500 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 10.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)','Bilirubin =< 1.5 upper limit of normal (ULN)','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN','Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration','As of Amendment 2, if the registering site is a photon center (registering patients to group I), the patient must agree to participate in the advanced imaging sub-study','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)','Recurrent or multifocal malignant gliomas','Any site of distant disease (for example, drop metastases from the GBM tumor site)','Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)','Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted','Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields','Severe, active co-morbidity, defined as follows:\t\r\n* Unstable angina at step 2 registration\r\n* Transmural myocardial infarction within the last 6 months prior to step 2 registration \r\n* Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)\r\n* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration\r\n* Serious and inadequately controlled arrhythmia at step 2 registration\r\n* Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection \r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol\r\n* Any other severe immunocompromised condition\r\n* Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity\r\n* End-stage renal disease (ie, on dialysis or dialysis has been recommended)\r\n* Any other major medical illnesses or psychiatric treatments that in the investigator’s opinion will prevent administration or completion of protocol therapy','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration','Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia)','Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter'
NCT02152995,https://www.clinicaltrials.gov/ct2/show/record/NCT02152995?term=NCT02152995&rank=1,'Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); confirmation of thyroid carcinoma will be done at Memorial Sloan-Kettering (MSK)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam; tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment','RAI-refractory disease on structural imaging, defined as any one of the following:\r\n* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed prior to enrollment in the current study, or\r\n* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion\r\n* The presence of at least one fluorodeoxyglucose (FDG) avid lesion','No recent treatment for thyroid cancer as defined as:\r\n* No prior RAI therapy is allowed < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 millicurie (mCi) of RAI is not considered RAI therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol; (previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol)\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy on this protocol','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grade =< 1 (except alopecia); grade 2 prior treatment related toxicities may be allowed after discussion with the principal investigator','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Hemoglobin >= 9 g/dL','Platelets >= 100 x 10^9/L','Albumin >= 2.5 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of child-bearing potential must have a negative pregnancy test within 2 weeks prior study registration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib administration','Ability to understand and the willingness to sign a written informed consent document','Patients must agree to undergo two separate biopsies of a malignant lesion; biopsies do not need to be done if one of the following apply:\r\n* If either the site investigator or person performing the biopsy judges that no tumor is accessible for biopsy or that biopsy poses too great of a risk to the patient (if the only tumor accessible for biopsy is also the only lesion that can be used for RECIST v1.1 response evaluation, then the patient may be exempt from biopsy after discussion with the MSK principal investigator)\r\n* The goal will be to have a minimum of 6 patients from Cohort A and 3 patients from Cohort B attempt to have one or both of these research biopsies done (for a total of 9 patients total); accrual may be limited only to subjects for whom tumor is accessible for biopsy and attempt at biopsy is considered safe if continued enrollment of those who are not candidates for biopsy make it impossible to reach the accrual goals for research biopsies described above (e.g., if 19 [of 25] patients are accrued to Cohort A without any biopsies having been obtained within the cohort, then all further subjects who are registered to that cohort must qualify for attempted research biopsy in order to be enrolled into the study [i.e., subjects who would have been excluded from having biopsies done due to the above reasons would be excluded from participating in the study; these conditions also apply to Cohort B])','Availability of archival tumor tissue from the thyroid cancer primary or metastasis (a tissue block or a minimum of 30 unstained slides would be required; patients with less archival tissue available may still be eligible for the study after discussion with the MSK principal investigator)','COHORT A: Confirmation in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory that one of the patient’s thyroid tumors (primary tumor, recurrent tumor, or metastasis) has an neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) or Kirsten rat sarcoma viral oncogene homolog (KRAS) or Harvey rat sarcoma viral oncogene homolog (HRAS) mutation at G12, G13, or Q61; this group of patients will also be referred to as “RAS MUT”','COHORT A: Patients must have progressive disease, defined as the presence of new or growing lesion(s) on radiologic imaging within 14 months of study enrollment and/or new/worsening disease related symptoms within 14 months of study enrollment; (progression according to RECIST v 1.1 criteria is not required)','COHORT B: Confirmation in a CLIA certified laboratory that one of the patient’s thyroid tumors (primary tumor, recurrent tumor, or metastasis) does not have any of the following mutations:\r\n* Mutation at V600 of the v-raf murine sarcoma viral oncogene homolog B (BRAF) gene\r\n* Mutation in NRAS or KRAS or HRAS at G12, G13, or Q61\r\n* These patients will be designated “BRAF/RAS wild type (WT)”','History of another malignancy; exception: patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligible; MSK can consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above','History of interstitial lung disease or pneumonitis','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study','Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to thyrotropin alpha (Thyrogen)','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study; (note: megestrol [Megace] if used as an appetite stimulant is allowed; thyroid-stimulating hormone [TSH] suppressive therapy is also allowed; palliative radiation therapy to non-target lesions is also allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','Patients with the following ophthalmological findings/conditions:\r\n* Intraocular pressure > 21 mmHg, or uncontrolled glaucoma (irrespective of intraocular pressure)\r\n* Current or past history of central serious retinopathy or retinal vein occlusion','History or evidence of cardiovascular risk including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < LLN\r\n* A QT interval corrected for heart rate using the Bazett’s formula (QTcB) >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Patients with intra-cardiac defibrillators\r\n* Known cardiac metastases','Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Study drug must not be administered to pregnant women or nursing mothers','HIV-positive patients on combination antiretroviral therapy are ineligible','Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)','Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration; those that have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been cleared after the last intravenous contrast administration'
NCT02159989,https://www.clinicaltrials.gov/ct2/show/record/NCT02159989?term=NCT02159989&rank=1,'Patients with advanced or metastatic cancer that is refractory to standard therapy or relapsed after standard therapy; patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective','Patients enrolled in the expansion cohort must have biopsiable disease; there will be preferential enrollment of patients with pancreatic neuroendocrine tumors or ovarian cancer during the dose expansion cohort','Patients must be >= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =< grade 1 toxicity or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field','Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal','Fasting serum glucose =< 130 mg/dL','Fasting triglycerides =< 300 mg/dL','Glycosylated hemoglobin (HbA1c) < 7.0%','Patients must have evaluable or measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Women of child-bearing potential MUST have a negative serum or urine pregnancy test within 7 days unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; women of child-bearing potential must agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [eg; United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug; or agree to practice true abstinence; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or\r\n* Agree to completely abstain from heterosexual intercourse','Ability to understand and the willingness to sign a written informed consent document','Ability to swallow oral medications','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =< grade 1 adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) or ziv-aflibercept','Uncontrolled intercurrent illness including active infection','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN0128 (TAK-228) and ziv-aflibercept','Patients with known human immunodeficiency virus infection are not to be enrolled in the study','History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days or manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease that may alter the absorption of MLN0128 (TAK-228)','New York Heart Association class III or greater congestive heart failure within last 6 months or uncontrolled hyperlipidemia (cholesterol > 300 mg/dl; triglyceride 2.5 X upper limit of normal [ULN] despite lipid lowering agent) within last 3 months','Uncontrolled diabetes (fasting serum glucose > 130 mg/dl) despite best medical management or poorly controlled diabetes mellitus defined as hemoglobin (Hb)A1c > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met','History of uncontrolled hypertension, defined as blood pressure > 150/95 mmHg, or systolic blood pressure > 180 mmHg when diastolic blood pressure < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment','Urine protein should be screened by dipstick or urine analysis; for proteinuria > 1+ or urine protein: creatinine ratio > 1.0, 24-hour urine protein should be obtained and the level should be < 2000 mg for patient enrollment','Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of- therapeutic range international normalized ratio (INR) (> 3) within the 4 weeks prior to drug administration','Evidence of clinically significant bleeding diathesis or underlying coagulopathy, non-healing wound','History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* Pulmonary embolism','Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator','Baseline prolongation of the rate-corrected QT interval (QTc) (e.g. repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)','Psychiatric illness/social situations that would limit compliance with study requirements','Have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)','Patients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug','Patients with known history of hepatitis B surface antigen-positive, or known history or suspected active hepatitis C infection are not to be enrolled in the study'
NCT02142803,https://www.clinicaltrials.gov/ct2/show/record/NCT02142803?term=NCT02142803&rank=1,'Patients must have a histologically/cytologically confirmed diagnosis of recurrent glioblastoma or an advanced solid tumor in which bevacizumab has shown benefit in specific disease population and for which standard or curative measures do not exist or are no longer effective','Measurable or evaluable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for non-GBM tumors and by Response Assessment in Neuro-Oncology (RANO) criteria for GBM','For stage 1 (all patients) and dose expansion (stage 2) endometrial and ovarian cancer cohorts, participants are allowed following unlimited prior therapy; for stage 2 GBM participants, no more than 2 prior relapses are allowed; for these patients, relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or a subsequent therapy; the intent therefore is that GBM patients enrolling onto stage 2 had no more than 3 prior therapies (initial and treatment for 2 relapses); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute 1 relapse\r\n* NOTE: for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of glioblastoma will be considered the first relapse; therefore, these participants may have had more than 3 prior therapies','Patients must have recovered from clinically significant toxicity of prior therapy to grade =< 1 or pre-treatment baseline; the following intervals from previous treatments are required prior to day 1 of study therapy:\r\n* 12 weeks from the completion of radiation for recurrent GBM unless there is surgical diagnosis of recurrence or a new lesion that was not previously radiated\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from an investigational agent (not Food and Drug Administration [FDA] approved) (or 5 half lives, whichever is shorter)\r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.) (or 5 half lives, whichever is shorter)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Hemoglobin >= 9.0 g/dL','Total bilirubin < 1.5 x institutional upper limit of normal with direct bilirubin within normal limits except for participants with Gilbert’s disease','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (=< 5 x upper limit of normal [ULN] if liver metastases are present)','Creatinine < 1.5 x normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine level above institutional normal based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)','Metabolic: fasting serum glucose (=< 130 mg/dL) and fasting triglycerides =< 300 mg/dL','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 6 months after completion of MLN 0128 or bevacizumab administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of MLN0128 or bevacizumab administration','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= three years prior to registration','Solid tumor patients must be off corticosteroids prior to registration; if GBM patient is receiving corticosteroids, patient must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline magnetic resonance imaging (MRI) or computed tomography (CT); if steroids are added or the steroids dose is increased between the date of the screening MRI or CT and the start of treatment, a new baseline MRI or CT is required','Patients must be able to swallow whole capsules','Ability to understand and the willingness to sign a written informed consent document','For stage 2 GBM participants, a block of paraffin embedded tissue or 30 unstained slides at standard 4-5 um thickness from any prior surgery demonstrating GBM pathology must be available for submission','Stage 2 endometrial and ovarian cancer patients must have at least one lesion amenable to biopsy; this determination will be made by a member of the interventional radiology team or surgical associate investigator and an associate investigator; this requirement is not necessary for patients in stage 1','Solid tumor patients in stage 2 must have a diagnosis of papillary serous, endometrioid or clear cell endometrial carcinoma or, high grade serous, clear cell, endometrioid or mucinous ovarian, fallopian or primary peritoneal carcinoma','Concurrent administration of any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 or bevacizumab','For all stage 2 participants, no prior treatment with mTOR, PI3 kinase or Akt inhibitors; prior treatment with mTOR, PI3 kinase or Akt inhibitors allowed in stage 1 only','For stage 2 GBM participants, no prior treatment with bevacizumab/vascular endothelial growth factor receptor (VEGFR) inhibitors; prior treatment with bevacizumab/VEGFR inhibitors is allowed in stage 1 for all participants, as well as stage 2 endometrial and ovarian cancer participants','Stage 1 solid tumor and stage 2 endometrial and ovarian cancer participants with known central nervous system (CNS) metastatic lesions which are symptomatic and/or growing; patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll; brain metastasis must be stable for 1 month with verification by imaging (brain MRI completed at screening demonstrating no current evidence of progressive brain metastases); CNS imaging will not be mandated for asymptomatic patients with no history of CNS metastases','Concurrent use of enzyme-inducing anti-epileptic drugs (EIAED); patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of MLN0128','Subjects taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the principal investigator should be consulted','Concurrent use of herbal supplements and other non-traditional medications; all herbal supplements and other non-traditional medications must be stopped before time of registration','Concurrent use of anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH); medication must be stopped before time of registration; if patient has recently been on anti-coagulants other than LMWH, patient must have international normalized ratio (INR) =< 2','Evidence of any significant intracranial hemorrhage, as determined by the treating investigator, within 6 weeks from registration or as seen on most recent MRI prior to screening/baseline MRI','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','History of any of the following within 6 months prior to start of MLN0128:','Left ventricular ejection fraction (LVEF) =< 55% as determined by multi gated acquisition (MUGA) scan or echocardiogram (ECHO)','Heart failure >= New York Heart Association (NYHA) grade 3','Significant ST depression of >= 1.5 mm in 2 or more leads and/or T wave inversions in >= 2 leads','Complete left bundle branch block','Right bundle branch block + left anterior hemiblock (bi-fascicular block)','Congenital long QT syndrome','QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG)','Requirement of inotropic support (excluding digoxin)','History or presence of clinically significant ventricular or atrial tachyarrhythmias, or cardiac arrest','Clinically significant resting bradycardia','Presence of unstable atrial fibrillation (ventricular response > 100 beats per minute)','Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria','History of arrhythmia requiring an implantable cardiac defibrillator','Angina pectoris =< 12 months prior to starting drug','Acute myocardial infarction =< 12 months prior to starting drug','Any valve disease Common Terminology Criteria for Adverse Events (CTCAE) grade','Ischemic myocardial event including angina requiring therapy and artery revascularization procedures','Placement of a pacemaker for control of rhythm','Pulmonary embolism','Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures','Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral MLN0128 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection that requires nutritional support)','Use of hematopoietic colony-stimulating growth factors (e.g. filgrastim [G-CSF], sargramostim [GMCSF], lanimostim [M-CSF]) =< 2 weeks prior to starting study drug; erythropoietin, darbepoetin and erythropoietin-biosimilars are allowed for as long as they have been initiated at least 2 weeks prior to study enrollment','Pregnant or nursing women; breastfeeding should be discontinued if the mother is treated with MLN0128','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; if an HIV-positive patient has adequate cluster of differentiation (CD4) counts (CD4 above the lower limit of institutional normal) and is on antiretroviral therapy with newer agents, which are not strong cytochrome (CYP) inhibitors, they will be eligible','Uncontrolled high blood pressure (i.e., systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 90 mmHg)','Pulmonary hypertension','Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air','Participants with poorly controlled diabetes mellitus (defined as hemoglobin A1c [HbA1c] > 7%); subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met','Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment','Serious or non-healing wound, ulcer or bone fracture','History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1','Invasive procedures defined as follows:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy\r\n* Anticipation of need for major surgical procedures during the course of the study\r\n* Core biopsy within 7 days prior to day 1 therapy','Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1','Evidence of bleeding diathesis or coagulopathy','Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies'
NCT02304458,https://www.clinicaltrials.gov/ct2/show/record/NCT02304458?term=NCT02304458&rank=1,'Parts A & C: patients must be >= 12 months and < 18 years of age at the time of study enrollment','Parts B1-B6, B8, D1-D6: patients must be >= 12 months and =< 30 years of age at the time of study enrollment','Part B7: patients must be >= 12 months and < 18 years of age at the time of study enrollment','Patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Parts A & C: patients with recurrent or refractory solid tumors, without central nervous system (CNS) tumors or known CNS metastases, are eligible; note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated\r\n* Part B1: patients with relapsed or refractory neuroblastoma\r\n* Part B2: patients with relapsed or refractory osteosarcoma\r\n* Part B3: patients with relapsed or refractory rhabdomyosarcoma\r\n* Part B4: patients with relapsed or refractory Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET)\r\n* Part B5: patients with relapsed or refractory Hodgkin lymphoma\r\n* Part B6: patients with relapsed or refractory non-Hodgkin lymphoma\r\n* Part B7: patients with unresectable melanoma or metastatic melanoma or relapsed melanoma or refractory melanoma\r\n* Part B8: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without Response Evaluation Criteria in Solid Tumors [RECIST] measurable lesion)\r\n* Once the dose-escalation portion of Part A is completed, cohorts that are open concurrently for eligible patients (including Parts B and C and potential pharmacokinetic [PK] expansion cohorts) may be selected at the treating physician’s discretion pending slot availability; in the event a disease group cohort in Part B is completed after the initial stage of Simon’s optimal two-stage design, for selected disease cohorts, a corresponding cohort in the same disease group for select disease types will be open in Part D:\r\n* Part D1: Patients with relapsed or refractory neuroblastoma\r\n* Part D2: Patients with relapsed or refractory osteosarcoma\r\n* Part D3: Patients with relapsed or refractory rhabdomyosarcoma\r\n* Part D4: Patients with relapsed or refractory Ewing sarcoma or peripheral PNET \r\n* Part D5: Patients with relapsed or refractory non-Hodgkin lymphoma\r\n* Part D6: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without RECIST measurable lesion)','Parts A & C: patients must have either measurable or evaluable disease','Parts B & D: patients must have measurable disease for Parts B1-B6 and D1-D5; melanoma patients in Part B7 must have either measurable or evaluable disease; neuroblastoma patients in Part B8 and D6 must be evaluable for MIBG response without evidence of RECIST measurable lesions','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 60 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): At least 7 days after the last dose of agent\r\n* Interleukins, interferons and cytokines (other than hematopoetic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoetic growth factors)\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* External beam radiation therapy (XRT)/external beam irradiation including protons:  >= 14 days after local XRT; >= 150 days after total body irradiation (TBI), craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation.\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Stem cell infusion (with or without TBI):  \r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 100 days after infusion, no evidence of graft versus host disease (GVHD) and no requirement for immunosuppression\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Patients must not have received prior exposure to nivolumab; for patients enrolled in parts C and D, patients must not have received prior nivolumab or ipilimumab','For patients with solid tumors without known bone marrow involvement:','Peripheral absolute neutrophil count (ANC) >= 750/mm^3','Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity, for Parts A and C; if dose-limiting hematologic toxicity is observed on either Part A or C, all subsequent patients enrolled must be evaluable for hematologic toxicity on that Part','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: maximum serum creatinine (mg/dL) 0.6 for males and females\r\n* Age 2 to < 6 years: 0.8 for males and females\r\n* Age 6 to < 10 years: 1 for males and females\r\n* Age 10 to < 13 years: 1.2 for males and females\r\n* Age 13 to < 16 years: 1.5 for males and 1.4 for females\r\n* Age >= 16 years: 1.7 for males and 1.4 for females','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air','Serum lipase =< ULN at baseline; patients with glucose intolerance should be on a stable regimen and be monitored','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of nivolumab; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of nivolumab','Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid; Note: use of topical or inhaled corticosteroids will not render a patient ineligible','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients with CNS tumors or known CNS metastases will be excluded from this trial; patients with a history of CNS metastases that have been previously treated may enroll if sequential imaging shows not evidence for active disease; patients with extra axial disease (e.g. skull [bone] metastasis that do not invade the dura) may enroll if there is no evidence for CNS edema associated with the lesion','Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody [ANA], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder','Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility','Patients who have an uncontrolled infection are not eligible','Patients with a history of congestive heart failure (CHF) or are at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs must have adequate cardiac function as clinically indicated:\r\n* Corrected QT interval (QTC) =< 480 msec\r\n* Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by gated radionuclide study','Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded','Patients who have received prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients who have received prior anti-PD1 directed therapy (monoclonal antibody [mAb] or small molecule) are not eligible','Parts C and D: patients who have received prior ipilimumab are not eligible'
NCT02166463,https://www.clinicaltrials.gov/ct2/show/record/NCT02166463?term=NCT02166463&rank=1,'Patients with newly diagnosed, pathologically confirmed cHL meeting one of the following Ann Arbor stages are eligible:\r\n* Stage IIB with bulk\r\n* Stage IIIB\r\n* Stage IVA\r\n* Stage IVB\r\n** If study eligibility by staging is uncertain, consultation with Imaging and Radiation Oncology Core (IROC) Rhode Island (RI) may be obtained prior to study enrollment','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 2 to < 6 years: male 0.8 mg/dL, female 0.8 mg/dL\r\n* 6 to < 10 years: male 1 mg/dL, female 1 mg/dL\r\n* 10 to < 13 years: male 1.2 mg/dL, female 1.2 mg/dL\r\n* 13 to < 16 years: male 1.5 mg/dL, female 1.4 mg/dL\r\n* >= 16 years: male 1.7 mg/dL, female 1.4 mg/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine transaminase [ALT]) < 2.5 x upper limit of normal (ULN) for age','Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram','Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin lymphoma (HL)','For children who are unable to cooperate for PFTs, the criteria are: no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry reading of > 92% on room air','Patients with nodular lymphocyte-predominant HL','Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible','Patients who are pregnant; (a negative pregnancy test is required for female patients of childbearing potential)','Lactating females who plan to breastfeed','Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 30 days after the last dose of chemotherapy','Patients known to be positive for human immunodeficiency virus (HIV) are not eligible','Patients who have received any previous chemotherapy or radiation therapy are not eligible','Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02180867,https://www.clinicaltrials.gov/ct2/show/record/NCT02180867?term=NCT02180867&rank=1,'Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:\r\n* Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials\r\n* Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and\r\n* Medically deemed able or unable to undergo chemotherapy\r\n* Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis','ELIGIBLE SITES:\r\n* Extremities: upper (including shoulder) and lower (including hip)\r\n* Trunk: body wall','INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis','ELIGIBILITY FOR CHEMOTHERAPY COHORT:','Stage T2a/b (> 5 cm) and grade 2 or 3 AND','One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases):\r\n* Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called “undifferentiated soft tissue sarcoma” or “soft tissue sarcoma not otherwise specified [NOS]”)\r\n* Synovial sarcoma\r\n* Angiosarcoma of soft tissue\r\n* Adult fibrosarcoma\r\n* Mesenchymal (extraskeletal) chondrosarcoma\r\n* Leiomyosarcoma\r\n* Liposarcoma (excluding myxoid liposarcoma)\r\n* Undifferentiated pleomorphic sarcoma\r\n* Embryonal sarcoma of the liver','Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort','Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort:\r\n* Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called “undifferentiated soft tissue sarcoma” or “soft tissue sarcoma NOS”) in patients < 30 years of age\r\n* Synovial sarcoma\r\n* Embryonal sarcoma of the liver','ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:','Patients with any size of grade 2 or 3 of the following “intermediate (rarely metastasizing)” or “malignant” tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort:\r\n* So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues\r\n* Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma\r\n* Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor\r\n* Chondro-osseous tumors - extraskeletal osteosarcoma\r\n* Pericytic (perivascular) tumors - malignant glomus tumor\r\n* Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor\r\n* Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma','Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study','Extent of disease:\r\n* Patients with non-metastatic and metastatic disease are eligible\r\n* Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor','Sufficient tissue and blood must be available to submit for required biology studies','Lansky performance status score >= 70 for patients =< 16 years of age','Karnofsky performance status score >= 70 for patients > 16 years of age','Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility','Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility','Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows:\r\n* 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female\r\n* 6 to < 10 years; 1 mg/dL male; 1 mg/dL female\r\n* 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female\r\n* 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female\r\n* >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age','Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram','Corrected QT interval (QTc) < 480 msec','No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination','Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible','Patient must have a life expectancy of at least 3 months with appropriate therapy','Patients with grade 1 NRSTS tumors of any size are not eligible','Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement','Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible)','Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible','Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:\r\n* Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication\r\n* Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication','Prior Therapy:\r\n* Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy\r\n* Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)\r\n* Patients must have had no prior radiotherapy to tumor-involved sites\r\n* Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded','Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors','CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted','CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible','CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John’s wort are not eligible (with the exception of glucocorticoids)','Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible','Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:\r\n* Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills\r\n* Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel\r\n* Active peptic ulcer disease\r\n* Malabsorption syndrome','Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesions\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal conditions which increase the risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment','Subjects with any of the following cardiovascular conditions within the past 6 months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible','History of serious or non-healing wound, ulcer, or bone fracture','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients who are unable to swallow whole tablets are not eligible','Patients with a body surface area < 0.5 m^2 are not eligible','Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible','Patients who are receiving any other investigational agent(s)','Pregnancy and breast feeding:\r\n* Female patients who are pregnant are ineligible\r\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment\r\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02196181,https://www.clinicaltrials.gov/ct2/show/record/NCT02196181?term=NCT02196181&rank=1,'Patients must have histologically or cytologically confirmed stage IV or unresectable stage III BRAF V600E or BRAF V600K mutant melanoma','Patients must have BRAF V600E or BRAF V600K mutation identified by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; acceptable analytic techniques include but are not restricted to deoxyribonucleic acid (DNA) sequencing, pyrosequencing, polymerase chain reaction (PCR), melting point assays, and immunohistochemistry','Contrast-enhanced computed tomography (CT) scans of the neck, chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the neck, chest, abdomen and pelvis; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)','Patients must not have received a prior BRAF or mitogen-activated protein kinase kinase (MEK) inhibitor','Patients must not have brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 7 days prior to registration','Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registration','Patients must not have received any major surgery or immunotherapy within 28 days prior to registration','Patients must not have any unresolved toxicity greater than National Cancer Institute (NCI)-CTCAE version (v) 4.0 grade 1 from previous anti-cancer therapy except alopecia within 7 days prior to registration','Absolute neutrophil count (ANC) >= 1,200/ul','Platelets >= 100,000/ul','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)','Serum albumin >= 2.5 g/dL','Serum creatinine =< 1.5 x mg/dL OR measured or calculated creatinine clearance >= 50 mL/min; creatinine measurements must be obtained within 28 days prior to registration','Patients must have lactate dehydrogenase (LDH) obtained within 28 days prior to registration in order to obtain baseline stratification information','Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA) within 28 days prior to registration','Patients must have corrected QT (QTc) =< 480 msec by electrocardiogram (ECG) (corrected using the Bazett’s formula) within 28 days prior to registration','Patients with known history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible:\r\n* History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)\r\n* Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:\r\n** Evidence of new optic disc cupping\r\n** Evidence of new visual field defects\r\n** Intraocular pressure > 21 mmHg\r\n* NOTE: ophthalmic exam is required for all patients; exam must be obtained within 28 days prior to registration','Patients must be able to take oral medications; patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of protocol treatment (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)','Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range','Patients must not have a history of pneumonitis or interstitial lung disease','Patients must not have any grade II/III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; patients with a history of atrial fibrillation must have atrial fibrillation controlled for at least 30 days prior to registration','Patients with known hepatitis B or hepatitis C are not eligible, regardless of concomitant antiretroviral therapy or current viral load','Patients with known human immunodeficiency virus (HIV) may be eligible providing they meet the following additional criteria:\r\n* Cluster of differentiation (CD)4 cells >= 500/uL\r\n* Serum HIV viral load of < 25,000 IU/ml\r\n* No current antiretroviral therapy\r\n** Tests must be obtained within 28 days prior to registration; patients who are HIV positive (+) and do not meet all of these criteria are not eligible for this study (HIV/hepatitis testing are not required for patients without known infection)','Prestudy history and physical must be obtained with 28 days prior to registration','Patients must have dermatology exam obtained within 28 days prior to registration to obtain baseline measurement; exam to be performed by treating physician or designated dermatologist','Patients must have Zubrod performance status of 0, 1 or 2','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; exception: patients with known history of colon cancer, cancer of the pancreas, or any cancer known to harbor an activating retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) mutation are ineligible regardless of stage or time since diagnosis','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; hormonal contraception is not allowed','Patients must be offered the opportunity to participate in specimen banking','Patients with cutaneous or superficial lesions that do not require imaging guidance for biopsy must be willing to undergo biopsies for tissue submission and blood draws for translational medicine','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','STEP 2: RANDOMIZATION','After completing one cycle of therapy, patients will be registered for randomization between intermittent and continuous dosing, provided that they were eligible for the initial step 1 registration and satisfy the following criteria','Patients must not have unequivocal disease progression (by RECIST v1.1) during the first cycle; patients must have disease assessed using the same method as baseline within +/- 5 days of the day 56 scheduled assessment (between days 51-55 of cycle 1, or days 1-5 of cycle 2); all disease must be assessed and documented on the follow-up tumor assessment form (RECIST 1.1)','Patients must be registered to step 2: randomization within +/- 5 days of starting cycle 2; patients MUST NOT be registered prior to the day 56 disease assessment'
NCT02270450,https://www.clinicaltrials.gov/ct2/show/record/NCT02270450?term=NCT02270450&rank=1,'Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:\r\n* Clinical evidence of a small bowel obstruction (via history, physical, and radiographic examination)\r\n* Bowel obstruction below (distal to) ligament of Treitz\r\n* Intra-abdominal primary cancer with incurable disease','Patients must have malignant bowel obstruction due to an intra-abdominal primary cancer (i.e. gastrointestinal [GI], pancreas, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal stromal tumor [GIST] [all sites], and sarcoma); patients may still have primary tumor as long as it is not a primary large bowel obstruction from colorectal cancer','Patient must be able to tolerate a major surgical procedure based on clinical evaluation, status of their cancer, and any other underlying medical problems','A member of the patient’s surgical team must indicate equipoise for the benefit of the surgical treatment for MBO; the surgeon must respond “Yes” to each of the following questions and sign the S1316 Surgical Equipoise Documentation form for the patient to be eligible:\r\n* Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?\r\n* Do you have equipoise? if the treating team finds that an operation is required (e.g., for acute abdomen), or they would not offer the patient an operation (e.g., patient is too weak to tolerate surgery), then there is no equipoise','Patients must not have signs of bowel perforation necessitating surgery or “acute” abdomen evidenced by peritonitis on physical exam within 2 days prior to registration','Patients must be registered to the study within 3 working days after being seen by surgical team for MBO or within 3 working days after completion of indicated treatment (e.g. total parenteral nutrition [TPN], anticoagulation reversal) to make them eligible for surgical intervention, whichever is later, and prior to any treatment (surgical or non-surgical) for MBO; treatment is defined as any medication or invasive interventions beyond nasogastric decompression, hydration, pain medications or antiemetic medications; NOTE: somatostatin analogues may be used prior to registration if that use is limited to not more than the two days just prior to registration','Radiographic confirmation of MBO is required prior to registration; scans may have been done before or after admission; scans done prior to admission must have been completed within 14 days prior to admission; computed tomography (CT) scans are preferred','Patients must have Zubrod performance status of 0-2 within 7 days prior to hospitalization','Serum albumin must be planned to be collected after admission, but prior to treatment','Patients must be able to complete the study questionnaires in English or Spanish','Prestudy history and physical must be obtained within 3 days prior to registration','Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','Patients must consent and provide both their contact information and that of their representative for a monthly 24-hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab'
NCT02201992,https://www.clinicaltrials.gov/ct2/show/record/NCT02201992?term=NCT02201992&rank=1,'Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed','Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization','Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5’ and 3’ ALK probes or the loss of the 5’ probe; this must have been performed:\r\n* By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR\r\n* Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)','Women must not be pregnant or breast-feeding','All females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception','Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','No known interstitial fibrosis or interstitial lung disease','No prior treatment with crizotinib or another ALK inhibitor','No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec','No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined','Patients must be adequately recovered from surgery at the time of randomization','The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)','The maximum time requirement between surgery and randomization must be:\r\n* 3 months (90 days) if no adjuvant chemotherapy was administered\r\n* 8 months (240 days) if adjuvant chemotherapy was administered\r\n* 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered','Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization\r\n* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study\r\n* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted','Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)','Total serum bilirubin =< 1.5 x ULN','Absolute neutrophil count (ANC) >= 1500/mm^3','Platelets >= 30,000/mm^3','Hemoglobin >= 8.0 g/dL','Serum creatinine =< 2 x ULN','Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined','Patients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years','Patients may not be receiving any other investigational agents while on study'
NCT02193282,https://www.clinicaltrials.gov/ct2/show/record/NCT02193282?term=NCT02193282&rank=1,'Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:\r\na) Patient registered to A151216 and the assessment performed centrally by the protocol-specified laboratory\r\nb) By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results\r\n* Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible\r\n* Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105','Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer','Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered','Eastern Cooperative Oncology Group (ECOG) performance status 0-1','No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration','Non-pregnant and non-lactating','No history of cornea abnormalities','Granulocytes >= 1,500/ul','Platelets >= 100,000/ul','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN','Serum creatinine =< 1.5 x ULN'
NCT02375204,https://www.clinicaltrials.gov/ct2/show/record/NCT02375204?term=NCT02375204&rank=1,'Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment; tumor may have originated in any primary site\r\n* NOTE: in rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established; this would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels [HCG >= 500; AFP >= 500] and typical pattern of metastases)','Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:\r\n* Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed); in the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study\r\n* Consecutive elevated serum tumor markers (HCG or AFP) that are increasing; increase of an elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease\r\n* Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase','Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy; prior cisplatin, vincristine, methotrexate, bleomycin, actinomycin D, cyclophosphamide, etoposide (POMBACE), carboplatin, bleomycin, vincristine, and cisplatin-bleomycin, etoposide, and cisplatin (CBOP-BEP), or methotrexate, actinomycin-D, etoposide, cisplatin, peg filgrastim (GAMEC) are allowed; Note: for patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed (including TI or TIP); therefore, these patients may have received 7 prior cycles of chemotherapy; 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy','No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy)\r\n* Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens; for example, a patient could have received 2 cycles of bleomycin, etoposide, and cisplatin (BEP) followed by 2 cycles of cisplatin, ifosfamide, and etoposide (VIP) if the switch from BEP to VIP was made due to pulmonary toxicity rather than disease progression; this would be considered 1 line of prior therapy; in addition, if a patient received 4 cycles of BEP and then underwent post-chemotherapy resection of residual tumor with findings of residual viable non-teratomatous GCT, and subsequently received 2 additional cycles of adjuvant chemotherapy (etoposide, cisplatin [EP] or an alternate regimen such as VIP) in the absence of disease progression, this would also be considered 1 regimen; however, if any change in therapy is prompted by tumor progression including rising tumor markers, this is considered to represent 2 lines of prior treatment\r\n* Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy)\r\n* Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse; patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy','No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue)','No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process; only one cycle is allowed','No concurrent treatment with other cytotoxic drugs or targeted therapies','No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy','No previous chemotherapy within 16 days prior to enrollment except for bleomycin which cannot have been given within 5 days prior to enrollment','Must have adequate recovery from prior surgery (e.g., healed scar, resumption of diet, etc.)','Age >= 14 years (>= 18 years in Germany)','Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Calculated (calc.) creatinine clearance >= 50 mL/min\r\n* Estimated creatinine clearance for patients >= 18 years old will be estimated by the Jelliffe equation modified for body surface area (BSA); patients with creatinine clearance estimated > 70ml/min by this formula are eligible; if the creatinine clearance estimated by the Jelliffe method is >= 50 mL/min but =< 70 mL/min, then a second method to confirm a creatinine clearance of >= 50 mL/min is required; methods of estimating glomerular filtration rate (GFR) that can be used for this confirmation consist of a 12 or 24-hour urine creatinine clearance or a nuclear creatinine clearance test; if the confirmatory creatinine clearance is < 50 mL/min, then the patient is not eligible; if the confirmatory creatinine clearance is >= 50 mL/min, the patient is eligible; if the cause of the patient’s renal dysfunction is tumor obstructing the ureters, then eligibility can be determined by the study chair even if it does not meet these minimal requirements; for patients < 18 years old, it is strongly suggested that a radioisotope estimation of GFR be obtained; if a radioisotope test is not possible, an estimated creatinine clearance using either a 12 or 24 hour urine creatinine clearance or the Schwartz formula can be used; patients will be considered eligible if the creatinine clearance is > 70 mL/min; if the creatinine clearance estimated by the Schwartz formula or urine creatinine clearance is >= 50 mL/min but =< 70 mL/min, then a second method to confirm a creatinine clearance of >= 50 mL/min is required; methods of estimating GFR that can be used for this confirmation consist of a 12- or 24-hour urine creatinine clearance if the Schwartz formula or radioisotope method was used as the primary method or a radioisotope estimation of GFR if the Schwartz formula or urine creatinine clearance method was used as the primary method; if the confirmatory creatinine clearance is < 50 mL/min, then the patient is not eligible; if the confirmatory creatinine clearance is >= 50 mL/min, the patient is eligible','Bilirubin =< 2.0 x upper limits of normal (ULN)','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 upper limits of normal (ULN)\r\n* Unless due to hepatic metastases in which case levels =< 5 x ULN are allowed','No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pT in situ [is]) transitional cell carcinoma (TCC) of the bladder, contralateral GCT, or intratubular germ cell neoplasia; patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed','Negative serology (antibody test) for the following infectious diseases:\r\n* Human immunodeficiency virus (HIV) type 1 and 2\r\n* Human T-cell leukemia virus (HTLV) type 1 and 2 (mandatory in United States [US] but optional in Canada and Europe)\r\n* Hepatitis B surface antigen\r\n* Hepatitis C antibody','No late relapse with completely surgically resectable disease; patients with late relapses (defined as relapse >= 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible; patients with late relapses who have unresectable disease are eligible','No large (>= 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery); treatment may begin >= 7 days after completion of local treatment; patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated; radiation therapy should not be given concurrently with high-dose carboplatin or etoposide','No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression'
NCT02224781,https://www.clinicaltrials.gov/ct2/show/record/NCT02224781?term=NCT02224781&rank=1,'STEP 1','Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1','Women must not be pregnant or breast-feeding\r\n* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for at least 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 7 months after the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Patients must have unresectable stage III or stage IV disease','Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization','Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive\r\n* NOTE: Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial; patients with uveal melanoma are not eligible for this trial','Patients must have BRAF V600 mutation, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)','Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease','Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to entering the study and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from registration and patients must be fully recovered from post-surgical complications','Patients must not receive any other investigational agents while on study or within four weeks prior to registration','Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) could be eligible; patients must not have taken any steroids =< 10 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible','Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility','White blood count >= 3,000/uL, obtained within 4 weeks prior to randomization','Absolute neutrophil count (ANC) >= 1,500/uL, obtained within 4 weeks prior to randomization','Platelet count >= 100,000/uL, obtained within 4 weeks prior to randomization','Hemoglobin > 9 g/dL, obtained within 4 weeks prior to randomization','Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min, obtained within 4 weeks prior to randomization','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases)','Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)','Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome, obtained within 4 weeks prior to randomization','Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to have aggressive disease and should be considered for BRAF inhibitor therapy off protocol), obtained within 4 weeks prior to randomization','Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency','Patients must not have a history of or evidence of cardiovascular risks including any of the following:\r\n* QT interval corrected for heart rate using the Bazett’s formula (QTcB) >= 480 msec. at baseline\r\n* History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration\r\n* History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multi gated acquisition scan (MUGA)\r\n* Intra-cardiac defibrillator\r\n* History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy','Individuals who are known to be human immunodeficiency virus (HIV) infected are eligible (note: HIV testing is not required for entry into the study)','Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV) infection are not eligible; patients with cleared HBV and HCV infection will be allowed','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible','The following medications or non-drug therapies are also prohibited while on treatment in this study:\r\n* Other anti-cancer therapies\r\n* Other investigational drugs\r\n* Patients taking any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible','Patients must not have history of retinal vein occlusion (RVO)','Patients must not have evidence of interstitial lung disease or pneumonitis','Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib','STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)','The patient must have met all eligibility criteria (except as detailed below) at the time of crossover\r\n* RECIST defined measurable disease is not required\r\n* Only prior systemic therapy as part of step 1 is allowed; patients who received allowed systemic therapy in the adjuvant setting prior to Step 1 and were eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other eligibility criteria\r\n* Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment\r\n* History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy\r\n* Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who underwent surgery or SRS to CNS metastases need not be off of steroids to start treatment \r\n* There is no restriction on serum LDH at crossover\r\n* Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover','Patients must have melanoma that is metastatic and clearly progressive on prior therapy','Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration','Patients must have recovered from adverse events (toxicities resolved to grade 1 or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step 2 even if still on steroids to control side effects, so long as toxicity has resolved to grade 1 or less','Patients must have discontinued radiation therapy prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications','Patients are ineligible if they have any currently active CNS metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) could be eligible to proceed; patients crossing over from dabrafenib/trametinib to nivolumab (nivo)/ipilimumab (ipi) must not have taken any steroids =< 10 days prior to registration for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases are ineligible','Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast'
NCT02203526,https://www.clinicaltrials.gov/ct2/show/record/NCT02203526?term=NCT02203526&rank=1,'Patients must have histologically or cytologically confirmed primary central nervous system diffuse large B-cell lymphoma; only patients with relapsed or refractory disease are eligible; patients with PCNSL that is only extracranial will not be eligible','At least 2 weeks have passed since prior chemotherapy, biological therapy, radiation therapy, major surgery, other investigational or anti-cancer therapy that is considered disease-directed','Ibrutinib must be discontinued 7 days before (when possible) until 7 days after major surgery, and 3 days before (when possible) until 3 days after minor surgery; thus, patients to be enrolled on an ibrutinib trial must have completed major surgery > 7 days before initiating treatment, and/or must have completed minor surgery > 3 days before initiating treatment','Recovered from prior toxicities to grade 0-1 at least 2 weeks prior to investigational therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) unless due to neurologic deficits caused by CNS lymphoma with the following exceptions: patients with ECOG performance status (PS) = 4 where neurologic deficits are unlikely to resolve with tumor resolution and may cause clinical management problems are excluded','Patients must have normal organ and marrow function as defined below, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated granulocyte-colony stimulating factor (G-CSF) (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening and randomization','Absolute neutrophil count >= 750 cells/mcL (0.75 x 10^9/L)','Platelets >= 50,000 cells/mcL (50 x 10^9/L)','Hemoglobin > 8.0 g/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN','Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 40 ml/min/1.73 m^2 unless lymphoma related','Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be < 1.5 x the upper limit of the normal range (ULN); except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulant','Left ventricular ejection fraction (LVEF) > 40% as assessed by echocardiogram or multi gated acquisition scan (MUGA)','Women of reproductive potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry','Female patients who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) must have a negative serum pregnancy test upon study entry','Male and female patients must agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug','Patient or appointed surrogate decision-maker or legally authorized representative must have ability to understand the purpose and risks of the study and willingness to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)','Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment','Prior exposure to a Bruton agammaglobulinemia tyrosine-protein kinase (BTK) inhibitor','History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study','Patients who are allergic to micafungin and/or voriconazole or any of their ingredients','Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor with the exception of voriconazole, which will be specifically studied in this protocol','Human immunodeficiency virus (HIV) positive patients will be excluded','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or an infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of study drug','Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ibrutinib','Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenic purpura (ITP) resulting in (or as evidenced by) declining platelet or hemoglobin (Hgb) levels within the 4 weeks prior to first dose of study drug','Presence of transfusion-dependent thrombocytopenia','History of prior malignancy, with the exception of the following:','Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician','Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease','Adequately treated carcinoma in situ without current evidence of disease','Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study','Unable to swallow capsules, or disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction','Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded)','History of stroke or intracranial hemorrhage within 6 months prior to enrollment','Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue risk; patients with suspicious radiologic evidence of aspergillosis infection (i.e., chest computed tomography [CT] and/or brain magnetic resonance imaging [MRI]) will not be eligible unless confirmatory laboratory testing of beta-D glucan and aspergillus antigen are negative','Concomitant use of warfarin or other vitamin K antagonists within the last 28 days','Concurrent systemic immunosuppressant therapy other than corticosteroids (e.g., cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drug','Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug','Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia','Known bleeding disorders (e.g., von Willebrand’s disease) or hemophilia','Major surgery within 4 weeks of first dose of study drug','Unwilling or unable to participate in all required study evaluations and procedures','Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification'
NCT02364557,https://www.clinicaltrials.gov/ct2/show/record/NCT02364557?term=NCT02364557&rank=1,'Pathologically confirmed metastatic breast cancer','Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis','Number of allowable metastases:\r\n* =< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:\r\n** Peripheral lung \r\n** Osseous (bone)\r\n** Spine\r\n** Central lung\r\n** Abdominal-pelvic metastases (lymph node/adrenal gland)\r\n* =< 2 metastases seen on standard imaging within 60 days prior to registration when any one metastasis is located in one of the following sites:  \r\n** Liver\r\n** Mediastinal/cervical lymph node','All known disease amenable to metastasis-directed therapy with either SBRT or resection\r\n* NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered\r\n* NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites\r\n* NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy','Maximum diameter of individual metastasis in any dimension =< 5 cm','For patients who have ONLY peripheral lung, osseous spinal abdominal-pelvic, and/or central lung metastasis: there are no restrictions on distance between the metastases; for patients with any other combination of the seven allowable metastatic sites: metastases must be > 5 cm away from each other (defined as Edge to Edge of tumor)\r\n* NOTE: If metastases are =< 5 cm away from each other, consider enrollment in NRG-BR001','Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)','The primary tumor site must be controlled prior to registration\r\n* For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration\r\n* The definition of control is definitive surgery (+/- radiotherapy) for the primary tumor','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 60 days prior to registration\r\n* Computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration','Zubrod performance status =< 2 within 60 days prior to registration','Absolute neutrophil count (ANC) >= 500 cells/mm^3','Platelets >= 50,000 cells/mm^3','Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration','The patient must provide study-specific informed consent prior to study entry','Pathologic evidence of local/regional breast tumor recurrence','Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years','Metastases with indistinct borders making targeting not feasible\r\n* NOTE: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician’s judgment will be required','Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)','Metastases located within 3 cm of the previously irradiated structures:\r\n* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)\r\n* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)\r\n* Brainstem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Whole lung previously irradiated with prior V20Gy > 30% (delivered in =< 3 Gy/fraction)\r\n* Primary tumor irradiated with SBRT\r\n* Metastasis irradiated with SBRT','Brain metastases','Exudative, bloody, or cytological proven malignant effusions','Severe, active co-morbidity defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration','Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible','Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol'
NCT02445391,https://www.clinicaltrials.gov/ct2/show/record/NCT02445391?term=NCT02445391&rank=1,'ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening','Female and male patients must have histologically confirmed invasive breast cancer that meets the following criteria:\r\n* Clinical stage II-III (American Joint Committee on Cancer [AJCC] 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed\r\n* ER- and PR- should meet one of the following criteria:\r\n** =< 10% cells stain positive, with weak intensity score (equivalent to Allred score =< 3)\r\n** =< 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score =< 3)\r\n* HER2 negative (not eligible for anti-HER2 therapy) will be defined as:\r\n** Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR\r\n** IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR\r\n** ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC\r\n** NOTE: patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol; multifocal or multicentric breast cancers are eligible as long as all tumors fulfill eligibility criteria\r\n** NOTE: patients that have a discrepancy in ER/PR/HER2 status between original diagnosis and surgical specimen (only applicable if ER/PR/HER2 status were repeated; repeating it is not mandatory) are not eligible for study participation (i.e. ER/PR/HER2 has to fulfill above criteria in both scenarios)','Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen\r\n* NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll\r\n* NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician','Must have completed definitive resection of primary tumor\r\n* Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible\r\n* Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable\r\n* Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory','Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination; please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure >= 1 cm in diameter; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis\r\n* NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast\r\n* NOTE: Despite lymph node involvement if residual invasive cancer in the breast is < 1 cm in diameter patients are not eligible for participation','Radiotherapy may be given before or after protocol treatment per standard of care guidelines; when radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation\r\n* Post-mastectomy radiotherapy is required for all patients with the following:\r\n** Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of lymph nodes at the time of definitive surgery\r\n** For patients with primary tumors < 5 cm or without lymph node involvement prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician\r\n** Radiation of regional nodal basins is at the discretion of the treating radiation oncologist\r\n* NOTE: Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy','Hemoglobin (Hgb) > 9.0 g/dL, must be obtained within 8 weeks prior to screening for protocol therapy','Platelets > 100,000 mm^3, must be obtained within 8 weeks prior to screening for protocol therapy','Absolute neutrophil count (ANC) > 1500 mm^3, must be obtained within 8 weeks prior to screening for protocol therapy','Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula, must be obtained within 8 weeks prior to screening for protocol therapy','Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL), must be obtained within 8 weeks prior to screening for protocol therapy','Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x upper limit of normal (ULN), must be obtained within 8 weeks prior to screening for protocol therapy','Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN, must be obtained within 8 weeks prior to screening for protocol therapy','No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort','No clinically significant infections as judged by the treating investigator','Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible','Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate or denosumab use is allowed','Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification\r\n* Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery\r\n* The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution\r\n* NOTE: Tissue must and can be submitted any time during screening period, even if patient is getting radiation\r\n* NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between registration and randomization needs to be observed, as long as:\r\n* Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date\r\n* Randomization occurs no more than 24 weeks from surgery date','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast resected at the time of definitive surgery completed','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Radiotherapy may be given before or after protocol treatment. when radiotherapy is planned prior to protocol treatment administration, patients must have completed adjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, if applicable','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgery','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100,000 mm^3','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) > 1500 mm^3','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR) =< 3 (to be done/tested only for subjects on warfarin)','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5 x ULN','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5 x ULN'
NCT02243605,https://www.clinicaltrials.gov/ct2/show/record/NCT02243605?term=NCT02243605&rank=1,'Young patient age between 12 – 15 could be included in only 6 centers (Bordeaux, Lyon, Villejuif, Lille, Marseille and Paris)','Patients must have histologically confirmed diagnosis of osteosarcoma or Ewing sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Tissus Mous et des Viscères) network','Relapsed disease after standard chemotherapy','Patients must have measurable disease (lesion in previously irradiated field could be considered as measurable if progressive at inclusion) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with spiral computed tomography (CT) scan','Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL','Lymphocyte count > 1,000/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal','Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (Cockcroft formula)','Hemoglobin >= 9 g/dL','Serum albumin >= 2.8 g/dL','Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis','Urine protein/creatinine ratio (UPCR) =< 1','Serum phosphorus >= lower limit of normal (LLN)','Serum calcium >= LLN','Serum magnesium >= LLN','Serum potassium >= LLN','Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons','Women of child-bearing potential and men must agree to use adequate contraception (see below) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of cabozantinib administration\r\n* Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)','Metastatic or unresectable locally advanced','Documented disease progression (as per RECIST v1.1) before study entry; for patients with osteosarcoma, this progression will be confirmed by central review on the basis of two CT scan or magnetic resonance imaging (MRI) obtained at less than 6 months in the period of 12 months prior to inclusion','Ability to understand and the willingness to sign a written informed consent document','In accordance with French Regulatory Authorities: Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees)','The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment','Prior treatment with cabozantinib','Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible','Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment; note: subjects with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents','The subject has received any other type of investigational agent within 28 days before the first dose of study treatment','The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)','The subject has a primary brain tumor','Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment','The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment','The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted','The subject requires chronic concomitant treatment of strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort)\r\n* it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians’ Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','The subject has experienced any of the following:\r\n* Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment','The subject has radiographic evidence of cavitating pulmonary lesion(s)','The subject has tumor in contact with, invading or encasing any major blood vessels','The subject has evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib','The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\r\n* Cardiovascular disorders including:\r\n** Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n** Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n** Any history of congenital long QT syndrome\r\n** Any of the following within 6 months before the first dose of study treatment:\r\n*** Unstable angina pectoris\r\n*** Clinically-significant cardiac arrhythmias\r\n*** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n*** Myocardial infarction\r\n*** Thromboembolic event requiring therapeutic anticoagulation (note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)\r\n* Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n** Any of the following within 28 days before the first dose of study treatment\r\n*** Intra-abdominal tumor/metastases invading GI mucosa\r\n*** Any evidence of active peptic ulcer disease, patients must be completely recovered\r\n*** Any evidence of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, patients must be completely recovered from these conditions\r\n*** Malabsorption syndrome\r\n** Any of the following within 6 months before the first dose of study treatment:\r\n*** Abdominal fistula\r\n*** Gastrointestinal perforation\r\n*** Bowel obstruction or gastric outlet obstruction\r\n*** Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment\r\n* Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy \r\n* Other clinically significant disorders such as:\r\n** Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n** Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n** History of organ transplant\r\n** Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n** History of major surgery as follows:\r\n*** Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment\r\n*** Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible','The subject is unable to swallow tablets','The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before treatment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard','The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee','The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Participation to a study involving a medical or therapeutic intervention in the last 30 days','Prior participation in this study'
NCT02298959,https://www.clinicaltrials.gov/ct2/show/record/NCT02298959?term=NCT02298959&rank=1,'In dose escalation, patients must have histologically or cytologically confirmed metastatic disease from any solid tumor; in dose expansion, patients must have histologically or cytologically confirmed metastatic melanoma, renal cell carcinoma, ovarian cancer, or colorectal cancer','Renal cell patients must have had at least one prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)','Ovarian cancer patients must be resistant to platinum therapy; therapy (i.e. within 6 months of last platinum therapy); patients who received greater than two prior platinum containing regimens will not be eligible','Patients with colorectal cancer should have failed at least one oxaliplatin-containing regimen','No more than two prior therapies for metastatic disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Estimated life expectancy of greater than 6 months','Leukocytes >= 2,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL OR >= 5.6 mmol/L','Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN','Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional ULN OR =< 5 X ULN for patients with liver metastases','Serum creatinine =< 1.5 X ULN or measured or calculated creatinine clearance (CrCl) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl); creatinine clearance should be calculated per institutional standard','International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy not requiring laboratory monitoring as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants; therapeutic Coumadin is not acceptable','Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants','Urine protein-creatinine ratio (UPCR) =< 1 on spot urinalysis or protein =< 500 mg/24 hour urine','Archival tissue must be available or newly obtained core or excisional biopsy of a tumor lesion','Patients must have measurable disease based on RECIST 1.1','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patients should continue contraceptive measures for 6 months from the last dose of all study medications','Female patients of childbearing potential should have a negative urine or serum pregnancy test within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required','Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year','Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK 3475 and ziv-aflibercept administrations','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\r\n* Note: patients with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study\r\n* Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy','Patients who are currently participating in or have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment','Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment','Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier','Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy','Lesions suspected to be at higher-risk for bleeding such as bowel involvement with tumor that invades into the bowel wall or involves the intraluminal component of bowel by imaging or direct visualization or central pulmonary lesions','Ulcerated skin lesions','Full anti-coagulant therapy Coumadin; patients may be receiving therapeutic Lovenox, Fragmin, or other heparin product that does not require laboratory monitoring','Poorly-controlled hypertension as defined blood pressure (BP) > 150/100 mmHg, or systolic (S) BP > 180 mmHg when diastolic (D) BP < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment','Pregnant or nursing women','Patients with known brain metastases should be excluded from this clinical trial','Patients with carcinomatous meningitis should also be excluded','Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 3 months prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 and ziv-aflibercept','Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study','Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator','Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial','Has received prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-cluster of differentiation 137 (CD137), ziv-aflibercept or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)(prior treatment with bevacizumab is not an exclusion criteria)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','If pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-3475','Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit 1 throughout the study period up to 120 days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); patients should continue contraceptive measures for 6 months from the last dose of all study medications','Patients who are human immunodeficiency virus (HIV) positive may participate if they meet the following eligibility requirements:\r\n* They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective\r\n* They must have a cluster of differentiation (CD)4 count of greater than 250 cells/mcL\r\n* They must not be receiving prophylactic therapy for an opportunistic infection','Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)','Has received a live vaccine within 30 days prior to the first dose of trial treatment','History within 6 months prior to treatment of myocardial infarction, severe/unstable angina pectoris, coronary artery bypass graft (CABG), New York Heart Association (NYHA) class III or IV congestive heart failure (CHF), stroke or transient ischemic attack (TIA)','History within 3 months prior to treatment of grade 3-4 gastrointestinal (GI) bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolus, or other uncontrolled thromboembolic event','Patients who are less than 4 weeks post-operative (op) after major surgery'
NCT02575794,https://www.clinicaltrials.gov/ct2/show/record/NCT02575794?term=NCT02575794&rank=1,'Patients must have histologically confirmed supratentorial high grade glioma (grade III or IV glioma) that is progressive or recurrent following radiation therapy and chemotherapy; patients with grade IV glioma must have progressed or recurred after initial treatment with radiation and temozolomide; patients with grade III glioma must have received at least radiation and one regimen of chemotherapy (temozolomide or procarbazine, lomustine, vincristine [PCV] regimen)','Patients must have measurable contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to undergo MRI of the brain with gadolinium','Patients may have had treatment for an unlimited number of prior relapses','Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Patients must have a life expectancy of at least 8 weeks','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must be able to provide written informed consent','Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Patients must be able to swallow oral medications','Part 2 (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:\r\n* Expectation that the surgeon is able to resect at least 100 mg of tumor from enhancing tumor and at least 100 mg from non-enhancing tumor with low risk of inducing neurological injury','Patients receiving any other investigational agents are ineligible','Patient must not have known sensitivity to terameprocol or any formulation excipients','Patients must not have known impaired cardiac function or clinically significant cardiac disease','Patients must not be on any anticoagulation','Patients on any moderate or strong cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) inducer (e.g., carbamazepine, rifampin) or inhibitor (e.g., amiodarone, fluconazole) are ineligible; CYP2C9 poor metabolizers will not be excluded','Patients on narrow-therapeutic drugs that are substrates for cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), CYP2C9, cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, phenytoin, pimozide, quinidine, sirolimus, tacrolimus, theophylline, tizanidine, warfarin)','Patient must not have prior gastrointestinal (GI) surgery or GI disease that might interfere with the absorption of terameprocol','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with terameprocol','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT02437851,https://www.clinicaltrials.gov/ct2/show/record/NCT02437851?term=NCT02437851&rank=1,'A single, biopsy-proven SISCCA as defined by the LAST criteria (=< 3 mm depth of invasion, horizontal spread of =< 7 mm, and completely excised with at least 1 mm margin clear of cancer irrespective of the amount of HSIL) documented per investigator assessment in combination with the pathology report within 16 weeks before Segment B enrollment','No evidence of any lymph node spread or distant metastases as determined by positron emission tomography (PET) computed tomography (CT) imaging within 16 weeks of enrollment; alternatively, for those without PET CT capability, a magnetic resonance imaging (MRI) or CT of the abdomen and pelvis and a chest x-ray confirming no evidence of metastatic disease is acceptable','Clinician believes that eradication of concomitant HSIL is reasonable and feasible based on the extent of disease and overall medical condition of the participant','HIV positive; documentation of HIV-1 infection by means of any one of the following:\r\n* Documentation of HIV diagnosis in the medical record by a licensed health care provider;\r\n* Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (documentation may be a record of an ART prescription in the participant’s medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant’s name; receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis [PrEP] regimen alone [e.g., Truvada], which is exclusionary);\r\n* HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL\r\n* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay\r\n** NOTE: A “licensed” assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies','For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to enrollment for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to enrollment','Prior to Segment B enrollment, participants on combination anti-retroviral therapy (cART) will be required to have a minimum CD4 count of >= 200 and participants not on cART will be required to have a minimum CD4 count of >= 350 to be eligible for the study; participants not currently on cART who have a CD4 count >= 200 and who agree to start cART immediately will be eligible for participation; laboratory data should be obtained within 16 weeks prior to Segment B enrollment','Participants must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status of 50% or greater)','Participants must have a life expectancy of 2 years or more','Participants must not have any other concurrent malignancy','Participants must have organ and marrow function within the following parameters within 16 weeks before Segment B enrollment:','Leukocytes: >= 3,000/mm^3','Absolute neutrophil count: >= 1,500/mm^3','Platelets: >= 100,000/mm^3','Women of childbearing potential (FCBP)* must have a negative urine pregnancy test within 7 days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator\r\n* A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment','Participants must be able to understand and willing to sign a written informed consent document','Participants must, in the opinion of the investigator, be capable of complying with the requirements of this protocol','Anal cancer that cannot be completely excised with a >= 1 mm clear margin from surrounding tissue or where excision to obtain a clear margin would compromise sphincter function or anal canal diameter','The participant’s SISCCA must not have been ablated','Concurrent anal canal or perianal HSIL or condyloma that in the judgment of the clinician cannot be cleared or can only be cleared with undue morbidity to the participant','No prior history of anal cancer, including SISCCA','Ongoing use of anticoagulant therapy other than aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be stopped for surgical procedures','Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 2 weeks before Segment B enrollment','Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL; Note: Kaposi’s sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy','Participants who are receiving any other investigational agents within 4 weeks prior to enrollment; investigational antiretroviral agents for HIV are acceptable','Participant plans to relocate away from the study site during study participation'
NCT02275533,https://www.clinicaltrials.gov/ct2/show/record/NCT02275533?term=NCT02275533&rank=1,'AML patients in first complete remission (CR) (CR1) or first complete remission with incomplete blood count recovery (CRi) after induction and consolidation chemotherapy; except young (< 60 years) AML patients in European LeukemiaNet favorable group; (the current trial will exclude young favorable group AML patients), patients could receive any cycle consolidation or no consolidation per the discretion by the treating physician','Within 60 days after bone marrow biopsy confirmed remission after the patients recover from their last course of chemotherapy, the goal will be to consent the eligible patient prior to the remission confirmation bone marrow biopsy at the end of the planned chemotherapy); ideally, the research samples will be collected during the bone marrow biopsy, and the patient will be enrolled to the study within 2 weeks of the bone marrow biopsy; if there is delay to enroll the patient after the bone marrow biopsy and research sample collection, it is ok not to repeat bone marrow biopsy within 4 weeks, after the last bone marrow biopsy, if there is no sign of disease relapse; a repeat bone marrow biopsy should be done if the delay of enrollment is more than 4 weeks after the last bone marrow biopsy; patients with confirmed remission within 60 days after the last bone marrow biopsy, without research samples collection, should have a repeat bone marrow biopsy conducted within two weeks prior to enrolling on the study','Patient is not a candidate for stem cell transplant due to advanced age or co-morbidities; or the enrollee does not have donor available; or the enrollee declines stem cell transplant due to personal belief; or stem cell transplant is not standard of care based on the risk category of disease','Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0 or 1 (Karnofsky >= 70%)','Life expectancy of greater than 6 months','Leukocytes >= 1,500/mcL','Absolute neutrophil count >= 1,000/mcL','Platelets >= 50,000/mcL or recovery to the baseline count','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN','Amylase and lipase =< 1.5 x ULN without any symptoms of pancreatitis','Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)','Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception','Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL','WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product','Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients should be excluded if they have had prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways','Patients with known central nervous system (CNS) involvement may be excluded; however, if CNS disease is cleared before the treatment with nivolumab, patients could be allowed if no permanent CNS damage','History of severe hypersensitivity reaction to any monoclonal antibody','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab','Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) might be enrolled if the viral load by PCR is undetectable with/without active treatment and absolute lymphocyte count >= 350/ul','Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment','Patients with active autoimmune disease or history of autoimmune disease that might recur should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis should be evaluated for the potential need for additional treatment before coming on study'
NCT02281760,https://www.clinicaltrials.gov/ct2/show/record/NCT02281760?term=NCT02281760&rank=1,'All patients will be previously or simultaneously enrolled in the natural history ECD protocol #11-HG-0207, “Clinical and Basic Investigations into Erdheim Chester disease”; eligible patients must have been diagnosed with Erdheim Chester disease, confirmed by pathological evaluation of the affected tissue with adequate staining; affected tissue must harbor the BRAF V600E or V600K mutation','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, MRI, or calipers by clinical exam','Prior treatment, involving interferon, anakinra, imatinib, steroids, chemotherapy with, but not limited to cladribine, vinblastine, 6-mercaptopurine and etoposide, or other medications used empirically for the treatment of ECD, will be acceptable; these therapies should have been completed and discontinued 4 weeks or more prior to enrollment in this study','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n* Exception will be made for patients with ECOG performance status =< 3 and Karnofsky performance scale >= 50%, who require the use of wheelchairs, walkers or canes as well as assistance with daily routines secondary to disabilities caused by ECD cerebellar or brain disease that has been stable for >= 3 months','Life expectancy of greater than 3 months','Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels','Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Amendments (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)','Absolute neutrophil count (ANC) >= 1.2 x 10^9/L','Hemoglobin >= 9 g/dL','Platelets >= 100 x 10^9/L','Albumin >= 2.5 g/dL','Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization','Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO)','Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration or randomization','Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed) for the duration of study participation, and for at least 2 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency','Ability to understand and the willingness to sign a written informed consent document','Inability to provide informed consent','Prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study; patients that have used other BRAF or mitogen-activated protein kinase kinase (MEK) inhibitor are excluded','Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded','Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomization','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)','Presence of malignancy other than the study indication under this trial within 3 years of study enrollment','Patients with history of rat sarcoma (RAS) mutation-positive tumors are not eligible regardless of interval from the current study; Note: RAS testing and absence of RAS mutation are required for eligibility','Leptomeningeal or brain metastases or metastases causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks','History or evidence of cardiovascular risks, except stable ECD cardiac lesion, including any of the following:\r\n* QT interval corrected for heart rate using the Bazett’s formula (QTcB) >= 480 msec\r\n* History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to randomization\r\n* History or evidence of current class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Intra-cardiac defibrillators\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy','Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO)','Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures','Pregnant women are excluded from this study; breastfeeding should be discontinued prior to treatment with dabrafenib/trametinib','History of retinal vein occlusion (RVO)','Interstitial lung disease or pneumonitis not secondary to ECD','Central serous retinopathy (CSR) including presence of predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes); or visible pathology (e.g., evidence of optic disc cupping, evidence of new visual field defects on automated perimetry, or intraocular pressure > 21 mmHg as measured by tonography) as assessed by ophthalmic examination','Inability to travel to the National Institutes of Health (NIH) Clinical Center','Patients with wild type BRAF gene molecular results on ECD affected tissue','Patients with confirmed diagnosis of ECD that are asymptomatic and with no visceral involvement are not eligible for this trial (patients with no target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)'
NCT02339740,https://www.clinicaltrials.gov/ct2/show/record/NCT02339740?term=NCT02339740&rank=1,'Patients must be newly diagnosed with a clinical diagnosis of APL (initially by morphology of bone marrow or peripheral blood)\r\n* Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted','If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible','NOTE: A lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma; if CNS disease is documented, patients are still eligible and will receive protocol directed intrathecal treatments','Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy','Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommended','Patients with secondary APL are excluded; this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation)','Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded','Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected QT interval [QTc] is normal at the time of APL diagnosis) are excluded','Patients with a baseline QTc of > 450 msec are excluded; Bazett’s formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)','Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded','Patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded','Patients with serum creatinine > 3.0 mg/dL and patients on active dialysis for renal dysfunction are excluded','Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded','Female patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential','Lactating females who plan to breastfeed their infants are excluded','Sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02412670,https://www.clinicaltrials.gov/ct2/show/record/NCT02412670?term=NCT02412670&rank=1,'Patients must have high grade upper tract urothelial carcinoma proven by one of the following:\r\n* Biopsy;\r\n* Urinary cytology with a 3-dimensional upper urinary tract mass on cross-sectional imaging; or\r\n* Urinary cytology and a mass visualized during upper urinary tract endoscopy','Patients must have a creatinine clearance >= 30 ml/min within 28 days of registration to be eligible for the study; this will be determined by Cockroft-Gault calculation and 24-hour urine creatinine clearance measurement (please note, renal function, measured by 24-hour urine creatinine clearance in screening and post operatively, are required)','Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','Patients must have no evidence of metastatic disease or clinically enlarged lymph nodes on computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis and CT chest obtained within 28 days of registration (a negative biopsy is required for lymph nodes >= 1 cm in size to confirm lack of involvement); patients with lymph nodes >= 1 cm in whom a biopsy is deemed not feasible are not eligible; patients with elevated alkaline phosphatase or suspicious bone pain should also undergo baseline bone scans to evaluate for bone metastasis','Patients with any component of small cell carcinoma are not eligible; other variant histologies are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma','Patients must not have peripheral neuropathy > grade 2','Patients must not have a history of allergy or hypersensitivity to methotrexate, vinblastine, doxorubicin (doxorubicin hydrochloride), cisplatin, gemcitabine (gemcitabine hydrochloride), carboplatin or filgrastim or pegfilgrastim','Patients must have a left ventricular ejection fraction (LVEF) >= 50% by (either multigated acquisition [MUGA] or 2-dimensional [2-D] echocardiogram) within 28 days of registration','Absolute neutrophil count (ANC) >= 1500/mm^3','Platelets >= 100,000/mm^3','Hemoglobin (HgB) >= 9','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2 X institutional upper limit of normal (ULN)','Total bilirubin within institutional normal limits (or < 2.5 X the ULN for patients with Gilbert’s disease)','Patients with concomitant primaries of the bladder/urethra are allowed, as long as these sites are surgically resected and non-invasive cancers (< cT1N0)','Patients must not have another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer; patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment','For patients who have creatinine clearance that meets > 50 ml/min they must not have received prior systemic doxorubicin','Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction in last 3 months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible','Patients who are known to have human immunodeficiency virus (HIV) or are on combination antiretroviral therapy are ineligible','Patients must have no prior radiation therapy to >= 25% of the bone marrow for prior systemic anthracycline therapy; prior intravesical anthracycline therapy for non-muscle invasive urothelial carcinoma of the bladder is permitted','Patients may have a history of resectable urothelial cancer (including neoadjuvant chemotherapy) as long as patients meet one of the following:\r\n* pT0, Tis, or T1N0 and have no evidence of disease (NED) for more than 2 years from surgery or chemotherapy;\r\n* pT2-3aN0 and NED for more than 3 years from surgery or chemotherapy; or\r\n* > pT3b, or N+ and NED for more than 5 years from surgery or chemotherapy','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study'
NCT02496208,https://www.clinicaltrials.gov/ct2/show/record/NCT02496208?term=NCT02496208&rank=1,'Patients in the phase I portion must have:\r\n* Histologically confirmed diagnosis of metastatic, genitourinary solid tumor\r\n* Metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least:\r\n** One evaluable site of disease \r\n** Or, appearance of one new bone lesion','Patients in the expansion portion must have:\r\n* Histologically confirmed diagnosis of metastatic:\r\n** Urothelial carcinoma of the bladder, urethra, ureter, renal pelvis, OR\r\n** Clear cell renal cell carcinoma OR\r\n** Adenocarcinoma of the bladder OR\r\n** Non-resectable squamous cell carcinoma of the penis OR\r\n** Squamous cell carcinoma of the bladder AND\r\n* Patients with urothelial cancer or renal cell carcinoma must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least:\r\n** One measurable site of disease (according to RECIST criteria) or bone disease by NaF PET/CT','Patients must have either progressed on least one standard therapy or there must be no standard treatment exists that has been shown to prolong survival for the patient’s disease; patients may have received any number of prior cytotoxic agents','Karnofsky performance status >= 70%','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,200/mcL','Platelets >= 75,000/mcL','Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal (ULN)','Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] equation or Cockroft-Gault formula) for patients with creatinine levels above institutional normal','Hemoglobin >= 9 g/dL','Serum albumin >= 2.8 g/dL','Lipase and amylase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis','Urine protein/creatinine ratio (UPCR) =< 2','Serum phosphorus >= lower limit of normal (LLN) (if below LLN, for asymptomatic patients replacement may be initiated if clinically indicated without delaying the start of study treatment)','Serum calcium >= LLN (if below LLN, for asymptomatic patients replacement may be initiated if clinically indicated without delaying the start of study treatment)','Serum magnesium >= LLN (if below LLN, for asymptomatic patients replacement may be initiated if clinically indicated without delaying the start of study treatment)','Serum potassium >= LLN (if below LLN, for asymptomatic patients replacement may be initiated if clinically indicated without delaying the start of study treatment)','Women of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 12 consecutive months; Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason','Women of child-bearing potential and men must agree to use adequate contraception, as defined below, prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 31 weeks after completion of all study medications; women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 23 weeks after completion of all study medications','Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 23 or 31 weeks for women or men respectively, after the last dose of study drugs, even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 23 or 31 weeks for women and men respectively after the last dose of study drugs','Tissue availability for programmed cell death ligand 1 (PD-L1) expression is mandatory for enrollment; however if archived tissue is unavailable the patient will be given the option to consent to pre and post treatment tissue biopsies; tissue biopsies will be collected pretreatment (prior to the first dose of therapy) and post treatment (after at least 1 dose, preferably 2 doses of nivolumab)','Ability to understand and the willingness to sign a written informed consent document','The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment','Patients who have been previously treated with MET or vascular endothelial growth factor receptor (VEGFR) inhibitors (except for patients on renal cell cancer [RCC] cohort) are not eligible for the expansion cohorts but can enroll in the phase I portion','Prior treatment with any therapy on the programmed cell death 1 (PD-1)/PD-L1 axis or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors unless enrolling the urothelial carcinoma with previous checkpoint inhibition therapy expansion cohort','The subject has received radiation therapy:\r\n* To the thoracic cavity or abdomen within 3 months before the first dose of study treatment, or has ongoing complications, or is without complete recovery and healing from prior radiation therapy\r\n* To bone or brain metastasis within 3 weeks before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatment','The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment','The subject has received prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment','The subject has received prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate','The subject has received any other type of investigational agent within 28 days before the first dose of study treatment','The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae','The subject has active brain metastases or epidural disease; subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging (MRI) scans for subjects with known brain metastases is required to confirm eligibility','The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.5 x the laboratory ULN within 7 days before the first dose of study treatment','The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, thrombin or factor Xa inhibitors; aspirin (up to 325 mg/day), low-dose warfarin (=< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted','The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort)','The subject has experienced any of the following:\r\n* Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\r\n* Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment','The subject has tumor invading any major blood vessels','The subject has evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib','The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:','Cardiovascular disorders including:\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n* The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard\r\n* Any history of congenital long QT syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Unstable angina pectoris\r\n** Clinically-significant cardiac arrhythmias\r\n** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n** Myocardial infarction\r\n** Cardiomyopathy','Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following that have not resolved within 28 days before the first dose of study treatment\r\n** Intra-abdominal tumor/metastases invading GI mucosa\r\n** Active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment','Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy','Other clinically significant disorders such as:\r\n* Severe active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid stimulating hormone [TSH], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and Mediport placement\r\n* In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery','The subject is unable to swallow tablets','History of severe hypersensitivity reaction to any monoclonal antibody','The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee','For disease specific studies: the subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib','Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), cluster of differentiation (CD)4 counts are greater than 350 and viral load is undetectable','Patients are excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study'
NCT02306161,https://www.clinicaltrials.gov/ct2/show/record/NCT02306161?term=NCT02306161&rank=1,'Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site','For the purpose of this study metastatic disease is defined as one or more of the following:\r\n* Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor; skip lesions in the same bone as the primary tumor do not constitute metastatic disease; skip lesions in an adjacent bone are considered bone metastases; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed\r\n* Contralateral pleural effusion and/or contralateral pleural nodules\r\n* Distant lymph node involvement\r\n* Patients with pulmonary nodules are considered to have metastatic disease if the patient has:\r\n** Solitary nodule >= 0.5 cm or multiple nodules of >= 0.3 cm unless lesion is biopsied and negative for tumor\r\n** Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor\r\n* Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on hematoxylin and eosin (H&E) stains; in the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study\r\n** This study requires bilateral bone marrow biopsies at study entry; the suggested approach for patients with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy)\r\n* Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or computed tomography (CT) (whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole body technetium bone scans may be performed at the discretion of the investigator and are not required; for patients without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry','Patients must have adequate tumor tissue to meet the minimum requirement for submission','Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required','Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females\r\n* Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and females\r\n* Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females\r\n* Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females\r\n* Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females\r\n* Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females\r\n* Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for females\r\n* Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for females','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)','Shortening fraction of >= 27% or','Ejection fraction of >= 50%','Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw','Patients with regional node involvement as their only site of disease beyond the primary tumor will not be eligible','Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and spinal cord) are not eligible','Patients who have received prior chemotherapy or radiation therapy are not eligible','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy','Patients with known pre-existing diabetes mellitus will be excluded from study','Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02428192,https://www.clinicaltrials.gov/ct2/show/record/NCT02428192?term=NCT02428192&rank=1,'Patients must have histologically or cytologically confirmed advanced leiomyosarcoma of the uterus (ULMS); advanced ULMS is defined as metastatic ULMS or unresectable primary ULMS','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients must have received at least one prior line of chemotherapy, for ULMS (either in the adjuvant or metastatic setting)','Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1','Life expectancy of greater than 9 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN/ =< 5 x ULN for subjects with liver metastases','Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)','Patients with a requirement for steroid treatment or other immunosuppressive treatment: patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease','Women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 31 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','For enrollment in the first stage of Cohort B, patients must have accessible pre-treatment and post-treatment (4-6 weeks) tumor for biopsy','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier; patients who have had prior pelvic radiation may be at increased risk for bowel perforation, and therefore may not have residual inflammatory disease of the bowel or residual bowel toxicity based on baseline imaging and clinical assessment; palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion\r\n* Bowel toxicity is not expected from the target field due to increased risk of perforation','Patients who are receiving any other investigational agents','Patients are excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-ligand 2 (L2), anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways','Active brain metastasis or leptomeningeal disease; patients with known brain metastases are allowed if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 12 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration','History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab','History of severe hypersensitivity reaction to any monoclonal antibody','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab','Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) or if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, fistula and abdominal carcinomatosis should be evaluated for the potential need for additional treatment before coming on study'
NCT02438722,https://www.clinicaltrials.gov/ct2/show/record/NCT02438722?term=NCT02438722&rank=1,'Patients must have histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 7th Edition) or recurrent non-small cell lung cancer (NSCLC)','Patients must have documented presence of an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation; T790M mutation or other molecular abnormality will be allowed as long as it accompanies one of the mutations listed above; EGFR testing must be performed using a Food and Drug Administration (FDA)-approved test or in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.','Patients must have tissue available and must agree to submission of tissue and blood; one to two paraffin-embedded tissue blocks or 15-20 unstained slides are requested (a minimum of 12 slides is required); cytology (i.e. fine-needle aspirations, pleural effusion specimens) is acceptable if a cell block or sufficient unstained slides are available; tumor material must be reviewed by a local pathologist who must confirm that at least 100 viable tumor cells are present in the sample and sign the S1403 Pathology Review Form prior to registration; patients must also be willing to submit blood samples for correlative research at baseline, during treatment and at progression','Patients enrolled at sites participating in the Repeat Biopsy Study must agree to submission of tissue obtained by a repeat biopsy performed at the time of disease progression','Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, afatinib, or any experimental EGFR tyrosine kinase inhibitors [TKI] agents); prior chemotherapy for non-metastatic disease (i.e. adjuvant therapy or concurrent chemo-radiotherapy) is allowed as long as > 12 months has passed since completion of therapy; adjuvant EGFR-directed therapy is not allowed; local therapy (i.e. palliative radiotherapy) is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of registration','Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; laboratory parameters are not acceptable as the only evidence of disease; in order to qualify as measurable, measurable disease must be outside previous radiation field; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)','Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have symptomatic brain metastases or evidence of leptomeningeal carcinomatosis; patients with asymptomatic brain metastases are eligible if off of steroids for at least 7 days prior to registration without development of symptoms','Patients must not have any known clinically active interstitial lung disease','Obtained within 28 days prior to registration: Absolute neutrophil count (ANC) >= 1,500/mcL','Obtained within 28 days prior to registration: Platelets >= 75,000/mcL','Obtained within 28 days prior to registration: Hemoglobin >= 9 g/dL','Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)','Obtained within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases)','Obtained within 28 days prior to registration: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 60 mL/min','Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn’s disease, malabsorption, etc)','Patients must be able to swallow medication by oral route','Patients must not have a history of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia or myocardial infarction within 6 months prior to registration; if clinically indicated, echocardiogram or multigated acquisition (MUGA) must be performed and cardiac ejection fraction must be >= 50%','Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment; tumor biopsy is allowed','Patients must not have a known history of active hepatitis B infection (defined as presence of hepatitis B surface antigen [Hep B sAg] and/ or Hep B deoxyribonucleic acid [DNA]), active hepatitis C infection (defined as presence of hepatitis C [Hep C] ribonucleic acid [RNA]) and/or known human immunodeficiency virus (HIV) seropositive','Patients must not have any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug','Patients must not be planning to receive any other investigational agents during the course of protocol treatment','Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to afatinib and/or cetuximab','Prestudy history and physical must be obtained with 28 days prior to registration','Patients must have Zubrod performance status of 0 - 2','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02323880,https://www.clinicaltrials.gov/ct2/show/record/NCT02323880?term=NCT02323880&rank=1,'Patients must have a body surface area (BSA) >= 0.84 m^2','Diagnosis: \r\n* Part A: Patients with recurrent or refractory solid tumors, including lymphoma and CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\r\n* Part B: Patients with recurrent or refractory high grade glioma (World Health Organization [WHO] grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma [DIPG]), not requiring surgical resection; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Part C: Patients with recurrent or refractory high grade glioma (WHO grade III/IV) and requiring surgical resection (excluding DIPG and disseminated tumors), who in the opinion of treating physicians, are medically stable to receive 3-4 doses of selinexor (8-10 days of treatment) before undergoing surgery without compromising the success of the procedure; note that if, in the opinion of treating physicians, current symptoms necessitate surgery before 3-4 doses will be able to be received, surgery should not be delayed to administer selinexor, and the patient would be ineligible for protocol therapy','Disease status:\r\n* Part A: Patients must have either measurable or evaluable disease\r\n* Parts B and C: Patients must have measurable disease on imaging','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* External beam radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to selinexor','For patients with solid tumors without known bone marrow involvement:','* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3','* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','* Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)','Patients with known bone marrow metastatic disease will be eligible for study if they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* =< 0.6 mg/dL (patients age 1 to < 2 years)\r\n* =< 0.8 mg/dL (patients age 2 to < 6 years)\r\n* =< 1 mg/dL (patients age 6 to < 10 years)\r\n* =< 1.2 mg/dL (patients age 10 to < 13 years)\r\n* =< 1.4 mg/dL (female patients age >= 13 years)\r\n* =< 1.5 mg/dL (male patients age 13 to < 16 years)\r\n* =< 1.7 mg/dL (male patients age >= 16 years)','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN = 150 U/L; for the purpose of this study, the ULN for SGOT is 50 U/L','Serum albumin >= 2 g/dL','Serum amylase =< 1.5 x ULN','Serum lipase =< 1.5 x ULN','Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled','Patients must be able to swallow tablets whole','Part C: Archived paraffin-embedded tissue (20 unstained slides or a tumor block) from a prior resection must be available as a control for correlative studies; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive use two effective methods of birth control- including a medically accepted barrier method of contraceptive method (e.g., male or female condom) for the entire period in which they are receiving protocol therapy; abstinence is an acceptable method of birth control','Concomitant medications\r\n* Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid \r\n* Investigational drugs: Patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients with body mass index (BMI) < 3rd percentile for age, as defined by WHO criteria for patients 1-2 years of age and Centers for Disease Control and Prevention (CDC) criteria for patients > 2 years of age, are not eligible','Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder are not eligible','Patients with known macular degeneration, uncontrolled glaucoma, or cataracts are not eligible'
NCT02063828,https://www.clinicaltrials.gov/ct2/show/record/NCT02063828?term=NCT02063828&rank=1,'Past history of any lung cancer','For stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease','For stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease','After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible:\r\n* Score >= 8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)-Anxiety/Depression Scale OR\r\n* Score >= 4 on the Distress Thermometer OR\r\n* Score > 5 on the Modified Cancer Acceptance Scale','Eastern Cooperative Oncology Group performance status 0-2','Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks','Must have telephone','Patient does not understand English','Active lung infection','Progressive cancer (must be considered no evidence of disease or stable)','Any change in psychotropic medications in past 30 days','Hearing loss that would preclude participating in interventions; adequate hearing to participate will be determined via: (1) response of “no” to the question [“Do you have a hearing problem now?”]; participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices; if necessary, potential study participants will receive a brief test trial with the RESPeRATE device; if they indicate inability to hear the guiding tones, they will not be enrolled in the study','CORTISOL EXCLUSION: Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted)'
NCT02498600,https://www.clinicaltrials.gov/ct2/show/record/NCT02498600?term=NCT02498600&rank=1,'Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer with documented disease progression (disease not amendable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report; NOTE: patients with mucinous histology are NOT eligible; patients with carcinosarcoma histology are NOT eligible','All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI','Patients must have at least one “target” lesion to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy','Appropriate for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Further protocol-specific assessments:\r\n** Recovery from effects of recent surgery, radiotherapy or chemotherapy\r\n** Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\r\n** Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n** Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C) \r\n** Any prior radiation therapy must be completed at least 4 weeks prior to registration\r\n** At least 4 weeks must have elapsed since major surgery','Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer; they must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment; patients are allowed to have received, but are not required to have received, one to two cytotoxic regimens for management of recurrent or persistent disease; (for the purposes of this study poly adenosine diphosphate [ADP] ribose polymerase [PARP] inhibitors given for recurrent or progressive disease will be considered cytotoxic; PARP inhibitors given as maintenance therapy in continuation with management of primary disease will not be considered as a separate cytotoxic regimen); if two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent','Performance status of 0, 1 or 2 within 28 days prior to registration','Absolute neutrophil count (ANC) >= 1,500/ul','Platelets >= 100,000/ul','Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN)','Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3.0 mg/dL is acceptable','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN','Albumin >= 2.8 g/dL','Adequate thyroid function within 28 days prior to registration defined as serum thyroid-stimulating hormone (TSH) in normal range','The patient or a legally authorized representative must provide study-specific informed consent prior to study entry','Platinum-free interval (PFI) - patients must have progressed < 12 months after completion of their last platinum-based chemotherapy; the date (platinum free interval) should be calculated from the last administered dose of platinum therapy to documentation of progression','Adequate oxygen saturation via pulse oximeter within 28 days prior to registration (i.e., patient can NOT have CTCAE hypoxia grade 2 or greater)','Left ventricular ejection fraction (LVEF) >= 50% (measured within 28 days of study entry)','Patients who have had prior therapy with nivolumab or with an anti-programmed cell death (PD)-1, anti-PD-ligand (L)1, anti-PD-L2, anti-cytotoxic T-lymphocyte-antigen (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways','History of severe hypersensitivity reaction to any monoclonal antibody','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy','Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, and the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued; patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease','Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure and unstable angina pectoris','Patients with history of organ transplant','Patients who are pregnant or nursing; women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IV/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab or nivolumab + ipilimumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception; women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL; if, following initiation of the investigational product(s), it is subsequently discovered that a study subject is pregnant or may have been pregnant at the time of investigational product exposure, including during at least 6 half-lives after product administration, the investigational product will be permanently discontinued in an appropriate manner (e.g., dose tapering if necessary for subject safety); the investigator must report this event and any outcomes by amendment through Cancer Therapy Evaluation Program (CTEP)-Adverse Event Reporting System (AERS); protocol-required procedures for study discontinuation and follow-up must be performed on the subject unless contraindicated by pregnancy (e.g., X-ray studies); other appropriate pregnancy follow-up procedures should be considered if indicated; in addition, the investigator must report and follow-up on information regarding the course of the pregnancy, including perinatal and neonatal outcome; infants should be followed for a minimum of 8 weeks','History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (cerebrovascular accident [CVA], stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment','In order for patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen, have cluster of differentiation (CD)4 counts > 350, with no detectable viral load on quantitative polymerase chain reaction (PCR)','Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Any of the following within 2 months of registration: active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption syndrome; any of the following within 6 months of registration: intra-abdominal abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition, gastrointestinal perforation; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration','No planned concomitant, non-protocol directed anti-cancer therapy','Grade >= 2 peripheral neuropathy'
NCT02317874,https://www.clinicaltrials.gov/ct2/show/record/NCT02317874?term=NCT02317874&rank=1,'Patients must have histologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective, and for which: a) there is reasonable expectation of response to the combination of carboplatin/paclitaxel OR b) breast cancer (BRCA) 1/2 germline mutation is present; results from Myriad will be acceptable; if testing for BRCA 1 and 2 germline mutations is done through another organization, a report from a genetics consult with a qualified medical professional confirming that the laboratory results show a recognized germline deleterious BRCA 1 or 2 mutation or rearrangement is required; if the latter cannot be obtained, principal investigator (PI) or study chair review of the lab results and confirmation of BRCA mutation or rearrangement will be required OR c) BRCA 1/2 somatic mutation previously identified using a Clinical Laboratory Improvement Amendments (CLIA) certified assay','Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Absolute neutrophil count >= 1,500/mcL','Hemoglobin >= 9 g/dL','Platelets >= 150,000/mcL','Total bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert’s disease','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN; =< 5 x ULN in setting of metastatic liver disease','Creatinine =< 1.5 x upper limit of normal OR creatinine clearance >= 50 mL/min','Ability to take oral medications','Patients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for at least 4 weeks and must be off steroid treatment for 2 weeks prior to study enrollment','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of talazoparib (BMN 673) administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or targeted therapies within 2 weeks prior to entering the study or those who have not recovered (=< grade 1) from adverse events due to agents administered with the exception of any grade of alopecia','No prior carboplatin unless given in neoadjuvant/adjuvant setting for curative intent and more than 6 months have elapsed since last carboplatin dose; in the case of relapsed ovarian cancer, patients are eligible if more than 6 months have elapsed since last carboplatin dose','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to talazoparib (BMN 673) or other agents used in study','Peripheral neuropathy of severity greater than grade 1','The following medications are contraindicated or must be used with caution\r\n* Contraindicated:\r\n** Cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) strong and moderate inhibitors\r\n** CYP2C8 inducers\r\n** Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) strong and moderate inhibitors\r\n** CYP3A4 inducers\r\n** CYP3A4 sensitive substrates\r\n* Exclusions: the following supportive care medications will be allowed will be allowed as they are routinely administered with carboplatin and paclitaxel and have no potential interaction with talazoparib (BMN 673): dexamethasone, aprepitant, fosaprepitant, and ondansetron); oral pain medications such as hydrocodone, oxycodone taken on an as needed basis are also permitted\r\n* Transdermal products designed for systemic delivery must be assessed for interaction potential; topical products not designed to provide systemic delivery (including inhaled products, ophthalmologic products and transvaginal preparations) do not need to be considered\r\n* Other contraindicated medications (per above) are not allowed unless close monitoring with labs or drug levels or by symptoms with subsequent dose adjustments is feasible; patients taking these concurrent medications are ineligible unless they can discontinue or switched to alternative medications prior to initiation of the study drug (at least 5 half-lives)\r\n* Use with caution:\r\n** CYP2C8 sensitive substrates\r\n** CYP2C8 weak inhibitors\r\n** CYP3A4 non-sensitive substrates\r\n** CYP3A4 weak inhibitors\r\n* These agents may be permitted if discontinuation is not feasible and no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels or by symptoms and consider dose adjustments of the medication','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with talazoparib (BMN 673)','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','No clinically significant bleeding (i.e. gastrointestinal [GI] bleed, intracranial bleeding) within 6 months or major surgery within 4 weeks; minor surgeries (i.e. port placement, cataract surgery) are allowed within 2 weeks','Anticoagulation and anti-platelet therapies are not permitted (this includes Coumadin, low molecular weight heparins, factor Xa inhibitors, aspirin and non-steroidal anti-inflammatory drug [NSAIDS] or other medicines with similar effects)'
NCT01885455,https://www.clinicaltrials.gov/ct2/show/record/NCT01885455?term=NCT01885455&rank=1,'STUDY SITE ELIGIBILITY:','On average, cares for at least 3 AA patients with early stage NSCLC per year (based on the last 3 years of cancer registry data)','Has a study site-specific nurse available to act as a PN or has a (study site-specific or shared) nurse available to act as a “clinical consultant” to a study site-specific, non-nurse navigator\r\n* Study sites randomized to the Intervention Arm are not eligible to register subjects (nor administer the protocol intervention), until the site’s identified PN(s) has/have completed the protocol-specific navigation training','STUDY PARTICIPANT ELIGIBLITY:','African American or Black race','Recently diagnosed (i.e., within 70 days of enrollment) with clinically suspicious or biopsy-proven early stage (i.e., stage I-II) NSCLC; the inclusion criteria will be operationalized as follows:\r\n* Recently diagnosed (i.e., within 70 days of definitive tissue biopsy) biopsy-proven NSCLC\r\n* Recently diagnosed (i.e., within 70 days of clinical diagnosis) probable NSCLC where \"probable NSCLC\" is defined as a suspicious lung nodule for which the patient was referred for\r\n** Invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Surgical or radiation oncology consultation and \"date of clinical diagnosis\" is defined as (whichever comes first)\r\n** Date of referral for invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Date of referral for surgical or radiation oncology consultation\r\n* Study sites should enroll patients that meet either of the above inclusion criteria as early as possible during the diagnostic work-up (i.e., if the patient meets the criteria for recently diagnosed, clinically suspicious NSCLC, definitive tissue biopsy is not required for eligibility)','Evaluated/treated for NSCLC at an eligible study site','Ability to understand written and/or spoken English','Access to a telephone','Ability to understand and willingness to sign a written informed consent document','Status post-surgical resection or definitive radiotherapy for recently diagnosed clinically suspicious or biopsy-proven early stage NSCLC','Locally advanced (stage IIIA-IIIB) or metastatic (stage IV) NSCLC','Previous history of lung cancer','Diagnosis of any other invasive cancer (other than non-melanoma skin cancer or carcinoma in situ of the cervix) that requires ongoing treatment or for which there is evidence of active disease','Currently in hospice care'
NCT02337517,https://www.clinicaltrials.gov/ct2/show/record/NCT02337517?term=NCT02337517&rank=1,'Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 50,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine =< 1.5 mg/dl OR creatinine clearance >= 55 mL/min using the Cockcroft-Gault equation for patients with creatinine levels above 1.5 mg/dl','Patients with chronic GVHD diagnosed within 3 years after hematopoietic stem cell transplant (HSCT) for any disease, with any graft, and any conditioning regimen with at least one manifestation secondary to fibrosis, including: sclerodermatous skin changes, dry mouth, dry eye, esophageal strictures, or vaginal GVHD','Failure to respond to corticosteroids, defined as:\r\n* Progression of chronic GVHD despite optimal first line therapy (> 0.5 mg/kg/day of prednisone dose equivalent [PDE] for two weeks) or\r\n* No improvement after 4-8 weeks of sustained therapy; sustained therapy should include 2 weeks of > 0.5 mg/kg/day of PDE or\r\n* Inability to taper steroid dosage to less than 0.5 mg/kg/day of PDE without worsening of chronic GVHD or \r\n* Need for second or third line therapy beyond corticosteroids and calcineurin inhibitors or sirolimus, irrespective of other criteria','Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 24 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 7 days prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient’s use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient’s understanding of GDC-0449 cause serious or life-threatening birth defects; patients must continue highly effective contraception during therapy and for 24 months after the last dose of GDC-0449\r\n* Women of childbearing potential are defined as follows:\r\n** Patients with regular menses\r\n** Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Women who have had a tubal ligation\r\n* Women are considered not to be of childbearing potential for the following reasons:\r\n** The patient has undergone hysterectomy and/or bilateral oophorectomy\r\n** The patient is post-menopausal defined by amenorrhea for at least 12 months in a woman > 45 years old\r\n* Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with GDC-0449 and for 3 months after the last dose to avoid exposing an embryo or fetus to GDC-0449','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are eligible provided that they meet the following criteria in addition to the other protocol criteria: \r\n* Cancer as the only acquired immunodeficiency syndrome (AIDS)-defining condition\r\n* Cluster of differentiation (CD)4 cell count >= 250\r\n* Treatment sensitive HIV and prospects for long term survival on the basis of HIV disease alone\r\n* Willing to take anti-HIV therapy that will have minimal potential for pharmacokinetic interactions with GDC-0449','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449','Patients receiving any medications or substances that are strong inducers/inhibitors or substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), CYP2C8, or CYP2C19 are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow capsules','Patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis are ineligible','Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with GDC-0449','More than 2 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus','Relapsed malignancy after transplantation'
NCT02339571,https://www.clinicaltrials.gov/ct2/show/record/NCT02339571?term=NCT02339571&rank=1,'Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1','Patients must have known v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutational status of tumor; wild-type (WT) or mutated, prior to randomization','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for at least one week prior to the start of the research study, and continuing for 5 months for women of childbearing potential and 7 months for sexually active males after the last dose of the study drugs','Patients must have unresectable stage III or stage IV melanoma; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive','Patients must have measurable disease per RECIST 1.1 criteria; all sites of disease must be evaluated within 4 weeks prior to randomization','Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or mitogen-activated protein kinase [MEK] agents); patients may have had prior anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment; patients may not have had any prior programmed cell death (PD)-1/PD-ligand (PD-L)1 agent in the adjuvant setting','Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting','Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to randomization and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from randomization and patients must be fully recovered from post-surgical complications','Patients must not receive any other investigational agents while on study or within four weeks prior to randomization','Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab; NOTE: Patients are permitted to receive the seasonal influenza vaccine; if seasonal influenza vaccine is considered, killed vaccines should be recommended','Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks prior to randomization are eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible','Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of randomization','White blood count >= 3,000/uL','Absolute neutrophil count (ANC) >= 1,500/uL','Platelet count >= 100,000/uL','Hemoglobin >= 9 g/dL','Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases)','Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)','Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome','Serum lactate dehydrogenase (LDH) =< 10 X ULN','Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consent','Patients with human immunodeficiency virus (HIV) infection are ineligible','Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are not eligible; patients with cleared HBV and HCV (0 viral load) infection will be allowed','Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study','Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis); other CNS autoimmune disease (e.g., multiple sclerosis)','Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible','Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)','Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics'
NCT02360215,https://www.clinicaltrials.gov/ct2/show/record/NCT02360215?term=NCT02360215&rank=1,'PRIOR TO STEP 1 REGISTRATION:','Brain metastases outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to Step 1 registration; an allowed exception, regarding ability to image brain metastases, would be that patients who had undergone radiosurgery or surgical resection and are planning adjuvant WBRT do not have to have visible disease but do need a pre-surgery MRI or computed tomography (CT) scan demonstrating brain metastases; however, the brain metastases could not have been within 5 mm of either hippocampus','Patients must have a post-gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2/FLAIR sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; this MRI must be obtained =< 21 days prior to step 1 registration','Patients must provide study-specific informed consent prior to registration','PRIOR TO STEP 2 REGISTRATION:','The following baseline neurocognitive assessments must be completed prior to Step 2 registration: HVLT-R, TMT, and COWA; the neurocognitive assessment will be uploaded into the NRG RAVE System for evaluation by Dr. Wefel; once the upload is complete, within one business day a notification will be sent to proceed to Step 2; NOTE: completed baseline neurocognitive assessments can be uploaded at the time of Step 1 registration','Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years prior to Step 2 registration; if the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)','History and physical examination within 28 days prior to Step 2 registration','Karnofsky performance status of >= 70 within 28 days prior to Step 2 registration','Serum creatinine =< 3 mg/dL (265 umol/L) and creatinine clearance >= 30 ml/min','Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg/dL, then BUN up to 30 mg/dL is permitted)','Patients may have had prior therapy for brain metastasis, including radiosurgery and surgical resection; patients must have completed prior therapy by at least 14 days prior to Step 2 for surgical resection and 7 days for radiosurgery','Negative serum pregnancy test (in women of childbearing potential) =< 14 days prior to Step 2; women of childbearing potential and men who are sexually active must practice adequate contraception while on study','Patients who are primary English or French speakers are eligible','Prior external beam radiation therapy to the brain or whole brain radiation therapy\r\n* Prior single-fraction or fractionated radiosurgery is permitted','Planned cytotoxic chemotherapy during the WBRT only; patients may have had prior chemotherapy','Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt','Severe, active co-morbidity defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration\r\n* Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease\r\n* Renal tubular acidosis or metabolic acidosis\r\n* Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; Note also that HIV testing is not required for eligibility for this protocol','Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','Prior allergic reaction to memantine (memantine hydrochloride)','Current alcohol or drug abuse (may exacerbate lethargy/dizziness with memantine)','Intractable seizures while on adequate anticonvulsant therapy—more than 1 seizure per month for the past 2 months','Patients with definitive leptomeningeal metastases','Patients with brain metastases from primary germ cell tumors, small cell carcinoma, unknown primary, or lymphoma','Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies','Contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function','Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan'
NCT02799485,https://www.clinicaltrials.gov/ct2/show/record/NCT02799485?term=NCT02799485&rank=1,'Participants may be treatment naive, refractory to or intolerant of one or more prior therapies, or treated with prior systemic treatment including but not limited to liposomal doxorubicin','Participants must have biopsy-proven KS involving skin with or without visceral involvement','If HIV-positive, any cluster of differentiation (CD)4 count will be allowed on study','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky performance score (KPS) >= 50%','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/mcL*\r\n* Participants may be receiving growth factor support to meet these criteria','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN','Creatinine within normal institutional limit for the reference lab OR creatinine clearance >= 60 mL/min/1.73 m^2 as calculated by Cockcroft-Gault formula for participants with creatinine levels above institutional normal','Participants must have cutaneous lesion(s) amenable to four (4) 5-mm tumor biopsies during the study (either 4 separate lesions measuring >= 5 mm each OR 2 separate lesions measuring >= 10 mm each) and at least five additional lesions measurable for assessment with no improvement over the past month','Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to enrollment and again within 24 hours prior to starting cycle 1 of sEphB4-HSA; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME during receipt of sEphB4-HSA, and 12 weeks after discontinuation of sEphB4-HSA; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Documentation of HIV status; if participant is HIV positive, HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA] test kit, and confirmed by Western blot or other approved test, or HIV rapid multispot antibody differentiation assay); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection\r\n* If the participant is HIV negative, documentation of a negative result for any federally approved, licensed HIV rapid test within 4 weeks prior to study enrollment will suffice; if the initial rapid test is positive, further approved confirmatory test results must be present to document the subject’s HIV status','If participant is HIV positive, participants must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment','There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment','Participants must, in the opinion of the investigator, be capable of complying with the protocol','Inability to understand and inability to provide informed consent','Participants who are receiving any other investigational agents','Participants who have had anti-neoplastic treatment for KS (including chemotherapy, radiotherapy, local treatment including topical fluorouracil [5-FU], biological therapy or investigational therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study OR those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Participants with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to sEphB4-HSA or other agents used in study','Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment','Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status)','Concurrent neoplasia requiring cytotoxic therapy','Participant is =< 2 years free of another primary malignancy; exceptions include the following:\r\n* Basal cell skin cancer \r\n* Cervical carcinoma in situ\r\n* Anal carcinoma in situ','Any steroid treatment except for that required for replacement therapy in adrenal insufficiency, topical or injected testosterone for hypogonadism, or inhaled steroids for the treatment of asthma','Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since that local treatment; any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion','Female participants who are pregnant, lactating, or breast-feeding','Breastfeeding should be discontinued if the mother is treated with sEphB4-HSA','Participants with a recent history (< 6 months) of a major infarct including but not inclusive to bowel ischemia, cerebral vascular accident, transient ischemic attack, myocardial infarction, limb ischemia, or skin necrosis','Participants with a QTcF (Fridericia correction formula) > 480 ms on 2 out of 3 electrocardiograms (EKGs) (if first EKG is < 480, no need to repeat, if first EKG is > 480 repeat twice for a total of 3 EKGs)','Participants with uncontrolled sustained hypertension which will be defined as systolic blood pressure > 140, and diastolic blood pressure > 90, even with use of anti-hypertensive medications','Participants with a recent history (< 6 months) of a major bleed which will be defined as a symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level 2 grams/dL or more, or leading to transfusion of two or more units of whole blood or packed red cells','Participants on any dose of warfarin or are on full dose anticoagulation with other agents including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to study enrollment; participants on prophylactic doses of low molecular weight heparin are allowed','Cardiac related illnesses including, but not limited to:\r\n* Symptomatic congestive heart failure including participants with grade III/IV cardiac disease as defined by the New York Heart Association functional criteria\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia','Proteinuria as defined as >= 2+ on urine dipstick; if dipstick urinalysis shows >= 2+ proteinuria, 24-hour urine for protein must be < 2 grams','Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications','Physical or psychiatric illness/social situations that in the estimation of the investigator would limit compliance with study requirements or place the participant at high risk of toxicity or non-compliance'
NCT02465060,https://www.clinicaltrials.gov/ct2/show/record/NCT02465060?term=NCT02465060&rank=1,'Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: \r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately','Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:\r\n* Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR\r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survival\r\n* NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years','Patients must have measurable disease','Patients must meet one of the following criteria:\r\n* Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected\r\n** NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR\r\n* Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:\r\n** Tissue must have been collected within 6 months prior to pre-registration to Step 0\r\n*** Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:\r\n**** Enrollment onto another investigational study is not permitted\r\n**** Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted\r\n***** Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy\r\n**** A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0\r\n** Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR\r\n* Results from one of the designated outside laboratories indicate a “rare variant” that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:\r\n** The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected “rare variant”\r\n** Patients with an applicable “rare variant” must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step\r\n** Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met\r\n*** NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH\r\n*** NOTE: Tumor tissue for the confirmation of “rare variant” by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory','Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted\r\n* NOTE: Warfarin may not be started while enrolled in the EAY131 study\r\n* Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)','Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months','Patients must not currently be receiving any other investigational agents','Patients must not have any uncontrolled intercurrent illness including, but not limited to:\r\n* Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)\r\n* Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6\r\n* Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Intra-cardiac defibrillators\r\n* Known cardiac metastases\r\n* Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study\r\n* NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial','Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible','Patients who are human immunodeficiency virus (HIV)-positive are eligible if: \r\n* CD4+ cell count greater or equal to 250 cells/mm^3\r\n* If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used\r\n* No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts\r\n* Probable long-term survival with HIV if cancer were not present','Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease\r\n* NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist\r\n* NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment\r\n* NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol','Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment','Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below); patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)\r\n* NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):\r\n** Temporary steroid use for computed tomography (CT) imaging in setting of contrast allergy\r\n** Low dose steroid use for appetite\r\n** Chronic inhaled steroid use\r\n** Steroid injections for joint disease\r\n** Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease\r\n** Topical steroid\r\n** Steroids required to manage toxicity related to study treatment, as described in the subprotocols\r\n** Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy\r\n*** NOTE: Steroids must be completed alongside last dose of chemotherapy','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Leukocytes >= 3,000/mcL','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Absolute neutrophil count >= 1,500/mcL','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Platelets >= 100,000/mcL','NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x institutional ULN is permitted)','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN (up to 5 times ULN in presence of liver metastases)','Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:\r\n* Resting corrected QT interval (QTc) =< 480 msec\r\n** NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs\r\n* The following only need to be assessed if the mean QTc > 480 msec\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc\r\n** For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required\r\n** For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc\r\n** Patient must not have hypokalemia (value < institutional lower limit of normal)\r\n* No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval\r\n** NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs'
NCT03047213,https://www.clinicaltrials.gov/ct2/show/record/NCT03047213?term=NCT03047213&rank=1,'Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1','Eligible patients should have a histologically confirmed locally advance or metastatic TCC who progressed after standard therapy','Patient must have TCCs tumors harboring a TSC1 or TSC2 mutation identified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory','Patients must have TCC tumor tissue available for submission in a form of at least 10 unstained slides or formalin-fixed paraffin-embedded (FFPE) block (FFPE block highly recommended and preferred); if the tissue were previously sent to Yale Tumor Profiling Laboratory (TPL) for prescreening, additional tissue submission may not be required if sufficient remaining tissue is available; but, must first consult with the principle investigator','Patient must have developed disease progression during or following treatment with at least one platinum- containing regimen (e.g., gemcitabine/cisplatin [GC], methotrexate-vinblastine-doxorubicin-cisplatin [MVAC], carboplatin, gemcitabine [CarboGem]) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence, or must be unfit or ineligible for cisplatin-based chemotherapy; there is no restriction on the number of prior lines of chemotherapeutics agents received\r\n* Patients who progressed within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant regimen are considered second-line patients; therefore, these patients may be also eligible\r\n* Patients who are unfit or ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria are eligible for this trial: \r\n** Eastern Cooperative Oncology Group (ECOG) performance score of 2\r\n** Creatinine clearance < 60 mL/min \r\n** A hearing loss (measured by audiometry) of 25 dB at two contiguous frequencies \r\n** Grade >= 2 peripheral neuropathy','ECOG performance status =< 2 (Karnofsky >= 60 %)','Life expectancy of greater than 12 weeks','Hemoglobin >= 9 g/dL','Fasting serum glucose =< 130 mg/dL','Glycosylated hemoglobin measurement (HbA1c) < 7.0%','Fasting triglycerides =< 300 mg/dL','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal (ULN) and =< 5 ULN if liver metastases are present','Creatinine =< 1.5 x upper normal institutional limits (UNL) OR creatinine clearance >= 40 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)','Patients with controlled diabetes are allowed on study; controlled diabetes is defined as fasting blood sugar (FBS) < 130 mg/dL, and patients whose FBS can be brought in this range with medical therapy are eligible for trial inclusion','Women of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN0128 (TAK-228)\r\n*Female patients must:\r\n** Be postmenopausal for at least 1 year before the screening visit, OR\r\n** Be surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g., USPI, SmPC, etc.;]) after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** AND agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug','Ability to swallow oral medications','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known untreated brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228)','Subjects who are on systemic corticosteroids (intravenous (IV) or oral steroids, excluding inhaled, topical or ophthalmic corticosteroids), or anti-epileptic drugs for treated brain metastasis','Subjects taking strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C9 within 1 week preceding the first dose of MLN0128 (TAK-228); if a subject requires treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C19 and/or CYP2C9, alternative treatment must be considered; if no alternative is available, one such medication may be allowed after discussing with the study principle investigator','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN0128 (TAK-228)','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; however, HIV patients treated with regimens that have low cytochrome P450 (CYP450) inhibition may be allowed as long as the patient’s general health and cluster of differentiation (CD)4 counts are within acceptable levels','Patients with symptomatic/untreated central nervous system (CNS) metastases; patients with treated and stable brain metastasis are allowed','Patients with impaired cardiac function or clinically significant cardiac disease; patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) will not be allowed; no ischemic myocardial or cerebrovascular event, class III or IV heart failure, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228)','Patients with untreated or active hepatitis B or C infection','Significant active cardiovascular or pulmonary disease at the time of study entry, including\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) \r\n* Pulmonary hypertension  \r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air   \r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement  \r\n* Medically significant (symptomatic) bradycardia','Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228)','Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs','History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures  \r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) \r\n* Pulmonary embolism','Subjects who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)','Patients who received prior PI3K, AKT or mTOR inhibitors are not allowed','Patients who received radiation therapy within the last 4 weeks; radiation exposure may not exceed 30% of marrow area'
NCT02535312,https://www.clinicaltrials.gov/ct2/show/record/NCT02535312?term=NCT02535312&rank=1,'Arm A dose escalation: patients with histologically or cytologically proven advanced solid tumors for which standard treatments are not available, or for whom the current dose level of cisplatin in combination with pemetrexed is appropriate; =< 2 prior cytotoxic chemotherapy regimen','Arm A dose level 4 (75 mg/m^2 cisplatin): patients with histologically proven chemotherapy-naive advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen (malignant mesothelioma, non-small cell lung cancer, ovarian cancer and thymoma)','Arm A 14-patients expansion cohort: patients with histologically or cytologically proven chemotherapy naive unresectable malignant pleural or peritoneal mesothelioma','Arm B (first stage of phase II of TRC102 and pemetrexed): patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline; intervening treatment is allowed','Prior pemetrexed is allowed except Arm A dose level 4 (cisplatin 75 mg/m^2)','Eastern Cooperative Oncology Group (ECOG) performance status 0 -1 (Karnofsky >= 70%)','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Hemoglobin >= 10.0 g/dl','Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)','Total bilirubin < 1.5 x ULN','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN or =< 5 x ULN if metastatic disease involves liver','Serum creatinine =< 1.5 x ULN or a calculated creatinine clearance >= 60 ml/min/1.73 m^2 (Cockcroft-Gault method) for patients receiving combination of cisplatin and pemetrexed and >= 45 ml/min/1.73 m^2 for patients receiving pemetrexed; 24 hour urine for creatinine clearance is acceptable if the calculated creatinine clearance is insufficient','For patients enrolled in arm A dose level 4, arm A 14-patients expansion cohort, and arm B (first stage of phase II of TRC102 and pemetrexed) measurable disease is required according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with solid tumors and modified RECIST criteria as described by Byrne and Novak for patients with malignant pleural mesothelioma; pleural effusion and ascites are not considered measurable disease','Patients must be able to swallow whole capsules; nasogastric or gastrointestinal (G)-tube administration is not allowed','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of the study drugs; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of TRC102, pemetrexed and cisplatin administration\r\n* Non-childbearing potential is defined as (by other than medical reasons): >= 45 years of age and has not had menses for >= 2 years, amenorrheic for < 2 years without hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation, or post hysterectomy, oophorectomy or tubal ligation; documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound; tubal ligation must be confirmed with medical records of the actual procedure otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit though 4 months after the last dose of study drugs','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had targeted therapy will be required to wait 2 weeks due to short half-life of the drugs; treatment with bisphosphonates is permitted','Patients who are receiving any other investigational agents','Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients with treated brain metastases, whose brain metastatic disease has remained stable for greater than or equal to 4 weeks without requiring steroid and anti-seizure medications are eligible to participate','History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or pemetrexed and cisplatin','No studies have been performed to assess potential metabolic and transport interactions of TRC102; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the case report form must capture the concurrent use of all other drugs, over-the-counter medications, or alternative therapies','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with TRC102','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Patients with known disorders associated with hemolysis','Patients with thromboembolic disease and on anticoagulation','Patients with a prior cumulative cisplatin dose > 300 mg/m^2 (pertains to Arm A only)'
NCT02488967,https://www.clinicaltrials.gov/ct2/show/record/NCT02488967?term=NCT02488967&rank=1,'The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines','Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1','The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination','All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:\r\n* By pathologic evaluation, primary tumor must be pT1-3\r\n* By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b\r\n* If pN0, pathological tumor must be >= 3.0 cm','The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:\r\n* Immunohistochemistry (IHC) 0-1+; or\r\n* IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or\r\n* ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells','The tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria:\r\n* ER-negative and PgR- negative by ASCO/CAP guidelines, OR\r\n* ER or PgR stains are positive in 1-9% of cells and neither is positive in >= 10% of cells','The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy','For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)','For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)','The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.\r\n* Sentinel lymphadenectomy alone:\r\n** If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;\r\n** If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes\r\n* Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or\r\n* Axillary lymphadenectomy with or without SN isolation procedure','The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days','Within 6 weeks prior to randomization: Absolute neutrophil count (ANC) must be >= 1200/mm^3','Within 6 weeks prior to randomization: Platelet count must be >= 100,000/mm^3','Within 6 weeks prior to randomization: Hemoglobin must be >= 10 g/dL','Within 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin','Within 6 weeks prior to randomization: Alkaline phosphatase must be =< 2.5 x ULN for the lab','Within 6 weeks prior to randomization: Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab\r\n* Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN','Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements above are met','Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease','Adequate renal function determined within 6 weeks prior to randomization defined as the most recent serum creatinine =< ULN or measured or calculated creatinine clearance > 60 mL/min','Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; (LVEF assessment performed by 2-dimensional [D] echocardiogram is preferred; however, multi gated acquisition [MUGA] scan may be substituted based on institutional preferences;) the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal','T4 tumors including inflammatory breast cancer','Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization','Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)','Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)','History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization','Previous therapy with anthracyclines or taxanes for any malignancy','Chemotherapy administered for the currently diagnosed breast cancer prior to randomization','Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization','Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;\r\n** History of documented congestive heart failure (CHF); or\r\n** Documented cardiomyopathy','Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)','Active hepatitis B or hepatitis C with abnormal liver function tests','Patients known to be human immunodeficiency virus (HIV) positive with a baseline cluster of differentiation (CD)4 count of < 250 cells/mm^3 or have a history of acquired immune deficiency syndrome (AIDS) indicator conditions','Intrinsic lung disease resulting in dyspnea','History of hospitalization in past 12 months for diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketotic syndrome (HHNS)','Active infection or chronic infection requiring chronic suppressive antibiotics','Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0','Conditions that would prohibit administration of corticosteroids','Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)','Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor EL','Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up','Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements','Pregnancy or lactation at the time of study entry; (note: pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to randomization)','Use of any investigational product within 4 weeks prior to randomization'
NCT02359565,https://www.clinicaltrials.gov/ct2/show/record/NCT02359565?term=NCT02359565&rank=1,'INCLUSION CRITERIA FOR STRATA A, B, D AND E','Tumor: patient must have one of the following diagnoses to be eligible:','Stratum A, currently closed to enrollment: Patients must have a recurrent, progressive or refractory DIPG following radiation therapy with or without chemotherapy\r\n* Histologic diagnosis is not required for patients with typical imaging findings of DIPG (defined as patients with a diffuse expansile mass centered in and involving at least 2/3 of the pons); patients with brainstem tumors who have undergone biopsy with a diagnosis of high-grade glioma or diffuse infiltrating glioma are also eligible','Stratum B: Patients must have a histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG) that is recurrent, progressive or refractory following therapy which included radiotherapy; spinal primary disease is eligible','Stratum D: Patients must have a histologically confirmed diagnosis of ependymoma that is recurrent, progressive or refractory following therapy which included radiotherapy','Stratum E: Patients must have a histologically confirmed diagnosis of medulloblastoma that is recurrent, progressive or refractory following therapy which included radiotherapy','Patients must have adequate pre-trial formalin-fixed paraffin-embedded (FFPE) tumor material available for use in the biology studies mutational analysis and genome wide sequencing for each stratum\r\n* Patients with DIPG who have tissue available are requested to submit similar tissue as patients in other strata; however, this is not required for eligibility','All subjects must have measurable disease in 2-dimensions on MRI scan of the brain; disease should be consistently measured with the two largest perpendicular dimensions','Patients must have received prior radiation therapy and/or chemotherapy and recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed','Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks prior to study enrollment or at least six (6) weeks if prior nitrosourea','Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment \r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration must be discussed with and approved by the study chair\r\n* Monoclonal antibody treatment and/or agents with prolonged half-lives: at least three half-lives must have elapsed prior to enrollment','Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment','Patients must have had their last fraction of:\r\n* Craniospinal irradiation >= 3 months prior to enrollment\r\n* Other substantial bone marrow irradiation >= 6 weeks prior to enrollment\r\n* Local palliative radiation therapy (XRT) (small port) >= 2 weeks','Patient must be >= 12 weeks since autologous bone marrow/stem cell transplant prior to enrollment','Patients must be fully recovered from all acute effects of prior surgical intervention','All races and ethnic groups are eligible for this study','Patients with neurological deficits should have deficits that are completely stable for a minimum of 1 week (7 days) prior to enrollment','Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of enrollment must be >= 70; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Absolute neutrophil count >= 1000 cells/uL','Platelets >= 75,000 cells /uL (unsupported, defined as no platelet transfusion within 7 days)','Hemoglobin >= 8 g/dl (may receive transfusions)','Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)','Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Albumin >= 2 g/dl','Serum creatinine based on age/gender as noted below; patients that do not meet the criteria below but have a 24 hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible\r\n* 1 to < 2 years: 0.6 mg/dl\r\n* 2 to < 6 years: 0.8 mg/dl\r\n* 6 to < 10 years: 1 mg/dl\r\n* 10 to < 13 years: 1.2 mg/dl\r\n* 13 to < 16 years: 1.5 mg/dl (male), 1.4 mg/dl (female)\r\n* >= 16 years: 1.7 mg/dl (male), 1.4 mg/dl (female)','Pulse oximetry > 93% on room air and no evidence of dyspnea at rest','Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (e.g. filgrastim, sargramostim, erythropoietin); 2 weeks must have elapsed for long-acting formulations','Patients must be willing to use brief courses (at least 72 hours) of steroids as directed for potential inflammatory side effects of the therapy if recommended by their treating physician','Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)','Patients of childbearing or child fathering potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity while being treated on this study and for 6 months after the last dose of study medication','The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelines','EXCLUSION CRITERIA FOR STRATA A, B, D AND E','Concurrent Illness\r\n* Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n** Patients with vitiligo or resolved asthma/atopy\r\n** Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome \r\n* History of or ongoing pneumonitis or significant interstitial lung disease\r\nNote: This would include non-infectious pneumonitis that required steroid use\r\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n* Patients with other current malignancies\r\n* Patients with known hypermutated brain tumors including those with CMMRD and Lynch syndrome are ineligible for enrollment in Strata A, B, D and E\r\n* Patients who have received a solid organ transplant','Patients with bulky tumor on imaging are ineligible; treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns\r\nBulk tumor is defined as:\r\n* Tumor with evidence of clinically significant uncal herniation or midline shift\r\n* Tumor with diameter of > 5 cm in one dimension on T2/fluid attenuated inversion recovery (FLAIR)\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect in either the brain or spine\r\n* Multi-focal/ metastatic disease: \r\nNote: A second focus of enhancement in a single FLAIR abnormality is permissible and will not exclude the subject\r\n** Patients with multi-focal parenchymal disease are ineligible\r\n** Patients with leptomeningeal metastatic disease are eligible\r\n* Strata B, D and E – patients whose tumor has a significant component involving the brainstem or with significant fourth ventricular compression are ineligible','Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible','Patients who have a known active hepatitis B or hepatitis C infection are ineligible; patient must have documented evidence of negative tests for the presence of hepatitis B surface antigen and hepatitis C (anti-hepatitis C virus [HCV] antibody OR hepatitis [Hep] C RNA-qualitative); human immunodeficiency virus (HIV)-positive patients are eligible if the following criteria are met:\r\n* Stable on their antiretroviral agents\r\n* Have CD4 counts above 400\r\n* Undetectable viral loads, and\r\n* No need for prophylactic medications for an opportunistic infections','Patients who have received the last vaccination of a live vaccine =< 30 days prior to enrollment are ineligible; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and must meet timeline for live vaccine','Patients with a history severe (>= grade 3) hypersensitivity reaction to a monoclonal antibody are ineligible','Patients who have received previous therapy with an anti-CTLA4, anti-CD137, anti-PD-L1 or anti-PD-1 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)','Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of anti-epileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose','Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as 0.75 mg/m^2/day) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study','INCLUSION CRITERIA FOR STRATUM C: Diagnosis of hypermutated brain tumors\r\nPatients with brain tumors and increased tumor mutation burden as determined by\r\n* Confirmed diagnosis of CMMRD syndrome by Clinical Laboratory Improvement Act (CLIA)-certified germline gene sequencing OR\r\n* Confirmation of high mutation burden by whole genome/exome sequencing performed in a CLIA-certified laboratory and/or the use of Foundation One next generation sequence panel or another CLIA approved targeted sequencing lab with publicly available correlations between number of mutations found in the panel and mutations per megabase and/or genome; for protocol purposes a high mutation burden will be defined as at least 100 non-synonymous coding-region mutations by whole exome/genome sequencing (well above two standard deviations of the number of median similar mutations described in pediatric CNS cancers) AND/OR a high tumor mutation burden (TMB) or intermediate TMB based on the reporting parameters of the panel; TMB parameters provided for the Foundation One reports are high tumor mutation burden is >= 20 mutations per megabase or intermediate TMB is between 6 to 19 mutations per megabase\r\n* Confirmed diagnosis of Lynch syndrome by CLIA-certified germline gene sequencing; patients with Lynch syndrome will not be accounted for in primary objective unless their tumors are determined to have the minimum number of mutations described above but they will still be eligible for this study\r\n* Low-grade tumors in patients with CMMRD or Lynch syndrome do not have to reach the threshold of 100 mutations for study inclusion','INCLUSION CRITERIA FOR STRATUM C: Patients must have a histologically confirmed primary brain tumor that is recurrent, progressive or refractory; inclusion criteria encompasses all types of brain tumors (e.g. gliomas, embryonal tumors or any other type of brain tumor as long as other eligibility criteria are met;\r\n* Patients with high-grade gliomas are eligible for this clinical trial at least 2 weeks after completion of radiotherapy independent of tumor progression/recurrence as long as they are not enrolled on any other therapeutic clinical trial and there is macroscopic residual disease\r\n* Patients with other concomitant tumors associated with CMMRD syndrome including gastrointestinal polyps/adenomas and carcinomas, lymphomas and leukemias will be eligible as long as they are not requiring anticancer therapy directed against these other cancers and meet all other eligibility criteria','INCLUSION CRITERIA FOR STRATUM C: Patients must have adequate pre-trial FFPE tumor material available and be willing to provide a blood sample for use in the genome wide sequencing studies; while tissue is required for genome-wide sequencing of tumor and germline samples, patients will be deemed eligible for the study with a minimum of approximately 10 unstained slides for the planned analysis','INCLUSION CRITERIA FOR STRATUM C: All subjects must have measurable disease in 2-dimensions on MRI scan of the brain and/or spine; disease should be consistently measured with the two largest perpendicular dimensions','INCLUSION CRITERIA FOR STRATUM C: Patients must have received prior radiotherapy and/or chemotherapy with the following exceptions:\r\n* Patients with secondary CNS cancers after a previous medical problem/malignancy who cannot receive full dose of radiotherapy (> 50 Gy) as long as they meet all other eligibility criteria\r\n* Patients with progressive low-grade gliomas and CMMRD or Lynch syndrome\r\nPatients must have recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed','INCLUSION CRITERIA FOR STRATUM C: Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks prior to study enrollment or at least six (6) weeks if prior nitrosourea','INCLUSION CRITERIA FOR STRATUM C: Patient must have received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration must be discussed with and approved by the study chair\r\n* Monoclonal antibody treatment and/or agents with prolonged half-lives: at least three half-lives must have elapsed prior to enrollment','INCLUSION CRITERIA FOR STRATUM C: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment','INCLUSION CRITERIA FOR STRATUM C: Patients must have had their last fraction of:\r\n* Craniospinal irradiation >= 3 months prior to enrollment\r\n* Other substantial bone marrow irradiation >= 6 weeks prior to enrollment\r\n* Local palliative radiation therapy (XRT) (small port) >= 2 weeks','INCLUSION CRITERIA FOR STRATUM C: Patient must be:\r\n* >= 12 weeks since autologous bone marrow/stem cell transplant prior to enrollment\r\n* >= 5 years since allogeneic bone marrow transplant prior to enrollment with no evidence of active graft versus (vs.) host disease','INCLUSION CRITERIA FOR STRATUM C: Patients must be fully recovered from all acute effects of prior surgical intervention','INCLUSION CRITERIA FOR STRATUM C: All races and ethnic groups are eligible for this study','INCLUSION CRITERIA FOR STRATUM C: Patients with neurological deficits should have deficits that are completely stable for a minimum of 1 week (7 days) prior to enrollment','INCLUSION CRITERIA FOR STRATUM C: Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of enrollment must be >= 60; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','INCLUSION CRITERIA FOR STRATUM C: Absolute neutrophil count >= 1000 cells/uL','INCLUSION CRITERIA FOR STRATUM C: Platelets >= 75,000 cells/uL (unsupported, defined as no platelet transfusion within 7 days)','INCLUSION CRITERIA FOR STRATUM C: Hemoglobin >= 8 g/dl (may receive transfusions)','INCLUSION CRITERIA FOR STRATUM C: Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)','INCLUSION CRITERIA FOR STRATUM C: ALT (SGPT) =< 3 x institutional upper limit of normal','INCLUSION CRITERIA FOR STRATUM C: Albumin >= 2 g/dl','INCLUSION CRITERIA FOR STRATUM C: Serum creatinine based on age/gender as noted below; patients that do not meet the criteria below but have a 24 hour creatinine clearance or GFR (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible\r\n* 1 to < 2 years: 0.6 mg/dl\r\n* 2 to < 6 years: 0.8 mg/dl\r\n* 6 to < 10 years: 1 mg/dl\r\n* 10 to < 13 years: 1.2 mg/dl\r\n* 13 to < 16 years: 1.5 mg/dl (male), 1.4 mg/dl (female)\r\n* >= 16 years: 1.7 mg/dl (male), 1.4 mg/dl (female)','INCLUSION CRITERIA FOR STRATUM C: Pulse oximetry > 93% on room air and no evidence of dyspnea at rest','INCLUSION CRITERIA FOR STRATUM C: Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (i.e. filgrastim; sargramostim; erythropoietin); 2 weeks must have elapsed for long-acting formulations','INCLUSION CRITERIA FOR STRATUM C: Patients must be willing to use brief courses (at least 72 hours) of steroids as directed for potential inflammatory side effects of the therapy if recommended by their treating physician','INCLUSION CRITERIA FOR STRATUM C: Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)','INCLUSION CRITERIA FOR STRATUM C: Patients of childbearing or child fathering potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity while being treated on this study and for 6 months after the last dose of study medication','INCLUSION CRITERIA FOR STRATUM C: The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelines','EXCLUSION CRITERIA FOR STRATUM C: Patients with diffuse intrinsic pontine or other brainstem high-grade glioma and those with primary spinal cord tumors','EXCLUSION CRITERIA FOR STRATUM C: Patients with bulky tumor on imaging are ineligible; treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns; bulky tumor is defined as:\r\n* Tumor with any evidence of uncal herniation or midline shift\r\n* Tumor with diameter of > 5 cm in one dimension on T2/FLAIR\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect\r\n* Metastatic disease: Patients with =< 5 separate foci of metastatic disease not causing mass effect on adjacent parenchyma and each measuring less than 0.5 cm in maximum diameter will be eligible for this arm of the study; patients with diffuse linear leptomeningeal spread are not eligible for this arm of the study\r\n* Multi-focal disease: Patients with multi-focal parenchymal disease will be eligible for stratum C if the sum of the product of the maximum perpendicular diameters of all measurable non-contiguous lesions is less than 16 cm^2; in such cases, a minimum of 2 and a maximum of 5 “target” non-contiguous lesions will be selected; the lower size limit of the target lesion(s) should be at least twice the thickness of the slices showing the tumor to decrease the partial volume effect (e.g., 8 mm lesion for a 4 mm slice)','EXCLUSION CRITERIA FOR STRATUM C: Concurrent illness\r\n* Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n** Patients with vitiligo or resolved asthma/atopy\r\n** Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome \r\n* History of or ongoing pneumonitis or significant interstitial lung disease\r\n* Note: This would include non-infectious pneumonitis that required steroid use\r\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n** Exception to this is the presence of gastrointestinal polyps/adenomas and non-metastatic carcinomas, and history of any previous malignancies in patients with CMMRD which will be allowed in this study\r\n* Patients who have received a solid organ transplant','EXCLUSION CRITERIA FOR STRATUM C: Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible','EXCLUSION CRITERIA FOR STRATUM C: Patients who have a known active hepatitis B or hepatitis C infection are ineligible; patient must have documented evidence of negative tests for the presence of hepatitis B surface antigen and hepatitis C (anti-HCV antibody OR Hep C RNA-qualitative); HIV-positive patients are eligible if the following criteria are met:\r\n* Stable on their antiretroviral agents\r\n* Have CD4 counts above 400\r\n* Undetectable viral loads, and\r\n* No need for prophylactic medications for an opportunistic infections','EXCLUSION CRITERIA FOR STRATUM C: Patients who have received the last vaccination of a live vaccine =< 30 days prior to enrollment are ineligible; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and must meet timeline for live vaccine','EXCLUSION CRITERIA FOR STRATUM C: Patients with a history severe (>= grade 3) hypersensitivity reaction to a monoclonal antibody are ineligible','EXCLUSION CRITERIA FOR STRATUM C: Patients who have received previous therapy with an anti-CTLA4, anti-CD137, anti-PD-L1 or anti-PD-1 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)','EXCLUSION CRITERIA FOR STRATUM C: Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of antiepileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose','EXCLUSION CRITERIA FOR STRATUM C: Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as =< 0.75 mg/m^2/day dexamethasone equivalent) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study'
NCT02363283,https://www.clinicaltrials.gov/ct2/show/record/NCT02363283?term=NCT02363283&rank=1,'Patients must have histologically or cytologically confirmed metastatic or locally recurrent uveal melanoma; because histologic or cytologic confirmation of primary uveal melanoma is not always possible, confirmation of the clinical diagnosis of uveal melanoma by the treating investigator is allowed; clinical diagnosis of uveal melanoma is often made by an ophthalmologist, not by tissue diagnosis; if an ophthalmologist diagnosed and treated a patient for uveal melanoma in the past, it is sufficient for a clinical diagnosis','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','The study will be limited to patients who are chemotherapy naive; patients may have received prior systemic or liver-directed local therapies for advanced uveal melanoma as long as those treatments do not involve chemotherapy; this includes, but is not limited to: immunotherapy, targeted therapy, transarterial embolization, radiofrequency ablation, or cryoablation; treatment must be completed at least 28 days prior to initiation of study therapy; radiation therapy is also allowed and must be completed at least 28 days prior to initiation of study therapy; lesions treated via radiation or liver-directed therapy may not be used as target lesions unless they demonstrate growth over a minimum of 3 months on subsequent imaging','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (V) 5 grade =< 1 (except alopecia); certain exceptions apply, such as immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement or rash from prior therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Leukocytes >= 3,000/uL','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal; =< 5 x institutional upper limit of normal if liver metastasis present','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after last CDX-011 (glembatumumab vedotin) dose; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of protocol treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of glembatumumab vedotin administration','Ability to understand and the willingness to sign a written informed consent document','Patients with a history of another malignancy except for those who have been disease-free for 2 years; patients with a history of definitively treated non-melanoma skin cancer or squamous cell carcinoma of the cervix are eligible; patients with definitively treated in-situ cancers are eligible, regardless of timeframe','Patients with neuropathy > grade 1','Patients who are receiving any other investigational agents; if the patient received a previous investigational or other agent or treatment, a washout period of 4 weeks is required','Patients receiving any medications or substances that are substrates of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) will be closely monitored for toxicity; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Human immunodeficiency virus (HIV)-positive patients on antiretroviral medications that are CYP3A4 substrates will be closely monitored; HIV-positive patients will be excluded if they have a cluster of differentiation 4 (CD4) count < 200','Pregnant or nursing women','Patients who have previously received CDX-011 (glembatumumab vedotin) or other monomethyl auristatin E (MMAE)-containing agents','Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin (e.g. Auristatin PHE, Auristatin PE, and symplostatin)'
NCT02381548,https://www.clinicaltrials.gov/ct2/show/record/NCT02381548?term=NCT02381548&rank=1,'Patients must have one of the following, histologically or cytologically confirmed:\r\n* Acute myeloid leukemia (AML) [non- acute promyelocytic leukemia (APL) AML]\r\n** If previously treated:\r\n*** AML that is relapsed or refractory to at least one prior line of therapy\r\n** If previously untreated, must meet all of the following:\r\n*** >= 60 years of age\r\n*** Secondary or therapy-related AML\r\n*** Does NOT bear favorable cytogenetic and/or molecular features, eg, core-binding factor abnormalities, FLT3 Internal Tandem Duplication (FLT3-ITD) negative/NPM1 mutated, biallelic CCAAT/enhancer binding protein alpha (CEBPA) mutation without FLT3-ITD\r\n* Chronic myeloid leukemia blast crisis (CML-BC)\r\n** Relapsed or refractory to at least one Bcr-Abl-TKI-containing regimen\r\n* Myelodysplastic syndrome (MDS), must meet all of the following:\r\n** Higher risk MDS [intermediate-2 or high risk by the original International Prognostic Scoring System (IPSS)]\r\n** Relapsed, refractory, or intolerant to at least one prior line of therapy containing hypomethylating agents (deoxyribonucleic acid [DNA] methyltransferase inhibitors)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)','Total bilirubin =< 1.5 × upper limit of normal (ULN) for the laboratory unless resulting from hemolysis','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × ULN for the laboratory','Creatinine within normal limits for the laboratory OR creatinine clearance >= 60 mL/min/1.73 m^2 (estimated glomerular filtration rate [eGFR]) for patients with creatinine levels above the ULN for the laboratory','Human immunodeficiency virus (HIV)-infected persons are eligible if they meet other eligibility criteria including the following:\r\n* No prior acquired immune deficiency syndrome (AIDS)-defining condition other than cluster of differentiation (CD)4+ cells nadir < 200/mm^3\r\n* Pre-leukemia CD4+ cell count >= 250/mm^3\r\n* Willing to adhere to antiretroviral therapy regimen with minimal overlapping toxicity and PK interactions with the experimental agents in this study; no zidovudine- and no ritonavir-containing regimens and no 3-drugs-in-1 pill regimens containing pharmacologic boosters are allowed; recommended regimens are integrase inhibitors combined with tenofovir and emtricitabine','Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of AZD1775 and belinostat administration','Ability to swallow medication','Ability to understand and the willingness to sign a written informed consent document','Clinical picture indicative of leukostasis or evidence of disseminated intravascular coagulopathy','Other investigational agent within 3 weeks prior to initiation of study therapy','Ongoing toxicities >= grade 2 from prior therapy','Acute promyelocytic leukemia (APL, M3)','Active central nervous system (CNS) leukemia','History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775 or belinostat','Stem cell transplant within previous 3 months prior to initiation of study therapy','Major surgical procedures =< 28 days before beginning study treatment or minor surgical procedures =< 7 day before beginning study treatment; no waiting required after placement of a vascular access device','Uncontrolled infection','Pregnant or nursing; women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study therapy\r\n* Note: Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD1775/belinostat','Circulating blast count >= 50,000/uL within the week preceding enrollment','Current candidacy for a potentially curative allogeneic stem cell transplant, unless declined','Corrected QT (QTc) interval >= 450 ms (ie, grade 1 or higher) on electrocardiogram (ECG) prior to initiation of study treatment\r\n* If baseline QTc on screening ECG is >= 450 ms (ie, grade 1 or higher):\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm QTc interval\r\n* For patients with baseline heart rate (HR) < 60 beats per minute (bpm) or > 100 bpm, manual measurement of QT interval by cardiologist is required, with Fridericia correction applied to that manual measurement to determine the QTc for eligibility consideration\r\n* Note: For patients with HR 60-100 bpm, manual measurement of QTc interval and use of Fridericia calculation is NOT required','Any of the following related to risk of torsades de pointes and sudden cardiac death:\r\n* History of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), torsades de pointes, or resuscitated cardiac arrest unless currently addressed with an implanted cardiac defibrillator\r\n* Concomitant treatment with an anti-arrhythmic agent to prevent or control arrhythmia; agents used for rate-control of atrial fibrillation are permitted provided that they are not prohibited due to potential drug interactions\r\n* Known congenital long QT syndrome\r\n* Second degree atrioventricular (AV) block type II, third degree AV block, or ventricular rate < 50 bpm or > 120 bpm','Unstable angina, myocardial infarction or New York Heart Association (NYHA) class III/IV congestive heart failure within 30 days preceding study enrollment','Ongoing or planned treatment with any of the following:\r\n* Atorvastatin\r\n* Strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\r\n** If any of these agents have been used, patients must be off them for >= 2 weeks before starting study treatment','Any known UGT1A polymorphism, heterozygous or homozygous','History of prior therapy with belinostat or AZD1775','Active gastrointestinal (GI) conditions that might predispose to drug intolerance or poor drug absorption','Receiving any other therapies for cancer treatment (with the exception of gonadotropin-releasing hormone [GnRH] agonists for prostate cancer); Note: hydroxyurea is allowed before initiation of study treatment and for the first 5 days of study treatment','Diagnosis or treatment for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy','Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk, interfere with the patient’s participation in the study, or hinder evaluation of study results'
NCT02381561,https://www.clinicaltrials.gov/ct2/show/record/NCT02381561?term=NCT02381561&rank=1,'Patients must have histologically or cytologically confirmed advanced, incurable cancers of the esophagus, liver, stomach, small bowel, pancreas, bile duct, colon or rectum and be eligible to receive chest, abdominal and/or pelvic radiation therapy (RT) for palliation; documentation of this is required in physician note; concomitant systemic therapy is not allowed during administration of palliative RT; palliative RT can be considered for advanced primary tumors or metastatic disease as above','Patients must not have received systemic chemotherapy for at least 4 weeks, and must not have received prior radiation therapy to the tumor site being irradiated on this study','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of IPdR administration','Ability to understand and the willingness to sign a written informed consent document','Human immunodeficiency virus (HIV) positive (+) patients with cluster of differentiation 4 (CD4) counts >= 250 cells/mm^3 on anti-viral therapy','Women of child-bearing potential must have a negative pregnancy test','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to IPdR','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IPdR'
NCT02500797,https://www.clinicaltrials.gov/ct2/show/record/NCT02500797?term=NCT02500797&rank=1,'PRE-REGISTRATION ELIGIBILITY CRITERIA:','Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility','REGISTRATION ELIGIBILITY CRITERIA:','Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review\r\n* Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST)','Measurable disease','Locally advanced/unresectable or metastatic disease','>= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy','No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)','No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment','Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less','No history of the following:\r\n* Active known or suspected autoimmune disease\r\n* Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes > 350 cluster of differentiation (CD)4+ cells and no detectable viral load\r\n* Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Active autoimmune colitis \r\n* Autoimmune panhypopituitarism \r\n* Autoimmune adrenal insufficiency \r\n* Known active hepatitis B or C\r\n** Hepatitis B can be defined as:\r\n*** Hepatitis B surface antigen (HBsAg) > 6 months\r\n*** Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B\r\n*** Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels\r\n*** Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation\r\n** Hepatitis C can be defined as:\r\n*** Hepatitis C antibody (Ab) positive\r\n*** Presence of hepatitis C virus (HCV) ribonucleic acid (RNA)\r\n* Known active pulmonary disease with hypoxia defined as:\r\n** Oxygen saturation < 85% on room air or\r\n** Oxygen saturation < 88% despite supplemental oxygen','No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration','Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min using the lean body mass formula only','Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted','AST/ALT =< 3 x upper limit of normal (ULN)','Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible','Re-registration Eligibility Criteria (for patients who crossover from arm 1 nivolumab alone to dual agent nivolumab and ipilimumab upon progression)','Re-registration: measurable disease','Re-registration: locally advanced/unresectable or metastatic disease','Patient MUST have had progressive disease (radiographic or clinical) while on arm 1 single agent nivolumab while registered to A091401','Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for re-registration','Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration','Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =< 12 months of re-registration to crossover dual agent therapy','No treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registration','Patients should have resolution of any toxic effects of prior therapy (except fatigue and alopecia) to NCI CTCAE, version 4.0, grade 1 or less, including immune toxicity','No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of re-registration','Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to re-registration is required','ECOG performance status 0 or 1','Re-registration: ANC >= 1,500/mm^3','Re-registration: platelet count >= 100,000/mm^3','Re-registration: creatinine =< 1.5 ULN OR calc. creatinine clearance > 45 mL/min (using lean body mass formula only)','Re-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted','Re-registration: AST/ALT =< 3 x ULN','Re-registration: TSH WNL; supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible'
NCT02516423,https://www.clinicaltrials.gov/ct2/show/record/NCT02516423?term=NCT02516423&rank=1,'PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)','No lytic lesions on skeletal survey and whole body positron emission tomography (PET)/computed tomography (CT) other than a single lesion associated with solitary bone plasmacytoma','For patients pre-registering after the completion of radiation therapy, documentation of a bone marrow aspirate and biopsy containing < 10% clonal plasma cells prior to start of radiation therapy','For patients pre-registering before the start of radiation therapy documentation of bone marrow aspirate and biopsy containing < 10% clonal plasma cells; radiation therapy should preferably begin within 28 days after bone marrow biopsy','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','All patients are required to be pre-registered to A061402 in order to submit post-radiation therapy (RT) bone marrow aspirate specimens to Roswell Park for MRD detection by flow cytometry; this submission is required prior to registration to confirm eligibility','REGISTRATION ELIGIBILITY CRITERIA (STEP 1)','No lytic lesions on skeletal survey and whole body PET/CT other than a single lesion associated with solitary bone plasmacytoma within 28 days prior to registration','Bone marrow aspirate and biopsy containing < 10% clonal plasma cells performed after completion of RT and within 28 days prior to registration','Participants must have disease that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains or by minimal residual detection; measurable disease is defined as one or more of the following:\r\n* Serum M protein > 0.5 G/DL, or\r\n* Urine M protein > 200 MG/24H, and/or\r\n* Serum FLC assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio\r\n* >= 50 plasma cells detectable by multicolor flow cytometry, at a sensitive level of 10^-4 (determined by central review)','No major surgery within 21 days of registration with stabilization or resolution of surgical adverse events','No investigational agent within 21 days prior to registration','No ongoing therapy with corticosteroids greater than 10 mg of prednisone or its equivalent per day; please note: inhaled and topical steroids are permitted','No prior proteasome inhibitor or immune-modulating drug (IMiD) use','Prior bisphosphonate use is permitted','For all patients:\r\n* Radiation dose should range from 4500 cGy to 6000 cGy\r\n* No treatment for this disease following radiation therapy','Not pregnant and not nursing\r\n* Females of childbearing potential (FCBP), defined as a female who 1) has achieved menarche (first menstrual cycle) at some point, or 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months):\r\n** Must have a negative serum or urine pregnancy test with a sensitivity of a least 50 mIU/mL within 10-14 days prior to registration and again within 24 hours of starting lenalidomide\r\n** Must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide\r\n** Must agree to ongoing pregnancy testing\r\n* Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy','ECOG performance status 0-2','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 75,000/mm^3','Hemoglobin >= 10 g/dL','Serum creatinine < 2.0 mg/dL (176.8 umol/liter)','Serum calcium =< 11.5 mg/dL','Calculated (calc.) creatinine clearance > 50 mL/min','Bilirubin =< 1.5 x upper limits of normal (ULN)','Aspartate aminotransferase (AST) =< 2.5 x upper limits of normal (ULN)','If history of prior malignancy, subject should be in complete remission for >= 5 years at the time of registration (with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection)','Human immunodeficiency (HIV) positive (+) patients are eligible provided they meet the other eligibility criteria and:\r\n* Cluster of differentiation (CD)4+ cells are >= 250/mm^3\r\n* There is no history of acquired immunodeficiency syndrome (AIDS) defining conditions other than historically low CD4+ cell count\r\n* The following antiretroviral agents are not allowed: zidovudine, stavudine, protease inhibitors, non-nucleoside reverse transcriptase inhibitors, combination pills with pharmacologic boosters\r\n* Recommended antiretroviral regimens to avoid pharmacokinetic (PK) interactions include strand integrase inhibitors with nucleoside reverse transcriptase inhibitors (for example, dolutegravir given with tenofovir and emtricitabine)','Patients with hepatitis B virus (HBV) infection are eligible provided they meet the other eligibility criteria and:\r\n* There is no evidence of hepatic damage related to HBV infection\r\n* They have had consistently suppressed HBV viral load to undetectable levels by polymerase chain reaction (PCR) for a minimum of 12 months','Patients with hepatitis C virus (HCV) infection are eligible provided they meet the other eligibility criteria and:\r\n* They have previously undergone curative therapy and have no evidence of active HCV infection\r\n* They have no evidence of liver damage owing to prior HCV infection','Patients with active HCV infection should be referred for HCV treatment and standard radiotherapy for the plasmacytoma','Known allergy to boron or excipients in the formulation','Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drugs including difficulty swallowing','Infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration','Diarrhea >= grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) categorization within 14 days of registration','Life-threatening illness unrelated to cancer','History of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide, or similar drugs','=< grade 2 peripheral neuropathy; patients with grade 1 peripheral neuropathy with pain will be excluded','No cardiac arrhythmias within 182 days of registration','No congestive heart failure (CHF) within 182 days of registration','No angina or myocardial infarction within 182 days of registration; in view of potential cardiac risk with lenalidomide, patients with stable angina will be excluded','Patients cannot be on systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use Ginkgo biloba or St. John’s worth within 14 days of registration','Corrected QT interval (QTc) < 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) =< 28 days before registration','Complete dental exam; complete elimination of dental and periodontal pathology including crowns on teeth susceptible to fracture, extraction of non-restorable or periodontally uncorrectable teeth; creation of an oral environment that the patient can efficiently maintain in a high state of health; and oral hygiene instruction to maintain excellent oral health'
NCT02521493,https://www.clinicaltrials.gov/ct2/show/record/NCT02521493?term=NCT02521493&rank=1,'Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])','Patient has one of the following: \r\n* Patients has previously untreated de novo AML and meets the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification\r\n** Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis\r\n* Patients has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)\r\n* Patients has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who:\r\n* Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR\r\n* Patients who have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart','Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD','There are no minimal organ function requirements for enrollment on this study\r\n* Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria','Each patient’s parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met','Patients with promyelocytic leukemia (French-American-British [FAB] M3)','Prior therapy\r\n* Patients =< 30 days from the last dose of cytarabine used for treatment of TMD'
NCT02392429,https://www.clinicaltrials.gov/ct2/show/record/NCT02392429?term=NCT02392429&rank=1,'Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea','Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)','Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)','Patients must have left ventricular ejection fraction (LVEF) > 45% or within institutional normal limits','Patients must be able to lie still for a 1.5 hour PET scan','Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine','Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center','The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)'
NCT02659800,https://www.clinicaltrials.gov/ct2/show/record/NCT02659800?term=NCT02659800&rank=1,'Patients must have histologically confirmed high grade glioma by pathology (World Health Organization [WHO] grade III and IV)','Patients’ post-operative treatment must have included at least 80% of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed','Patients must have CD4 =< 300 cells/mm^3 in the last week (7 days) of standard radiation + temozolomide treatment (58-60 Gy radiation with temozolomide 75 mg/m2 daily during radiation)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Patients must be able to provide written informed consent','Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use two birth control methods (either two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry and for the duration of study participation (through at least 90 days after the last study injection); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Dexamethasone dose must be provided for treatment group assignment:\r\n* Group A: patients not on dexamethasone or on a dose =< 0.75 mg daily (or equivalent of an alternative corticosteroid)\r\n* Group B: patients who require dexamethasone >= 4 mg daily (or equivalent of an alternative corticosteroid)\r\n** Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7; corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient’s group assignment','Patients receiving any other investigational agents are ineligible','Patients with known hypersensitivity to NT-I7 or any component used in the vehicle/formulation are ineligible','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NT-I7','Patients with human immunodeficiency virus (HIV) are excluded','Patients with a known or screening-period-determined corrected QT (QTc) interval > 450 msec and patients who require a therapy with a drug known to prolong the QT/QTc interval, are ineligible','Patients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn’s disease, autoimmune hepatitis, Wegener’s etc., are ineligible'
NCT02398773,https://www.clinicaltrials.gov/ct2/show/record/NCT02398773?term=NCT02398773&rank=1,'Capable and willing to provide informed consent','Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 7 days prior to FES PET/CT scan and [18F]-fluorodeoxyglucose (FDG)-PET/CT scan to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy or \r\n* Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study','Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor [AI], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed','Medically stable as judged by patient’s physician','Life expectancy must be estimated by patient’s physician at > 6 months','Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)','Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES','Patient must NOT be in liver failure as judged by the patient’s physician','Histologically confirmed metastatic breast cancer','Primary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-) by IHC; patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligible','The pathology report and either (1) tissue (blocks or an unstained slides) or (2) a photomicrograph of the ER IHC slides from at least one site of metastatic disease and/or from primary breast cancer must be available for central review and analysis\r\n* NOTE: if photomicrographs are submitted, the submission of hematoxylin and eosin (H&E), PR and Ki67 IHC’s, if performed, are also to be submitted','Patient must NOT have human epidermal growth factor-2 positive (HER2+) metastatic disease','Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy','Patient must NOT have received prior endocrine therapy for metastatic disease (i.e., must be first-line endocrine therapy for metastatic disease)','Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated > 2 years prior to diagnosis of metastatic disease\r\n* Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline','Patient must NOT have a history of > 1 line of administered chemotherapy for metastatic disease and must be off chemotherapy for a minimum of 2 weeks; prior chemotherapy in the adjuvant setting is allowed','Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as 1.5 cm or greater and visualized on PET/CT with [18F]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study','Patient must be able to lie still for a 20-30 minute PET/CT scan','Patient must NOT weigh more than the maximum weight limit for the table for the PET/CT scanner at the institution where the study is being performed','The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN (or current ACRIN) approval'
NCT02407405,https://www.clinicaltrials.gov/ct2/show/record/NCT02407405?term=NCT02407405&rank=1,'Patients must have positive genetic testing for NF1 in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory or a diagnosis of NF1 based on clinical National Institutes of Health (NIH) consensus criteria of at least one other diagnostic criterion in addition to the presence of a PN; NF1 mutation analysis will be performed on germline deoxyribonucleic acid (DNA) as described by Messiaen & Wimmer; histologic confirmation of tumor is not necessary in the presence of consistent clinical and imaging findings, but should be considered if malignant transformation of a PN is clinically suspected; additional criteria are as follows:\r\n* Six or more cafe-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1','Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable as per criteria above; measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the National Cancer Institute (NCI) Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as “typical PN” or “nodular PN” versus \"solitary nodular PN\" prior to enrollment','The PN must be inoperable, defined as a PN that cannot be surgically completely removed without risk for substantial morbidity due to: encasement of or close proximity to vital structures, invasiveness, or high vascularity of the PN; the PN either causes morbidity or it is growing and has the potential to cause morbidity such as (but not limited to): head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or are significantly disfiguring, and lesions of the extremity that cause limb hypertrophy or loss of function or pain; PN growth will be defined as a >= 20% increase in PN volume within approximately 3 years prior to enrollment on this trial','Patients must have a PN amenable to a percutaneous biopsy to participate in the biopsy portion of this study, and must be willing to undergo pre-, and on treatment tumor biopsies; there should be no contraindication for serial biopsies; NOTE: up to 10 patients who meet all criteria, but have PN which cannot be biopsied safely, will be eligible for the treatment portion of the study','Must be able to undergo serial MRI scans for response evaluation','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (patients who are wheelchair bound because of paralysis secondary to a plexiform neurofibroma should be considered ambulatory when they are up in their wheelchair; similarly, patients with limited mobility secondary to need for mechanical support (such as an airway PN requiring tracheostomy or continuous positive airway pressure [CPAP] will also be considered ambulatory for the purpose of the study)','Hemoglobin >= 10 g/dL (not requiring red blood cell [RBC] transfusions)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL (not requiring platelet transfusions)','Total bilirubin =< 1.5 upper limit of normal (ULN), with the exception of patients with Gilbert syndrome','Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) & aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3.0 X ULN','Creatinine =< upper limit of normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy','Normal ejection fraction (echocardiogram [ECHO]) >= 53% (if a range is given then the upper value of the range will be used) or cardiac MRI','Fridericia's corrected QT interval (QTcF) =< 450 msec','Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document','Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated','Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study','Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity, or if a patient with a surgical option refuses surgery\r\n* Since there is no standard effective chemotherapy for patients with NF1 and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, or other VEGFR inhibitors are eligible for enrollment\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and no prior radiation therapy should have been directed at the target PN\r\n* At least 4 weeks must have elapsed since receiving medical therapy directed at the PN\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing\r\n* Patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) before entering this study','Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees','Patients who are receiving any other investigational agents, or have received an investigational agent within the past 30 days','May not have a NF1 related tumor such as optic pathway glioma or malignant peripheral nerve sheath tumor, which requires treatment with chemotherapy or surgery','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements; patients with HIV who have adequate CD4 counts and who have no requirement for antiviral therapy will be eligible','Pregnant or breast-feeding females are excluded; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; abstinence is an acceptable method of birth control','Prior treatment with selumetinib or another specific MEK 1/2 inhibitor','Supplementation with vitamin E greater than 100% of the daily recommended dose','Inability to swallow capsules, since capsules cannot be crushed or broken','Inability to undergo MRI and/or contraindication for MRI examinations following the MRI protocol; prosthesis or orthopedic or dental braces that would interfere with volumetric analysis of target PN on MRI','Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption','Uncontrolled hypertension (despite medical therapy); blood pressure should be < 140/90 in accordance with American Heart Association definition of hypertension','While not an exclusion criterion, unless clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medications; in particular, patients should avoid medications that are known to either induce or inhibit the activity of hepatic microsomal isoenzymes CYP1A2, CYP2C19 and CYP3A4','Known cardiac disorder, including:\r\n* Known inherited coronary disease\r\n* Symptomatic heart failure (New York Heart Association [NYHA] class II-IV prior or current cardiomyopathy, or severe valvular heart disease)\r\n* Current cardiomyopathy\r\n* Severe valvular heart disease\r\n* Atrial fibrillation\r\n* Ejection fraction (ECHO) < 53%\r\n* QTcF > 450 msec','Known ophthalmologic conditions, such as:\r\n* Current or past history of central serous retinopathy\r\n* Current or past history of retinal vein occlusion\r\n* Known intraocular pressure (IOP) > 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of IOP); patients with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair\r\n* Subjects with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility\r\n* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal PN (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study','Known severe hypersensitivity to selumetinib or any excipient of selumetinib or history of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib','Have had recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access','Have any unresolved chronic toxicity with CTC AE grade >= 2, from previous anti-NF1 therapy, except for alopecia','Clinical judgment by the investigator that the patient should not participate in the study'
NCT02408861,https://www.clinicaltrials.gov/ct2/show/record/NCT02408861?term=NCT02408861&rank=1,'Participants must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; participants with uncontrolled Kaposi sarcoma are permitted (KS must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable KS despite HAART for greater than or equal to 3 months)\r\n* For participants in the 24 participant solid tumor cohort, only those histologies not known to respond to single agent nivolumab (such as pancreas, prostate, and microsatellite stable [MSS] colorectal cancer) will be excluded\r\n* For participants in the relapsed refractory HIV-cHL expansion cohort, participants must have histologically confirmed, relapsed/refractory (defined as relapsed/refractory to one or greater lines of therapy) HIV-associated classical Hodgkin lymphoma','HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant’s relevant medical history and/or current management of HIV infection','Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration; Note: for participants with Kaposi sarcoma, the following apply: at least five measurable cutaneous KS lesions or any number of lesions with systemic unresectable disease with no previous local radiation, surgical, or intralesional cytotoxic therapy that would prevent response assessment','Prior therapy for metastatic disease permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least 4 weeks prior to registration','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Leukocytes >= 2,000/mm^3, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Absolute neutrophil count >= 1,000/mm^3, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Platelets >= 75,000/mm^3, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation and must have a total bilirubin less than 3.0 mg/dL, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (serum glutamic oxaloacetic transaminase [SGOT])/ALT (serum glutamate pyruvate transaminase [SGPT]) =< 3 X ULN, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Creatinine < 1.5 UNL or creatinine clearance (CrCl) > 50 ml/min, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Hemoglobin >= 9 g/dL, within 2 weeks prior to enrollment','PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum albumin >= 2.8 g/dL, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Leukocyte count: no lower limit, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Absolute neutrophil count: > 500/mcL, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Platelets: > 50,000/mcL, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Hemoglobin: >= 9 g/dL unless bone marrow involvement secondary to Hodgkin lymphoma is present, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum albumin: >= 2.8 g/dL, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 × institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than 3.0 mg/dL), within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5 x ULN, within 2 weeks prior to enrollment','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (SGOT) / ALT (SGPT): =< 3 x ULN','PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Creatinine: < 1.5 x upper normal limit (UNL) or CrCl > 50ml/min, within 2 weeks prior to enrollment','HIV plasma HIV-1 ribonucleic acid (RNA) below detected limit obtained by Food and Drug Administration (FDA)-approved assays (limit of detection: 75) within 4 weeks prior to registration','CD4 counts: \r\n* For Stratum 1: CD4+ cell count greater than 200 cells/mm^3 obtained within 2 weeks prior to enrollment at any United States (U.S.) laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent\r\n* For Stratum 2: CD4 cell count between 100-200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent\r\n* Expansion Cohort: CD4 cell count for this cohort will be specified once Stratum 1 and Stratum 2 have completed enrollment\r\n* Solid Tumor Expansion Cohort: CD4+ cell count greater than 200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent\r\n* cHL Cohort: CD4 cell count of at least 100 cells/mm^3','Participants must be purified protein derivative (PPD) negative; alternatively, the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay can be used; an individual is considered positive for M. tuberculosis infection if the IFN-gamma response to tuberculosis (TB) antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control); the result must be obtained within 12 weeks prior to enrollment; PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment','Women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 72 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment','Participants who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV RNA) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided total bilirubin is =< 1.5 x institutional ULN, and AST (SGOT) and ALT (SGPT) must be =< 3 X institutional upper limit of normal, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/mL (if hepatitis B positive) within 2 weeks prior to enrollment','Ability to understand and to sign a written informed consent document','Participants who have received any other investigational agents within the 4 weeks prior to enrollment; concurrent radiation therapy is not permitted, except palliative (limited-field) radiation therapy, if all of the following criteria are met:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion','Participants with known brain metastases or leptomeningeal metastases must be excluded unless they qualify for enrollment as described below because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; participants with brain metastases are permitted if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks or more after treatment is complete and within 4 weeks prior to the first dose of nivolumab administration','History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab, nivolumab, or other agents used in study, or history of severe hypersensitivity reaction to any monoclonal antibody','Participants should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration; these drugs may interfere with the activity of ipilimumab and nivolumab if administered at the time of the first ipilimumab dose; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if >= 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted; use of anabolic steroids is permitted','Participants with clinical or radiographic evidence of pancreatitis are excluded','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Participants should be excluded if they have had prior treatment with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), anti-programmed cell death ligand 2 (PD-L2), anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways; prior immune modulating therapy including vaccines may be eligible; prior immune events must be evaluated and the risk for new events which may represent continued sub clinical disease or a new process at previously damaged site or immune potentiation (e.g. ipilimumab followed by IL2 causing bowel perforation, ipilimumab followed by indoleamine 2,3-dioxygenase [IDO] inhibitor resulting in clinical hypophysitis); please keep in mind that inflammatory events may occur weeks to months following the last dose of ipilimumab and possibly nivolumab; assessment of potential effects of prior therapy should include:\r\n* Immune status\r\n* Organ damage\r\n* Risk of autoimmunity\r\n* Immunopotentiation','The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except =< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs)','The participant has a primary brain tumor','Participant has >= grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative)','Opportunistic infection within the last 3 months','Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; participants with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and participants with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Participants who have had evidence of Clostridium (C.) difficile infection, active or acute diverticulitis, intra-abdominal abscess, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis, which are known risk factors for bowel perforation, should be evaluated for the potential need for additional treatment before coming on study','cHL COHORT ONLY: history of allogeneic transplant','Criteria for Solid Tumor Expansion and Lymphoma Cohorts:\r\n* Inclusion and exclusion criteria for this cohort are the same as above, with the following rule for CD4 count based on tolerability in Phase I; if, participants with lymphocyte T CD4 count between 100-200/mm^3 (Stratum 2) are shown to tolerate treatment in the Phase I dose de-escalation portion at the same dose level as those with CD4 counts > 200/mm^3 (Stratum 1), participants in the expansion cohort with CD4 counts >= 100/mm^3 are permitted; otherwise, the expansion is open to all solid tumor patients except those whose tumors are known not to respond to nivolumab (pancreas, prostate and MSS colon cancer); for the relapsed refractory HIV-cHL cohort, participants with CD4 count >= 100/mm^3 are permitted'
NCT02588443,https://www.clinicaltrials.gov/ct2/show/record/NCT02588443?term=NCT02588443&rank=1,'Histological documentation of primary adenocarcinoma of the pancreas','Surgically eligible for tumor resection with curative intent','Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1','Absolute neutrophil count (ANC) >= 1,500','Hemoglobin (Hgb) > 9','Platelets (Plt) > 100','Creatinine (Cr) < 1.5 upper limit of normal (ULN)','Total bilirubin =< 1.5 x ULN','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (values post biliary stenting allowed for eligibility)','Signed, written informed consent','Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms; in addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded','Patients with M1 disease or a history of M1 disease','Patients with any type of recurrent pancreatic adenocarcinoma','Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer','Previous treatment with any other compound that targets CD40','Concurrent treatment with any anticancer agent outside of this protocol','Prior allogeneic bone marrow transplant','History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen’s syndrome, vasculitis/arteritis, Behcet’s syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis; (vitiligo is allowed)','History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, hospitalization for acutely decompensated congestive heart failure','History of deep venous thrombosis or migratory thrombophlebitis (Trousseau)','Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer associated disseminated intravascular coagulation [DIC])','Prior allergic reactions attributed to other monoclonal antibodies','Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline','Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial','Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in dwelling catheters','Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)','Pregnancy or breast-feeding – female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment; women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method; female patients should not become pregnant while participating in this research study or for 90 days following therapy; male patients should not father a child while in this research study or for 90 days following therapy','Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures'
NCT02470091,https://www.clinicaltrials.gov/ct2/show/record/NCT02470091?term=NCT02470091&rank=1,'Female patients must have a bone age of equal to or greater than 12 years of age as determined by local read of appropriate radiographic imaging','Male patients must have a bone age of equal to or greater than 14 years of age as determined by local read of appropriate radiographic imaging','Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence','Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n* Note: patients in Cohort 1 will be stratified as follows:\r\n** Stratum 1: Patients >= 11 years of age but < 18 years\r\n** Stratum 2: Patients >= 11 years of age but < 50 years','Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment\r\n* Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment\r\n** Note: the definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection\r\n* Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as: \r\n** 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm\r\n* Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421\r\n** Note: this applies if AOST1421 is open to enrollment at the enrolling institution on the day the patient consents','Patient must have adequate tumor specimen available for submission','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL)\r\n* Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)\r\n* Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age','Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)','Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)','Patients who are receiving other cancer directed therapy at the time of enrollment','Patients who have previously received denosumab','Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium','Patients receiving bisphosphonates','Pre-existing conditions\r\n* Disorders associated with abnormal bone metabolism\r\n* Hypocalcemia that is not corrected with oral calcium supplementation\r\n* Vitamin D < 20 mg/mL\r\n* Paget’s disease\r\n* Prior history or current evidence of osteonecrosis of the jaw\r\n* Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery or planned invasive dental procedures during the anticipated course of study therapy\r\n* Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi syndrome) or congestive heart failure','Pregnancy and breast feeding\r\n* Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential\r\n* Lactating females who plan to breastfeed their infants while on study therapy and through 5 months after completion of study therapy\r\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 5 months after the end of study treatment','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02417701,https://www.clinicaltrials.gov/ct2/show/record/NCT02417701?term=NCT02417701&rank=1,'Patients must have histologically or cytologically confirmed stage IV or recurrent squamous cell lung cancer that harbors any of the NFE2L2 mutations; any KEAP1 mutation will be eligible','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients must have completed at least 1 prior line of systemic therapy; patients who have declined first line therapy or for whom first-line therapy would be clinically inappropriate, will be considered eligible for the trial','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Fasting serum glucose =< 130 mg/dL','Hemoglobin A1C (HBA1C) < 7.0%','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Patients with controlled diabetes are allowed on study; controlled diabetes is defined as fetal bovine serum (FBS) =< 130 mg/dL in the context of this study','Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, prior to study through 90 days (or longer, as mandated by local labeling [eg, USPI, SmPC, etc;]) after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; any woman who becomes pregnant while receiving MLN0128 (TAK-228) will be removed from the trial; men treated or enrolled on this protocol must also agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and 120 days after completion of MLN0128 (TAK-228) administration; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug','Ability to understand and the willingness to sign a written informed consent document','Ability to swallow oral medications','Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events from prior treatments','Patients who are receiving any other investigational agents','Patients with untreated central nervous system (CNS) metastases; patients with treated CNS metastases who are off steroids are eligible','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; no ischemic myocardial or cerebrovascular event, class III or IV heart failure, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228)','Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN0128','Patients previously treated with an mammalian TOR (mTOR) or PI3K inhibitor','Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs','Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C19 within 1 week preceding the first dose of study drug','Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)'
NCT02523014,https://www.clinicaltrials.gov/ct2/show/record/NCT02523014?term=NCT02523014&rank=1,'Documentation of disease:\r\n* Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review\r\n* Molecular documentation: presence of SMO, PTCH1 or NF2 mutation in tumor sample as documented by central laboratory\r\n* Progressive OR residual disease, as defined by the following: \r\n** Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions\r\n** Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months\r\n** Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; at least 24 weeks must have elapsed from completion of radiation to registration','Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins; multifocal disease is allowed','Prior treatment \r\n* Prior medical therapy is allowed but not required\r\n* No limit on number of prior therapies\r\n* No chemotherapy, other investigational agents within 28 days of study treatment\r\n* No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study\r\n* For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval > 24 weeks must have elapsed from completion of radiation therapy to registration\r\n* Steroid dosing stable for at least 4 days \r\n* Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue\r\n* No craniotomy within 28 days of registration','Not pregnant and not nursing:\r\n* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Patient history:\r\n* Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months\r\n* No metastatic meningiomas (as defined by extracranial meningiomas) allowed\r\n* No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug\r\n* No known active hepatitis B or C\r\n* No current Child Pugh class B or C liver disease\r\n* No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)\r\n* No uncontrolled diabetes defined as a known diabetic with hemoglobin A1C (HBA1C) > 7.5 OR fasting glucose > 140\r\n* No uncontrolled hypertension defined as blood pressure (BP) > 140/90\r\n* No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration','Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min','Urine protein:creatinine ratio (UPC) =< 45 mg/mmol; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)','Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert’s disease','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)','Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)','Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)','Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)'
NCT02595424,https://www.clinicaltrials.gov/ct2/show/record/NCT02595424?term=NCT02595424&rank=1,'Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal (GI) origin; primary tumors arising from the lung, gynecologic organs or prostate are not permitted','Patients must have pathologically/histologically confirmed tumor of non-small cell histology','Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization and must be acquired by multiphasic computed tomography (CT) or contrast magnetic resonance imaging (MRI)\r\n* NOTE: positron emission tomography (PET)-CT scans are allowed provided the CT portion of the exam is equivalent to a diagnostic CT scan and includes both oral and IV contrast','Patients may not have had any prior systemic treatment for this malignancy (for example chemotherapy or somatostatin analogues); prior palliative radiation is permitted but radiated lesions may not be used for measurement','Patients may not have received any of the protocol agents within 5 years prior to randomization','Any prior surgeries must have been completed at least 4 weeks prior to randomization','Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2','Patients may not be receiving any other investigational agents while on study treatment','Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed','Leukocytes >= 3,000/mm^3','Absolute neutrophil count >= 1,500/mm^3','Hemoglobin >= 9 g/dL','Platelets >= 100,000/mm^3','Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN or (=< 5 X institutional ULN if the patient has liver metastases)','Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation','Patients must have a life expectancy of >= 12 weeks as determined clinically by the treating physician','Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible','Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency will be excluded','Patients must NOT have active or uncontrolled infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia or a serious psychiatric illness/social situation that would limit compliance with study requirements','Patients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consent','Patients must NOT have a history of allergic reactions attributed to compounds of similar chemical or biochemical composition to cisplatin, carboplatin, etoposide, temozolomide or capecitabine','Patients must NOT have absorption issues that would limit the ability to absorb study agents','Patients with a history of the following within =< 12 months of study entry are not eligible:\r\n* Arterial thromboembolic events\r\n* Unstable angina\r\n* Myocardial Infarction','Patients with symptomatic peripheral vascular disease are not eligible','Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR\r\n* Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years','Women must not be pregnant or breast-feeding \r\n* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study','Patients must be able to swallow pills','Patients must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for the treatment and the protocol','Patients who are known to have human immunodeficiency virus (HIV) or are on combination antiretroviral therapy are ineligible'
NCT02446600,https://www.clinicaltrials.gov/ct2/show/record/NCT02446600?term=NCT02446600&rank=1,'Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through Myriad, Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports\r\n* Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months (or 182 days) after last receipt of platinum-based therapy\r\n* Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy','Patients must have signed an approved informed consent and authorization permitting release of personal health information','Patients must have evaluable disease – defined as one of the following:\r\n* Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR\r\n* Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)','Prior therapy:\r\n* Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Patients may have received an unlimited number of platinum-based therapies in the recurrent setting\r\n* Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line\r\n* Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed\r\n* Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable','Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky >= 60%)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 10 g/dL','Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine collection demonstrating =< 500 mg over 24 hours','Total bilirubin =< 1.5 x the institutional ULN','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional ULN','Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm','Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib','Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol','Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III','Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions','Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks','Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)','Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed','Patients may not have previously received a PARP inhibitor','CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease','Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib','Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution','History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula','History of intra-abdominal abscess within the past 3 months','Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs','Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)','Any concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence','Patients with any of the following:\r\n* History of myocardial infarction within six months\r\n* Unstable angina\r\n* Resting electrocardiogram (ECG) with clinically significant abnormal findings\r\n* New York Heart Association (NYHA) classification of III or IV','If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function','History of stroke or transient ischemic attack within six months','Any prior history of hypertensive crisis or hypertensive encephalopathy','Clinically significant peripheral vascular disease or vascular disease (including aortic aneurysm or aortic dissection)','Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib','Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cediranib or olaparib','Known human immunodeficiency virus (HIV)-positive individuals are ineligible','Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies','No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated','No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)'
NCT02502266,https://www.clinicaltrials.gov/ct2/show/record/NCT02502266?term=NCT02502266&rank=1,'Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory\r\n* Note: Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be accepted; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA rearrangement is required; a copy of Myriad or other BRCA mutational analysis (positive or variants of unknown significance [VUS] or negative) reports will be requested but not required for study enrollment','Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease','Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable','Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])','No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit','Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed','Patients may not have previously received a PARP-inhibitor','Patient must have provided study specific informed consent prior to study entry','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 10 g/dL','Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN; if intrahepatic liver metastases are present, AST and ALT must be =< 5 times institutional ULN','Creatinine =< 1.5 x the institutional ULN','Urine protein: creatinine ratio urine protein creatinine (UPC) of =< 1 OR less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with 2+ proteinuria on dipstick must also have a 24-hour urine collection demonstrating protein of =< 500 mg over 24 hours','Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.0','Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; it is strongly recommended that patients who are on three antihypertensive medications must be actively followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to cediranib alone and the combination of olaparib and cediranib arms','Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits','Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib','Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of olaparib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions','Any other investigational agents within the past 4 weeks','Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, nintedanib, and trebananib; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed','Prior use of PARP-inhibitors','CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease','Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib','Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs','History of intra-abdominal abscess within the past 3 months','History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula','Dependency on IV hydration or total parenteral nutrition (TPN)','Any concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence','Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug','Patients with any of the following:\r\n* History of myocardial infarction within six months\r\n* Unstable angina\r\n* Resting electrocardiogram (ECG) with clinically significant abnormal findings\r\n* New York Heart Association functional classification of III or IV','If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function','History of stroke or transient ischemic attack within six months','Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)','Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted','Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated\r\n* No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)','Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies','Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements','Known human immunodeficiency virus (HIV)-positive individuals are ineligible','Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible\r\n* Strong inhibitors and inducers of UGT/PgP should be used with caution','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cediranib or olaparib'
NCT02443077,https://www.clinicaltrials.gov/ct2/show/record/NCT02443077?term=NCT02443077&rank=1,'PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)','Patients must have paraffin tissue from the diagnostic or relapse biopsy available to be submitted for central pathology review and integral molecular subtyping; this review is mandatory prior to registration to confirm eligibility and should be initiated as soon as possible; determination of cell-of-origin subtype will be performed using the lymphoma subtyping test (LST) assay','ELIGIBILITY CRITERIA (STEP 1)','Diagnosis of World Health Organization (WHO) diffuse large B-cell lymphoma, high grade B-cell lymphoma not otherwise specified, or B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma','Determination of activated B-cell–like (ABC) subtype by pre-registration central review','Patient must be deemed eligible to proceed with high-dose chemotherapy and autologous stem cell transplantation by local transplant center','New York Heart Association class I or less; ordinary physical activity does not cause undue fatigue, palpitations, dyspnea, or angina pain; patients 60 years or older must have a left ventricular ejection fraction (LVEF) at rest >= 40% measured by echocardiogram or multi-gated acquisition (MUGA)','Diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)','Forced expiratory volume in 1 second (FEV1) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)','Forced vital capacity (FVC) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)','Total Bilirubin =< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert’s syndrome','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN)','Creatinine =< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) >= 40 mL/min by Cockcroft-Gault formula','Prothrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN','Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. R-CHOP, DA-EPOCH-R, etc)','No more than 3 prior regimens for large cell component (e.g. one induction and two salvage therapies); monoclonal antibody alone or involved field/involved site radiotherapy do not count as lines of therapy','Prior use of ibrutinib is allowed unless patient has had disease progression while receiving ibrutinib','Patient must have chemosensitive disease as defined by at least a partial response to salvage therapy at their latest assessment','No major surgery =< 7 days prior to registration and no minor surgery =< 3 days prior to registration (with the exception of intravenous access placement, e.g. Hickman or peripherally inserted central catheter [PICC])','Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test must be obtained within 14 days prior to registration\r\n* Women of childbearing potential must use adequate contraception from study start to one month after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence; men must practice complete abstinence or agree to use an adequate contraception method from study start to one month after the last dose of protocol therapy','Patients should not require chronic use of strong CYP3A inhibitors or strong CYP3A inducers','Patients should not require concurrent therapeutic doses of steroids (> 20 mg of prednisone/day or equivalent) unless they need them for the indications; steroids should be discontinued for 14 days before starting protocol treatment','Human immunodeficiency virus (HIV) infected patients are eligible provided they meet all other eligibility criteria, and:\r\n* There is no prior history of acquired immunodeficiency syndrome (AIDS) defining conditions other than historically low CD4+ T-cell count or B-cell lymphoma\r\n* In the opinion of an expert in HIV disease, prospects for long-term survival are excellent were it not for the diagnosis of lymphoma\r\n* Use of HIV protease inhibitors as part of the anti-HIV regimen OR as a pharmacologic booster is not allowed\r\n* Zidovudine is not allowed\r\n* Once daily combination pills for HIV containing a pharmacologic booster such as cobicistat are not allowed\r\n* Patients with multi-drug resistant HIV are not eligible','Patients cannot have:\r\n* Active central nervous system or meningeal involvement by lymphoma; patients with a history of central nervous system (CNS) or meningeal involvement must be in a documented remission by cerebrospinal fluid (CSF) evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 91 days prior to registration\r\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\r\n* A known bleeding diathesis\r\n* Requirement for warfarin or similar vitamin K antagonists; these drugs are prohibited 28 days prior to the first treatment and throughout the trial\r\n* History of stroke or intracranial hemorrhage =< 6 months before treatment\r\n* Currently active, clinically significant hepatic impairment (Child-Pugh class B or C according to the Child Pugh classification\r\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study\r\n* Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; (PCR positive patients will be excluded)','Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2'
NCT02423057,https://www.clinicaltrials.gov/ct2/show/record/NCT02423057?term=NCT02423057&rank=1,'Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy','Patients must have measurable or evaluable disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy > 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal','Women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of TdCyd','Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 2 weeks since any prior palliative radiation or cyberknife therapy; patients must have recovered to grade 1 from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment','Ability to understand and the willingness to sign a written informed consent document','Willingness to provide blood and urine samples for research purposes','Ability to swallow pills/capsules','Patients who are receiving any other investigational agents','Pregnant women and women who are breastfeeding are excluded from this study','Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known human immunodeficiency virus (HIV) infection requiring protease inhibitor therapy, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 1 month after treatment of the brain metastases; patients should not be on anti-seizure medications; these patients may be enrolled at the discretion of the principal investigator','Malabsorption syndrome or other conditions that would interfere with intestinal absorption','Patients who cannot tolerate pneumocystis jirovecii pneumonia (PJP) prophylaxis (i.e., known Bactrim and pentamidine allergies)'
NCT02453620,https://www.clinicaltrials.gov/ct2/show/record/NCT02453620?term=NCT02453620&rank=1,'Dose escalation: patients must have histologically or cytologically confirmed solid tumor malignancy that is metastatic or unresectable and for whom either standard curative or palliative measures do not exist or are no longer effective, or for whom anti-PD-L1/cytotoxic T-lymphocyte antigen (CTLA)-4 is appropriate','Dose expansion: patients must have histologically or cytologically confirmed invasive adenocarcinoma of the breast (human epidermal growth factor receptor 2 [HER2]-negative) that is locally advanced/metastatic and has progressed despite standard therapy; at least 1 prior chemotherapy regimen in the metastatic setting, and two lines of hormonal therapy (administered in the adjuvant or metastatic setting) for patients with hormone receptor-positive disease; NOTE: HER2-negativity will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines; patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible','Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >= 70%)','Life expectancy of greater than 12 weeks','Hemoglobin (HgB) >= 9.0 g/dL','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert’s syndrome with documented approval by the protocol chair','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional ULN','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min using the modified Cockcroft-Gault formula','Negative (serum or urine) pregnancy test, for women of childbearing potential only','Patients must have measurable or evaluable/non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; patients with bone only disease are not eligible; NOTE: for patients with metastatic disease in the liver, tumor burden should not be deemed significant (e.g., to no more than 30% of total liver volume as assessed by local review/investigator)','Adequate pulmonary function as assessed by oxygen saturation >= 90% when ambulating and not requiring supplemental oxygen','Patient must have an accessible non-bone tumor lesion from which serial core biopsy specimen can be obtained; NOTE: if baseline biopsy is attempted and is unsuccessful (e.g., patient intolerance, inadequate tissue), the patient will still be considered eligible for the study; if core biopsy is not possible, other methods may be approved in advance by the protocol chair/designee','Women of child-bearing potential (WOCPB) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at baseline; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; NOTE: a WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes','Willingness to provide tissue and blood samples for mandatory translational research','Willingness to return to the enrolling institution for follow-up','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows:\r\n* Chemotherapy < 3 weeks prior to registration\r\n* Hormone therapy < 2 weeks prior to registration\r\n* Targeted therapy (other than below) < 2 weeks prior to registration (e.g., tyrosine kinase inhibitors)\r\n* Trastuzumab < 6 weeks prior to registration\r\n* Bevacizumab < 6 weeks prior to registration\r\n* Nitrosoureas/mitomycin C < 6 weeks prior to registration\r\n* Radiotherapy < 3 weeks prior to registration (NOTE: a previously irradiated lesion may not be used as a target lesion unless there is evidence of post-radiation progression)\r\n* Surgery < 3 weeks prior to registration\r\n* Other approved or investigational agents < 3 weeks prior to registration unless otherwise noted by the protocol chair\r\n* Patients who have received prior epigenetic (e.g., histone deacetylase [HDAC] inhibitors such as entinostat, panobinostat, vorinostat, romidepsin or demethylating agents such as 5-azacitidine or decitabine) immunomodulatory or other checkpoint inhibitors should only be considered after discussion with the protocol chair\r\n* Those who have not recovered from acute adverse events to grade < 2 or baseline due to agents administered, with exception of alopecia, unless approved by the protocol chair','Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition entinostat, nivolumab, or ipilimumab; history of severe hypersensitivity reaction to any monoclonal antibody','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','NOTE: patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity; NOTE: subjects must have baseline oxygen/saturation level requirements as above','Patients with active or untreated brain metastases or leptomeningeal metastases are excluded from this clinical trial; NOTE: patients with previously treated brain metastases must have stable neurologic status and magnetic resonance imaging (MRI) imaging following local therapy (surgery or radiation) for at least 4 weeks, with no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration (stable low dose dexamethasone allowed at discretion of protocol chair)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that in the judgment of the investigator would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued','Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; patients who have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C antibody (hepatitis C virus [HCV] Ab)/ribonucleic acid (HCV RNA) indicating acute or chronic infection are also ineligible (baseline testing required)','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Patients requiring concurrent administration of valproic acid are also excluded','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study','Another active malignancy =< 3 years prior to registration with the exception of non-melanotic skin cancer or carcinoma-in-situ of any type; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer; any malignancy considered to be indolent and that has never required therapy may allowed at the discretion of the protocol chair'
NCT02564198,https://www.clinicaltrials.gov/ct2/show/record/NCT02564198?term=NCT02564198&rank=1,'Part A: Patients with recurrent or refractory non-CNS solid tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except patients with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); patients in part A cannot have CNS metastases','Part B: Patients with recurrent or refractory CNS tumors will be eligible and must have a histological verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with CNS-germ cell tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-HCG','Patients must have either measurable or evaluable disease','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky performance status >= 50% for patients > 16 years of age and Lansky >= 50 for patients =<16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to ramucirumab','For patients with solid tumors without known bone marrow involvement:','Peripheral absolute neutrophil count (ANC) >= 1000/mm^3','Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts specified above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity.','Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: \r\n* 1 to < 2 years: 0.6 mg/dL (male), 0.6 mg/dL (female)\r\n* 2 to < 6 years: 0.8 mg/dL (male), 0.8 mg/dL (female)\r\n* 6 to < 10 years: 1 mg/dL (male), 1 mg/dL (female)\r\n* 10 to < 13 years: 1.2 mg/dL (male), 1.2 mg/dL (female)\r\n* 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Serum albumin >= 2 g/dL','Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study','A blood pressure (BP) =< the 95th percentile for age, height, and gender, and not receiving medication for treatment of hypertension; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP','International normalized ratio (INR) =< 1.5','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use a highly effective method of contraception during protocol therapy and for at least 3 months after the last dose of ramucirumab; a highly effective method of contraception is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly; barrier methods used alone are not highly effective methods of contraception; for female patients, if a barrier method is used, a hormonal method must be used with it to ensure that pregnancy does not occur; abstinence is an acceptable method of birth control; those who become pregnant while on treatment with ramucirumab must discontinue immediately and consult their treating physician','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients who are chronically receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs are not eligible','Patients who are currently receiving anti-platelet agents are not eligible','Patients who are receiving anti-hypertensive medications for control of blood pressure at the time of enrollment are not eligible for this trial','Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or Coumadin are not eligible for this trial','Patients who are currently receiving belimumab (a monoclonal antibody for systemic lupus erythematosus) are not eligible','Patients who are currently receiving bisphosphonate derivatives are not eligible','Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* Surgical or other wounds must be adequately healed prior to enrollment; Note: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy','Bleeding and thrombosis:\r\n* Patients with evidence of active bleeding: intratumoral hemorrhage by current imaging, or bleeding diathesis are not eligible\r\n* Patients with known or prior history in prior 3 months of esophageal varices are not eligible\r\n* Patients with a history of CNS arterial/venous thromboembolic events including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study enrollment are not eligible\r\n* Patients with a history of deep vein thrombosis (including pulmonary embolism) within 3 months prior to study enrollment are not eligible\r\n* Patients with a history of hemoptysis or other signs of pulmonary hemorrhage within 3 months prior to study enrollment are not eligible\r\n* Patients with a history of >= grade 3 bleeding disorders, vasculitis, or had a significant (>= grade 3) episode from the gastrointestinal bleeding, within 6 months prior to enrollment are not eligible\r\n* For part B: patients with CNS tumors and evidence of new CNS hemorrhage of more than punctate size and/or more than three foci of punctate hemorrhage on baseline magnetic resonance imaging (MRI) obtained within 14 days prior to study enrollment are not eligible; Note: echocardiogram (ECHO) gradient MRI sequences per institutional guidelines are required for patients with CNS tumors','Patients with known cardiac disease per the New York Heart Association definition such as myocardial infarction, severe or unstable angina, peripheral vascular disease, or congestive heart failure or peripheral vascular disease are not eligible','Patients who have a history of fistula, gastrointestinal ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible','Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible','Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible','Immunocompromised patients (other than that related to the primary oncologic diagnosis or to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT02466971,https://www.clinicaltrials.gov/ct2/show/record/NCT02466971?term=NCT02466971&rank=1,'Patient has a new, unrated histologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone ; the presence or absence of para?aortic lymph node metastasis will be based on pre-therapy 18F?FDG PET/CT; if the baseline 18F?FDG PET/CT identifies hypermetabolic para?aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F?FDG PET/CT scan','Patient must provide study specific informed consent prior to study entry','Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent','Absolute neutrophil count > 1,500/uL','Platelets > 100,000/uL','Hemoglobin > 10 g/dL','Total bilirubin < 2.0 mg/dL','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal','Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal','Creatinine =< 1.5 mg/dL to receive weekly cisplatin\r\n* Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used','Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)','Patient has a life expectancy of greater than 20 weeks','Patient does not have known brain metastases (testing optional)','Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible','Patient does not have a known allergy to compounds of similar or biologic composition as triapine','Patient does not have known glucose?6?phosphate dehydrogenase (G6PD) deficiency (G6PD testing optional)','Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)','Patient has another concurrent active invasive malignancy','Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician','Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; proteinuria or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements','Patient is receiving another investigational agent for the treatment of cancer','Patient is currently pregnant; patient must agree to use two forms of birth control if they are of child-bearing potential','Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible','Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation','Patients with self-reported or known diagnosis of G6PD deficiency'
NCT02474173,https://www.clinicaltrials.gov/ct2/show/record/NCT02474173?term=NCT02474173&rank=1,'Patients must have histologically confirmed measurable or unmeasurable advanced or metastatic breast cancer for which standard curative measures do not exist or are no longer effective \r\n* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Primary and/or metastatic breast tumor must be negative for over-expression of estrogen and progesterone receptors; patients with weak estrogen receptor and/or progesterone receptor expression (< 10% on immunohistochemistry [IHC]) will be eligible','Primary and/or metastatic breast tumor must be negative for human epidermal growth factor receptor (HER-2/neu) over-expression based on IHC (0 or 1+, 2+ if fluorescence in-situ hybridization [FISH] test is negative) or FISH (HER2/copy number of centromere of chromosome 17 [CEP17] ratio < 2.0 or < 4 Her-2/neu signals per nucleus)','Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible','Prior taxane is allowed (as long as the patient is not experiencing grade > 1 neuropathy and had no history of disease progression on a taxane therapy within 3 months prior to study enrollment)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Leukocytes >= 2,000/uL','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Total bilirubin less than or equal to the institution's upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (except for patients with liver metastases in whom AST/ALT can be < 5 x institutional upper limit of normal)','Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal','Left ventricular ejection fraction of > 50% on baseline echocardiography or multi-gated acquisition (MUGA) scan','Corrected QT interval (QTc) of < 480 milliseconds','Female subjects with child bearing potential must have a negative pregnancy test at screening; child bearing potential is defined as sexually active patients with menses less than 1 year prior to enrollment, < 65 years of age, have no history of oophorectomy or hysterectomy','Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and 3 months after completion of study treatment administration; adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study','Patients who are receiving any other investigational agents within 4 weeks or 5 half-lives (whichever is later) prior to the first dose of the study regimen','Prior radiation therapy within 2 weeks prior to the first dose of the study regimen','Patients in whom prior treatment related toxicities have not recovered to grade 1 or less (except for alopecia)','Recent initiation of bone modifying therapy with a bisphosphonate or denosumab unless it has been started more than 4 weeks prior to the first dose of the study regimen; patients who are already enrolled in this study can initiate bone modifying therapy after the first set of re-staging scans (>= 8 weeks from cycle 1, day 1)','Prior therapy with AT13387 or another HSP90 inhibitor','Patients with known brain metastases should be excluded from this clinical trial; however, patients with previously treated and stable brain metastases are eligible as long as they are no longer requiring steroids, completed radiation therapy more than 2 weeks prior to the first dose of study regimen and have no seizures or worsening neurologic symptoms','History of grade 3-4 immediate hypersensitivity reaction to paclitaxel','History of clinically significant allergic reactions attributed to compounds of similar chemical or biologic composition to AT13387 or paclitaxel','The use of CYP2C8 and CYP3A4 inhibitors/inducers while not prohibited in this study, is discouraged whenever feasible; concurrent use of strong CYP2C8 and CYP3A4 inhibitors/inducers should be documented and the principal investigator (PI) of the study shall be notified prior to dosing; as part of the enrollment/informed consent procedures, the patients will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AT13387 and paclitaxel','Patients who are human immunodeficiency virus (HIV) positive on highly active anti-retroviral therapy (HAART) will be excluded from the study','Inability to understand and sign informed consent','Any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient'
NCT02484430,https://www.clinicaltrials.gov/ct2/show/record/NCT02484430?term=NCT02484430&rank=1,'World Health Organization (WHO)-defined acute lymphoblastic leukemia and either:\r\n* Relapsed after achieving remission\r\n* Refractory to therapy\r\n* Newly diagnosed and ineligible for intensive chemotherapy induction\r\nNote: patients with T lineage and B lineage ALL are eligible for this trial; likewise, patients with Philadelphia chromosome positive (Ph+) (as long as they are not candidate for other therapies for Ph+) and Ph- ALL are eligible','Bone marrow blasts of at least 10%','At least 4 weeks away from any previous antineoplastic or investigational agent; patients may receive hydroxyurea or glucocorticoids for suppression of leukocytosis, but these must be stopped at least 24 hours (h) prior to initiation of therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of > 2 months','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine =< 1.5 x institutional upper limit of normal','Fasting blood glucose (FBG) < 130 mg/dL','Hemoglobin A1C (HbA1C) < 7.0%','Relapse after SCT is allowed but no active graft-versus-host disease (GVHD) as per treating physician; also must not exceed the number of prior induction regimens listed above; SCT does not count as line of therapy','Negative serum pregnancy test result; Note: women of child-bearing potential and men must agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), Summary of Product Characteristics (SmPC), etc]) after the last does of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN0128 (TAK-228) administration','Ability to understand and the willingness to sign a written informed consent document','No prior therapy with mTOR inhibitors except for rapalog treatment as part of graft-versus-host (GVH) prophylaxis or treatment','Human immunodeficiency virus (HIV) infected patients (if HIV positive)\r\n* HIV infected individuals are eligible provided they meet all the protocol eligibility criteria in addition to the following:\r\n** No history of acquired immune deficiency syndrome (AIDS) defining illness other than a historic CD4+ T-cell nadir < 200/mm^3\r\n** Prior to leukemia diagnosis, the HIV disease was uncomplicated as evidenced by:\r\n*** The CD4+ T-cell counts were generally in excess of 300/mm^3\r\n*** The HIV viral loads were less than 200 copies/ml if on anti-HIV therapy\r\n*** If the HIV is newly diagnosed or there is no history of using anti-HIV therapy, there are no AIDS defining conditions or other HIV-related symptoms\r\n*** Zidovudine is not allowed as part of the anti-HIV therapy','Patients with diabetes controlled by diet or medication are allowed on trial; controlled diabetes is defined as FBG < 130 mg/kL in the context of this study','Patients who have had chemotherapy or radiotherapy =< 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; treatment with glucocorticoids, hydroxyurea, and tyrosine kinase inhibitors is allowed up to 24 hour prior to initiation of therapy','Patients with white blood cell (WBC) > 30,000 are not eligible to start therapy; however, it is permissible to use glucocorticoids and/or hydroxyurea to diminish peripheral WBC to less than 30,000 provided these agents are stopped at least 24 hours prior to the first dose of MLN0128 (TAK-228)','Patients who are receiving any other investigational agents','Patients with known other active cancers; skin cancers (basal or squamous) are exempted','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228)','There are no prohibitions of specific medications on the basis of anticipated drug-drug interactions','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; no ischemic myocardial or cerebrovascular event, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228)','Any patient receiving chronic corticosteroid administration prior to study enrollment is ineligible','Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes','Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs'
NCT02484443,https://www.clinicaltrials.gov/ct2/show/record/NCT02484443?term=NCT02484443&rank=1,'Patients must have histologic diagnosis of osteosarcoma at original diagnosis','Patients must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:\r\n* Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment**\r\n* Pathologic confirmation of metastases from at least one of the resected sites\r\n** For patients with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery\r\n* Note: If surgery related changes such as atelectasis are seen on the post-operative computed tomography (CT) scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected; patients with positive microscopic margins will be eligible to enroll','Patient must have adequate tumor specimen available for submission','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive anti-cancer therapy: must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Radiation therapy (RT): >= 2 weeks for local palliative radiation therapy (RT) (small port); >= 6 weeks must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation\r\n* Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies','Patient must not have received pegfilgrastim within 14 days of enrollment','Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment','Patient must not have received immune suppressants: corticosteroids (for other than allergic reactions and anaphylaxis), cyclosporine or tacrolimus within 7 days of enrollment\r\n* Note: the use of topical and/or inhalational steroids is allowed','Total absolute phagocyte count (APC = [%neutrophils + %monocytes) x white blood cells [WBC]) is at least 1000/uL','Platelet count >= 50,000/uL','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* 1 month to < 6 months: 0.4 (male) 0.4 (female)\r\n* 6 months to < 1 year: 0.5 (male), 0.5 (female)\r\n* 1 to < 2 years: 0.6 (male), 0.6 (female)\r\n* 2 to < 6 years: 0.8 (male), 0.8 (female)\r\n* 6 to < 10 years: 1 (male), 1 (female)\r\n* 10 to < 13 years: 1.2 (male), 1.2 (female)\r\n* 13 to < 16 years: 1.5 (male), 1.4 (female)\r\n* >= 16 years: 1.7 (male), 1.4 (female)','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)','Shortening fraction of >= 27% by echocardiogram, or','Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram','No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry > 94%','Patient has no known history of seizure disorder','Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2','Patients with distant bone metastases at original diagnosis or relapse (patients with only skip lesions will be eligible)','Patients with concurrent local and pulmonary recurrence at the time of enrollment; note: patients who had local recurrence previously that has been treated and now present with an isolated pulmonary recurrence and meet the surgical resection criteria stated above will be eligible','Patients with primary refractory disease with progression of the primary tumor on initial therapy','Patients with CNS disease or other sites of extra-pulmonary metastases at the time of most recent episode of disease recurrence preceding enrollment','Patients with a prior hypersensitivity reaction to sargramostim','Patients who have received prior anti-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigen','Female patients who are pregnant are ineligible','Lactating females are not eligible unless they have agreed not to breastfeed their infants','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation; patients should maintain adequate contraception for a minimum of 2 months after the last dose of ch14.18 (dinutuximab)'
NCT02496663,https://www.clinicaltrials.gov/ct2/show/record/NCT02496663?term=NCT02496663&rank=1,'Patients with stage IV or recurrent/metastatic histologically confirmed non-small cell lung cancer (NSCLC)','NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q or for EGFR Exon 20 insertion expansion cohort D, NSCLC must harbor an EGFR Exon 20 insertion performed by a Clinical Laboratory Improvement Act (CLIA) certified test','For Dose escalation cohort - progressive disease on at least one prior EGFR-tyrosine kinase inhibitor (TKI) (previous treatment with 3rd generation EGFR-TKI including AZD9291 allowed for dose escalation)','For Dose Expansion Cohort A: patient must 1) have progression of disease on erlotinib, gefitinib or afatinib as last previous systemic treatment, 2) have biopsy of tumor taken after progression on erlotinib, gefitinib or afatinib which must be EGFR-T790M negative confirmed by central testing prior to treatment (if EGFR-T790M status is unknown, patients may consent for trial and for biopsy and testing for EGFR T790M will be performed as part of initial biopsy for trial), and 3) be treatment naive to 3rd generation EGFR-TKI (rociletinib, EGFR inhibitor HM61713 [HM61713] and AZD9291) and EGFR monoclonal antibodies','For Dose Expansion Cohort B: patient must 1) have progression of disease on a 3rd generation EGFR-TKI such as AZD9291, rociletinib, HM61713, 2) be treatment naive to an EGFR monoclonal antibody, and 3) have a biopsy of tumor taken after progression on last EGFR-TKI that indicates loss of EGFR-T790M (EGFR-T790M negative) confirmed by central testing prior to treatment (if EGFR-T790M status is unknown, patients may consent for trial and for biopsy, and testing for EGFR T790M will be performed as part of initial biopsy for trial)','For Dose Expansion Cohort C: patient must 1) have progression of disease on a 3rd generation EGFR-TKI such as AZD9291, rociletinib, HM61713, 2) be treatment naive to an EGFR monoclonal antibody, 3) have a biopsy of tumor taken after progression on last EGFR-TKI that indicates preservation of EGFR-T790M post-progression on 3rd generation EGFR-TKI with biopsy confirmation by central testing prior to treatment (if EGFR-T790M status is unknown, patients may consent for trial and for biopsy, and testing for EGFR T790M will be performed as part of initial biopsy for trial','For Dose Expansion Cohort D: patient must 1) tumor that harbors an EGFR Exon 20 insertion by a CLIA certified test, and 2) have progressive disease on or after platinum based chemotherapy, and 3) be treatment naive to both EGFR-TKI and EGFR monoclonal antibody','Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent for a fresh tumor biopsy; (mandatory for Cohorts A, B, C; optional for dose escalation and Cohort D)','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension >= 10 mm (>= 1 cm) by computed tomography (CT) imaging or magnetic resonance imaging (MRI) within 42 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic; laboratory parameters are not acceptable as the only evidence of disease','Any number of prior therapies is allowed','Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Patients must have the ability to swallow tablets','Life expectancy of greater 3 months','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal','Creatinine =< 1.5 x ULN OR','Creatinine clearance >= 50 mL/min','Women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and for 3 months for women and 6 months for men following the date of the last dose of AZD9291 and/or necitumumab:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 3 months after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 6 months following completion of therapy','Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post menopausal (amenorrheic for at least 12 months); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Patients with untreated brain metastases are allowed provided that the patient is clinically asymptomatic and stable; patients with a prior history of symptomatic brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases at enrollment\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration\r\n* The brain metastases are stable on pre-registration imaging','Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs','Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2','Ability to understand and the willingness to sign a written informed consent document','Major surgery within 21 days of starting protocol treatment','Patients must discontinue previous EGFR-TKI at least 7 days prior to study enrollment','Patients who are receiving any other investigational agents','Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease','Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects of CYP3A4','Patients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, gastrointestinal disease limiting absorption of AZD9291 such as a malabsorption syndrome or inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements','Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec','Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiography (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)','Congenital long QT syndrome or family history of long QT syndrome','Left ventricular ejection fraction < 50% on echocardiogram or multi-gated acquisition (MUGA)','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD9291 and necitumumab','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT02498613,https://www.clinicaltrials.gov/ct2/show/record/NCT02498613?term=NCT02498613&rank=1,'Patients must have histologically confirmed, metastatic or unresectable malignancy of the following types: (a) non-small cell lung cancer (NSCLC), (b) triple-negative breast cancer (TNBC; defined by estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1% and HER2 1+ or less by immunohistochemistry [IHC]; if HER-2 expression is 2+, a negative fluorescence in situ hybridization [FISH] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC)','Must have received at least one line of standard systemic treatment for locally advanced or metastatic disease setting of the respective tumor type; for NSCLC, it is either PD-1/PD-L1 inhibitor, or platinum-containing chemotherapy, or an EGFR tyrosine kinase inhibitor or an ALK inhibitor if sensitizing mutation present; TNBC: platinum-containing chemotherapy; PDAC: fluorouracil (5-FU-), gemcitabine-, or taxane-containing chemotherapy either with or without radiation therapy; SCLC: platinum-containing chemotherapy for limited or extensive stage disease','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1','Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study principal investigator (PI)','Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky >= 50%)','Life expectancy of >= 4 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin > 9 g/dL','Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN','Creatinine =< 1.5 x ULN OR','Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','A urine protein:creatinine ratio of < 1 or < 1 g protein on 24-hour urine collection','International normalized ration (INR) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed','Activated partial thromboplastin time (aPTT) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed','Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib','Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; elevated thyroid stimulating hormone (TSH) with normal T3 and T4 are allowed; patients on thyroid replacement therapy are allowed','Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol','Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities, and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of cediranib and olaparib administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or RT within 3 weeks prior to start of the study agents, or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier','Patients should not have received any other investigational agents within the past 4 weeks','Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should be excluded from this clinical trial; screening brain MRI (or CT if MRI contraindicated) will be required for patients with recurrent NSCLC, TNBC, or SCLC; brain MRI (or CT if MRI contraindicated) is required for PDAC if clinically suspected by patient’s symptoms or neurological exam; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study; for patients with known and treated brain metastases is allowed in this study if they fulfill the following criteria:\r\n* The lesions have improved or remained stable radiographically and clinically for at least 6 weeks after completion of brain irradiation or stereotactic brain radiosurgery and off steroids for at least 6 weeks','Patients who have received prior inhibitor of VEGF signaling and a poly (ADP-ribose) polymerases (PARP) inhibitor administered in combination; unless administered in combination, patients who received a prior PARP inhibitor or a prior VEGF-signaling inhibitor agent are allowed after discussing with the PI','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib','Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension','Current use of natural herbal products or other complementary alternative medications (CAM) or “folk remedies”','Patients with concomitant or prior invasive malignancies within the past 3 years; subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','History of myocardial infarction within 6 months prior to registration','History of stroke or transient ischemic attack within 6 months prior to registration','NYHA classification of III or IV','Current cardiac arrhythmia requiring concurrent use of anti-arrhythmic drugs','History of hypertensive crisis or hypertensive encephalopathy within 3 years prior to registration','Clinically significant peripheral vascular disease or abdominal aortic aneurysm (> 5 cm) or aortic dissection; if known history of abdominal aortic aneurysm with >= 4 cm in diameter, all of the following must be met: \r\n* An ultrasound (US) within the last 6 months prior to registration will be required to document that it is =< 5 cm\r\n* Patient must be asymptomatic from the aneurysm\r\n* Blood pressure must be well controlled as defined in this protocol','A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib (percutaneous/endobronchial biopsies are allowed)','History of bowel obstruction within 1 month prior to starting study drugs','History of hemoptysis or any significant bleeding within the last 1 month prior to enrollment','Presence of cavitation of central pulmonary lesion','History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the 3 months prior to enrollment','Patients may not have current dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)','Patients may not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the P.I.; patients who are on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (non-steroidal anti-inflammatory drugs [NSAIDs]/aspirin, clopidogrel), heparin, low molecular weight heparin (LMWH), warfarin, and a direct thrombin inhibitor, will be excluded','Patients may not have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cediranib and olaparib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Any condition that, in the opinion of the treating investigator would interfere with evaluation of the investigational product or interpretation of subject safety or study results'
NCT02503709,https://www.clinicaltrials.gov/ct2/show/record/NCT02503709?term=NCT02503709&rank=1,'Patients must have histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective','Patients must have evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; measurable disease is defined as at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','There are no limits on prior lines of therapy; however, patients must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study (except alopecia)','Eastern Cooperative Oncology Group (ECOG) performance status 0-1','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,500/microliters','Platelets >= 100,000/microliters','Total bilirubin =< 1.5 X institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal','Creatinine < 1 X institutional upper limit of normal OR creatinine clearance >= 50 mL/min determined by Cockcroft-Gault formula','Creatine phosphokinase =< institutional upper limit of normal','Women of childbearing potential and male patients with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after completion of study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of childbearing potential enrolling on study must have a negative pregnancy test within 72 hours of enrollment in order to be eligible; breastfeeding should be discontinued while the mother is treated with onalespib and AT7519M','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patients who have had prior onalespib or AT7519M as a monotherapy will not be excluded','Patients who are receiving any other investigational agents','Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients with brain metastatic disease that has previously been treated and remained stable on MRI >= 2 months after treatment, without steroids or anti-epileptic medications; these patients may be enrolled at the discretion of the principal investigator','History of allergic reactions attributed to compounds of similar chemical or biologic composition to onalespib or AT7519M','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; additionally, patients with other co-morbid disease or metabolic dysfunction that would render the subject at high risk for treatment complications may be excluded at the discretion of the principal investigator in the interest of patient safety','Pregnant women are excluded from this study','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy known to interact with CYP isoenzymes are ineligible; in addition, HIV patients with CD4 count < 200 cells/uL are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated','Consistent corrected QT (QTc) > 450 msec for men and > 470 msec for women by Fridericia formula, on 3 separate electrocardiograms (ECGs); patients with a history of long QTc syndrome or personal or family history of ventricular arrhythmias will be excluded','Patients with pre-existing retinal disease on ophthalmologic exam will be excluded','Patients with left ventricular ejection fraction < 50% on echocardiogram or multigated acquisition scan will be excluded','Patients with grade >= 2 peripheral neuropathy will not be permitted on study'
NCT02503722,https://www.clinicaltrials.gov/ct2/show/record/NCT02503722?term=NCT02503722&rank=1,'Patients with stage IV or recurrent/metastatic histologically or cytologically confirmed non-squamous NSCLC','NSCLC must harbor an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q)','Progressive disease on at least one prior EGFR-TKI (previous treatment with 3rd generation EGFR-TKI including osimertinib [AZD9291] allowed for dose escalation only)','Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent to a fresh tumor biopsy (mandatory for dose expansion cohort only; optional for dose escalation)','For the dose expansion portion ONLY, patient must: 1) have progression of disease with erlotinib, gefitinib or afatinib as last previous systemic treatment, 2) tumors must be EGFR T790M negative confirmed by central testing prior to treatment (If EGFR-T790M status is unknown, patient may consent for trial for biopsy and testing for EGFR T790M will be performed as part of the initial biopsy for the trial: patients who test positive for EGFR T790M by central testing will be ineligible for the dose expansion), 3) be treatment naive for 3rd generation EGFR-TKI (CO-1686 and osimertinib [AZD9291]) and mTOR inhibitors','Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension >= 10 mm (>= 1 cm) by computed tomography (CT) imaging or magnetic resonance imaging (MRI) within 28 days prior to start of protocol therapy; the CT from a combined positron emission tomography (PET)/CT may be used if it is of diagnostic quality; laboratory parameters are not acceptable as the only evidence of disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated \r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration \r\n* The brain metastases are stable on pre-registration imaging','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Hemoglobin >= 90 g/L (or >= 9 g/dL)','Platelets >= 100 x 10^9/L','Calculated creatinine clearance of > 50 mL/min using Cockcroft Gault equation equation or 24-hour urine sampling','Total bilirubin =< 1.5 institutional upper limit of normal','Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Fasting plasma glucose =< 130 mg/dL (or 7.2 mmol/L)','Glycosylated hemoglobin (Hb A1c) =< 7%','Fasting triglycerides =< 300 mg/dL (3.42 mmol/L)','Cholesterol =< 300 mg/dL (7.75 mmol/L)','Fridericia's correction formula (QTcF) =< 470 msec','Patients must have had sufficient time between a prior therapy and resolution of toxicities from the prior therapies prior to registration as follows:\r\n* Prior EGFR inhibitor: A minimum of 7 days must have elapsed from the last dose of the prior EGFR inhibitor and resolution of any drug-related toxicity to < grade 2 except for alopecia\r\n* Chemotherapy: A minimum of 21 days must have elapsed from the last dose and resolution of toxicity to < grade 1 excluding =< grade 1 peripheral neuropathy or alopecia\r\n* Surgery: A minimum of 21 days must have elapsed following major surgery and resolution of toxicity to < grade 1 and complete wound healing must have occurred\r\n* Radiation: A minimum of 14 days must have elapsed following radiation therapy and resolution of all radiation induced toxicity excluding alopecia\r\n* Treatment with an investigational drug: A minimum of 3 months or five half-lives of the compound, whichever is greater, must have elapsed from last treatment date','Ability to understand and the willingness to sign a written informed consent document','Available for follow-up of their disease after treatment until progressive disease is documented and resolution of related adverse events until < grade 2','Any serious intercurrent or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol including but not limited to: \r\n* Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL or 7.2 mmol/L)\r\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\r\n* Active infections \r\n* Gastrointestinal disease limiting the ability to swallow oral medications or absorb oral medications including refractory nausea and vomiting, chronic gastrointestinal diseases, inflammatory bowel disease; malabsorption syndromes\r\n* Patients with enteric stomata or significant bowel resection\r\n* Prior history of corneal ulceration\r\n* Patients with any evidence of severe or uncontrolled systemic liver disease including those with known hepatitis B and hepatitis C (excluding treated hepatitis C that has been cured)\r\n* Active bleeding diatheses','Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) e.g. medically significant (symptomatic) bradycardia, complete left bundle branch block, third degree heart block and second-degree heart block or history of arrhythmia requiring an implantable cardiac defibrillator; or within the last 6 months before administration of the first dose of drug:\r\n** Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n** Placement of a pacemaker for control of rhythm\r\n** Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n** Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures\r\n** New York Heart Association (NYHA) class III or IV heart failure\r\n** Pulmonary embolism\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTcF > 470 msec (mean value) obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value, or history of congenital long QT syndrome, or torsades de pointes); any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\r\n* Left ventricular ejection fraction (LVEF) by either multigated acquisition (MUGA) or echocardiography (ECHO) less than lower limit of normal','Patients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers','Concurrent anti-cancer therapy','History of hypersensitivity attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) or osimertinib (AZD9291)','Pregnant women or women who are breast feeding are not eligible for the study','Women of non-child bearing potential must be:\r\n* Women more than 50 years must be post-menopausal for at least 12 months following the end of all exogenous hormonal treatments OR\r\n* Women under 50 years must be postmenopausal for at least 12 months following the end of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution OR\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation','Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of registration and must agree to:\r\n* Practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 120 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc.;]) after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together','Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:\r\n* Practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug','Inability to discontinue drugs that are strong cytochrome P450 3A4 (CYP3A4) or P450 3A5 (CYP3A5), cytochrome P450 2C19 (CYP2C19), and cytochrome P450 2C9 (CYP 2C9) inhibitors and/or inducers; and substrates of CYP 3A4/5 or CYP1A2 that are sensitive or have a narrow therapeutic window at least three weeks prior to study registration','Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug','Consumption of grapefruit or grapefruit juice is not permitted during the study; patients should not consume food or beverages containing the fruit or juice of grapefruits or Seville oranges within 7 days before the first dose of study drug and throughout the study','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','No concomitant use of proton pump inhibitors (PPI) is allowed; any prior PPI must be discontinued at least one week before receiving MLN0128 (TAK-228)'
NCT02613364,https://www.clinicaltrials.gov/ct2/show/record/NCT02613364?term=NCT02613364&rank=1,'Have a confirmed diagnosis of cancer','Have received surgery, chemotherapy, and/or radiation therapy','Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-60 months','Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index','Be able to read and understand English','Be able to provide written informed consent','Have contraindications to functional testing or yoga participation according to the treating physician or the physician's designee','Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study','Be planning to start yoga on their own during the time they are enrolled in the study','Have a confirmed diagnosis of sleep apnea or restless leg syndrome','Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy','Have distant metastases'
NCT02308085,https://www.clinicaltrials.gov/ct2/show/record/NCT02308085?term=NCT02308085&rank=1,'Has received adjuvant endocrine therapy (selective estrogen receptor modulator [SERM] alone, gonadotropin-releasing hormone [GnRH] analogue plus SERM or aromatase inhibitors [AI]) for >= 18 months but =< 30 months for early breast cancer\r\n* Note: patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible','The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment','Patient wishes to become pregnant\r\n* Note: patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible','Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry [IHC]), and treated with curative intent\r\n* Note:\r\n** Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible\r\n** Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible\r\n** Patients with breast cancer 1/2, early onset (BRCA1/2) mutations are eligible\r\n** Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant human epidermal growth factor receptor 2 [HER2]-targeted therapy) according to institutional policy and patient’s desire','Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record; (Note: it is understood that patients’ menopausal status may be unclear at the time of study enrollment)','Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record','Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment','Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial','The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines','Patient must be accessible for follow-up','Post-menopausal patients at breast cancer (BC) diagnosis, as determined locally','History of hysterectomy, bilateral oophorectomy or ovarian irradiation','Patients with current local, loco-regional relapse and/or distant metastatic breast cancer','Patients with a history of prior (ipsilateral [ipsi]- and/or contralateral) invasive BC','Patients with previous or concomitant non-breast invasive malignancy; exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix','Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety','Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable','Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements'
NCT02562716,https://www.clinicaltrials.gov/ct2/show/record/NCT02562716?term=NCT02562716&rank=1,'Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible','Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form','Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis; the local interpreting radiologist must review the scans and sign the S1505 local radiology checklist prior to registration; resectable is defined as:\r\n* No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)\r\n* No involvement, or < 180 degrees interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence\r\n* No evidence of metastatic disease; lymphadenopathy (defined as nodes measuring > 1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 disease and makes the patient ineligible; if, however, such nodes are biopsied and are negative, then enrollment can be considered after review with the study chairs\r\n* Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease','CT scans or MRIs used to assess disease at baseline must be submitted for central review','Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration','Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer','Patients must have a Zubrod performance status of 0-1','Absolute neutrophil count (ANC) >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 x IULN','Serum albumin >= 3 g/dL','Serum creatinine =< IULN within 14 days prior to registration','Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will NOT be eligible','No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method for up to 3 months after the final administered dose of chemotherapy; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures','CA19-9 must be performed within 14 days prior to registration','Prestudy history and physical must be obtained within 28 days prior to registration','Sites must seek additional patient consent for the future use of specimens','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02520778,https://www.clinicaltrials.gov/ct2/show/record/NCT02520778?term=NCT02520778&rank=1,'Histologically confirmed non-squamous NSCLC, with incurable advanced or metastatic disease','Prior genotyping positive for an EGFR activating mutation (L858R, exon 19 deletion, G719X, L861Q)','Progression after prior treatment with an EGFR TKI; in addition to this one prior line of therapy, any additional prior lines of therapy are permitted; prior treatment with a third-generation EGFR TKI is allowed for the dose escalation phase, but is not permitted for the expansion cohort','Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR TKI; or willing to undergo a new tumor biopsy prior to registration (for the dose escalation portion only this requirement can be waived if T790M status has already been determined using a local assay)','For the dose expansion portion only, patient must: 1) have a tumor which is EGFR-T790M positive and 2) be treatment naive to T790M-directed EGFR TKI (e.g. AZD9291, rociletinib, etc); T790M testing may be done locally or centrally on study, but if done locally, tissue must be available for central confirmation','Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)','Any number of prior therapies are allowed','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)','Patients must have the ability to swallow oral dosage forms','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Hemoglobin >= 8.0 g/dL','Platelets >= 100,000/mcL','Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)','Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 x ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN','Creatinine =< 2.0 mg/dL','Creatinine clearance >= 50 mL/min','Women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and for 3 months for women and 6 months for men following the date of the last dose of AZD9291 and/or navitoclax:\r\n* Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)\r\n* Vasectomized male subject or vasectomized partner of female subjects\r\n* Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 3 months after study completion\r\n* Intrauterine device (IUD)\r\n* Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)\r\n* Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and 6 months following completion of therapy','Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months)','Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration\r\n* The brain metastases are stable on pre-registration imaging','Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs','Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2','Ability to understand and the willingness to sign a written informed consent document','Major surgery within 21 days of starting protocol treatment','Patients must discontinue previous EGFR-TKI at least 7 days prior to study enrollment','Patients who are receiving any other investigational agents','Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease','Patients currently receiving (or unable to stop use at least 1 week prior to receiving the 1st dose of AZD9291) medications or herbal supplements known to be potent inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; patients are eligible if they stop use of these compounds at least 1 week prior to receiving any treatment on this protocol','Patients receiving anticoagulation or anti-platelet therapy are excluded; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor','Patients with an underlying condition predisposing them to bleeding or currently exhibiting signs of clinically significant bleeding','Patients with a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug','Patients with a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months)','Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (QTc using Frederica’s formula [QTcF]) > 470 msec\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Congenital long QT syndrome or family history of long QT syndrome','Patients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, gastrointestinal disease limiting absorption of AZD9291 such as a malabsorption syndrome or inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD9291 and navitoclax','History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents','Patients with human immunodeficiency virus (HIV) on antiretroviral therapy are ineligible'
NCT02520791,https://www.clinicaltrials.gov/ct2/show/record/NCT02520791?term=NCT02520791&rank=1,'Pathologic diagnosis of one of the following:\r\n* For dose escalation:\r\n** Confirmed diagnosis of peripheral T-cell lymphoma (PTCL) or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy; anaplastic large cell lymphoma (ALCL) and natural killer T-cell lymphoma nasal type (NKTCL) are excluded\r\n** Advanced stage cutaneous T-cell lymphoma (CTCL), specifically CTCL NOS, small/medium T-cell lymphoma (SMTCL) and mycosis fungoides (MF) stage IB, IIA, IIB, III and IV that have relapsed after at least one specific prior therapy (e.g. interferon, photopheresis, denileukin difitox, bexarotene, etc); anaplastic cutaneous large cell lymphoma (ACLCL) and lymphomatoid papulopsis are excluded\r\n** Follicular lymphoma grade 1, 2 or 3A that meets the following criteria: \r\n*** Relapsed or refractory to at least 2 lines of therapy AND\r\n*** Relapsed or refractory post autologous cell transplantation (HCT)\r\n* For dose expansion/dose confirmation phase: \r\n** Patients with confirmed diagnosis of peripheral T-cell lymphoma (PTCL) follicular type or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy','At least 14 days from the last therapy dose or 5 half-lives (whichever is shorter), and resolution of toxicity related to the last therapy, excluding grade 2 or less peripheral neuropathy and alopecia; for radiation therapy, a minimum of 2 weeks and resolution of all acute toxicity will be required','Patients must have at least one measurable lesion that can be accurately measured with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, or physical exam (by calipers only); (PTCL, AITL and follicular lymphoma patients will be assessed on this study using the Lugano criteria for the evaluation of lymphomas; CTCL and MF patients will be assessed using International Society for Cutaneous Lymphomas [ISCL] and European Organization for Research and Treatment of Cancer [EORTC criteria])','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 6 months','Leukocytes >= 3,000/mcL','Hemoglobin >= 90 d/L (or >= 9g/dL)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 75,000/mcL','Absolute CD4 count > 200 cells/uL','Total bilirubin < 1.5 upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine < 1.5 mg/dl (= 132 umol/L) or','Creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Availability of tissue for correlative studies; patients must have at least 6-8 unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available; if not enough archived tissue is available, a fresh tumor biopsy prior to study initiation is mandatory; for patients who have undergone a fresh baseline biopsy at baseline, the archived tissue is not mandatory','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for 3 months after the last dose of the drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must have either had a prior vasectomy or agree to use effective contraception prior to the study, during the study, and for 3 months after the last dose of the drug; males should avoid fathering children during and for at least three months after therapy is completed','Ability to understand and the willingness to sign a written informed consent document','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI-570 or history of anaphylaxis to any biological component','Any history or evidence of opportunistic infection within 6 months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)','Evidence of active infection by hepatitis B and/or C; for patients with hepatitis B treated with anti-virals to undetectable viral load, and for patients with hepatitis C with undetectable ribonucleic acid (RNA) levels and no evidence of liver damage, enrollment may be considered and should discuss first with study’s principal investigator','History of human immunodeficiency virus (HIV) infection','History of primary immunodeficiency','Receipt of live or live attenuated vaccine within 12 weeks prior to enrollment','All potential patients must undergo a tuberculosis (TB) test prior to study entry (either purified protein derivative [PPD] or QuantiFERON-TB Gold, whichever is preferred and available at the Institution); patients with a history of TB (even if treated), or evidence of active or latent TB, are excluded; the diagnosis of active TB is defined per current guidelines; patients with a positive TB test (e.g. PPD or QuantiFERON-TB Gold) will be excluded; patients with history of Bacille-Calmette-Guerin (BCG) vaccination will be tested with QuantiFERON-TB Gold test in order to rule out exposure to TB','Patients who have undergone allogeneic stem cell transplantation','Patients who have undergone autologous stem cell transplantation within 3 months from study entry','Major surgery within 30 days prior or during the study period','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MEDI-570','Patients with active, known, or suspected autoimmune disease\r\n* Participants with well-controlled asthma and/or mild allergic rhinitis (seasonal allergies) are eligible\r\n* Participants with the following disease conditions are also eligible: \r\n** Vitiligo,\r\n** Type 1 diabetes mellitus\r\n** Residual hypothyroidism due to autoimmune condition only requiring hormone replacement\r\n** Euthyroid participants with a history of Grave’s disease (participants suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug)\r\n** For patients with ITP (idiopathic thrombocytopenic purpura) or AIHA (autoimmune hemolytic anemia), a case by case discussion with study principal investigator (PI) may be considered','Patients with a weight of < 39 kg'
NCT02490878,https://www.clinicaltrials.gov/ct2/show/record/NCT02490878?term=NCT02490878&rank=1,'PRE-REGISTRATION ELIGIBILITY CRITERIA:','Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas','Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)','Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized','REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA','A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation','Symptomatic brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where symptomatic is defined as:\r\n* New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits\r\n* Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg daily for 1 week','Clinical eligibility supported by central imaging real-time review\r\n* The presence of at least the following conventional magnetic resonance (MR) image characteristic:\r\n** Conventional MR\r\n*** Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the transverse relaxation time (T2)-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the longitudinal relaxation time (T1)-weighted post-gadolinium sequence on a comparable axial slice','If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study:\r\n* DSC MR\r\n** The cut-offs below will be based on gradient echo type echo planar imaging (GRE- EPI) DSC perfusion images, acquired without using a gadolinium pre-load:\r\n*** Relative cerebral blood volume (rCBV) < 1.5 in the enhancing-lesion relative to normal-appearing white matter (NAWM)\r\n*** Percentage of signal recovery (PSR) >= 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve','Centers that standardly use positron emission tomography (PET) or magnetic resonance spectroscopy (MRS) to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility; both PET and MRS are not mandatory for study eligibility','PRIOR TO START OF TREATMENT:','Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI','No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration','No bevacizumab =< 3 months of study registration','Central imaging real-time review (72 hour turn around) to confirm eligibility (for institutions that opt to utilize central imaging review to confirm eligibility)','Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration and confirmation they are not nursing is required','Karnofsky performance status >= 60%','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Hemoglobin >= 10 g/dL (allowing transfusion or other intervention to achieve this minimum hemoglobin)','Blood urea nitrogen measurement (BUN) < 30 mg/dL','Creatinine < 1.7 mg/dL','Bilirubin =< 2.0 mg/dL','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3.0 x upper limits of normal (ULN)','International normalized ratio (INR) < 1.5 x ULN unless patients are receiving anti-coagulation therapy; patients receiving anti-coagulation therapy with an agent such as warfarin or heparin are allowed to participate if INR =< 3.0','Urine protein to creatinine (UPC) ratio < 0.5 or if >= 0.5, 24-hour urine protein must be < 1000 mg','Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires; assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult','No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor','No excess risk of bleeding (any of the following):\r\n* Bleeding diathesis or coagulopathy\r\n* Thrombocytopenia\r\n* Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study\r\n* Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past 7 days','No uncontrolled hypertension (systolic blood pressure =< 160 millimeters of mercury [mmHg] or diastolic =< 100 mmHg); patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet','No history of arterial thrombotic events within the past 6 months, including:\r\n* Transient ischemic attack (TIA)\r\n* Cerebrovascular accident (CVA)\r\n* Peripheral arterial thrombus\r\n* Unstable angina or angina requiring surgical or medial intervention\r\n* Myocardial infarction (MI)\r\n* Significant peripheral artery disease (i.e., claudication on less than one block)\r\n* Significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)','Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation','No current New York Heart Association classification II, III, or IV congestive heart failure','No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months','No central lung metastases with excessive active bleeding','No uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements','No history of serious non-healing wound, ulcer, or bone fractures'
NCT02535325,https://www.clinicaltrials.gov/ct2/show/record/NCT02535325?term=NCT02535325&rank=1,'Patients must have pathologic diagnosis of adenocarcinoma or large cell carcinoma of the lung with confirmation by immunohistochemistry (e.g., transcription termination factor 1 [TTF-1] positivity) (histologic tissue diagnosis is recommended, but cytology is acceptable); stage IIIA/IIIB or oligometastatic stage IV in which the patient is still considered an appropriate candidate for aggressive chemoradiotherapy for the primary tumor; oligometastatic disease is defined as =< 5 metastatic sites (=< 3 lesions per organ); for intracranial metastasis, the patient should have asymptomatic disease that is stable on steroids or 1 to 3 symptomatic metastatic lesions treated with stereotactic radiosurgery (SRS)','Eastern Cooperative Oncology Group (ECOG) performance status < 2','Life expectancy of greater than 12 months','Ability to swallow and retain orally-administered medication and does not have any clinically significant gastro-intestinal abnormalities (e.g., malabsorption syndrome or major resection of the stomach or bowel)','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x institutional upper limit of normal','Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR','Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Hemoglobin >= 9 g/dL without transfusion within 7 days prior to enrollment','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of methoxyamine administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had prior chemotherapy or any other investigational drug within 30 days of registration or prior radiotherapy to the study treatment volume; prior surgery is allowed; there must be at least 6 weeks between mitomycin or nitrosoureas and any new therapy','Patients who are receiving any other investigational agents','Patients with a history of any active malignancy requiring on-going treatment, except basal cell carcinoma or squamous cell carcinoma of the skin','History of allergic reactions attributed to compounds of similar chemical or biologic composition to methoxyamine or to pemetrexed or cisplatin','Undetectable haptoglobin or evidence of glucose-6-phophate dehydrogenase (G6PD) deficiency, pyruvate kinase deficiency, hemoglobinopathy, hereditary spherocytosis, thalassemia or other disorder associated with hemolysis','Patients receiving any medications or substances that are inhibitors or inducers of nonsteroidal anti-inflammatory drugs (NSAIDS), probenecid, salicylates, sulfonamides are ineligible; concomitant drugs that are sensitive CYP450 substrates or strong and moderate CYP450 inducers and inhibitors should be avoided; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with methoxyamine','Patients who are known to be human immunodeficiency positive (HIV)-positive and are on combination antiretroviral therapy are ineligible'
NCT02535338,https://www.clinicaltrials.gov/ct2/show/record/NCT02535338?term=NCT02535338&rank=1,'PHASE I: Patients must have metastatic/recurrent, histologically confirmed NSCLC that harbors an EGFR activating mutation (exon 21 L858R, exon 19 deletion, exon 18 G719X, exon 21 L861Q) with progressive disease by RECIST 1.1 on a previous EGFR-tyrosine kinase inhibitor (TKI); OR patients must have metastatic/recurrent histologically confirmed NSCLC that harbors an EGFR exon 20 insertion with progressive disease on platinum containing chemotherapy','PHASE II COHORT A: Patients must have metastatic/recurrent histologically confirmed NSCLC that harbors an EGFR activating mutation (exon 21 L858R, exon 19 deletion, exon 18 G719X, exon 21 L861Q) with stable disease by RECIST 1.1 as best response on erlotinib compared to pre-treatment erlotinib imaging by RECIST 1.1 or progressive disease compared to pre-treatment imaging by RECIST 1.1 after a minimum duration of treatment on erlotinib of 12-weeks; patients must be enrolled within 6 months of initiation of erlotinib','PHASE II COHORT B: Patients must have metastatic/recurrent histologically confirmed NSCLC that harbors an EGFR exon 20 insertion with progressive disease on or after platinum doublet chemotherapy','FOR PHASE I: If patient is on erlotinib at the time of signed consent, the patient does NOT need to be discontinued prior to initiation of erlotinib and onalespib; other EGFR-TKIs must be discontinued at least 7 days prior to initiation of erlotinib and onalespib','FOR PHASE II COHORT A: If patient is on erlotinib at the time of signed consent, erlotinib does NOT need to be discontinued prior to receiving treatment erlotinib and onalespib; last dose of erlotinib must be less than 28 days from when patient signs consent','FOR PHASE II COHORT B: (EGFR exon 20 insertions): Prior EGFR-TKIs including erlotinib is allowed; if patient is on erlotinib at the time of signed consent, erlotinib does NOT need to be discontinued prior to initiation of erlotinib and onalespib','Local testing for EGFR-mutations for this study is acceptable provided it was performed in a Clinical Laboratory Improvement Act (CLIA) certified lab','Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration','Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs','Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2','Measurable disease by RECIST 1.1','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of erlotinib and/or onalespib administration','Ability to understand and the willingness to sign a written informed consent document','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and/or onalespib','History of pneumonitis attributed to an EGFR inhibitor; history of radiation pneumonitis is allowed provided steroid administration for pneumonitis was not required','Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec','Left ventricular ejection fraction =< 50% as demonstrated by echocardiogram or multigated acquisition scan (MUGA)','Drugs that are known to increase torsades de pointes should be avoided; patients must discontinue these medications prior to enrollment on study; selection of alternate concomitant medications with no or minimal torsades de pointes potential is recommended','Strong CYP3A4 inducers and inhibitors should be avoided; selection of alternate concomitant medications with no or minimal CYP3A4 enzyme inhibition potential is recommended; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with erlotinib and onalespib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Prior treatment with a Hsp90 inhibitor','Treatment with proton pump inhibitors within 3 days prior to study entry; if treatment with an histamine (H2)-receptor antagonist such as ranitidine is required, erlotinib must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist; although the effect of antacids on erlotinib pharmacokinetics has not been evaluated, the antacid dose and the erlotinib dose should be separated by several hours, if an antacid is necessary','Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren’s syndrome), congenital abnormality (e.g., Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)'
NCT02635009,https://www.clinicaltrials.gov/ct2/show/record/NCT02635009?term=NCT02635009&rank=1,'PRIOR TO STEP 1 REGISTRATION','Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration;\r\n* High-grade neuroendocrine carcinoma or combined SCLC and non-small cell lung cancer (NSCLC) is permitted','Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy, Note:\r\n* Post-chemotherapy restaging imaging must be completed no earlier than 56 days prior to Step 1 registration\r\n• For patients with limited-stage small cell lung cancer who receive thoracic radiotherapy concomitant with chemotherapy, patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy\r\n• For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted; if consolidative thoracic radiotherapy is performed prior to study registration, then patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy','Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) magnetic resonance imaging (MRI) scan and an axial T2/fluid attenuation inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; sites may contact the Imaging Co-Chairs for further information or assistance if needed\r\n* This MRI must be obtained within 56 days of Step 1 registration.\r\n* Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study','Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study','Prior to chemotherapy +/- or thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:\r\n* History/physical examination;\r\n* Computed tomography (CT) of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET)/CT scan prior to initiating chemotherapy or thoracic radiotherapy)\r\n* MRI of the brain with contrast or diagnostic head CT with contrast\r\n* For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC','After chemotherapy, patients must be restaged prior Step 1 registration using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have:\r\n* History/physical examination within 30 days of Step 1 registration\r\n* No central nervous system (CNS) metastases (repeat MRI required) within 56 days prior to Step 1 registration\r\n* No progression in any site\r\n* Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration\r\n** If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment\r\n** Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression','Zubrod performance status 0-2 within 30 days prior to Step 1 registration','Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration','Patients who are primary English or French speakers are eligible','Patients must sign a study-specific informed consent prior to study entry','PRIOR TO STEP 2 REGISTRATION','The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (parts A and B), and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, within 3 business days, a notification will be sent to the site to proceed to Step 2 registration; at minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible','Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall. as determined by central assessment by the Neurocognitive Co-Chair, Dr. Wefel','Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields','Radiographic evidence of CNS metastases','Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt','Planned concurrent chemotherapy or anti-tumor agent during PCI','Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted','Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia','Severe, active comorbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Uncontrolled, clinically significant cardiac arrhythmias\r\n* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter\r\n** Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to Step 1 registration\r\n** Note: HIV testing is not required for eligibility for this protocol','Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception'
NCT02568553,https://www.clinicaltrials.gov/ct2/show/record/NCT02568553?term=NCT02568553&rank=1,'Histologically or cytologically confirmed relapsed cluster of differentiation (CD)19+ non-Hodgkin lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, gray zone, primary mediastinal, Burkitt's, diffuse large B cell, small lymphocytic lymphoma)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Absolute neutrophil count > 1000/mcL','Platelets >= 50,000/mcL','Total bilirubin =< 1.5 x institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','AST (SGOT)/ALT(SGPT) (only if elevated liver function tests [LFTs] are due to disease) =< 5.0 x institutional upper limit of normal','Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl])','Patients must have had at least two prior chemotherapeutic or biologic (e.g. rituximab alone) regimens and not currently eligible for standard curative options; steroids alone and local radiation do not count as regimens','Any prior therapy must have been completed at least 4 weeks prior to entry into the study','Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure','Patients must have radiographically measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; lesions in previously irradiated anatomic areas (external beam radiation) cannot be considered target lesions unless there has been documented growth of those lesions after radiotherapy','Ability to understand and the willingness to sign a written informed consent document','Human immunodeficiency virus (HIV) infected patients are eligible provided they meet all the other eligibility criteria of the study in addition to the following: \r\n* No history of acquired immune deficiency syndrome (AIDS)-defining conditions other than lymphoma or history of CD4+ T-cells below 200/mm^3 prior to beginning combination antiretroviral therapy (cART)\r\n* After HIV diagnosis and during treatment with cART, patients should have maintained CD4+ T-cells >= 350/mm^3 prior to lymphoma diagnosis; patients who never immune reconstituted to a stable level above 350/mm^3 are not eligible\r\n* At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to >= 250/mm^3\r\n* At the time of study entry the HIV viral load must be undetectable by standard laboratory assay \r\n* During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV+ status\r\n* No history of non-adherence to cART and willing to adhere to cART while on study\r\n* Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed:\r\n** Efavirenz not allowed\r\n** Stavudine not allowed\r\n** Zidovudine not allowed\r\n* Patients must be willing to be followed at a minimum of approximately every 3 months by physician expert in HIV disease management','Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide and blinatumomab or other agents used in study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide','Concurrent use of other anti-cancer agents or treatments','Known active hepatitis, type B or C; patients on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible','Prior treatment with blinatumomab or CD-directed CAR T-cell therapy','Prior treatment with lenalidomide within 8 weeks prior to entering the study'
NCT02567409,https://www.clinicaltrials.gov/ct2/show/record/NCT02567409?term=NCT02567409&rank=1,'Patients must have histologically or cytologically confirmed metastatic urothelial carcinoma; urothelial cancer derived from the bladder, ureter or upper tract is permitted','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients must have access to archival tumor tissue for proposed correlative studies; these may be derived from transurethral resection of bladder tumors (TURBT), cystectomy, or biopsy; if archival tissue is not available for proposed correlatives, patients may be enrolled at the discretion of the study principal investigator (PI) (SKP)','No prior cytotoxic chemotherapy for metastatic disease; prior immunotherapy is permitted','At least 12 months have elapsed since platinum-based peri-operative treatment','Karnofsky >= 70% (Eastern Cooperative Oncology Group [ECOG] performance status 0-1)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine clearance >= 50 mL/min by either measured (using the Cockcroft-Gault, Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology [CKD-EPI] formula) or calculated clearance (i.e. glomerular filtration rate [GFR])','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of VX-970 administration','Ability to understand and the willingness to sign a written informed consent document','Radiotherapy within 4 weeks of protocol therapy','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970, cisplatin, or gemcitabine','Concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with VX-970; these potential risks may also apply to other agents used in this study','Patients with >= grade 2 neuropathy'
NCT02567422,https://www.clinicaltrials.gov/ct2/show/record/NCT02567422?term=NCT02567422&rank=1,'Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas','Clinical staged III or IV HNSCC that is not amenable to surgical resection','Patients with primary oropharynx HNSCC must be HPV (-) according to local institutional definition using either p16 immunohistochemistry or HPV testing','Carcinoma of the neck of unknown primary site origin (regardless of HPV/p16 status) is eligible','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of VX-970 administration','Ability to understand and the willingness to sign a written informed consent document','Women of childbearing potential who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for up to 6 months following the last administration of study treatment; men who are sexually active must be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for 6 months after completion of VX-970 administration','Patients with nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), and salivary gland carcinomas are not eligible','Patients who are receiving adjuvant chemoradiation after surgical resection of the primary site of disease','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','Patients on tacrolimus or any other immunosuppressants with significant interaction with cisplatin','Patient who requires live vaccine administration','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970 or cisplatin','Prior systemic chemotherapy for the current cancer (prior chemotherapy for a different cancer is allowed)','Prior receipt of radiotherapy that would result in overlap of the new and old radiation therapy fields','Uncontrolled intercurrent illness including, but not limited to:\r\n* Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation\r\n* Symptomatic congestive heart failure (requiring hospital stay within the last 6 months)\r\n* Myocardial infarction within the last 6 months\r\n* Unstable angina pectoris, cardiac arrhythmia\r\n* Psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with VX-970','Human immunodeficiency virus (HIV)-positive patients with well-controlled disease, as determined by CD4 count and viral load, who are on antiretroviral therapy that does not contain a strong inducer or inhibitor of CYP3A4 are allowed on trial; HIV-positive patients on combination antiretroviral therapy with strong inducers or inhibitors of CYP3A4 are ineligible; patients with poorly controlled HIV are not eligible','Definitive clinical or radiographic evidence of distant metastasis or adenopathy below the clavicles','Concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of'
NCT02567435,https://www.clinicaltrials.gov/ct2/show/record/NCT02567435?term=NCT02567435&rank=1,'Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1A','Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment','Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below','RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants\r\n* ERMS\r\n** Stage 1, group III (non-orbit)\r\n** Stage 3, group I/II\r\n** Stage 2/3, group III\r\n** Stage 4, group IV, < 10 years old\r\n* ARMS:\r\n** Stages 1-3, groups I-III','Specimen Submission: Patients must have sufficient tissue available for the required biology studies','Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age','Peripheral absolute neutrophil count (ANC) >= 750/uL','Platelet count >= 75,000/uL','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female)\r\n* 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female)\r\n* 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female)\r\n* 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female)\r\n* 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female)\r\n* 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female)\r\n* 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female)\r\n* >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female)\r\n* Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (ie. percutaneous nephrostomies or ureteric stents) of the urinary tract','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met','Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent','Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment','Patients with uncontrolled hyperglycemia','Patients with uncontrolled hyperlipidemia','Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed','Female patients who are pregnant are not eligible; Note: a pregnancy test is required for female patients of childbearing potential prior to study entry','Lactating females who plan to breastfeed their infants are not eligible'
NCT02572453,https://www.clinicaltrials.gov/ct2/show/record/NCT02572453?term=NCT02572453&rank=1,'Patients must have histologically confirmed, relapsed/refractory ALK+ ALCL (with ALK positivity defined by immunohistochemistry and/or fluorescence in situ hybridization [FISH]/cytogenetics from any prior biopsy), MCL, or BCL6+ DLBCL (with BCL6 positivity defined by immunohistochemistry from any prior biopsy) and meet the following criteria:','Patients must have measurable disease that has not been previously irradiated, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional imaging or >= 10 mm with spiral computed tomography (CT) scan; if the patient has been previously irradiated, there must be evidence of progression since the radiation\r\n* Please note, this trial includes mandatory tumor biopsies pre-treatment, during cycle 1 and at the time of disease progression of accessible tumor; having accessible tumor for biopsy is not required for eligibility; we expect that at least 80% of patients will have accessible tumor for these biopsies, however','ALK+ ALCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen including an anthracycline, if not contraindicated, and prior brentuximab; prior crizotinib or other ALK inhibitor therapy, while recommended, is not mandatory; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant','MCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen and prior ibrutinib or other BTK inhibitor therapy; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant','BCL6+ DLBCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included an anthracycline, if not contraindicated; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,000/mcL','Platelets >= 75,000/mcL, unless due to marrow involvement by lymphoma in which case a platelet count of >= 30,000/mcL will be used','Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome or hemolysis, in which case =< 3.0 x ULN is allowed','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal','Creatinine =< 1.5 x ULN or a creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Potassium above the institutional lower limit of normal (supplementation to meet this is allowed)','Magnesium above the institutional lower limit of normal (supplementation to meet this is allowed)','Human immunodeficiency virus (HIV)+ patients are eligible for the trial provided they meet the other study criteria in addition to the following:\r\n* CD4+ T-cells >= 250/mm^3\r\n* HIV sensitive to antiretroviral therapy\r\n* Zidovudine not allowed\r\n* Long term survival anticipated on the basis of HIV alone were it not for the lymphoma\r\n* No concurrent acquired immunodeficiency syndrome (AIDS)-defining illness other than the lymphoma','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after the completion of AT13387 (onalespib) administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of AT13387 (onalespib) administration','Patients must be willing to not take St. John wort or grapefruit juice while participating in this trial and should avoid drugs that are strong inducers of P-gp, and to switch to alternative drugs when available','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; steroids for symptom palliation are allowed, but must be either discontinued or on stable doses at the time of initiation of protocol therapy','Patients who are receiving any other investigational agents; all investigational agents other than ibrutinib must have been discontinued at least 4 weeks prior to beginning treatment; prior ibrutinib therapy must have been discontinued at least 2 weeks prior to beginning therapy','Patients with known leptomeningeal or brain metastases should be excluded from this clinical trial; imaging or spinal fluid analysis to exclude central nervous system (CNS) involvement is not required, unless there is clinical suspicion by the treating investigator','History of allergic reactions attributed to compounds of similar chemical or biologic composition to AT13387 (onalespib)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\r\n* There will be no exclusion of patients with known visual impairment or symptoms, including by not limited to peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; patients will have a baseline ophthalmologic exam to serve as a point of comparison and further exams as needed should visual symptoms develop; no pretreatment eye exam findings or ocular symptoms have been associated with an increased risk of ocular toxicity seen with AT13387','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AT13387 (onalespib)','Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study','Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years; patients with prostate cancer are allowed if prostate specific antigen (PSA) is less than 1','Patients should not receive immunization with attenuated live vaccine within one week of study entry or during study period','History of noncompliance to medical regimens','Consistent corrected QT (QTc) > 450 msec for men and > 470 msec for women by Fridericia formula, on 3 separate electrocardiograms (ECGs)','Left ventricular ejection fraction (LVEF) < 50%, regardless of whether there are symptoms of heart failure'
NCT02749903,https://www.clinicaltrials.gov/ct2/show/record/NCT02749903?term=NCT02749903&rank=1,'Histologically proven diagnosis of salivary cancer by central pathology review','AR expression detected by immunohistochemistry by central review','Measurable disease','Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease','Any number of prior lines of therapy','No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration','No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed)','Not pregnant and not nursing\r\n* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months\r\n* For women of childbearing potential only, a negative pregnancy test done =< 5 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','No history of the following\r\n* Prior brain metastases\r\n* Leptomeningeal disease\r\n* Seizures\r\n* Class 3 or 4 congestive heart failure\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 170 mmHg or diastolic BP > 105 mmHg) despite optimal medical management\r\n* Major surgery =< 4 weeks of registration','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min','Total bilirubin =< 1.5 x upper limit of normal (ULN)','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 upper limit of normal (ULN)','Chronic concomitant treatment with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration','Chronic concomitant treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration'
NCT02761057,https://www.clinicaltrials.gov/ct2/show/record/NCT02761057?term=NCT02761057&rank=1,'Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain >= 50% of the papillary component','Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment form','Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)','Patients must not have cavitating pulmonary lesions; patients must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration','Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery','Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic renal cell carcinoma (RCC); if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registration','Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 14 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration','Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution','Patients must not be receiving or planning to receive any other investigational agents','Patients must have a complete physical examination and medical history within 28 days prior to registration','Patients must have a Zubrod performance status of 0 – 1','White blood cell count (WBC) >= 2,000/mcL; must be obtained within 28 days prior to registration','Absolute neutrophil count (ANC) >= 1,000/mcL; must be obtained within 28 days prior to registration','Platelet count >= 75,000/mcL; must be obtained within 28 days prior to registration','Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN); must be obtained within 28 days prior to registration','Serum transaminase (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase [AST] and serum glutamate pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) must be =< 2.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN; must be obtained within 28 days prior to registration','Serum creatinine must be =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) must be > 30 mL/min; must be obtained within 28 days prior to registration','Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) >= 50%; patients must have corrected QT (QTc) interval < 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration','Baseline urinalysis should show urine protein < 3+ and must be obtained within 28 days prior to registration; if urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein','Patients must not have inadequately controlled hypertension; patients must have documented blood pressures of systolic blood pressure (SBP) < 150 and diastolic blood pressure (DBP) < 90 within 14 days of starting randomization; blood pressure medications (any number) are permitted','Patients must be able to take oral medications (i.e., swallow pills whole); patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible','Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula; examples of this include (but are not limited to) Crohn’s disease or tumor with transmural extension through the gastrointestinal lining','Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration','Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration','Patient’s baseline imaging must not indicate the presence of tumor invading or encasing any major blood vessels','Patients must not have any unresolved wounds from previous surgery','Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years; men receiving active surveillance for prostate cancer may also be enrolled','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Patients must have tissue available and be willing to submit for independent pathologic review in order to classify type I versus type II papillary disease','Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines'
NCT02581930,https://www.clinicaltrials.gov/ct2/show/record/NCT02581930?term=NCT02581930&rank=1,'Histologically confirmed melanoma of cutaneous primary; metastatic melanoma from unknown primary are allowed','Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Stage IV disease','If BRAFV600-mutant, documented refractory disease to at least one BRAF inhibitor (dabrafenib or vemurafenib) and/or a MEK inhibitor (trametinib or cobimetinib), defined as progression of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria while on treatment; subjects with MAPK inhibitor-intolerance are eligible if they meet criteria','Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least 2 infusions of the same drug; radiographic disease progression will be documented by the institutional radiologist based on any radiographic evidence (magnetic resonance imaging [MRI], computed tomography [CT], positron emission tomography [PET], or other modalities, etc.) of disease progression on two separate radiographic scans assessment obtained at least 4 weeks apart; this minimum 4-week interval is required to define PD-1 inhibitor resistance based on imaging; alternatively, clinical disease progression may be documented on examination by the treating investigator','Prior treatment-related toxicity resolved to =< grade 1 or baseline with the exception of alopecia and permanent grade =< 2 toxicities related to prior immune checkpoint inhibitor treatment (e.g. PD-1/PD-L1, CTLA-4, CD40, LAG3) treatment with the review and approval by the lead principal investigator (PI)','Prior radiation allowed (no restriction on amount); measurable lesion(s) may not have been previously irradiated','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 3 months','Hemoglobin >= 9.0 g/dL','Absolute neutrophil count (ANC) > 1,500/uL','Platelets > 100,000/uL','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x upper limit of normal (ULN); =< 5 x ULN, if liver metastasis','Total bilirubin =< 1.5 x ULN unless Gilbert’s syndrome of disease infiltration of the liver is present','Creatinine clearance estimated glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (Cockcroft-Gault)','Patients with brain metastases are allowed provided that:\r\n* No leptomeningeal disease is present\r\n* Intracranial disease is controlled by prior local therapies (craniotomy, stereotactic radiosurgery, whole brain irradiation), as evidenced by brain MRI 4 weeks post treatment indicating no new intracranial disease\r\n* Stable or decreasing dose of steroids provided patient on =< 20 mg of prednisone or its equivalent daily','Ibrutinib should be held at least 3 to 7 days pre- and post-surgery, depending upon the type of surgery and risk of bleeding','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 90 days after completion of ibrutinib administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of ibrutinib administration','Negative serum pregnancy test within 7 days of treatment initiation with ibrutinib in women of childbearing potential (WOCBP)','Ability to swallow oral medications','Patients with autoimmune disease requiring systemic corticosteroid treatment (and previously ineligible to receive systemic immunotherapies for melanoma) are allowed on condition that they do not receive more than 20 mg of daily dose methylprednisolone, prednisone, or its equivalent; this does not include autoimmune diseases caused by previous immunotherapy treatments for melanoma that require ongoing treatment with corticosteroids (e.g. autoimmune colitis or autoimmune hepatitis receiving corticosteroids)','Willing to consent to allow access to known archival tumor tissue (NOTE: designated pathologist from participating site OR lead principal investigator must sign-off to ensure “sufficient” tumor should be available for support of tumor imaging studies [multi-color immunofluorescence])','If archival tumor tissue from a metastatic melanoma lesion is unavailable OR designated pathologist from participating site cannot sign-off to ensure that “sufficient” tumor is available from existing archival tumor block for support of tumor imaging studies, patients must be willing to consent to undergo a biopsy to collect metastatic tumor tissue; collection of fresh biopsy tissue does not guarantee enrollment, unless the pathologist from the participating site signs-off that “sufficient” tumor has been collected','Ability to understand and the willingness to sign a written informed consent document','Subjects who are unable to tolerate BRAF inhibitor and/or MEK inhibitor therapy due to grade >= 2 toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) from these agents, irrespective of antitumor response, are eligible on condition that: (a) toxicities persisted despite change from doublet to singlet therapy (i.e. from concurrent BRAF inhibition plus MEK inhibition to BRAF inhibition alone), (b) toxicities are attributed to a class effect, and therefore switch from one drug to another is expected to induce the same type of toxicity (e.g. ocular toxicities or cardiac dysfunction from MEK inhibitor), (c) drug-specific toxicities that do not resolve with switch from one BRAF inhibitor to another (i.e. dabrafenib to vemurafenib, or vice versa), will be eligible for enrollment in 9922; in other words, patients will be allowed to enroll into the NCI9922 study despite lack of progression to MAPK inhibitor treatments, on condition that grade 2 or higher toxicities attributed to MAPK inhibitors resolve to grade 1, or less, at the time of study enrollment','Patients with melanoma of mucosal or ocular primary','Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to cycle 1 day 1; patients who have had tyrosine kinase inhibitors (such as Braf or MEK inhibitors) within 15 days of cycle 1 day 1','Patients who are receiving any other biologic, cytotoxic or investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib (difficulty breathing, lip swelling, itching or rash)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ibrutinib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are eligible; unless the patient’s cluster of differentiation (CD)4+ count is below the institutional lower limit of normal','Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) resulting in (or as evidenced by) declining platelet or hemoglobin (Hgb) levels within the 4 weeks prior to first dose of study drug','Presence of transfusion-dependent thrombocytopenia','Need for daily corticosteroids at high doses (prednisone >= 20 mg daily, or an equivalent) is prohibited from 28 days prior to first dose and during treatment with ibrutinib; brief (up to 7 days) and episodic use of systemic corticosteroids for other general conditions (e.g. pre-medication for radiographic imaging due to intravenous [IV] contrast allergy, chronic obstructive pulmonary disease [COPD] exacerbation, poison ivy, etc.) is allowed','Prior exposure to ibrutinib or other ITK inhibitors','History of prior malignancy, with the exception of the following:\r\n* Non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix\r\n* Prostate cancer not under active systemic treatment other than hormonal therapy and with documented undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL)\r\n* Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) provided patient has isolated lymphocytosis (Rai stage O), and does not require systemic treatment (for “B” symptoms, Richter’s transformation, lymphocyte doubling time [< 6 months], lymphadenopathy or hepatosplenomegaly)\r\n* Lymphoma of any type of hairy-cell leukemia provided patient is not on active systemic treatment and is in complete remission, as evidenced by PET/CT scans and bone marrow biopsies for at least 3 months\r\n* History of malignancy provided that patient has completed therapy and is free of disease for >= 2 years; if patient had other malignancy within the last 2 years from which he may have been completely cured by surgery alone, he may be considered to be enrolled on condition that the risk of development of distant metastatic disease based on American Joint Committee on Cancer (AJCC) staging system is less than 30%','Currently active clinically significant cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease, as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug','Unable to swallow capsules, or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption, such as malabsorption syndrome, resection of portions of small bowel larger than 3 feet, or poorly controlled inflammatory bowel disease affecting the small intestine','Known serologic status reflecting active hepatitis B or C infection; patients that are hepatitis B core antibody positive, but antigen negative, will need a negative polymerase chain reaction (PCR) prior to enrollment (NOTE: hepatitis B antigen or PCR positive patients will be excluded)','History of stroke or intracranial hemorrhage within 6 months prior to enrollment','Current life-threatening illness, medical condition, or organ system dysfunction, which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk','Received anticoagulation therapy with warfarin, or equivalent vitamin K antagonists, within the last 28 days prior to day 1 of ibrutinib; patients with familial coagulopathic diseases (e.g. hemophilia, von Willebrand disease) are also excluded; if applicable, subjects must discontinue fish oil and vitamin E supplements within 7 days prior to initiating ibrutinib therapy','Subjects with known hepatic insufficiency (i.e. Child-Pugh score A [mild], Child-Pugh score B [moderate] or Child-Pugh score C [severe]) according to Child-Pugh criteria','Subjects who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP 450 3A inhibitor'
NCT02797470,https://www.clinicaltrials.gov/ct2/show/record/NCT02797470?term=NCT02797470&rank=1,'Inclusion criteria associated with type and status of lymphoma','Biopsy-proven intermediate or high-grade non-Hodgkin’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):\r\n* In partial remission\r\n* Relapsed after initial complete remission\r\n* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)\r\n* In complete remission with high-risk features as specified by the International Prognostic Index','Biopsy-proven advanced stage follicular lymphoma, that have failed at least two lines of therapy multi-agent chemotherapy, but responds to salvage therapy (i.e., chemosensitive disease) (timeline 8 months prior to enrollment)','Biopsy-proven advanced stage mantle cell lymphoma with proliferation-related Ki-67 antigen (Ki-67) > 10% in first complete remission (timeline 8 months prior to enrollment)','Biopsy-proven Hodgkin’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment)\r\n* In first, or greater relapse after initial complete remission\r\n* In partial remission\r\n* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)','Biopsy-proven Burkitt’s lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):\r\n* In second complete remission after relapse following initial complete remission\r\n* Failed induction therapy, but responds (very good partial remission, complete remission, or near complete remission) to salvage therapy (i.e., chemosensitive disease)','Biopsy proven plasmablastic lymphomas, or peripheral T cell lymphoma (with the exception of anaplastic lymphoma kinase positive [ALK+] type in first or second complete remission) (timeline 8 months prior to enrollment)','NOTE: Patients meeting the following criteria are exempt from the 8 month timeline and do not require additional biopsy:\r\n* Patients who have never achieved a complete remission on the last biopsy-proven site of disease and went on to the next therapy then achieved a complete remission\r\n* Patients who relapsed quickly (within 3 months of their last chemotherapy) and now have achieved a complete remission with salvage therapy','INCLUSION CRITERIA ASSOCIATED WITH HIV-1 STATUS','HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme linked immunosorbent assay [ELISA], test kit, and confirmed by western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection','Must be on a multi-drug anti-HIV regimen (excluding zidovudine [AZT, ZDV, Retrovir], or agents containing zidovudine [e.g., Combivir and Trizivir], and efavirenz [Sustiva], or agents containing efavirenz [e.g., Atripla]), and have an HIV-1 viral load < 50 copies/mL by reverse transcriptase-polymerase chain reaction (RT-PCR) within 6 months prior to study enrollment; for patients who have had negative viral loads in the past 6 months and no known HIV viral load (VL) > 500 copies/mL within the past 6 months, minor fluctuations of viral load (isolated escalations up to 500 copies/mL) are acceptable; the participant's history of negative viral loads may be documented with recent laboratory results and/or a record from the participant's HIV care provider; participants on zidovudine [AZT, ZDV, Retrovir; including Combivir and Trizivir] and efavirenz [Sustiva; including Atripla] must switch to an alternative regimen without anticipated drug-drug interactions or myelosuppressive properties based on known viral resistance patterns and/or ART history, such as raltegravir and Truvada (emtricitabine and tenofovir) at least two weeks prior to the transplant','Participants with CD4 counts > 50/microL are eligible for this study if their viral load is < 50 copies/mL by reverse transcription polymerase chain reaction (RT-PCR) since majority of the participants have received aggressive chemotherapy that can potentially decrease the CD4 counts despite the ART therapy; timeline: within 3 weeks prior to start of trial','GENERAL INCLUSION CRITERIA (TIMELINE: 8 WEEKS PRIOR TO START OF TRIAL, UNLESS OTHERWISE SPECIFIED)','Karnofsky performance status of 70-100%; Eastern Cooperative Oncology Group (ECOG) performance status =< [2]','Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) >= 2.5 times upper limit of normal (ULN)','Serum bilirubin =< 2.5 times ULN except for participants who are on atazanavir or indinavir, provided that the participant’s direct bilirubin is within normal institutional limits','Participants who are hepatitis C virus antibody positive, or hepatitis B virus surface antigen positive must be free of clinical evidence of cirrhosis as determined by the principal investigator in consultation with the gastroenterology service; timeline: within 3 weeks prior to enrollment','Participants with hepatitis B should be on appropriate anti-viral therapy at the time of the transplant, and their viral load should be negative; timeline: within 3 weeks prior to enrollment','Serum creatinine =< 2 times ULN; timeline: within 3 weeks prior to enrollment','Creatinine clearance >= 60 mL/min by the modified Cockcroft-Gault formula; timeline: within 3 weeks prior to enrollment','Prothrombin time (PT)/partial thromboplastin time (PTT) =< 2 times normal; timeline: within 3 weeks prior to enrollment or','International normalized ratio (INR)/PTT =< 2 times normal; timeline: within 3 weeks prior to enrollment','Forced expiratory volume in 1 second (FEV-1) or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) >= 50% predicted; timeline: within 4 weeks prior to enrollment','Left ventricular ejection fraction (LVEF) >= 50% by 2-dimensional (2D) echocardiogram (ECHO) or multigated acquisition (MUGA) scan; timeline: within 4 weeks prior to enrollment','Not pregnant or nursing, with negative serum pregnancy test; pregnant women are excluded from this study; breastfeeding should be discontinued; timeline: within 3 weeks prior to enrollment','Participants should agree to practice effective contraceptive precautions and to use at least one method of contraception for the duration of the study and for 3 months post-transplant','Life expectancy of greater than 3 months','Ability to understand and the willingness to sign a written informed consent document','Receipt of a stable ART regimen for at least 3 weeks prior to start of trial','Participants with > 5% involvement of bone marrow by malignant cells (either by manual count or flow cytometry) prior to stem cell collection','Participants with any abnormal cytogenetics in the bone marrow not related to the lymphoma, and not deemed to be constitutional','Participants with unexplained anemia, and/or thrombocytopenia','Participants with clear evidence of myeloproliferative disorders, or myelodysplastic disorders in the marrow','Presence of any active central nervous system (CNS) disease at the time of evaluation (parenchymal or leptomeningeal)','Any history of HIV-1 associated encephalopathy','Participants with persistently low CD4 counts less than 200 and a history of any acquired immune deficiency syndrome (AIDS)-defining infection in the last 6 months before screening are excluded from the study','Symptomatic/active bacterial, or fungal, or any other opportunistic infection','Active cytomegalovirus (CMV) retinitis, or other active CMV-related organ dysfunction','Relapse of pneumocystis carinii pneumonia within the past year before enrollment','Intractable, severe diarrhea, defined as > 1.500 cc diarrheal fluid per day, or diarrhea causing persistent severe electrolyte abnormalities, or hypoalbuminemia','History of active myocardial ischemia, cardiomyopathy, uncontrolled dysrhythmia, or congestive heart failure within the last 6 months before enrollment','Dementia of any kind','Seizures within the past 12 months before enrollment','History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy','History of other prior malignancy, except squamous cell carcinoma of the cervix or anus, superficial basal cell or squamous cell skin cancer, or other malignancy curatively treated more than 5 years ago before enrollment','Active psychosocial condition that would hinder study compliance and follow-up','Any perceived inability to directly (and without the means of a legal guardian) provide informed consent','Any medical or physical contraindication, or other inability to undergo hematopoietic progenitor cell (HPC) collection','Participants who are receiving any other investigational agents','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'
NCT02589522,https://www.clinicaltrials.gov/ct2/show/record/NCT02589522?term=NCT02589522&rank=1,'Patients with a histologically confirmed diagnosis of non-small cell lung cancer (NSCLC), including neuroendocrine tumors or small cell lung cancer (SCLC) who are being evaluated for palliative WBRT (with or without neurosurgical resection or stereotactic radiosurgery [SRS]) for radiologically or histologically diagnosed brain metastases presumed to be from the lung cancer are eligible for this Phase I study; group 2 will only include NSCLC patients','Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity','Group 2 patients should have archived or fresh tumor tissue available from the non-craniotomy site and will have fresh tumor tissue available from the planned craniotomy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Leukocytes >= 3,000/mcL','Absolute neutrophil count (ANC) >= 1,500/mcL','Platelets >= 100,000/mcL','If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULN','If no known liver metastases: aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) < 2 x ULN; if known liver metastases, then: AST/SGOT < 5 x ULN','Creatinine within normal institutional limits for age OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN','Negative serum or urine pregnancy test result for females of child bearing potential\r\n* Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of VX-970 administration','Ability to understand and the willingness to sign a written informed consent document','Patients with 1-3 brain metastases, each < 3 cm by contrast MRI, with stable systemic disease and ECOG score of 0-2, who would otherwise be eligible for SRS/stereotactic radiation therapy (SRT) alone should not be enrolled into this study unless WBRT is recommended due to any medical reasons or logistic limitations as determined by the treating physician; patients who develop recurrence post-SRS/SRT or surgery alone and are recommended WBRT will be eligible for the protocol','Presence of diffuse leptomeningeal carcinomatosis (focal/localized involvement is acceptable), > 1 cm mid-line shift, uncal herniation or significant hemorrhage/hydrocephalous (small intra-lesional hemorrhage is acceptable); patients with seizure at presentation who have been started on levetiracetam and have been stable for 48 hours prior to study registration are eligible at the discretion of treating physician','Patients who have received systemic cytotoxic chemotherapy, immunotherapy for 3 weeks before initiation of planned WBRT or patients who have not recovered from serious (Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more) adverse events from the previously received agents; for oral targeted agents or any other investigational agents, at least 4 half-lives of the agent (6 weeks for nitrosoureas or mitomycin C) should have elapsed prior to starting study treatment','Patients must not have received prior WBRT (previous SRS/SRT done at least 4 weeks from the planned start of WBRT is acceptable); patients planned upfront to undergo SRS/SRT/fractionated boosts or neurosurgery after WBRT are not eligible; however, these treatments/procedures can be performed once the dose limiting toxicity (DLT) assessment has been completed, if felt clinically necessary','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with VX-970','History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970','Concomitant administration with strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; ongoing phenytoin should be either discontinued if clinically safe or transitioned to non-enzyme-inducing antiepileptics like levetiracetam with a 8-day washout period (half-life 18-22 hours, time to steady-state 4-8 days) prior to first dose of VX-970 (7-days prior to WBRT)','Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland','Uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements; this includes but is not limited to, ongoing uncontrolled serious infection requiring i.v. antibiotics at the time of registration, symptomatic congestive heart failure, unstable angina pectoris, symptomatic/uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Patients with known diagnoses that are associated with germline DDR defects such as Li Fraumeni syndrome and ataxia telangiectasia are excluded from the study'
NCT02595866,https://www.clinicaltrials.gov/ct2/show/record/NCT02595866?term=NCT02595866&rank=1,'Histologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed, or in patients otherwise ineligible for standard therapy, or for an indication that anti-programmed cell death protein 1 (PD-1) therapy has been shown to be effective in studies in HIV-uninfected participants; disease-specific criteria will be applied for certain common cancers and cancers strongly associated with HIV; however, enrollment will not be confined to these tumors','Non-small cell lung cancer (NSCLC)\r\n* Metastatic or locally advanced disease that progressed after at least one prior therapy \r\n* Note: patients who have actionable molecular targets (e.g., epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], c-ros oncogene 1[ROS1] mutations) must have received (when indicated) prior appropriate targeted therapy using Food and Drug Administration (FDA)-approved agents','AIDS-related non-Hodgkin lymphoma and other non-Hodgkin lymphoma\r\n* Failed standard first-line therapy; and\r\n* Failed autologous stem cell transplant if indicated for histology (i.e diffuse large B-cell lymphoma) or autologous stem cell transplant is not feasible','Classical Hodgkin lymphoma\r\n* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and\r\n* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve but is ineligible or unable to receive brentuximab vedotin; and\r\n* May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)','Hepatocellular carcinoma (HCC)\r\n* Not eligible for curative attempt resection or liver transplant','Kaposi sarcoma (KS) (following prior KS-specific therapy (Cohorts 1-3)\r\n* (KS) impacting physical and/or psychological wellbeing and not amenable to local therapy and one or more of the following: \r\n** Stable KS by despite 6 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine [vincristine sulfate], vinblastine); or\r\n** Progressive disease despite 3 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or\r\n** Patient who has received a cumulative lifetime dose of anthracycline of >= 550 mg/m^2; or\r\n** Recurrent or progressive KS after completion of prior first line chemotherapy\r\n** Intolerant of or refuse further cytotoxic chemotherapy\r\n** No KSHV-associated multicentric Castleman disease in past 5 years\r\n** For KS patients, the following laboratory values supersede values below:\r\n*** Platelets > lower limit of normal\r\n*** Hemoglobin > 10 g/dL','Melanoma\r\n* Unresectable or metastatic and disease progression following a B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor if BRAF V600 positive\r\n* Note: prior therapy with ipilimumab not required','Available pretreatment biopsy, either fresh (optimal) or archival (acceptable)','Resolution of any adverse events (AEs) from prior treatments must be resolved to baseline or grade =< 1 AE if resolvable at enrollment (with the exception of alopecia), neuropathy, and ototoxicity (i.e., AEs that are not expected to improve within the washout period)','On an effective combination cART regimen, generally a 3-drug regimen based on Department of Health and Human Services (DHHS) treatment guidelines\r\n* Patients must be on cART >= 4 weeks; and\r\n* Evidence of viral suppression defined as HIV viral load < 200 copies/mL; and \r\n* No symptomatic AEs > grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) criteria probably or definitely attributed to cART; and\r\n* No laboratory AEs noted on protocol defined screening laboratories > grade 1 by CTCAE criteria probably or definitely attributed to cART, with exceptions noted below\r\n* Note: if cART is modified during the screening period, patients must be on an effective new regimen for >= 2 weeks and otherwise meet eligibility criteria\r\n* Most patients have viral loads that are suppressible to < 50 copies/mL, but about 25% of patients will occasionally have blips up to 400–500 copies/mL, which do not appear to correlate with lack of viral suppression in most studies; thus, an HIV viral load of =< 400 copies/mL for an occasional “blip” will be allowed, if there is documentation of an HIV viral load < 200 on the same regimen and no significant treatment interruption','CD4+ T-cell count >= 100 cells/uL','Patients must have marrow function and organ function as defined below\r\n* Note: to remain on treatment, any abnormal lab values allowed by the PI must remain stable or improve during treatment; similar off treatment rules will be applied to all patients, except the following: the grade of any abnormal laboratory (lab) value allowed by the protocol principal investigator (P.I.) at enrollment will be considered the patient’s baseline for potentially resuming therapy after modification/holding of therapy when off treatment criteria are applied','Leukocytes no lower limit','Absolute neutrophil count > 500/mcL','Platelets > 50,000/mcL','Hemoglobin > 9 g/dL','Total bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert’s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimen','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional ULN','Creatine kinase < 5 X institutional ULN','Serum creatinine < 2.5 X institutional ULN OR measured or calculated* creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) >= 30 mL/min for subject with creatinine levels > 2.5 X institutional ULN\r\n* Creatinine clearance should be calculated per institutional standard','Thyroid stimulating hormone (TSH) within institutional limits (ie: normal); if TSH is greater or less than institutional limits patients may participate if their T4 is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed','Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1','At least 2 weeks from end of chemotherapy with resolution of neutropenia to above level','At least 2 weeks from end of radiation therapy','At least 4 weeks from end of monoclonal antibody therapy','At least 2 weeks from end of targeted therapy','Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* Note: women of child-bearing potential must agree to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity beginning with the screening visit and for the duration of study participation, through 120 days beyond last dose of MK-3475 administration; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Men treated or enrolled on this protocol must agree to use 2 adequate methods of contraception starting with the screening visit, for the duration of study participation, and through 120 days after the last dose of MK-3475 administration','No prior treatment with anti-PD-1 or anti-PD-L1','Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or other tumor-specific criteria or disease assessable by physical exam or other methods if not measurable by RECIST','Baseline tumor tissue, either fresh (preferred) or from paraffin block/unstained slides if contemporary biopsy is unsafe or not otherwise obtainable from the primary tumor site or metastatic site to be available for use on correlative studies','Ability to understand and the willingness to sign a written informed consent document','Active systemic immunosuppressive therapy','Systemic steroid therapy or steroid therapy that cannot be discontinued with more than 7 consecutive days of steroids within the prior 2 weeks\r\n* Note: the use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 15 mg/day) as replacement therapy is permitted; inhaled or topical corticosteroids are permitted','Current or history of systemic autoimmune disease requiring systemic therapy\r\n* Note: the following will NOT be exclusionary:\r\n** The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms\r\n** Clinical evidence of vitiligo or other forms of depigmenting illness\r\n** Mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis)','Grade 3 or 4 immune related toxicity associated with prior ipilimumab therapy that has not resolved to grade 0 or 1','Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)','Active tuberculosis (TB):\r\n* Patients who are undergoing first month of therapy (RIPE or equivalent) for active TB\r\n* Patients with TB immune reconstitution syndrome (IRIS) requiring corticosteroids\r\n** Note: patients who are receiving therapy beyond month one of initial therapy with no evidence of TB IRIS requiring corticosteroid therapy, or those receiving treatment for latent tuberculosis (INH or alternative) may be eligible after discussion with the protocol P.I.','Cirrhosis with Child-Pugh score of B or C','Uncontrolled hepatitis B virus (HBV) infection, defined as plasma HBV DNA detectable by polymerase chain reaction (PCR)\r\n* Note: the following will NOT be exclusionary:\r\n** A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute HBV infection\r\n** Patients with chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines','Uncontrolled hepatitis C virus (HCV) infection, defined as plasma HCV RNA detectable by PCR\r\n* Note: the following will NOT be exclusionary:\r\n** Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection\r\n** Patients who have been successfully treated for HCV as long as therapy for HCV has been completed','Patients who are receiving any other investigational agents for cancer','Extensive active brain disease including symptomatic brain metastases or the presence of leptomeningeal disease, and all patients with infratentorial tumors\r\n* Note: patients with brain metastasis after definitive therapy with surgery or stereotactic radiation and stable off steroids for > 4 weeks are eligible as are patients with asymptomatic brain metastasis as long as less than 1 cm and thus deemed as not requiring therapy by the primary physician and the lesions(s) are not infratentorial','Pregnancy or nursing or unwilling to take adequate birth control during therapy','Prior organ allograft or allogeneic transplantation, if the transplanted tissue is still in place','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia','Medical or psychiatric illness or social situations that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves','Clinically significant lung disease including known history or evidence of interstitial lung disease or chronic obstructive pulmonary disease (COPD) that requires oxygen therapy','Active non-infectious pneumonitis >= grade 2 or history of grade 3 non-infectious pneumonitis requiring steroids within the past 12 months; or any history of grade 4 non-infectious pneumonitis','Grade 3-4 ascites or pleural effusion\r\n* Note: The following will NOT be exclusionary: A participant who is clinically stable following treatment for ascites or pleural effusion (including therapeutic thoracentesis or paracentesis)','Receipt of live vaccines within 30 days before the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, H1N1 flu, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccine','History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 (pembrolizumab)'
NCT02595879,https://www.clinicaltrials.gov/ct2/show/record/NCT02595879?term=NCT02595879&rank=1,'Pathologic diagnosis of stage IB2-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous or adenocarcinoma of the vulva that is not amenable to curative surgical resection alone','Patient must be able to tolerate imaging requirements of an 18-FDG-PET-CT scan','Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2','Life expectancy greater than 6 months','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Platelets >= 100 x 10^9/L','Hemoglobin (Hgb) >= 9.0 g/dL','International normalized ratio (INR) =< 2','Serum creatinine =< 1.5 x upper limit of normal (ULN)','Blood urea nitrogen (BUN) < 25 mg/dL','Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN','Resting oxygen saturation (O2 sat) must be >= 92%','Able to take oral medication and has no history of gastric surgery or pathology','Not pregnant and not breastfeeding; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patient must have documented negative urine pregnancy test must be resulted within 7 days before initiating protocol therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued if the mother is treated with triapine; potential risks may also apply to other agents used in this study','Healthy human immunodeficiency virus (HIV)-infected patients are eligible, provided that they meet all the other study criteria in addition to the following (HIV testing is not required for study enrollment):\r\n* CD4+ cell count >= 250/mm^3\r\n* HIV viral loads undetectable by standard clinical tests','Able to understand and willingness to sign a written informed consent document','Patients with other active invasive malignancies will be excluded; patients with prior malignancies will be excluded (except [1] non-melanoma skin cancer or prior in situ carcinoma of the cervix; [2] patients with other invasive malignancies who had [or have] cancer present within the last five years)','Patients with hypermetabolic para-aortic disease identified on baseline 18-FDG-PET-CT','No prior pelvic radiation therapy or chemotherapy','Patients receiving any other investigational agents','Patients with known glucose-6-phosphate dehydrogenase deficiency (G6PD) are excluded; pre-registration testing for G6PD is at the investigator’s discretion and is not required for study enrollment','Patients with known brain metastases are excluded','History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or cisplatin','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements','Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)'
NCT02595892,https://www.clinicaltrials.gov/ct2/show/record/NCT02595892?term=NCT02595892&rank=1,'Patients must have histologically confirmed high grade serous ovarian or primary peritoneal or fallopian tube cancer; platinum resistant disease is defined as progression within 6 months after last platinum regimen','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; measurable disease by RECIST version (v)1.1 with at least one measurable target lesion','Prior therapy: No line limit but no more than 1 prior regimens in the platinum resistant setting; no prior treatment targeting the ATR/checkpoint kinase 1 (CHK1) pathway and no prior gemcitabine as single agent; hormonal therapies immunotherapy, and antiangiogenic therapies (as single agents) do not count as lines; poly (adenosine diphosphate [ADP]-ribose) polymerases (PARP)-inhibitors count as line of therapy; prior carboplatin/gemcitabine is allowed provided that there was no disease progression within 12 months after completion of the carboplatin/gemcitabine regimen; subjects may begin protocol treatment at least 4 weeks or 5 half-lives, whichever is shorter, after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 70%)','Life expectancy of greater than 6 months','Within 2 weeks prior to initiation of study treatment: Leukocytes >= 3,000/mcL','Within 2 weeks prior to initiation of study treatment: Absolute neutrophil count >= 1,500/mcL','Within 2 weeks prior to initiation of study treatment: Platelets >= 100,000/mcL','Within 2 weeks prior to initiation of study treatment: Total bilirubin within normal institutional limits','Within 2 weeks prior to initiation of study treatment: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Within 2 weeks prior to initiation of study treatment: Creatinine =< upper limit of institutional normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Confirmation of availability of a formalin-fixed, paraffin-embedded (FFPE) tumor specimen with adequate tumor tissue (either one paraffin embedded tissue block OR 10 5-micron unstained slides from the block on regular (non-plus) slides and 1 hematoxylin and eosin [H&E] slide)','All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =< 1 prior to study entry','At least 4 weeks since major surgery or radiation therapy','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','No known hypersensitivity or contraindication to the components of study treatment (M6620 [VX-970], gemcitabine)','Ability to understand and the willingness to sign a written informed consent document','Patients with primary platinum refractory disease, defined as progression while first line platinum based chemotherapy','Patients who have had chemotherapy within 4 weeks or five half-lives, whichever is shorter, (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who have had radiotherapy within 4 weeks','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial; a scan to confirm the absence of brain metastasis is not required','History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970) or gemcitabine','Concomitant administration with strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A (CYP3A4 enzyme) are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with M6620 (VX-970) and/or gemcitabine','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated'
NCT02734537,https://www.clinicaltrials.gov/ct2/show/record/NCT02734537?term=NCT02734537&rank=1,'PRE-REGISTRATION (STEP 0)','Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA: T2-T4a, N0-3, M0 or T1-T2, N1-3, M0','Patient has undergone total resection of the primary tumor with curative intent\r\n* NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days','For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)','Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery are not eligible','A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\r\n* NOTE: Complete the FoundationOne requisition form','Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received chemotherapy within two years of surgical resection of the primary tumor','Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease','Patients with recurrent disease or multiple primaries are ineligible','RANDOMIZATION (STEP 1)','NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion','Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization','The patient must have the following assessments done =< 8 weeks prior to randomization:\r\n* Examination by a head and neck surgeon,\r\n* Neck computed tomography (CT) scan (from skull base to clavicle) and\r\n* Chest x-ray (or chest CT scan or CT/positron emission tomography (PET) of the chest) to rule out distant metastatic disease','Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization','Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study','Absolute neutrophil count >= 1,500/mm^3','Platelets >= 100,000/mm^3','Total bilirubin =< the upper limit of normal (ULN)','Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula','Patient must not have an intercurrent illness likely to interfere with protocol therapy'
NCT02595905,https://www.clinicaltrials.gov/ct2/show/record/NCT02595905?term=NCT02595905&rank=1,'Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by in-situ hybridization [ISH])\r\n* Local Regional Recurrence\r\n** In the breast (after preserving therapy)\r\n** In the chest wall (after mastectomy)\r\n** In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes\r\n** In the skin of the chest wall (not breast)\r\n** In the reconstructed breast','Patients must also meet at least one of the following criteria:\r\n* Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (=< 1%), progesterone receptor (PR)-negative (=< 1%), and HER2–negative\r\n* BRCA mutation: previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required','Patients must have measurable or non-measurable disease; patients must have a chest/abdominal/pelvis computed tomography (CT) scan (or positron emission tomography [PET]/CT of diagnostic quality, conventional or spiral) prior to registration; if the patient is unable to undergo CT with IV contrast due to allergy or renal insufficiency, a non-contrast CT may be performed; all scans needed for assessment of measurable disease must be performed within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form','Patients must have adequate tissue available and must agree to have specimens submitted for germline BRCA deoxyribonucleic acid (DNA) sequencing and other correlative studies\r\n* NOTE: Blood for BRCA mutation testing is to be collected and submitted after registration but before treatment','Patients must have had =< 1 prior cytotoxic regimen for metastatic disease (unless enrolling in the Progressive Brain Metastases Cohort); note that endocrine and immunotherapies do not count as cytotoxic regimens','Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration','Patients must not have received prior cisplatin or poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors; prior carboplatin in the adjuvant/neoadjuvant setting and prior treatment with iniparib is allowed, if completed more than 6 months prior to study entry','Patients must not have received any chemotherapy within 14 days prior to registration','Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registration','Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registration','Patients must have recovered to =< grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be =< grade 1','Patients must have a performance status of 0-2 by Zubrod criteria','Absolute neutrophil count (ANC) of >= 1,500/mL within 21 days prior to registration','Hemoglobin >= 9 g/dL within 21 days prior to registration','Platelet count >= 100,000/ mL within 21 days prior to registration','Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome or if liver metastases are present)','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (IULN) (or =< 5 x IULN if liver metastases are present)','Patients must have adequate renal function with serum creatinine level =< IULN within 21 days prior to registration','Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values','Patients must not have a clinically relevant hearing impairment >= grade 2','Patients must be able to swallow whole capsules','Patients with a history of uncontrolled seizure disorder; including focal or generalized seizure may not have had a seizure within one year prior to registration','Patients with known brain metastases must either meet the additional criteria and enroll as part of the Progressive Brain Metastases Cohort, or have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 14 days of stable neurologic function prior to registration; patients with previously incidentally discovered or asymptomatic brain metastasis(es) must receive surgical excision and/or radiation therapy prior to registration; patients with progressive brain metastases following prior treatment are not eligible for the Standard Cohort, but may be considered for the Progressive Brain Metastases Cohort','Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol','Patients must not have baseline peripheral neuropathy that exceeds grade 1','Patients must have a complete history and physical examination within 28 days prior to registration','Patients must not be pregnant or nursing; men and women of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution’s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study had been entered in the system','Progressive Brain Metastases Cohort\r\n* S1416 is one study with two cohorts; patients who have progressive brain metastases after surgical excision and/or intracranial radiation will be in the Progressive Brain Metastases Cohort and will require a baseline magnetic resonance imaging (MRI); patients with previously treated brain metastases, stable disease and stable neurologic function for 14 days prior to trial registration will be in the Standard Cohort and may obtain MRI of the brain at the physician’s discretion; randomization and treatment is the same for both cohorts\r\n* In addition to all of the previous eligibility criteria, patients with progressive brain metastases who do not satisfy the conditions to enroll in the standard cohort (neurologic stability for 14 days following surgery and/or radiation therapy) must also meet the following criteria to enroll as part of the brain metastases cohort:\r\n** Patients with progressive brain metastases must have a baseline brain MRI within 28 days prior to registration; brain metastases must be progressive and >= 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., whol brain radiation therapy [WBRT], stereotactic radiosurgery [SRS], gamma knife [GK] or local equivalent); patients must not have evidence of diffuse leptomeningeal disease on brain MRI or by previously documented cerebrospinal fluid (CSF) cytology; discrete dural metastases are permitted; there must be no evidence of hemorrhage or impending herniation on baseline brain imaging; patients with contraindication to gadolinium-enhanced MRI imaging are not eligible\r\n** Patients must be on a stable or decreasing dose of steroids for >= 7 days prior to registration\r\n** If patient had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration\r\n** Patients enrolling in the Progressive Brain Metastases Cohort can have received up to 3 prior lines of cytotoxic chemotherapy for metastatic disease; note that for enrollment in the standard cohort, patients must have had =< 1 prior cytotoxic regimen for metastatic disease'
NCT02595918,https://www.clinicaltrials.gov/ct2/show/record/NCT02595918?term=NCT02595918&rank=1,'Patients must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)','The preoperative Memorial Sloan-Kettering (MSK) nomogram estimates the patient’s likelihood of freedom from metastatic recurrence within the first 12 years following radical or partial nephrectomy to be =< 80%','Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','No evidence of metastases other than regional lymphadenopathy as assessed by imaging of the chest, abdomen and pelvis with CT of the chest and CT or MRI of the abdomen; regional lymph nodes, per 7th edition American Joint Committee on Cancer (AJCC) staging manual (2010) for kidney cancer, include the following positions: renal hilar, precaval, paracaval, retrocaval, interaortocaval, paraaortic, preaortic, and retroaortic','Scheduled to undergo nephrectomy as part of treatment plan, per assessment through an MSK urologic surgeon listed as investigator on this trial','Availability of a frozen biopsy core prior to cycle 1, day 1','Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >= 80%)','Leukocytes >= 2,500/mcL','Absolute neutrophil count >= 1,500/mcL (without granulocyte colony-stimulating factor support within 2 weeks prior to cycle 1, day 1)','Platelets >= 100,000/mcL (without transfusion within 2 weeks prior to cycle 1, day 1)','Hemoglobin >= 9.0 g/dL (patients may be transfused to meet this criterion)','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN','Creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)','Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception','Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL','WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days','Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Prior systemic therapy for renal cell carcinoma','Inability to safely delay surgery by 8 weeks as per surgeon’s discretion','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab','History of severe hypersensitivity reaction to any monoclonal antibody','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab','Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)','Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible','Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted','Diagnosis of any second malignancy within the last 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, per investigator’s discretion (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)','Use of live vaccines against infectious disease (e.g. varicella) within 28 days of initiation of study therapy; killed vaccinations (e.g. influenza) are allowed at any appropriate time before and during the study'
NCT02595931,https://www.clinicaltrials.gov/ct2/show/record/NCT02595931?term=NCT02595931&rank=1,'Patients must have histologically confirmed metastatic or unresectable malignancy that is refractory to standard therapy or for which no standard therapy exists and where irinotecan is deemed a reasonable treatment option','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','No limit on prior lines of therapy for metastatic disease; prior adjuvant or neoadjuvant chemotherapy does not count as a prior line of therapy as long as completion of the adjuvant or neoadjuvant therapy was more than 1 year prior to patient enrollment','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 70%)','Life expectancy of greater than 12 weeks','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN); if liver involvement, =< 5 x ULN','Creatinine clearance >= 60 mL/min/1.73 m^2','Patients must have archived tumor tissue from prior tumor biopsy or surgical resections available for submission that is sufficient to complete molecular profiling','FOR PATIENTS ENROLLED IN THE EXPANSION COHORT: willingness to undergo mandatory biopsies (day -14, approximately 4 hours post end of irinotecan infusion and day 1, approximately 4 hours post end of irinotecan infusion [= 3 hours post end of VX-970]); patients enrolled to this cohort should have tumors deemed easily accessible for biopsies with low likelihood of complication','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of VX-970 administration; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after study completion','Ability to understand and willingness to sign a written informed consent document','Patients who have had chemotherapy or other systemic therapy or radiotherapy or patients who have not recovered from adverse events due to prior administered agents as follows:\r\n* Chemotherapy < 4 weeks prior to entering the study\r\n* Radiotherapy < 4 weeks prior to entering the study\r\n* Nitrosoureas/mitomycin C < 6 weeks prior to entering the study\r\n* Targeted therapy < 2 weeks (or 5 half-lives, whichever is longer) prior to entering the study\r\n* Those who have not recovered from clinically significant adverse events due to prior agents administered to grade =< 1 or baseline, with exception of alopecia and peripheral neuropathy, unless approved by the protocol chair','Patients who are receiving any other investigational agents','Patients with unstable brain metastases should be excluded; however, patients with known brain metastases may participate in this clinical trial if they are clinically stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to trial treatment','History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970 or irinotecan','Concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; medications that enhance glucuronidation (i.e. phenytoin, phenobarbital, carbamazepine, rifampin, etc.) should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Uncontrolled intercurrent illness including, but not limited to, severe active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients with chronic viral hepatitis may participate in this clinical trial if they are clinically stable with acceptable liver function','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with VX-970','Human immunodeficiency virus (HIV)-positive patients with well-controlled disease, as determined by CD4 count and viral load, who are on antiretroviral therapy that does not contain a strong inducer or inhibitor of CYP3A4 (e.g. regimens containing ritonavir, cobicistat, efavirenz or etravirine) are allowed on trial; HIV-positive patients on combination antiretroviral therapy with strong inducers or inhibitors of CYP3A4 are ineligible; patients with poorly controlled HIV are not eligible'
NCT02595944,https://www.clinicaltrials.gov/ct2/show/record/NCT02595944?term=NCT02595944&rank=1,'Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins','Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease','Eastern Cooperative Oncology Group (ECOG) performance status 0-1','Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization','Non-squamous tumors must not be positive for epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangement (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)','Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol','Women must not be pregnant or breast-feeding','All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion','Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements','No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)','Patients must have adequately recovered from surgery and any administered chemotherapy/radiotherapy at the time of randomization (NOTE: adjuvant chemotherapy and/or radiation is not required)\r\n* Minimum time between date of surgery and randomization is 4 weeks (28 days)\r\n* Maximum time allowed between surgery and randomization:\r\n** 3 months (90 days) if no chemotherapy is administered\r\n** 8 months (240 days) if adjuvant chemotherapy was administered\r\n** 10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered','Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy) (NOTE: adjuvant chemotherapy and/or radiation is not required)','Serum aspartate transaminase (aspartate aminotransferase [AST]) and serum alanine transaminase (alanine aminotransferase [ALT]) =< 2.5 x upper limit normal','Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)','White blood cell (WBC) >= 2000/uL','Neutrophils >= 1000/uL','Platelets >= 100 x 10^3/uL','Hemoglobin >= 8 g/dL','Serum creatinine =< 2 x ULN','Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy','Patients must not be receiving any other investigational anti-cancer agents while on study','Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll','Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization; inhaled, intra-articular, and epidural steroids are permissible','Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity','Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load','Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab'
NCT02642965,https://www.clinicaltrials.gov/ct2/show/record/NCT02642965?term=NCT02642965&rank=1,'Patients must have had histologic verification of AML at original diagnosis','Patient must have one of the following:\r\n* Recurrent disease with >= 5% blasts in the bone marrow (M2/M3 bone marrow), with or without extramedullary disease.\r\n* Recurrent disease with an absolute blast count greater than 1,000 per microliter in the peripheral blood with or without extramedullary disease','To be eligible for the dose-finding phase: (the dose-finding phase completed in 12/2016) \r\n* Relapsed patients\r\n** Patients must be in first relapse, and\r\n** Patients must not have received prior re-induction therapy\r\n* Refractory patients\r\n** Patients must not have received more than one attempt at remission induction, which may consist of up to two different therapy courses; Children Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is an example\r\n* Treatment-related AML (t-AML)\r\n** Patients must be previously untreated for secondary AML','To be eligible for the phase 2 efficacy phase:\r\n* Relapse patients:\r\n** Patients must be in first marrow relapse, and \r\n** Patients must not have received prior re-induction therapy; donor lymphocyte infusion (DLI) is considered a re-induction attempt','Patients must have the status of CNS1 or CNS2 only, and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsy','Patients must have a performance status corresponding to an Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; Note: patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 prior to enrollment','Myelosuppressive chemotherapy: must not have received myelosuppressive chemotherapy within 3 weeks of entry onto this study (excluding hydroxyurea)\r\n* Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of CPX-351','Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent such as steroids, retinoids; Note: for agents that have known adverse events occurring beyond 7 days after administration (i.e. monoclonal antibodies), this period must be extended beyond the time during which acute adverse events are known to occur','Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation; Note: patients must have received =< than 13.6 Gray (Gy) prior radiation to the mediastinum','Stem cell transplant (SCT): no evidence of active graft vs. host disease for at least 4 weeks; for allogeneic SCT patients, >= 3 months must have elapsed since transplant\r\n* Must have received no more than 1 prior autologous or allogeneic stem cell transplant.\r\n* Patients must be off all systemic immunosuppressive therapy for at least 2 weeks, excluding hydrocortisone for physiologic cortisol replacement','Intrathecal cytotoxic therapy:\r\n* No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone\r\n* At least 14 days must have elapsed since receiving liposomal cytarabine (DepoCyte) by intrathecal injection','Growth factors:\r\n* Patients must not have received growth factors for 7 days prior to CPX-351\r\n* Patients must not have received pegfilgrastim for 14 days prior to CPX-351','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (males and females)\r\n* Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (males and females)\r\n* Age 6 to < 10 years: maximum serum creatinine 1.0 mg/dL (males and females)\r\n* Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (males and females)\r\n* Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (males) and 1.4 mg/dL (females)\r\n* Age >= 16 years: maximum serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)','Direct bilirubin < 1.5 x upper limit of normal (ULN) for age and institution','Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 3.0 x upper limit of normal (ULN) for age and institution (unless it is related to leukemic involvement)','Shortening fraction of >= 27% by echocardiogram, or','Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram','Corrected QT (using Bazett's formula [QTcB]) interval < 500 msecs','Patients with seizure disorder may be enrolled if on anticonvulsants and if seizures are well controlled','Central nervous system (CNS) toxicity =< grade 2','Patients with a known history of human immunodeficiency virus (HIV) are eligible, if they meet all of the following conditions:\r\n* No history of HIV complications with the exception of cluster of differentiation (CD)4 count < 200 cells/mm^3\r\n* No antiretroviral therapy with overlapping toxicity such as myelosuppression\r\n* HIV viral loads below the limit of detection\r\n* No history of highly active antiretroviral therapy (HAART)-resistant HIV','Patients who have received > 450 mg/m^2 daunorubicin equivalents; patients who relapse after receiving AAML0531/AAML1031 therapy will be eligible for this study, provided they have not received any additional anthracyclines; NOTE: for the purposes of determining eligibility for this protocol, the following cardiotoxicity multipliers will be used to determine daunorubicin equivalents:\r\n* Doxorubicin (doxorubicin hydrochloride): 1\r\n* Mitoxantrone: 3\r\n* Idarubicin: 3\r\n* Epirubicin: 0.5','Patients who are currently receiving another investigational drug','Patients receiving medications for treatment of left ventricular systolic dysfunction','Patients with any of the following diagnoses:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)','Patients with documented active, uncontrolled infection at the time of study entry','Patients with known active hepatitis B virus (HBV) and hepatitis C virus (HCV) infections','Patients with prior allergy to daunorubicin and/or cytarabine','Female patients who are pregnant are ineligible','Lactating females are not eligible','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 6 months after the last dose of chemotherapy','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02750826,https://www.clinicaltrials.gov/ct2/show/record/NCT02750826?term=NCT02750826&rank=1,'Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer\r\n* A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy)\r\n* Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study\r\n* Bilateral breast carcinoma is allowed provided either:\r\n** Diagnoses are synchronous – that is, within 3 months of one another – and at least one of the two breast carcinomas meet the eligibility criteria and neither is Her-2 positive or inflammatory; OR\r\n** The contralateral breast cancer was at least 5 years prior to the current diagnosis\r\n* No evidence of metastatic disease','Her-2 negative, defined as:\r\n* In-situ hybridization (ISH) ratio of < 2.0 (if performed)\r\n* Immunohistochemistry (IHC) staining of 0-2 positive (+) (if performed) \r\n* Deemed to not be a candidate for Her-2 directed therapy','Eligible tumor-node-metastasis (TNM) stages include:\r\n* Estrogen receptor (ER) and progesterone receptor (PR) negative (defined as < 1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3\r\n** Note: Patients with T1, N1mi disease are NOT eligible\r\n* ER and/or PR positive (defined as >= 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0\r\n** Note: Patients with T0N0, T1N0 and T1, N1mi disease are NOT eligible\r\n* ER and/or PR positive (defined as >= 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0\r\n** Note: Patients with T0N0, T1N0, T2N0 and T1-2, N1mi disease are NOT eligible\r\n* The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM; the same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy','No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable)','Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required; (subjects with bilateral total mastectomies do not require imaging)','Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration\r\n* Chest X-ray, 2 view (or chest CT, or positron emission tomography [PET]/CT) is required only if clinically indicated or recommended by National Comprehensive Cancer Network (NCCN) guidelines\r\n* Bone scans (with x-rays of abnormal areas) are required only if indicated or recommended by NCCN guidelines\r\n* Abdominal imaging is required only if clinically indicated or recommended by NCCN guidelines','PRIOR TREATMENT','All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration\r\n* All triple negative patients must receive chemotherapy of the treating physician’s choice\r\n* ER/PR+ patients must receive chemotherapy (of the treating physician’s choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone\r\n* Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration\r\n** Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable','Surgical margins must be clear of invasive carcinoma; if there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended; if further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered; in situ lobular disease at the margin is acceptable','All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection, as per pre-specified institutional guidelines','All women who undergo breast conserving therapy must receive concomitant radiotherapy; radiation after mastectomy is to be administered according to pre-specified institutional guidelines; radiation must be completed at least 21 days prior to registration','Patients with hormone receptor positive breast cancer as defined above must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression; (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required); hormonal therapy can be initiated prior to or during protocol therapy','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','COMORBID CONDITIONS','No history of other malignancy within the past 4 years, except for malignancies with a > 95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer); patients cannot have metastatic breast or other cancer','No diabetes mellitus currently treated with insulin or sulfonylureas','No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet','No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement; moderate arthritis that does not preclude physical activity is not a reason for ineligibility','No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration','No comorbid conditions that would cause life expectancy of less than 5 years','No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent','No chronic (>= 1 month) use of oral steroids at the time of study enrollment; inhaled or topical steroids are acceptable','BMI >= 27 kg/m^2 documented within 56 days prior to study registration; the most recent body mass index (BMI) obtained must be used for eligibility; if most recent BMI is < 27 then the patient is not eligible to enroll','Self-reported ability to walk at least 2 blocks (at any pace)','Not participating in another weight loss, physical activity or dietary intervention clinical trial; co-enrollment in some trials involving pharmacologic therapy is allowed; participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial','Able to read and comprehend either English or Spanish'
NCT02717455,https://www.clinicaltrials.gov/ct2/show/record/NCT02717455?term=NCT02717455&rank=1,'RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients with progressive DIPG, as defined by progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity wean, electrolyte disturbances, sepsis, hyperglycemia, etc.), OR an increase in the bi-dimensional measurement, taking as a reference the smallest disease measurement recorded since diagnosis, OR the appearance of a new tumor lesion since diagnosis\r\n* Please note: patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation\r\n* Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of malignant glioma World Health Organization (WHO) II-IV','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Body surface area (BSA) \r\n* Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2\r\n* Patients must have a BSA >= 0.65 m^2 for doses of 10 mg/m^2 - 22 mg/m^2 \r\n* Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2 - 36 mg/m^2','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patient must be able to swallow capsules whole','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within 7 days of enrollment must be >= 50%; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must have recovered from the acute treatment-related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have received their last dose of known myelosuppressive anticancer therapy or immunotherapy at least 21 days prior to enrollment (42 days if prior nitrosourea)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Biologic or investigational agent (anti-neoplastic): patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment \r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur, and discussed with the principal investigator','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment\r\n* Note: A list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have had their last fraction of: \r\n* Craniospinal irradiation or radiation to >= 50% of pelvis > 3 months prior to enrollment\r\n* Focal irradiation to the primary site > 42 days prior to enrollment\r\n* Local palliative irradiation other than previously irradiated primary site (small port) >= 14 days','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Absolute neutrophil count >= 1,000/mm^3','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days, and recovery from post-transfusion nadir)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Hemoglobin >= 8 g/dl (may receive transfusions)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Albumin >= 3 g/dl','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Potassium >= lower limit of normal (LLN)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Serum total calcium (correct for serum albumin) or ionized calcium >= LLN','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Serum creatinine based on age/gender as noted below; patients that do not meet the criteria below but have a 24-hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible\r\n* 2 to < 6 years: 0.8 mg/dL\r\n* 6 to < 10 years: 1 mg/dL\r\n* 10 to < 13 years: 1.2 mg/dL\r\n* 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Cardiac function: \r\n* Left ventricular ejection fraction >= 50 by gated radionuclide study OR shortening fraction of >= 27% by echocardiogram\r\n* Patient has no ventricular arrhythmias except for benign premature ventricular contractions\r\n* Patient has a corrected QT (QTc) interval =< 450 ms','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must be off all colony-forming growth factor(s) for at least 7 days prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have elapsed if patients received poly(ethylene glycol) (PEG) formulations','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must agree to avoid grapefruit or grapefruit juice and Seville (sour) oranges during the entire study','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Female patients of childbearing potential must have a negative serum or urine pregnancy test','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have received re-irradiation)','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had prior histone deacetylase (HDAC), deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors for the treatment of their DIPG','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had valproic acid within 28 days prior to enrollment','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had prior bone marrow transplant','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have any other significant concurrent illness','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat; for example severe inflammatory bowel disease','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have a history of any other malignancy','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients are known to be refractory to red blood cell or platelet transfusions','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who are receiving any other anticancer or investigational drug therapy','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who are required to receive any medication which can prolong the QTc interval','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Female patient is breastfeeding','RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions','NON-PROGRESSED DIPG (STRATUM 2): Patients with DIPG who have not yet progressed by clinical or radiographic criteria\r\n* Please note: patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation\r\n* Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of malignant glioma World Health Organization (WHO) II-IV','NON-PROGRESSED DIPG (STRATUM 2): BSA\r\n* Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2\r\n* Patients must have a BSA >= 0.65 m^2 for doses of 10mg/m^2 - 22 mg/m^2\r\n* Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2 - 36 mg/m^2','NON-PROGRESSED DIPG (STRATUM 2): Patient must be able to swallow capsules whole','NON-PROGRESSED DIPG (STRATUM 2): Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within 7 days of enrollment must be >= 50%; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','NON-PROGRESSED DIPG (STRATUM 2): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must not have received any other prior therapy for treatment of their central nervous system (CNS) malignancy besides standard radiation therapy','NON-PROGRESSED DIPG (STRATUM 2): Patients must have recovered from the acute treatment-related toxicities (defined as =< grade 1) of radiotherapy prior to entering this study','NON-PROGRESSED DIPG (STRATUM 2): Patients must have had their last fraction of focal irradiation to the primary site > 14 days prior to enrollment; patients must not have received local palliative irradiation or craniospinal irradiation','NON-PROGRESSED DIPG (STRATUM 2): Absolute neutrophil count >= 1,000/mm^3','NON-PROGRESSED DIPG (STRATUM 2): Platelets >= 100,000/ mm^3 (unsupported, defined as no platelet transfusion within 7 days, and recovery from post-transfusion nadir)','NON-PROGRESSED DIPG (STRATUM 2): Hemoglobin >= 8 g/dl (may receive transfusions)','NON-PROGRESSED DIPG (STRATUM 2): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)','NON-PROGRESSED DIPG (STRATUM 2): ALT(SGPT) =< 3 x institutional upper limit of normal','NON-PROGRESSED DIPG (STRATUM 2): Albumin >= 3 g/dl','NON-PROGRESSED DIPG (STRATUM 2): Potassium >= LLN','NON-PROGRESSED DIPG (STRATUM 2): Serum total calcium (correct for serum albumin) or ionized calcium >= LLN','NON-PROGRESSED DIPG (STRATUM 2): Serum creatinine based on age/gender as noted below; patients that do not meet the criteria below but have a 24-hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible\r\n* 2 to < 6 years: 0.8 mg/dL\r\n* 6 to < 10 years: 1 mg/dL\r\n* 10 to < 13 years: 1.2 mg/dL\r\n* 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)','NON-PROGRESSED DIPG (STRATUM 2): Left ventricular ejection fraction >= 50 by gated radionuclide study OR shortening fraction of >= 27% by echocardiogram','NON-PROGRESSED DIPG (STRATUM 2): Patient has no ventricular arrhythmias except for benign premature ventricular contractions','NON-PROGRESSED DIPG (STRATUM 2): Patient has a QTc interval < 450 ms','NON-PROGRESSED DIPG (STRATUM 2): Patients must be off all colony-forming growth factor(s) for at least 7 days prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have elapsed if patients received PEG formulations','NON-PROGRESSED DIPG (STRATUM 2): Patients must agree to avoid grapefruit or grapefruit juice and Seville (sour) oranges during the entire study','NON-PROGRESSED DIPG (STRATUM 2): Female patients of childbearing potential must have a negative serum or urine pregnancy test','NON-PROGRESSED DIPG (STRATUM 2): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat','NON-PROGRESSED DIPG (STRATUM 2): The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines','NON-PROGRESSED DIPG (STRATUM 2): Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have received re-irradiation','NON-PROGRESSED DIPG (STRATUM 2): Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician','NON-PROGRESSED DIPG (STRATUM 2): Patients have impairment of GI function or GI disease that may significantly alter the absorption of panobinostat; for example severe inflammatory bowel disease','NON-PROGRESSED DIPG (STRATUM 2): Patients have diarrhea > CTCAE grade 2','NON-PROGRESSED DIPG (STRATUM 2): Patients have any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results','NON-PROGRESSED DIPG (STRATUM 2): Patients have a history of any other malignancy','NON-PROGRESSED DIPG (STRATUM 2): Patients are known to be refractory to red blood cell or platelet transfusions','NON-PROGRESSED DIPG (STRATUM 2): Patients who are receiving any other anticancer or investigational drug therapy','NON-PROGRESSED DIPG (STRATUM 2): Patients who are required to receive any medication which can prolong the QTc interval','NON-PROGRESSED DIPG (STRATUM 2): Female patient is breastfeeding','NON-PROGRESSED DIPG (STRATUM 2): Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions'
NCT02601209,https://www.clinicaltrials.gov/ct2/show/record/NCT02601209?term=NCT02601209&rank=1,'Patients must have slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility and proper cohort assignment\r\n* HISTOLOGIC COHORT 1: Undifferentiated pleomorphic sarcoma (includes: malignant fibrous histiocytoma, myxofibrosarcoma, high grade sarcoma not otherwise specified [NOS])\r\n* HISTOLOGIC COHORT 2: Leiomyosarcoma (either uterine or extra-uterine)\r\n* HISTOLOGIC COHORT 3: Other (either malignant peripheral nerve sheath tumor or synovial sarcoma); during the phase II portion of the study, enrollment will be limited to maximum of 25 patients in this cohort\r\n** Note that the phase I is limited to the histologic subtypes listed above; since patients will be enrolling onto dose cohorts during the phase I, they will not enroll onto specific histologic cohorts, although the histologic subtype informed will be collected during patient enrollment','Histologic documentation: Eligible patients must have histopathologically confirmed sarcoma of one of the subtypes listed, by central review','Locally advanced or metastatic disease; locally advanced disease is defined as disease not amenable to local therapy such as surgery and/or radiation','Measurable disease','Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment','There is no limit to the number of prior lines of treatment a patient has received','No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration','No treatment with radiation therapy =< 28 days before study registration','Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less','Prior treatment with pazopanib or any phosphoinositide 3-kinase (PI3K), mTOR, protein kinase B (AKT), or dual PI3K/mTOR complex (CREB regulated transcription coactivator [TORC]1/TORC2) inhibitors will be prohibited','Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status =< 1','Patient history: patients who have any of the following are NOT eligible:\r\n* Central nervous system (CNS): Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Heme: Active bleeding or bleeding diathesis\r\n* Gastrointestinal (GI):\r\n** Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration\r\n** Acute GI bleed within 28 days of registration\r\n* Diabetes mellitus: Patients with diabetes mellitus with inadequate control, based on either a glycosylated hemoglobin (Hgb A1c) of > 7.0 or fasting blood glucose above or equal to 130 mg/dL\r\n* Cardiac and vascular disorders:\r\n** History of congenital long QT syndrome or torsades de pointes\r\n** Any arrhythmia that is currently not rate-controlled (rate between 60 and 100)\r\n** Prolongation of corrected QT interval via Fridericia’s formula (QTcF) > 480 msec\r\n** Ongoing unstable angina\r\n** Symptomatic peripheral vascular disease\r\n** Arterial thrombosis within 28 days of registration including transient ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI)\r\n** Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) must be on a stable dose of anticoagulation for 14 days prior to registration\r\n** Uncontrolled hypertension, defined as blood pressure (BP) > 140/90\r\n** Multi gated acquisition scan (MUGA) with ejection fraction (EF), 50% or echocardiogram (echo) with low EF\r\n** Class III or IV congestive heart failure (CHF) within 28 days of registration','Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study','Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study','Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 x upper limit of normal (ULN)','Total bilirubin =< 1.5 x upper limit of normal (ULN); unless patient has Gilbert disease','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN); if liver metastases, =< 5 x upper limit of normal (ULN)','Urine protein creatinine (UPC) =< 1; if UPC >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g/L','Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however if the Free T4 is normal and patient is clinically euthyroid, patient is eligible'
NCT02627443,https://www.clinicaltrials.gov/ct2/show/record/NCT02627443?term=NCT02627443&rank=1,'Histologically confirmed high grade serous or endometrioid ovarian, peritoneal or fallopian tube malignancy that is metastatic and for which curative measures do not exist; pathology must be reviewed and confirmed at Mayo Clinic Department of Pathology; the histology can be confirmed from tissue that was taken at the time of diagnosis; a biopsy at the time of recurrence prior to enrollment on study is not required','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients must be in their first platinum sensitive recurrence; this is defined as recurrence that occurred greater than six months after completion of first line platinum based therapy; for the phase 1 portion of the study, patients must have a platinum free interval between 6 months and 1 year and are not eligible or unwilling to undergo a second cytoreductive surgery','Children are excluded from this study, but will be eligible for future pediatric trials','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 6 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count (ANC) >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 × institutional upper limit of normal (ULN)','Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Negative serum pregnancy test result for females of child bearing potential','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of VX-970 administration; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, excluding alopecia; patients with treatment related effects, such as peripheral neuropathy, that are grade 1 or less are eligible','Prior exposure to gemcitabine','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970, carboplatin, gemcitabine or to these specific compounds','VX-970 is primarily metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with VX-970; these potential risks also apply to the other agents used in this study, such as carboplatin and gemcitabine','Patients with Li Fraumeni syndrome are excluded from the study'
NCT02631733,https://www.clinicaltrials.gov/ct2/show/record/NCT02631733?term=NCT02631733&rank=1,'Patients must have pathologically confirmed diagnosis of a solid tumor cancer for which there is no known standard therapy capable of extending life expectancy','Prior poly ADP ribose polymerase (PARP) inhibitor therapy is allowed; patients with ovarian cancer and a BRCA mutation should have had prior treatment with olaparib per guidelines for standard of care treatment','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Hemoglobin > 9 g/dL','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL without the use of hematopoietic growth factors','Platelets >= 100,000/mcL','Total bilirubin below normal institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (=< 5 x ULN is acceptable if liver metastases are present)','Creatinine =< 1.5 x ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of childbearing potential and male patients should use effective contraception during treatment with MM-398 and for 90 days following the final dose of veliparib and MM-398 for both female and male patients; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','IMAGING CORRELATIVE STUDY: Patients will be eligible to participate in the FMX imaging study if the participating study center offers this test and they do not meet any of the following criteria:\r\n* Evidence of iron overload as determined by:\r\n** Fasting transferrin saturation of > 45% and/or\r\n** Serum ferritin levels > 1000 ng/ml\r\n* A history of allergic reactions to any of the following:\r\n** Compounds similar to ferumoxytol or any of its components as described in full prescribing information for ferumoxytol injection\r\n** Any IV iron replacement product (e.g. parenteral iron, dextran, iron-dextran, or parenteral iron polysaccharide preparations)\r\n** Multiple drugs\r\n* Unable to undergo MRI or for whom MRI is otherwise contraindicated (e.g. presence of errant metal, cardiac pacemakers, pain pumps or other MRI incompatible devices; or history claustrophobia or anxiety related to undergoing MRI)','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those whose adverse events have not resolved to grade 1 or less (except alopecia) from agents administered more than 4 weeks earlier; patients must have completed prior biological therapies and/or targeted therapies >= 2 weeks prior to study enrollment; patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (i.e. radiation to > 25% of bone marrow)','Patients who are receiving any other investigational agents','Subjects with symptomatic brain metastases will be excluded from trial secondary to poor prognosis; however, subjects who have had treatment for their brain metastasis and whose brain disease is stable without steroid therapy for at least 3 months may be enrolled','History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib and MM-398; if patients have a history of allergic reactions to compounds resembling MM-398, they will be excluded from participating in the FMX MRI study, if applicable','Patients who have severe hypersensitivity to irinotecan hydrochloride (HCl)','Patients with known and confirmed diagnosis of interstitial lung disease (IDL)','Clinically significant gastrointestinal (GI) disorders, including history of small bowel obstruction unless the obstruction was a surgically treated remote episode','Patient is unable to swallow or keep down oral medication','Patients at the National Cancer Institute (NCI) site and other selected centers who are willing to undergo an optional pre-treatment ferumoxytol MRI must not have evidence of iron overload, a known hypersensitivity to ferumoxytol or any other IV iron product, a documented history of multiple drug allergies, or those for whom MRI is otherwise contraindicated, including claustrophobia or anxiety related to undergoing MRI; this exclusion criterion applies only to patients enrolling at NCI and other selected sites; of note, the principal investigator (PI) will allow other centers to offer FMX MRI scans if the site in question is willing and the site PI can identify the necessary resources and expertise at their center','Active infection','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with any of these agents','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated','Patients who need chronic use of medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible','Patients with a high risk of seizures should be excluded from the protocol (e.g. those patients with an uncontrolled seizure disorder, and/or patients who have had a focal or generalized seizure within the last 12 months)'
NCT02631746,https://www.clinicaltrials.gov/ct2/show/record/NCT02631746?term=NCT02631746&rank=1,'Patients with any stage of pathologically confirmed cluster of differentiation (CD)3+ acute, lymphoma, chronic, or smoldering subtypes of ATLL','Documentation of HTLV infection (enzyme linked immunosorbent assay [ELISA]) in individual with confirmation of HTLV-1 infection (by immunoblot or polymerase chain reaction [PCR]) or a consistent clinical picture (including two of the following: 1) CD4+ leukemia or lymphoma, 2) hypercalcemia, and/or 3) Japanese, Caribbean or South American birthplace)','Patients with acute or lymphoma forms must have received at least one cycle of combination chemotherapy (with or without mogamulizumab) or interferon (with or without zidovudine and/or arsenic); individuals with chronic or smoldering acute T-cell lymphoma (ATL) are not required to have had prior treatment or could have received any number of previous courses of therapy','Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)','Life expectancy > 12 weeks','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation; women should continue birth control for 23 weeks after stopping nivolumab, and men should continue birth control for 31 weeks after stopping nivolumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 31 weeks after completion of nivolumab administration','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab','Prior allogeneic transplantation','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Any condition requiring > 10 mg/d prednisone equivalents','Current or prior HTLV-1 associated inflammatory diseases, including but not limited to myelopathy, uveitis, arthropathy, pneumonitis, or a Sjogren’s disease-like disorder','Prior treatment with anti-PD-1, anti-programmed death-ligand (PD-L)1, anti-PD-L2 antibody','Grade 2 or greater toxicity from prior therapy','Grade 2 or greater diarrhea','Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies (other than HTLV-associated arthropathy), and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study','Patients who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV RNA) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided their total bilirubin: =< 1.5 x institutional upper limit of normal (ULN) AST (SGOT)/ALT (SGPT): =< 2.5 x institutional upper limit of normal','Patients with concurrent human immunodeficiency virus (HIV) infection may be enrolled if compliant with 3 or more drug anti-retroviral regimen and virus load less than 50 copies/ml and CD4 count greater than 250 cells/ml, and no concurrent opportunistic infection or other malignancy','Any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab'
NCT02890355,https://www.clinicaltrials.gov/ct2/show/record/NCT02890355?term=NCT02890355&rank=1,'Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible','Patients must have metastatic disease that is measurable; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form','Patients must not have history of brain metastases','Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below','Prior systemic therapy and chemoradiotherapy for treatment of resectable, borderline resectable or locally advanced unresectable disease is allowed and does not count toward prior therapy for metastatic disease','Patients who received systemic therapy with gemcitabine/nab-paclitaxel for resectable or borderline/locally advanced unresectable disease and progressed with metastatic disease within 3 months of the past dose of systemic therapy are eligible','Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration','Patients must not have received prior irinotecan-based chemotherapy (e.g. irinotecan hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin [FOLFIRINOX] or FOLFIRI)','Patients must not have received prior PARP inhibitor therapy including, but not limited to ABT-888, olaparib, rucaparib, and talazoparib (BMN637)','Patients must have a Zubrod performance status of 0-1','Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,500/mcL','Within 14 days prior to registration: Hemoglobin >= 9 g/dL','Within 14 days prior to registration: Platelets >= 100,000/mcL','Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)','Within 14 days prior to registration: Serum albumin >= 3.0 g/dL','Within 14 days prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN; patients with liver metastases may have AST and ALT of =< 5.0 x IULN','Within 14 days prior to registration: Serum creatinine =< 2.0 mg/dL','Patients must have CA19-9 obtained within 14 days prior to registration; if CA19-9 is normal a carcinoembryonic antigen (CEA) must be tested within 14 days prior to registration','Patients must have blood urea nitrogen (BUN), alkaline phosphatase, sodium, potassium, calcium, glucose, chloride, and bicarbonate levels obtained within 14 days prior to registration','Patients must not have any clinically significant and uncontrolled major medical condition(s) including, but not limited to uncontrolled nausea/vomiting/diarrhea; active uncontrolled infection; symptomatic congestive heart failure (New York Heart Association [NYHA] class >= II); unstable angina pectoris or cardiac arrhythmia; psychiatric illness/social situation that would limit compliance with study requirements','Patients must not have active seizure or history of seizure','Patients must be able to swallow whole capsule','Patients must have a complete physical examination and medical history within 28 days prior to registration','Patients must not have known Gilbert’s syndrome','Patients must not have known hypersensitivity to irinotecan, fluorouracil, or leucovorin','Patients of childbearing potential must have a negative pregnancy test within 28 days prior to registration and must not be nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and for 6 months following completion of treatment; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients must be willing and able to undergo a biopsy after signed consent and prior to registration; patients must have tumor tissue and blood samples available and be willing to submit tumor and blood samples; NOTE: core biopsy required; fine needle aspiration (FNA) is not an acceptable substitute for core biopsy','If archival tumor is available for submission, patients must be willing to submit tumor sample','Patients must be offered the opportunity to participate in specimen banking for future use','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02642042,https://www.clinicaltrials.gov/ct2/show/record/NCT02642042?term=NCT02642042&rank=1,'DISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable','DISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST 1.1])','DISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to registration','PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient’s lung cancer occurred more than 12 months after the last day of chemotherapy','PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration','PRIOR/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required','PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitor','PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration','PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =< CTCAE grade 1','PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery','PRIOR/CONCURRENT THERAPY CRITERIA: The concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John’s Wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','CLINICAL/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2','CLINICAL/LABORATORY CRITERIA: Absolute neutrophil count (ANC) >= 1500/mcL; these results must be obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Platelet count >= 100,000/mcL; these results must be obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Hemoglobin >= 9 grams/dl; these results must be obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases); these results must be obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min; this result must have been obtained within 28 days prior to registration','CLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection','CLINICAL/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis','CLINICAL/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to uncontrolled congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study','CLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett’s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation','CLINICAL/LABORATORY CRITERIA: Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) within 42 days prior to registration','CLINICAL/LABORATORY CRITERIA: Patients must not have untreated or unresolved retinopathy or have a history (or current evidence) of retinal vein occlusion determined by an ophthalmology exam within 42 days prior to registration','CLINICAL/LABORATORY CRITERIA: Patients must not have an immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO) or other agents used in the study','CLINICAL/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA] and/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity','CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible','CLINICAL/LABORATORY CRITERIA: Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation and for 4 months after the last dose of the drug; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','SPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research','REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','REGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02823652,https://www.clinicaltrials.gov/ct2/show/record/NCT02823652?term=NCT02823652&rank=1,'(STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):','Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)','Patients must speak English and have an adequate ability to view a website (primary intervention study)','(STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:','Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay','Patients must be able to speak English and hear by phone'
NCT02785952,https://www.clinicaltrials.gov/ct2/show/record/NCT02785952?term=NCT02785952&rank=1,'Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)','Patients must have been assigned to S1400I','Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways','Patients must not have an active, known, or suspected autoimmune disease; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger','Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations','Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration; inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease','Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed','Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)','Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity','Patients must also be offered participation in banking for future use of specimens','Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration; (Note: For the Canadian sites, testing for lipase only is acceptable)','Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia\r\n* Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function as clinically indicated\r\n* Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram','Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study'
NCT03077451,https://www.clinicaltrials.gov/ct2/show/record/NCT03077451?term=NCT03077451&rank=1,'Biopsy-proven KS involving skin (with or without visceral involvement) without need for urgent cytotoxic therapy; there should be no evidence of improvement in KS in the 4 weeks immediately prior to study enrollment','Known human immunodeficiency virus (HIV)-1 infection status, as documented by any nationally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by approved test at each study site; United States (U.S.) participants only: alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either:\r\n* Approved diagnostic tests, or\r\n* The referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection\r\n** Participants enrolled outside the U.S. must have a confirmatory diagnostic test sequence as appropriate per national standards, detailed as above, performed regardless of prior documented HIV status; for HIV-negative participants, testing must be performed no more than 1 month prior to study enrollment; NOTE: the term “licensed” refers to a U.S. Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme/chemiluminescence immunoassay (E/CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load','Participant may be either previously untreated for KS or refractory to or intolerant of any one or more prior KS therapies','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mm^3','Absolute neutrophil count >= 1,500/mm^3','Platelets >= 100,000/mm^3','Total bilirubin: within normal limits at each study site local laboratory','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT) (serum glutamate-pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal','Creatinine levels =< upper limit of institutional normal; or creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal','HIV seropositive participants must be on antiretroviral therapy (ART) with the following criteria:\r\n* A complete ART regimen that does not include the study drug as one of a minimum of 3 active drugs, which may include an integrase inhibitor or efavirenz in combination with nucleoside reverse-transcriptase inhibitors (NRTIs)\r\n* The ART regimen must not include protease inhibitor (PIs); participants must not have received a PI-based regimen for at least 4 weeks prior to enrollment\r\n* Participants must either have an undetectable HIV plasma ribonucleic acid (RNA), or if plasma RNA detectable, must be on the same stable regimen for a minimum of 12 weeks prior to study enrollment\r\n* No minimum cluster of differentiation (CD)4 count, but maximum HIV plasma RNA of 1,000 copies/mL','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study enrollment and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study enrollment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to study enrollment','Participants who are receiving any other investigational agents','Participants with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to nelfinavir','Participants receiving any medications or substances that have antiviral activity against KSHV or that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) are ineligible; each ART regimen must be reviewed by the PI before determining eligibility to receive nelfinavir mesylate (NFV); sensitive substrates should be avoided; of the antiretroviral drugs, only delaviridine, nevirapine, cobicistat-boosted antiretrovirals (strong CYP3A4 inhibitor), maraviroc (sensitive CYP3A4 substrate), and PIs (strong CYP3A4 inhibitor) are excluded; the following drugs are also prohibited:\r\nStrong Inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* HIV: non-nucleoside reverse transcriptase inhibitors (delaviridine, nevirapine), protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir), cobicistat-boosted antiretrovirals (e.g., elvitegravir); NOTE: Clinical trials have demonstrated that there are no clinically significant drug-drug interactions between nelfinavir and the following antiretrovirals: efavirenz (strong CYP3A4 inhibitor), etravirine (strong CYP3A4 inhibitor); therefore, these antiretrovirals will not be excluded\r\n* Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* GI: cimetidine, aprepitant\r\n* Hepatitis C: boceprevir, telaprevir\r\n* Miscellaneous: seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids\r\nStrong Inducers of CYP3A4:\r\n* Glucocorticoids: cortisone (> 50 mg), hydrocortisone (> 40 mg), prednisone (> 10 mg), methylprednisolone (> 8 mg), dexamethasone (> 1.5 mg)\r\n* Anticonvulsants: phenytoin, carbamazepine, primidone, phenobarbital and other enzyme inducing anti-convulsant drugs (EIACD)\r\n* Antibiotics: rifampin (rifampicin), rifabutin, rifapentine\r\n* Miscellaneous: St. John’s Wort, modafinil\r\nStrong Inhibitors of CYP2C9:\r\n* Antifungals: fluconazole; lists including medications and substances known or with the potential to interact with the CYP3A or 2C19\r\nDrugs with KSHV antiviral activity:\r\n* Participants receiving any medications or substances that may interfere with KSHV replication are ineligible\r\nBecause the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the physicians’ desk reference may also provide this information; as part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product; lists include medications and substances known or with the potential to interfere with KSHV replication','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with high dose nelfinavir','Chronic diarrhea as defined by loose or watery stools occurring more than 3 times daily at baseline lasting more than 4 weeks or not abating on condition-appropriate therapy prior to study enrollment','Participant is < 2 years free of another primary malignancy; exceptions include basal cell skin cancer, stage 0-I squamous cell cancer of the skin, cervical carcinoma in situ, anal carcinoma in situ','Use of systemic corticosteroid therapy (except for replacement doses of glucocorticoid and/or mineralocorticoid for adrenal insufficiency); inhaled or intranasal corticosteroids for allergic or bronchospastic conditions are permitted'
NCT02724579,https://www.clinicaltrials.gov/ct2/show/record/NCT02724579?term=NCT02724579&rank=1,'Patients must be newly diagnosed and have a confirmed molecular diagnosis of classical histologic type (non large cell/anaplastic [LC/A]) WNT medulloblastoma from rapid central pathology screening review on APEC14B1 (immunohistochemistry [IHC]/molecular screening [positive nuclear beta (B)-catenin by IHC and positive for catenin beta 1 [CTNNB1] mutation) and confirmation of =< 1.5 cm^2 maximal cross-sectional area of residual tumor from rapid central imaging review','Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study\r\n* Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status','Patients must have eligibility confirmed by rapid central imaging review on APEC14B1; standard whole brain magnetic resonance imaging (MRI) with and without contrast (gadolinium) and spine MRI with contrast (gadolinium) must be performed at the following time points:\r\n* Pre-operative to include an MRI of the brain with and without contrast (including post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast fluid-attenuated inversion recovery [FLAIR])\r\n* Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may be obtained if pre-operative imaging is not possible or is suboptimal; pre-operative spine imaging is strongly preferred, due to the potential of post-operative sequelae, which could affect metastasis detection\r\n* Post-operative brain MRI within 72 hours of surgery','Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422\r\n* Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)\r\n** Note: patients must begin treatment within 36 days of definitive surgery','Patients must have no previous radiotherapy or chemotherapy other than corticosteroids','Peripheral absolute neutrophil count (ANC) >= 1000/uL','Platelet count >= 100,000/uL (transfusion independent)','Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)\r\n* 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)\r\n* 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)\r\n* 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)\r\n* >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)\r\n** The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)','Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and','Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the purpose of this study, the upper limit of normal [ULN] for SGPT is 45 U/L)','Central nervous system function defined as:\r\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\r\n* Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment','Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible','Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids','Female patients who are pregnant are ineligible','Lactating females are not eligible unless they have agreed not to breastfeed their infants','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation','All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02689453,https://www.clinicaltrials.gov/ct2/show/record/NCT02689453?term=NCT02689453&rank=1,'Patients diagnosed with a leukemia or lymphoma as follows:\r\n* Chronic or acute leukemia forms of HTLV-1 associated adult T-cell leukemia;\r\n* Peripheral T-cell lymphoma (angioimmunoblastic, hepatosplenic, or not otherwise specified); or,\r\n* Cutaneous T-cell lymphoma stage III or IV with circulating monoclonal cells (B1 or B2) and/or erythrodermia (T4)\r\nNOTE: Diagnosis must be validated by the Pathology Department, National Cancer Institute (NCI)','Patients must have measurable or evaluable disease; NOTE: All patients with greater than 10% abnormal CD4+ homogeneous CD3^low strongly CD25+ expressing cells, or greater than 5% Sezary cells, among the peripheral blood mononuclear cells (PBMCs) in the peripheral blood will be deemed to have evaluable disease','Abnormal T cells must be CD52+ as assessed by flow cytometry or immunohistochemistry','Patients must have a life expectancy of >= 2 months','Patients must have been refractory or relapsed following front line therapy for adult T-cell leukemia (ATL); those with Cutaneous T-cell lymphoma (CTCL) or Peripheral T-cell lymphoma (PTCL) who have CD30+ disease must have progressed during or after treatment with brentuximab vedotin, or are unable to receive treatment due to allergy or intolerance','Patients must have recovered to less than grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation or biologic therapy within 2 weeks prior to beginning treatment; NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the principal investigator (PI) (e.g., alopecia)','Diffusing capacity divided by the alveolar volume (DDLCO/VA) and forced expiratory volume (FEV) – 1.0 > 50% of predicted on pulmonary function tests','Serum creatinine of =< 1.5 x the upper limit of normal','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the upper limit of normal','Absolute neutrophil count >= 1,500/mm^3','Platelets >= 100,000/mm^3','Eastern Cooperative Oncology Group (ECOG) =< 1','Patients must be able to understand and sign an informed consent form','All patients must use adequate contraception during participation in this trial and for 3 months following completing therapy','Patients who have received any systemic corticosteroid therapy within 4 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), with the exception of physiological replacement doses of cortisone acetate or equivalent','Patients who have undergone allogeneic stem cell transplantation and have required systemic treatment for GVHD (including but not limited to oral or parenteral corticosteroids, ibrutinib, and extracorporeal phototherapy) within the last 12 weeks','Clinical evidence of (parenchymal or meningeal) central nervous system (CNS) involvement or metastasis; in subjects suspected of having CNS disease, a magnetic resonance imaging (MRI) scan of the brain and lumbar puncture should be done to confirm','Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C\r\n* Positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antigen (HBsAb) positive and hepatitis B core antibody (HBcAb) negative) or a fully resolved acute hepatitis B infection is not an exclusion criterion\r\n* Positive hepatitis C serology is an exclusion criterion\r\nNOTE: HIV-positive patients are excluded from the study','Concurrent anticancer therapy (including other investigational agents)','History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible)','Patients with smoldering and lymphomatous ATL','Pregnant or nursing patients','Patients who have previously received alemtuzumab are ineligible','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, moderate/severe graft versus host disease, cognitive impairment, active substance abuse, or psychiatric illness/social situations that, in the view of the investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements'
NCT02713386,https://www.clinicaltrials.gov/ct2/show/record/NCT02713386?term=NCT02713386&rank=1,'Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up','Women of childbearing potential should be willing and able to use medically acceptable forms of contraception during the trial','Patients must have clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation','Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded [FFPE] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these','All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease\r\n* Further protocol-specific assessments','Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0, 1, or 2 within 28 days prior to registration','Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, within 14 days prior to registration; this ANC cannot have been induced by granulocyte colony stimulating factors','Platelets greater than or equal to 100,000/mcl, within 14 days prior to registration','Hemoglobin greater than 9.0 mg/dl (transfusions are permitted to achieve baseline hemoglobin level), within 14 days prior to registration','Estimated creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 according to the Cockcroft-Gault formula, within 14 days prior to registration','Bilirubin =< 1.5 x upper limit of normal (ULN), within 14 days prior to registration','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN, within 14 days prior to registration','Alkaline phosphatase =< 2.5 x ULN, within 14 days prior to registration','Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1','Ability to swallow and retain oral medication','The patient must provide study-specific informed consent prior to study entry','Patients with suspected non-gynecologic malignancy, such as gastrointestinal','Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy','Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued','Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease','Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer','Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma','Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions','Severe, active co-morbidity defined as follows:\r\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment\r\n* Known brain or central nervous system metastases or history of uncontrolled seizures\r\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)\r\n* Partial or complete gastrointestinal obstruction','Patients who are not candidates for major abdominal surgery due to known medical comorbidities','Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol','Patients who are unwilling to be transfused with blood components','Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy)','Receipt of an investigational study drug for any indication within 30 days or 5 half-lives (whichever is longer) prior to day 1 of protocol therapy','Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations','Patients who are pregnant or nursing; women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a screening negative serum or urine pregnancy test within 14 days of registration; a second pregnancy test must be done within 24 hours prior to the start of the first cycle of study treatment; women must not be breastfeeding\r\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL','Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection or known history of tuberculosis'
NCT02921256,https://www.clinicaltrials.gov/ct2/show/record/NCT02921256?term=NCT02921256&rank=1,'The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines','Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2','Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact; Note: prior to randomization, the investigator must specify and document the following: \r\n* Distance of the lowest tumor margin from the anal verge; and \r\n* Intent for sphincter sparing surgical resection or not according to the primary surgeon','The tumor must be clinically determined to be locally advanced stage II or stage III rectal cancer, defined as meeting any ONE of the following criteria:\r\n* Distal location: cT3-4 =< 5 cm from the anal verge, any N (as defined by measurement on magnetic resonance imaging [MRI], transrectal ultrasound [ERUS]/pelvic computed tomography [CT] (with IV contrast) scan or palpable on digital rectal examination [DRE])\r\n* Bulky: any cT4 with the majority of the untreated tumor < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon, or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan\r\n* High risk for metastatic disease with 4 or more regional lymph nodes (cN2)\r\n* Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)\r\n** Note: clinical stage of the primary tumor and nodes may be determined locally by endoscopic ultrasound or abdominal/pelvic MRI (MRI is preferred); CT scan with IV contrast is acceptable provided there is evidence of T4 and/or N2 disease; clinical nodal or \"cN\" status for eligibility includes the total number of nodes (N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0 cm in any axis on cross sectional or endoscopic imaging','At least two (2) untreated core biopsy specimens from the untreated tumor (formalin-fixed, paraffin-embedded [FFPE]) must have been collected previously and be available for submission per protocol requirements','Patients must have the ability to swallow and retain oral medication','Absolute neutrophil count (ANC) must be >= 1200/mm^3','Platelet count must be >= 100,000/mm^3','Hemoglobin must be >= 10 g/dL','Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin','Alkaline phosphatase must be =< 3 x ULN for the lab','Aspartate aminotransferase (AST) must be =< 3 x ULN for the lab;\r\n* Note: if alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 3 x ULN; if both were performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3 x ULN, serologic testing for hepatitis B and C must be performed and results for viral infection must be negative','Serum creatinine =< ULN for the lab and measured or calculated creatinine clearance > 60 mL/min','Serum potassium, magnesium, and calcium levels within 28 days before randomization must be within normal limits (WNL) for the lab','International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history','Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease must:\r\n* Have a cluster of differentiation (CD)4 count >= 200 cells/uL within 30 days before beginning study therapy\r\n* Be off all antiretroviral therapy (prophylaxis/treatment) more than 60 days before beginning study therapy, and\r\n* Have no evidence of opportunistic infections','Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards','Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, etc.)','Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 28 days prior to randomization; Note: Distant clinical staging to exclude patients with overt metastatic disease is determined by CT scan with IV contrast (chest/abdomen/pelvis), with or without PET scan (preferred); MRI of the abdomen and pelvis and a chest x-ray (posterioranterior [PA] and lateral) is acceptable; (it is recommended that the same imaging tests that are performed before randomization be used at follow-up time points)','History of prior invasive rectal malignancy, regardless of disease-free interval','Cardiac disease that would preclude the use of any of the drugs included in the GI002 treatment regimen; this includes but is not limited to:\r\n* Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker\r\n* Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of other antiarrhythmic drugs is permitted\r\n* Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker\r\n* Complete left bundle branch block (LBBB)\r\n* History of long QT syndrome\r\n* Corrected QT (QTc) >= 450ms','Sensory or motor neuropathy >= grade 2','Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic) or have a history of abdominal surgery that may interfere with gastrointestinal motility or absorption','Active seizure disorder uncontrolled by medication','Any antineoplastic therapy for this cancer before randomization','Synchronous colon cancer','Other invasive malignancy within 5 years before randomization; exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix','Chemotherapy within 5 years before randomization; (for the purposes of this study, hormonal therapy is not considered chemotherapy)','Prior treatment with an investigational compound being tested in this study (e.g., poly ADP ribose polymerase [PARP] inhibitor)','Major surgery within 4 weeks before randomization','Any therapeutic pelvic radiation','Pregnant women','Nursing women who are unwilling to discontinue nursing','Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 3 months after the last dose of study therapy','Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up'
NCT02717507,https://www.clinicaltrials.gov/ct2/show/record/NCT02717507?term=NCT02717507&rank=1,'Males and females must weigh >= 40 Kg','Patient must have had a cancer diagnosis < 21 years of age, irrespective of current age','Patient must have a lifetime cumulative anthracycline dose occurring prior to age 22: total dose must be >= 250 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy\r\n* Note: Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used to document lifetime receipt of anthracycline dose','Patient must have completed cancer treatment >= 2 years prior to study enrollment','Receiving treatment for cardiomyopathy or heart failure','Ejection fraction of < 50% by radionuclide angiogram or echocardiogram','Shortening fraction of < 25% by echocardiogram','Uncorrected primary obstructive or severe regurgitative valvular disease:\r\n* Nondilated (restrictive); or\r\n* Hypertrophic cardiomyopathy; or\r\n* Significant systemic ventricular outflow obstruction','Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device','Significant conduction defects (i.e. second or third degree atrioventricular block or sick sinus syndrome)','Bradycardia: heart rate < 50 beats per minute (BPM)','Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment','History of drug sensitivity or allergic reaction to alpha or beta-blockers','Low resting systolic blood pressure: < 90 mmHg','Use of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diuretics','History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e. asthma) requiring therapy','Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times upper limit of institutional normal','Gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications','Endocrine disorders (such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism) not controlled with medication','Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center’s Glycemic Target Goals is hemoglobin A1C < 7%)','Anemia (hematocrit < 28%)','Currently using select CYP2D6 inhibitor or inducer medications','Inability to swallow pills','Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to starting study drug','Lactating females are not eligible unless they have agreed to not breastfeed their infants','Sexually active female patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method during study and for 2 months after stopping the study drug; abstinence is an acceptable method of birth control','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02927249,https://www.clinicaltrials.gov/ct2/show/record/NCT02927249?term=NCT02927249&rank=1,'Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility','Any ER/progesterone receptor (PgR) status allowed','Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed','Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever','Patients must be enrolled within 1 year after diagnosis','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed','No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention','No history of any prior stroke (hemorrhagic or ischemic)','No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors','No history of atrial fibrillation or myocardial infarction','No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)','No chronic (duration > 30 days) daily use of oral steroids','No known allergy to aspirin','No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study','Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use'
NCT02933489,https://www.clinicaltrials.gov/ct2/show/record/NCT02933489?term=NCT02933489&rank=1,'Patents must be scheduled for routine screening DBT','Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed','Patient’s breast density must be known; patients must have mammographically dense breasts, American College of Radiology (ACR) Breast Imaging (BI)- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening','Patient must be asymptomatic for breast disease and undergoing routine screening','Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia [ADH], atypical lobular breast hyperplasia [ALH], lobular breast carcinoma in situ [LCIS], papilloma, radial scar)','Patient must not be taking chemoprevention for breast cancer','Patient must not have undergone breast ultrasound within 12 months prior to randomization','Patient must not have previously had a breast MRI','Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging [MIBI])','Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period','Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of >= 20-25%)','Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible\r\n* No history of untreatable claustrophobia\r\n* No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication\r\n* No history of sickle cell disease\r\n* No contraindication to intravenous contrast administration\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice\r\n* Weight less than or equal to the MRI table limit\r\n* No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography [CESM] or contrast enhanced digital mammography [CEDM])\r\n* No women who have breast prosthetic implants (silicone or saline)'
NCT02728596,https://www.clinicaltrials.gov/ct2/show/record/NCT02728596?term=NCT02728596&rank=1,'Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic','Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage (or disease setting); patient must not have had any systemic therapy in the 180 days just prior to registration; prior biologic therapy, immunotherapy, and hormonal therapy are allowed','Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; this treatment may be neoadjuvant or adjuvant chemotherapy; patients must not be receiving or planning to receive concurrent radiation during systemic treatment','Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim','Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish','Patients may have had a prior malignancy','Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of Institutional Review Board approval for this study has been entered in the system'
NCT02728258,https://www.clinicaltrials.gov/ct2/show/record/NCT02728258?term=NCT02728258&rank=1,'Patients must have the psychological ability and general health that permits completion of the study requirements and required follow-up','Women of child-bearing potential (WOCBP) must agree to use adequate contraception when sexually active; patients should continue contraception for 6 months after finishing study drug','Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial','Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS]); histologic confirmation of the primary tumor is required','All patients must have a somatic PIK3CA gene mutation (i.e., R88Q in exon 1, N345K in exon 4, C420R in exon 7, E542K, E545X [E545A, E545D, E545G, and E545K], Q546X [Q546E, Q546K, Q546L, and Q546R] in exon 9, and M1043I, H1047X [H1047L, H1047R, and H1047Y], or G1049R in exon 20) in a representative primary or metastatic tumor sample confirmed by the Roche COBAS PIK3CA Mutation Test at Q^2 Solutions','All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI','Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as ‘non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy','Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay required for minor procedures (e.g., tumor fine-needle aspiration [FNA] or core biopsy, venous access device placement)','Patients may have received prior radiation therapy for treatment of endometrial cancer; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy and/or palliative radiation therapy; all radiation therapy must be completed at least 4 weeks prior to registration','Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least 4 weeks prior to registration','Patients may have received prior therapy (including chemotherapy, biologic/targeted therapy and immunotherapy) for treatment of endometrial cancer; all therapy must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registration','Patients must have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen\r\n* Patients are allowed to receive, but not required to receive, up to a total of 3 lines of chemotherapy','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Completion of pre-study protocol specific assessments as required','Performance status (Eastern Cooperative Oncology Group [ECOG]/Karnofsky) of 0, 1 or 2 within 28 days prior to registration','Absolute neutrophil count (ANC) >= 1,500/mcl','Platelets >= 75,000/mcl','Hemoglobin (Hgb) >= 8 g/dL','Creatinine =< 1.5 x upper limit of normal (ULN)','Bilirubin =< 1.5 x ULN (=< 3 x ULN for patients with Gilbert syndrome)','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN','Left ventricular ejection fraction (LVEF) >= 50%','Fasting cholesterol less than or equal to 300 mg/dl; fasting triglycerides less than or equal to 300 mg/dl','Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normal','The patient must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information','Diabetic patients (type I or II diabetes mellitus) must have baseline hemoglobin (Hb)A1c levels NOT higher than 8.5% at study entry','Patients with hypertension on medical management must have systolic blood pressure < 150 mmHG or diastolic pressure < 90 mmHG at study entry','Note: ULN is institutional or laboratory upper limit of normal','Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 28 days of registration; the patient and her sexual partner(s) must agree to use adequate contraception when sexually active for the duration of the study and for 6 months after finishing study drug; a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone (FSH) level in the postmenopausal range maybe used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy','Patients who have had prior therapy with any phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTor) pathway inhibitor','Patients who have the following histologies: mucinous, squamous, sarcomas, carcinosarcomas, clear cell','Congestive heart failure > New York Heart Association (NYHA) class II','Myocardial infarction or unstable angina less than 6 months before registration','Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before registration','Non-healing wound, ulcer or bone fracture','Active, clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2','History of, or current autoimmune disease','Human immunodeficiency virus (HIV) infection','Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel; patients with active HBV or hepatitis C infection are not eligible for enrollment; patients with serologic markers of HBV immunization due to known vaccination (hepatitis B surface antigen [HBsAg] negative, anti-hepatitis B core [HBc] negative and anti-hepatitis B surface [HBs] positive) will be eligible','Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated:\r\n* Cervical carcinoma in situ\r\n* Non-melanoma skin cancer\r\n* Superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])','Patients with seizure disorder requiring medication','Patients with evidence or history of bleeding diathesis; any hemorrhage or bleeding event >= CTCAE grade 3 within 4 weeks prior to registration','Proteinuria of CTCAE grade 3 or higher (estimated by urine protein: creatinine ratio >= 3.5 on a random urine sample); patients who recently (i.e., at least 30 days prior to registration) discontinued an anti-angiogenic therapy which caused proteinuria (ie, grade 2 (> 2 to > 3 g of protein or 1-3.5 g/24 hours [h]) or grade 3 proteinuria (> 4 of protein or > 3.5 g/24 h) are not eligible for enrollment until proteinuria improves to < 2 g of protein per 24 h','History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)','Concurrent diagnosis of pheochromocytoma','Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure, excluding alopecia','Known hypersensitivity to any of the test drugs, test drug classes, or excipients in the formulation','Strong CYP3A4 inhibitors and inducers; concomitant use of strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and inducers of CYP3A4 (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) are not permitted within two weeks prior to start of study treatment and for the duration of treatment with copanlisib','Grapefruit and grapefruit juice (CYP3A4 inhibitor), Seville oranges and star fruit consumption is not permitted during the study','Anti-arrhythmic therapy other than beta blockers or digoxin','Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids','Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies','Concomitant radiotherapy','Women who are breast feeding'
NCT03055013,https://www.clinicaltrials.gov/ct2/show/record/NCT03055013?term=NCT03055013&rank=1,'ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):','Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization\r\n* If biopsy was performed as part of patients standard care, and will not be performed during step 0 proceed directly to randomization','ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):','Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or (if preoperative biopsy was uninformative) - “unknown” histology; RCC must have been confirmed by biopsy within 4 months prior to randomization; if the biopsy clearly demonstrated a benign condition or a different type of cancer, the patient is not eligible to be randomized','Clinical stage >= T2NxM0 or TanyN+ disease for which radical or partial nephrectomy is planned','Patients must have no clinical or radiological evidence of distant metastases (M0)','No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted; examples of these prohibited therapies include:\r\n* Radical or partial nephrectomy for prior RCC\r\n* Metastectomy for RCC\r\n* Radiation therapy to the renal bed or any distant metastatic sites\r\n* Antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC\r\n* Prior treatment with an anti-programmed cell death 1 (PD-1), anti-programmed cell death-ligand 1 (PD-L1), anti-PD-L2, anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways','Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy, or\r\n* Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use accepted and effective methods of contraception, as described in the informed consent form (ICF), or to abstain from sexual intercourse for the duration of their participation in the study; women of childbearing potential should use adequate methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually active males should use adequate methods to avoid pregnancy for 31 weeks after the last dose of nivolumab','Patient must have no prior history of RCC that was resected with curative intent within the past 5 years','Patients must not have other current malignancies:\r\n* Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years prior to the time of registration and they are not receiving any current treatment\r\n* Prior or current prostate cancer is excluded\r\n** A history of superficial Ta urothelial cancer is permitted (not being currently treated) but T1 or greater disease is excluded','No active known or suspected autoimmune disease; the following are permitted: patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune or non-autoimmune condition requiring hormone replacement, asymptomatic hypothyroidism not requiring treatment, psoriasis not requiring systemic treatment, or conditions not expected to recur','No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications; no treatment with other immunosuppressive agents within 14 days prior to the first dose of study drug; topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.; a brief (less than 3 weeks) course of corticosteroids (any amount) for prophylaxis (for example: contrast dye allergy) or for treatment of non-autoimmune conditions (for example: delayed-type hypersensitivity reaction caused by a contact allergen) is permitted if > 14 days since last dose','No uncontrolled adrenal insufficiency','No known chronic active liver disease or evidence of acute or chronic hepatitis B virus (HBV) or hepatitis C (HCV)','Patients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics','No known evidence of human immunodeficiency virus (HIV) infection','No known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results','No major surgery within 28 days prior to randomization','Patients currently enrolled in other clinical trials testing a therapeutic intervention','White blood cells >= 2000/uL, within 4 weeks of randomization','Absolute granulocyte count (AGC) >= 1,500/mm^3, within 4 weeks of randomization','Platelet count >= 100,000/mm^3, within 4 weeks of randomization','Hemoglobin >= 9.0 g/dL, within 4 weeks of randomization','Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 40 mL/min, within 4 weeks of randomization','Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN, within 4 weeks of randomization','No history of severe hypersensitivity to a monoclonal antibody','Signed, dated informed consent'
NCT02723864,https://www.clinicaltrials.gov/ct2/show/record/NCT02723864?term=NCT02723864&rank=1,'Patients must have histologically confirmed solid tumors for which standard therapy known to prolong survival has failed in the metastatic setting or for which standard therapies do not exist','Tumor amenable to biopsy and willingness to undergo tumor biopsies before and after M6620 (VX-970) treatment during the expansion phase of the trial (biopsies optional during the escalation phase)','Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study and >= 1 week since any palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy > 3 months','Absolute neutrophil count >= 1,500/mcL','Hemoglobin >= 9 g/dL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 X institutional upper limit of normal','Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 1.5 X institutional upper limit of normal (or =< 3 X upper limit of normal [ULN] in the setting of liver metastases)','Creatinine =< 1.5 X institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completing study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of administration of study agents','Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible','Patients must be able to swallow whole tablets or capsules; nasogastric or g-tube administration is not allowed; any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed','Ability to understand and the willingness to sign a written informed consent document','During the expansion phase of the protocol, patients must have disease amenable to biopsy and be willing to undergo pre- and post-treatment biopsies','Patients who are receiving any other investigational agents','Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients whose brain metastatic disease status has remained stable for >= 4 weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator','Uncontrolled intercurrent illness including, but not limited to, ongoing or active untreated infection, or psychiatric illness/social situations that would limit compliance with study requirements','Patients required to be on any of the concomitant medications are excluded','Pregnant women and women who are breastfeeding are excluded from this study','Patients who have had prior platinum-based therapy who have > grade 1 neurotoxicity or ototoxicity at the time of enrollment will not be permitted on study','Patients with a seizure history will not be permitted on protocol; patients on anticonvulsant medications will not be permitted on study','Patients in the expansion cohort undergoing tumor biopsies may not be on anticoagulants'
NCT03091660,https://www.clinicaltrials.gov/ct2/show/record/NCT03091660?term=NCT03091660&rank=1,'Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days prior to registration','Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration','Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration','Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification','Patients must not have pure squamous cell carcinoma or adenocarcinoma','Patients’ disease must not have micropapillary components','Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms','No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible','Patients must have a Zubrod performance status of 0-2','Patients must not have received prior intravesical BCG or intradermal BCG','Patients must not be taking oral glucocorticoids at the time of registration','Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study','Patients must not have known history of tuberculosis','Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml); for PPD readings done outside of 48-72 hour window, patients must have PPD test and reading repeated to confirm eligibility','Patients must be >= 18 years of age','Prestudy history and physical must be obtained within 90 days prior to registration; patients must have a complete blood count (CBC) and basic metabolic panel including creatinine, potassium, chloride, blood urea nitrogen (BUN), carbon dioxide (CO2) and glucose within 28 days prior to registration','Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies'
NCT02839343,https://www.clinicaltrials.gov/ct2/show/record/NCT02839343?term=NCT02839343&rank=1,'Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review','No prior chemotherapy or radiation for pancreatic cancer','No definitive resection of pancreatic cancer','Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study','Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment','No grade >= 2 neuropathy','No known Gilbert’s syndrome or known homozygosity for UGAT1A1*28 polymorphism','No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration','Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1','Absolute neutrophil count (ANC) >= 1,500/mm^3','Platelet count >= 100,000/mm^3','Creatinine =< 1.5 x upper limit of normal (ULN) or','Calculated (calc.) creatinine clearance > 45 mL/min','Total bilirubin =< 2.0 mg/dL','Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)'
NCT02808650,https://www.clinicaltrials.gov/ct2/show/record/NCT02808650?term=NCT02808650&rank=1,'Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or in patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)','Patients must have either measurable or evaluable disease','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age \r\n* Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid \r\n* Hematopoietic growth factors: >= 14 days must have elapsed since the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed since the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed after infusion, and no evidence of graft-versus-host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed after completion\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X ray (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY2606368','For patients with solid tumors without known bone marrow involvement: \r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8.0 g/dl at baseline (may receive packed red blood cell [PRBC] transfusions)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: maximum serum creatinine (mg/dL)\r\n* 1 to < 2 years: 0.6 (male and female) \r\n* 2 to < 6 years: 0.8 (male and female) \r\n* 6 to < 10 years: 1 (male and female) \r\n* 10 to < 13 years: 1.2 (male and female) \r\n* 13 to < 16 years: 1.5 (male), 1.4 (female) \r\n* >= 16 years: 1.7 (male), 1.4 (female)','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L','Serum albumin >= 2 g/dL','Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study','Corrected QT (QTc) =< 480 msec\r\n* Note: Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause Torsades De Pointes; If possible, alternative agents should be considered\r\n* Patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available','Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled','Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) resulting from prior therapy must be =< grade 2','For patients with CNS tumors, any baseline neurologic deficit, including seizures, must be stable for at least one week prior to initiating study treatment','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Tissue blocks or slides must be sent if available; if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 3 months after participation in this study; abstinence is an acceptable method of contraception','Corticosteroids: Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Investigational drugs: Patients who are currently receiving another investigational drug are not eligible','Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible','Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Strong CYP1A2 inhibitors: Patients must not have received strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, zafirlukast) for at least 7 days prior to enrollment and must not receive them for the duration of the study','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to LY2606368 or to its formulation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT02775851,https://www.clinicaltrials.gov/ct2/show/record/NCT02775851?term=NCT02775851&rank=1,'COHORT A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR','COHORT B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per RECIST 1.1','Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient’s chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)','Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration','Patients must not have received prior systemic treatment for this melanoma','Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol','Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration','Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) prior to registration','Obtained within 28 days prior to registration: Absolute neutrophil count (ANC) >= 1,500/mcl','Obtained within 28 days prior to registration: Platelets >= 50,000/mcl','Obtained within 28 days prior to registration: Hemoglobin >= 8 g/dL','Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome)','Obtained within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)','Patients must have lactate dehydrogenase (LDH) performed within 28 days prior to registration','Patients must have Zubrod performance status =< 2','Patients must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis','Patients must not have an active infection requiring systemic therapy','Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment','Patients must not have received live vaccines within 42 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette–Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are not allowed','Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate CD4 counts (>= 350 mm^3), and serum HIV viral load of < 25,000 IU/ml; patients must be on a stable anti-viral therapy','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated in situ cancer, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years','Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing','Patients must have specimens available and institutions must be planning to submit for centralized pathology review and for integrated translational medicine objectives','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02775812,https://www.clinicaltrials.gov/ct2/show/record/NCT02775812?term=NCT02775812&rank=1,'STEP 1 (REGISTRATION)','Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), hypopharynx or larynx','Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx squamous cell carcinoma (SCC) within 63 days prior to registration; note: patients may have a biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but demonstrate rapid gross recurrence or are determined to have gross persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible','Patients must have at least one of the following high risk pathologic features:\r\n* Extracapsular nodal extension\r\n* Invasive cancer at the primary tumor resection margin (tumor on ink); Note: Patients who have a positive margin and undergo re-resection with final negative margin are eligible only if they can be enrolled within 63 days of initial gross total resection AND extracapsular nodal extension was also present; patients who have a positive margin and undergo re-resection with final negative margin and do not have extracapsular nodal extension, are NOT eligible','Pathologic stage III or IV HNSCC, including no distant metastases, based on the following minimum diagnostic workup:\r\n* General history/physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration\r\n* Examination by an ear nose and throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation\r\n* Pre-op Imaging of the head and neck: a neck computerized tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via transfer of images and data (TRIAD); the report is to be uploaded into Rave\r\n* Chest imaging with either a CT scan (with or without contrast) or CT/PET (with or without contrast) that includes the chest within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement','For patients with oropharyngeal cancer only: the institution will do p16 testing, and if p16 is negative, this tissue must be submitted for central review for confirmation before Step 2 registration; note: if the institution finds that the patient is p16 positive, the patient is excluded from this trial on the basis of distinct biology, prognosis, and low- or intermediate-risk rather than high-risk status','Zubrod performance status of 0-1 within 28 days prior to registration','Absolute neutrophil count (ANC): >= 1,500 /mm^3','Platelets: >= 100,000 / mm^3','Hemoglobin: >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)','Creatinine clearance (CrCl) >= 50 ml/min within 14 days prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula','Serum total bilirubin: =< 1.5 X ULN OR','Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN','International normalized ratio (INR) or prothrombin time (PT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants','Activated Partial Thromboplastin Time (aPTT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants','The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chlorine (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion','For women of childbearing potential, a negative serum pregnancy test within 14 days of registration','Female patients of childbearing potential and men receiving MK-3475 (pembrolizumab) who are sexually active with women of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of MK-3475 (pembrolizumab); note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient','Patients with feeding tubes are eligible for the study','The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, including consent for mandatory tumor tissue, serum, and blood submission for immune correlatives (all patients) and p16 analysis (oropharyngeal cases only)','STEP 2 (REGISTRATION)','For patients with oropharyngeal cancer only: p16 negative, confirmed by central pathology review','Definitive clinical or radiologic evidence of metastatic disease','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even if diagnosed and treated < 3 years ago','Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 differentiated thyroid carcinoma, who are eligible','Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy, or immune therapy for the study cancer; note: prior cytotoxic chemotherapy or biologic/targeted therapy for a different cancer is allowable; however, a prior anti-programmed cell death (PD)-1, anti-PD-L1, or anti-programmed cell death 1 ligand 2 (PD-L2) agent is not permitted','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Severe, active co-morbidity defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration\r\n* Transmural myocardial infarction within 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Note: if the infection resolves and the patient is on oral (p.o.) and still within, the required registration timeframe, then the patient is eligible\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration\r\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the cisplatin and IMRT involved in this protocol may be significantly immunosuppressive; patients with known HIV, CD4 counts >= 250/uL, and undetectable viral loads who are stable on an antiretroviral regimen may be included\r\n* A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the MK-3475 (pembrolizumab)\r\n* Known history of active TB (Bacillus tuberculosis)\r\n* Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); Note: patients who have been curatively treated for hepatitis C and have no detectable viral load are eligible\r\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment','Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):','Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels','Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)','Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels','Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels','Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels','Patients who are pregnant, nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of MK-3475 (pembrolizumab)','Hypersensitivity to MK-3475 (pembrolizumab) or any of its excipients;','Patients who have received a live vaccine within 30 days of planned start of study therapy; Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed','Patients for whom it is not in the best interest to participate in the study, in the opinion of the treating investigator'
NCT02780804,https://www.clinicaltrials.gov/ct2/show/record/NCT02780804?term=NCT02780804&rank=1,'Patients must have a body surface area (BSA) of >= 1.17 m^2 at time of study enrollment','Patients must be able to swallow intact tablets','Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)','Patients must have either measurable or evaluable disease','Patient’s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Solid tumor patients: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Lymphoma patients: a waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e. corticosteroid, vincristine, thioguanine[6MP], and/or methotrexate)\r\n** >=14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy; additionally, patients must have fully recovered from all acute toxic effects of prior therapy; Note: cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Hematopoietic growth factors: >= 14 days must have elapsed from the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without traumatic brain injury [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed from infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed from infusion\r\n* Cellular therapy: >= 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* External beam radiation (XRT)/External beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days must have elapsed from the last dose of systemically administered radiopharmaceutical therapy\r\n* Histone deacetylase (HDAC) inhibitors: Patients must not have received prior therapy with entinostat; patients who have received therapy with other HDAC inhibitors are eligible','Peripheral absolute neutrophil count ( ANC) >= 1000/mm^3','Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Hemoglobin >= 8.0 g/dl, with or without transfusion','Patients with known bone marrow metastatic disease will not be eligible','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 1 to < 2 years: 0.6 mg/dL for males and females\r\n* 2 to < 6 years: 0.8 mg/dL for males and females\r\n* 6 to < 10 years: 1.0 mg/dL for males and females\r\n* 10 to < 13 years: 1.2 mg/dL for males and females\r\n* 13 to < 16 years: 1.5 mg/dL for males and 1.4 mg/dL for females\r\n* > = 16 years: 1.7 mg/dL for males and 1.4 mg/dL for females','Bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/l; for the purpose of this study, the ULN for SGPT is 45 U/l','Serum albumin >= 2 g/dl','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 3 months after participation in this study; abstinence is an acceptable method of contraception; those who become pregnant while on treatment with entinostat must discontinue immediately and consult their treating physician','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients requiring concurrent administration of valproic acid are not eligible for this trial','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients with a BSA ? 1.17 m^2 at time of study enrollment are not eligible','Patients who are not able to swallow intact tablets are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients with a history of allergy to medications that have a benzamide structure (e.g., metoclopramide, procarbazine, domperidone, cisapride etc.) are not eligible'
NCT03030417,https://www.clinicaltrials.gov/ct2/show/record/NCT03030417?term=NCT03030417&rank=1,'Patients must have histologically documented metastatic solid tumors which have progressed after one line of therapy, or lymphoma which has progressed after all Food and Drug Administration (FDA)-approved therapy','Patients must have measurable or evaluable disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)','Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with serum creatinine levels > 1.5 x higher than institutional normal','Anticoagulation with low-molecular-weight heparin (LMWH) will be permitted; patients receiving treatment with warfarin or any of the new oral anticoagulants (NOACs) (rivaroxaban, apixaban, dabigatran, or edoxaban) will be given the option to switch to LMWH','Patients must have recovered to grade 1 or baseline from adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy, biologic therapy, or definitive radiotherapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or 5 half-lives, whichever is shorter, prior to entering the study; palliative-intent radiotherapy (30 Gy or less) must be completed at least 2 weeks prior to start of treatment, and may not be to a lesion that is included as measurable disease; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion, and should have recovered to grade 1 or baseline from any toxicities','Patients receiving denosumab or bisphosphonates for any cancer, or undergoing androgen deprivation therapy for prostate cancer, are eligible for this therapy','Prior therapy with topoisomerase I inhibitors is allowed','Human immunodeficiency virus (HIV)-positive patients are eligible provided the following criteria are met: CD4 count > 350/mm^3, an undetectable viral load, and not receiving prophylaxis antibiotics','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women and men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of LMP744 administration','Ability to understand and the willingness to sign a written informed consent document','Willingness to provide blood and new tumor biopsy samples for research purposes if on the expansion phase of the study','Patients who are receiving any other investigational agents','Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 1 month after treatment of the brain metastases; patients on anti-seizure medications or steroid therapy may be enrolled at the discretion of the principal investigator','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated'
NCT03165721,https://www.clinicaltrials.gov/ct2/show/record/NCT03165721?term=NCT03165721&rank=1,'Have recurrent or refractory/unresectable disease for which there is no known curative therapy\r\n* Wild type-GIST: patients with recurrent or progressive disease will be eligible; newly diagnosed patients with resectable localized disease will not be eligible; newly diagnosed patients with metastatic disease and newly diagnosed patients with residual tumor following surgical debulking will be eligible\r\n* PHEO/PGL: patients with recurrent or progressive disease will be eligible; newly diagnosed patients with PHEO/PGL that is metastatic at diagnosis and/or unresectable will be eligible; patients with PHEO/PGL with localized (non-metastatic), resectable disease will not be eligible\r\n* Renal cell cancer associated with HLRCC: patients with localized, resectable HLRCC-associated renal cell cancer will not be eligible; patients with metastatic and/or unresectable HLRCC-associated renal cell cancer will be eligible','Have one of the following confirmed histologically, cytologically, or through biochemical testing:\r\n* Wild-type GIST (GIST without KIT or PDGFRA mutation);\r\n* PHEO/PGL with a germline mutation in SDHA, SDHB, SDHC, or SDHD;\r\n* Renal cell cancer associated with HLRCC\r\n* Testing will be performed in Clinical Laboratory Improvement Act (CLIA) certified labs using genetic tests for KIT/PDGFRA and testing panels developed for patients with PHEO/PGL; results from outside labs will be accepted; pathologic diagnosis will be reviewed and verified at the Clinical Center','Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan','Prior therapy requirements:\r\n* Wt-GIST: previously untreated participants are eligible\r\n* PHEO/PGL with germline SDH subunit mutation: 131I-methyl-iodobenzylguanine (MIBG) in patients with MIBG avid tumors or cytotoxic chemotherapy (cyclophosphamide, vincristine, and dacarbazine [CVD] or temozolomide) is required prior to enrollment on this trial; however, patients who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator will also be eligible\r\n* HLRCC-associated renal cell cancer: previously untreated participants are eligible','Prior therapy wash-out period requirements\r\n* Participants must be at least 4 weeks from prior surgical procedures and surgical incisions must be healed\r\n* Participants must have had their last fraction of external beam radiation therapy at least 4 weeks prior to enrollment; participants with prior radiation therapy must be at least 4 weeks post therapy and have had progression of disease outside the radiation port\r\n* Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 28 days prior to enrollment, their last dose of a monoclonal antibody at least 28 days prior to enrollment, and their last dose of any investigational agent at least 28 days prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] v.4.0) level prior to enrollment (does not apply to alopecia)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky >= 60% in patients > 16 years of age, Lansky >= 60 for patients =< 16 years of age','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 6 months following participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability of subject or legally guardians (if the patient is < 18 years old) to understand and the willingness to sign a written informed consent document','Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy, including investigational agents for their disease','History of allergic reactions to SGI-110 or decitabine','Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, symptomatic pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SGI-110','Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses, or renal transplant, including any patient known to have hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) will be excluded; patients with HIV who have adequate CD4 count, not requiring antiretroviral medication, may be enrolled','Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study'
NCT03137771,https://www.clinicaltrials.gov/ct2/show/record/NCT03137771?term=NCT03137771&rank=1,'Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up.','Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trialtreatment on this study and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.','Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases.','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination by a radiation oncologist (and a surgeon if surgery is planned) within 30 days prior to registration\r\n* Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least diagnostic quality computed tomography (CT) chest through the adrenals or positron emission tomography (PET)/CT, within 30 days prior to registration.','Zubrod performance status 0, 1, or 2 within 30 days prior to registration.','Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN with metastatic liver disease within 14 days prior to registration.','Total bilirubin =< 1.5 x ULN within 14 days prior to registration.','Absolute neutrophil count (ANC) >= 1.5 x 10^9/L within 14 days prior to registration.','Platelets >= 100 x 10^9/L within 14 days prior to registration.','Negative serum pregnancy test within 30 days prior to registration for females of childbearing potential.','Patients must have received first-line/induction systemic therapy comprising of immunotherapy and/or platinum-based chemotherapy (a total of 4 cycles or courses), and achieved stable disease or a partial response.','Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, adjuvant therapy for stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted.','Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to stereotactic body radiation therapy (SBRT) or resection (at least one disease site must be amenable to radiation); some examples of what constitutes specific radiation treatment sites defining distinct metastatic disease sites are as follows: a) A lesion in each adrenal gland represents 2 of 3 sites of metastatic disease allowed to be treated on protocol; b) Similarly to NRG study RTOG 0631, disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment; and c) Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment.','For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation. If the primary disease is found in the peripheral or central lung parenchyma without nodal disease, for instance, SBRT may be employed at the discretion of the treating institution. If primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation; surgery should only be used for metastatic tumors that can be completely resected by lobectomy, segmentectomy, or wide wedge resection.','If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy.','Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy.','The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.','Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable.','Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression within 30 days prior to enrollment.','At least one site of metastatic disease or primary disease must be determined by radiation oncologist to be treatable with radiation.','Subjects may receive palliative radiotherapy for symptomatic metastases prior to enrollment provided that there is at least one other non-irradiated lesion amenable to LCT at the time of enrollment.','Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy.','Cutaneous metastasis of NSCLC.','Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions.','Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year.','Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if not a candidate for surgery for these lesions and if:\r\n* Spinal cord previously irradiated to > 40 Gy\r\n* Brachial plexus previously irradiated to > 50 Gy\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy\r\n* Brainstem previously irradiated to > 50 Gy\r\n* Lung previously irradiated with prior V20 Gy > 35%','Patients receiving targeted therapy (non-cytotoxic, non-immunotherapy based systemic therapy) for NSCLC in the first-line setting. Such designations would include but not be limited to treatments targeting EGFR mutant positive or ALK positive NSCLC in the first-line setting.','If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study.','Patients with malignant pleural effusions that do not resolve after first-line systemic therapy. Patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line systemic therapy.','Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 radiation/surgery plans to cover these distinct metastatic disease entities.','Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 180 days after the completion of all treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding are also excluded.','Participation in any investigational drug study (excluding non-oncology and/or symptom management studies) within 4 weeks prior to registration.','Known human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.','Patients who received prior pembrolizumab, patients on chronic steroids or who have active autoimmune disease for which they received systemic treatment in the previous 2 years with corticosteroids, disease modifying agents, or immunosuppressive drugs; replacement therapy (thyroxine, insulin or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is allowed; patients with active interstitial lung disease or who have a history of pneumonitis for which they had received glucocorticoids are not eligible.','Prior bevacizumab therapy is excluded.'
NCT03033992,https://www.clinicaltrials.gov/ct2/show/record/NCT03033992?term=NCT03033992&rank=1,'Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory','Patients must have failed standard therapy and at the time of study entry have recurrent, progressive or refractory disease with no known curative options','Subjects must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two planes\r\n* This disease must be located primarily in the supratentorial region\r\n* Patients with significant disease that is metastatic outside of the supratentorial region are ineligible','Patients must have recovered from the acute treatment related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study','Patient must have received last dose of known myelosuppressive chemotherapy > 21 days prior to enrollment; > 42 days if nitrosurea','Biologic agent - must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent > 7 days prior to study enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur','Immunomodulatory treatment - patient must have received last dose > 21 days prior to enrollment','Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment','Patients must have had their last fraction of: \r\n* Craniospinal irradiation (> 24 Gy) > 3 months prior to enrollment\r\n* Focal irradiation > 42 days prior to enrollment\r\n* Local palliative irradiation (small port) > 14 days','Optune device application start date must be at least 4 weeks (28 days) from central nervous system (CNS) surgical procedure; excluding ventriculoperitoneal (VP) shunts, endoscopic third ventriculostomy (ETV) for which treatment could start 10 days post procedure; non-CNS surgical procedures such as but not limited to central venous catheter insertion at the discretion of treating physician and study chair','Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment','Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of enrollment must be >= 60; patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Absolute neutrophil count >= 1.0 x 10^9/L','Platelets >= 100 x 10^9/L (transfusion dependent)','Hemoglobin >= 8 g/dl (may receive transfusions)','Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)','Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 times institutional upper limit of normal','Albumin >= 2 g/dl','Serum creatinine based on age/gender; patients that do not meet the criteria but have a 24 hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible:\r\n* 2 to < 6 years: 0.8 mg/dL (male and female)\r\n* 6 to < 10 years: 1 mg/dL (male and female)\r\n* 10 to < 13 years: 1.2 mg/dL (male and female)\r\n* 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)\r\n* >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)','Patients must have minimum head circumference of 44 cm','Patients must be willing to use the Optune device >= 18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment','Female patients of childbearing potential must have a negative serum or urine pregnancy test','Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study','The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines','If patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollment','Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results','Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient’s first malignancy has been in remission for at least 5 years from the end of treatment','Patients who are receiving any other anticancer or investigational drug therapy are not eligible','Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to device usage plan, other study procedures, and study restrictions','Patients with primarily infra-tentorial or spinal cord tumor are not eligible','Patients for who clinical suspicion is present of metastatic disease in the cerebrospinal fluid (CSF) or spine must have magnetic resonance imaging (MRI) of spine and CSF obtained (lumbar puncture or through Ommaya, external ventricular drain [EVD] or shunt) with negative cytology; patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible','Patients with major skull defects (such as missing bone without replacement) are not eligible','Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed','Patients with pacemaker, defibrillator, or documented significant arrhythmia, are not allowed','Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters','Patients with history of hypersensitivity to conductive hydrogel are not eligible'
NCT03041701,https://www.clinicaltrials.gov/ct2/show/record/NCT03041701?term=NCT03041701&rank=1,'Patients of any age must have histologically or cytologically confirmed embryonal or alveolar rhabdomyosarcoma (RMS) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI)','Patients must have measurable disease as per RECIST (version 1.1)','Patients must be able to undergo appropriate imaging studies to monitor tumor response','Archival tissue of tumors (slides or blocks [blocks preferred]) must be available for analysis; If tissue is not available, patients willing to undergo a pre-treatment biopsy may enroll','Prior Therapies:\r\n* There is no maximum number of prior medical therapies\r\n* There must be no curative or life prolonging treatments available\r\n* Patients who have received other IGF-1R antibodies or inhibitors are eligible, as long as an appropriate washout period has elapsed \r\n* Participants must have had their last fraction of external beam radiation therapy that is local and palliative at least 2 weeks prior to enrollment, and had their last substantial bone marrow radiation at least 6 weeks prior to enrollment\r\n* Participants must have had their last dose of temozolomide at least 4 weeks prior to enrollment; their last dose of other cytotoxic chemotherapy at least 3 weeks prior to enrollment; their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 3 half-lives prior to enrollment, and their last dose of any investigational agent at least 4 weeks prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.0) level prior to enrollment (does not apply to alopecia)','Patients must have the ability to swallow tablets','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky > 50% (if >= 16 years of age); or children < 16 years old must have a Lansky performance of >= 50%','Absolute neutrophil count >= 1,000/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 X upper limit of normal (ULN), with exception of patients with Gilbert syndrome','Alanine aminotransferase (ALT) =< 3.0 X ULN','Creatinine within normal institutional limits','Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Normal blood glucose for age','Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy','Cardiac Function: Fridericia's correction formula (QTcF) < 480 milliseconds (Fridericia correction), and ejection fraction (EF) >= 50%','Contraception:\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of administration of either agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\r\n* Negative pregnancy test is required for women of childbearing potential','Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document','Patients will be strongly encouraged to participate in 10-C-0086; if a patient does not agree to enroll on 10-C-0086, germline genetic analysis will not be performed','Patients who are receiving any other investigational agents','Patients with known brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib or ganitumab or other agents used in study','Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible','Patients who require concurrent treatment with antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, and/or ibuprofen)','Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded','Patients may not have any clinically significant cardiovascular disease including the following:\r\n* Myocardial infarction or ventricular tachyarrhythmia within 6 months\r\n* Major conduction abnormality (unless a cardiac pacemaker is present)\r\n* Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out corrected QT (QTc) prolongation; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study','Uncontrolled intercurrent illness including, but not limited to, the following: ongoing or active infection; history of significant bleeding disorder, including congenital (von Willebrand’s disease) or acquired (anti-factor VIII antibodies) disorders; large pleural effusions; or psychiatric illness/social situations that would limit compliance with study requirements','Patients with known pre-existing diabetes mellitus','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with dasatinib'
NCT03070886,https://www.clinicaltrials.gov/ct2/show/record/NCT03070886?term=NCT03070886&rank=1,'Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology)','Baseline PSA nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration','Baseline testosterone level obtained post prostatectomy prior to step 1 registration','Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy [HIFU] prior to prostatectomy is allowed)','Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform\r\n* Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation','Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration\r\n* For example: Patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date\r\n* Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibility','Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])','Any pT-stage based on American Joint Committee on Cancer 7th edition eligible; study entry will be based on the following diagnostic workup:\r\n* History/physical examination within 60 days prior to step 1 registration\r\n* Negative distant metastatic workup: \r\n** A computed tomography (CT) scan of the abdomen and pelvis (with contrast [CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy]) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; (Please note: Lymph nodes will be considered negative (NO)if they are =< 1.5 cm short axis);\r\n** Bone scan within 120 days prior to step 1 registration; (please note: a sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis)','Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration','Platelets >= 100,000 cell/mm^3','Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is NOT allowed)','Absolute neutrophil count >= 1500 cells/mm^3','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal','Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndrome','The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration','Definitive clinical or radiologic evidence of metastatic disease','Prior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 years','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields','Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed','Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed','Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration','Severe and/or active co-morbidity defined as follows:\r\n* History of inflammatory bowel disease\r\n* History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration\r\n* Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable','Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol'
NCT02828358,https://www.clinicaltrials.gov/ct2/show/record/NCT02828358?term=NCT02828358&rank=1,'Infants must be > 36 weeks gestational age at the time of enrollment','Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic','Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment','Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment','Patients with Down syndrome','Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy','With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1'
NCT03141684,https://www.clinicaltrials.gov/ct2/show/record/NCT03141684?term=NCT03141684&rank=1,'Patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery; diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients with newly diagnosed, unresectable, metastatic and measurable ASPS will also be eligible if they show clinical evidence of disease progression (including history and increasing physical symptoms); on-study documentation will include a physician’s rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)','Age >= 6 years at the NCI clinical center (>= 18 years at other participating sites)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky or Lansky >= 70%)','Life expectancy of greater than 3 months','Leukocytes >= 2,500/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 8 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN (AST and/or ALT =< 5 x ULN for patients with liver involvement)','Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)','Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault','Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document or a parent/guardian able to do the same','Willingness to provide biopsy samples for research purposes (patients >= 18 years of age at the National Cancer Institute [NCI] Clinical Center only)','Any prior therapy must have been completed >= 4 weeks or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator [PI]’s discretion); patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment); patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center PI, with a screening echocardiogram','Prior treatment with anti-PD-1 or anti-PD-L1 therapeutic antibody, or pathway-targeting agents\r\n* Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:\r\n** Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose\r\n** No history of severe immune-related adverse effects from anti-CTLA-4 (NCI Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)','Treatment with any other investigational agent within 4 weeks (or within five half-lives of the investigational product, whichever is shorter) prior to cycle 1, day 1 (minimum of 1 week between prior therapy and study enrollment); patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the coordinating center PI’s discretion, and should have recovered to eligibility levels from any toxicities','Treatment with systemic immunostimulatory agents (including, but not limited to, interferon-alpha or interleukin-2 [aldesleukin]) within 6 weeks prior to cycle 1, day 1.','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and systemic mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\r\n* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\r\n** Evaluable or measurable disease outside the CNS\r\n** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)\r\n** No history of intracranial hemorrhage or spinal cord hemorrhage\r\n** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted\r\n** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1\r\n* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\r\n** Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study\r\n** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1\r\n** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies (i.e., antibodies with generic names ending in \"ximab\" or \"zumab\", respectively) or fusion proteins','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with atezolizumab','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; patients must also have a CD4 count > 350 cells/mm^3 with an undetectable viral load','Patients on supraphysiologic doses of steroids or use of such within the previous six weeks','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography  (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab \r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab'
NCT02834013,https://www.clinicaltrials.gov/ct2/show/record/NCT02834013?term=NCT02834013&rank=1,'Patients are eligible under ONE of the following criteria:\r\n* Patients must have histologically confirmed rare cancer and must be able to submit specimens; NOTE: Subsequent to site’s Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 “National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)” to register to this study\r\n* FOR PATIENTS ENROLLED IN EAY131 “NCI-MATCH” PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 “NCI-MATCH” protocol or who are off protocol treatment on EAY131, “NCI-MATCH” and have no further molecularly-matched treatment recommendations per EAY131, “NCI-MATCH” or who are otherwise unable to receive EAY131, “NCI-MATCH” therapy','Patients that do not qualify for one of the histologic cohorts may be considered for registration in the “Not Otherwise Categorized” Rare Tumors cohort with confirmation of at least one of the study chairs via email','Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis','Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR \r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survival','Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form','No other prior malignancy is allowed except for the following:\r\n* Adequately managed stage I or II cancer from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease free for one year\r\n* Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission','Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed >= 4 weeks prior to registration','Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible','Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible','Patients are not eligible if they have had or are planned for solid organ transplant; patients who have received allogeneic hematopoietic stem cell transplant are eligible if:\r\n* The transplant occurred at least 90 days prior to registration, \r\n* Patient has no prior acute graft versus host disease (GVHD), and \r\n* Within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3 consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl measured, wherein the patient did not receive any platelet transfusions within 7 days prior to laboratory assessment','Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration','Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration','Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S1609','Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab','Patients must have a Zubrod performance status of 0-2','Within 28 days prior to registration: ANC >= 1,000/mcL','Within 28 days prior to registration: Platelets >= 75,000/mcL','Within 28 days prior to registration: Hemoglobin >= 8 g/dL','Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert’s disease, total bilirubin =< 3.0 x IULN','Within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN','Within 28 days prior to registration: Serum creatinine =< 2.0 x IULN','Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight','Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4 must be obtained','Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the institutional normal ranges OR cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days prior to registration','Females of childbearing potential must have negative serum or urine pregnancy test 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of “reproductive potential” if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, “effective contraception” also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, “effective contraception” also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures','Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible','Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration:\r\n1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3\r\n2. If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; once daily combinations that use pharmacologic boosters may not be used\r\n3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts','Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10mg or equivalent); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Chron’s disease), as well as symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years is permitted; short-term steroid premedication for contrast allergy is permitted','Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)\r\n* Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated','Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration','Patients must not have symptomatic interstitial lung disease or pneumonitis','Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration'
NCT02839707,https://www.clinicaltrials.gov/ct2/show/record/NCT02839707?term=NCT02839707&rank=1,'Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up','Women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial','High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, nitric oxide synthase [NOS]; mixed epithelial carcinoma; undifferentiated carcinoma); NOTE: low grade serous, mucinous and carcinosarcoma histologies are excluded; ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer; required data element: submission of pathology report','Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy; the date should be calculated from the last administered dose of platinum therapy)','1-2 prior regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit','Measurable disease (defined by RECIST v. 1.1) or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of cancer antigen [CA]25 >= 2 x upper limit of normal [ULN])','Performance status 0, 1 or 2','Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,500/mcl','Within 14 days prior to registration: Platelets >= 100,000/mcl','Within 14 days prior to registration: Hemoglobin (Hgb) >= 8 g/dl','Within 14 days prior to registration: Creatinine =< 1.5 x institutional upper limit of normal (ULN)','Within 14 days prior to registration: Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended (24-hour urine protein level must be < 1000 mg for patient enrollment); UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion – a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm','Within 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Within 14 days prior to registration: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN (AST and/or ALT =< 5 x ULN for patients with liver involvement)','International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (or on stable dose of therapeutic anticoagulation, such as low-molecular-weight heparin, warfarin or rivaroxaban)','Thyroid-stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy)','The patient or legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information','Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation','Patients who have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy) within 3 weeks prior to entering the study','Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study','Patients with prior treatment with anti-programmed cell death (PD)-1, anti- programmed cell death ligand (PD-L)1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 therapeutic antibody or other similar agents','Patients with prior treatment with bevacizumab (or any other anti vascular therapy, e.g., cediranib) for platinum resistant recurrence; (Note: prior bevacizumab in initial therapy and/or platinum sensitive recurrent setting is allowed)','Patients with prior treatment with PLD','Prior radiotherapy to the abdomen or pelvis','Patients who have not recovered from adverse events to < grade 1 (other than alopecia) due to agents administered more than 3 weeks earlier; however, the following therapies are allowed:\r\n* Hormone replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1','Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1','Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day 1','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or steroids as computed tomography [CT] scan contrast premedication) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia within the past 28 days; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\r\n* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\r\n** Evaluable or measurable disease outside the CNS\r\n** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)\r\n** No history of intracranial hemorrhage or spinal cord hemorrhage\r\n** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted\r\n** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1\r\n* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\r\n** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study\r\n** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1\r\n** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen, or type 2 diabetes mellitus are eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A cluster of differentiation (CD)4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years, with the exception of those with a negligible risk of metastases or death, such as carcinoma in situ of the breast or cervix','Severe, active co-morbidity defined as follows:\r\n* Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction\r\n* Patients who require parental hydration and/or nutrition\r\n* Patients who require drainage gastrostomy tube\r\n* Evidence of bleeding diathesis or clinically significant coagulopathy\r\n* Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture\r\n* History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment','Significant cardiovascular or cerebrovascular disease including:\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] >= 150; diastolic blood pressure [DBP] >= 90)\r\n* History of myocardial infarction within 6 months\r\n* Unstable angina\r\n* New York Heart Association functional classification II, III or IV\r\n* Baseline ejection fraction =< 50% as assessed by echocardiogram or multi-gated acquisition (MUGA)\r\n* Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months\r\n* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or peripheral arterial thrombosis) within 6 months','History of abdominal/pelvic or tracheoesophageal fistula or gastrointestinal perforation and/or abscess within 6 months prior to initiation of treatment','Pregnant or lactating patients'
NCT02839720,https://www.clinicaltrials.gov/ct2/show/record/NCT02839720?term=NCT02839720&rank=1,'Patients must have a documented germline neurofibromatosis 1 (NF1) mutation in a Clinical Laboratory Improvement Act (CLIA) certified laboratory or a diagnosis of NF1 based on clinical National Institutes of Health (NIH) consensus criteria; in addition to substantial cutaneous neurofibroma burden, at least one of the criteria below have to be present:\r\n* Six or more cafe-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1','Patients must have substantial cutaneous neurofibroma burden causing distress to the patient by disfigurement or itching; patients must have >= 9 measurable cutaneous neurofibromas; for the purpose of this study measurability will be defined for each of the lesions selected as target lesions as a neurofibroma with a longest diameter >= 4 mm in the longest diameter','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Hemoglobin >= 10 g/dL (not requiring red blood cell [RBC] transfusions)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL (not requiring platelet transfusions)','Total bilirubin =< 1.5 X upper limit of normal (ULN), with the exception of patients with Gilbert syndrome who are required to have =< 3 X ULN','Alanine transferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 X ULN','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and prothrombin time (PT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy','Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document','Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated','Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study','Since there is no standard effective chemotherapy for patients with NF1 and cutaneous neurofibromas, patients may be treated on this trial without having received prior medical therapy directed at their plexiform neurofibromas (PN)','Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimens previously received for NF1 related; or other tumor manifestations','Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-intron, sorafenib, or other vascular endothelial growth factor (VEGFR) inhibitors are eligible for enrollment','Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study','At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and the target cutaneous neurofibromas have to be in areas outside of a prior radiation field','At least 4 weeks must have elapsed since receiving medical therapy directed at NF1 related tumor manifestations','At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing','Patients who received prior medical therapy for a NF1 related tumor must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 before entering this study','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 weeks after dosing with selumetinib ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform her treating physician immediately','Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees','Patients who are receiving any other investigational agents, or have received an investigational agent within the past 30 days','May not have a NF1 related tumor such as optic pathway glioma or malignant peripheral nerve sheath tumor, which requires treatment with chemotherapy, radiation, or surgery','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements; patients with HIV who have adequate cluster of differentiation (CD)4 counts and who have no requirement for antiviral therapy will be eligible','Pregnant or breast-feeding females are excluded; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; abstinence is an acceptable method of birth control','Prior treatment with selumetinib or another specific MEK 1/2 inhibitor','No supplementation with vitamin E is permitted','Inability to swallow capsules, since capsules cannot be crushed or broken','Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption','Strong inhibitors or inducers of hepatic microsomal isoenzymes','While not an exclusion criterion, unless clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medications; in particular, patients should avoid medications that are known to strong inhibitor or inducers of hepatic microsomal isoenzymes CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4/5, UGT1A1, UGT1A3 and transporters BCRP and P-gp','Known cardiac disorder, including:\r\n* Uncontrolled hypertension (blood pressure [BP] of >= 150/95 despite medical support/management)\r\n* Acute coronary syndrome within 6 months prior to starting treatment\r\n* Uncontrolled angina – Canadian Cardiovascular Society grade II-IV despite medical support/management\r\n* Heart failure New York Heart Association (NYHA) class II or above\r\n* Prior or current cardiomyopathy including but not limited to the following:\r\n** Known hypertrophic cardiomyopathy\r\n* Known arrhythmogenic right ventricular cardiomyopathy\r\n* Baseline left ventricular ejection fraction (LVEF) =< 55%\r\n* Previous moderate or severe impairment of left ventricular systolic function (LVEF < 45% on echocardiography or equivalent on multi-gated acquisition scan [MUGA])\r\neven if full recovery has occurred\r\n* Severe valvular heart disease\r\n* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiography (ECG) at rest\r\n* Fridericia's correction formula (QTcF) interval > 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) are excluded; the use of medication(s) that can prolong corrected QT (QTc) interval is prohibited while treated on this study','Known ophthalmologic conditions, such as:\r\n* Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR)\r\n* Current or past history of retinal vein occlusion\r\n* Known intraocular pressure (IOP) > 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of IOP); patients with controlled glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) may be eligible after discussion with the study chair\r\n* Subjects with any other significant abnormality on ophthalmic examination (performed by an ophthalmologist) should be discussed with the study chair for potential eligibility \r\n* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal PN (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study','Known severe hypersensitivity to selumetinib or any excipient of selumetinib or history of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib','Have had recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access','Have any unresolved chronic toxicity with CTCAE grade >= 2, from previous anti-NF1 therapy, except for alopecia','Clinical judgment by the investigator that the patient should not participate in the study'
NCT03109301,https://www.clinicaltrials.gov/ct2/show/record/NCT03109301?term=NCT03109301&rank=1,'Body surface area (BSA) >= 0.55 m^2','Able to swallow intact capsules','Must have either a clinical diagnosis of NF1 or a germline NF1 mutation, or in patients without the NF1 syndrome, demonstrate an NF1 mutation in the GIST verified in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; in patients without the NF1 syndrome, confirmation of the NF1 mutation in the GIST is required for enrollment','For a clinical diagnosis of NF1 patients must have at least two of the diagnostic criteria for NF1 listed below:\r\n* Six or more cafe-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* A neurofibroma or plexiform neurofibroma\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1','Patients must have a histologically or cytologically confirmed measurable GIST without platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) or KIT proto-oncogene receptor tyrosine kinase (KIT) mutations; GIST may be newly diagnosed or recurrent provided that it meets criteria for progressive or metastatic disease; metastatic disease refers to disease outside the gastrointestinal (GI) tract, not simply a multifocal primary tumor; testing performed by the Laboratory of Pathology, National Cancer Institute (NCI), unless previously conducted by a CLIA/College of American Pathologists (CAP) external laboratory; analysis will include evaluation of 4 exons of KIT (9, 11, 13, 17) and 3 exons of PDGFRA (12, 14, 18)','Patients must have measurable GIST as defined by RECIST v 1.1 as at least one lesion not previously irradiated, that can be accurately measured at baseline >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements','Progressive disease: GIST has demonstrated progression as defined by RECIST v1.1 within the past 12 months; patients whose tumors do not meet this criterion, and have a diagnosis of NF1, may enroll on the NF1 natural history study','Eastern Cooperative Oncology Group (ECOG) =< 2 (patients >= 16 years of age must have a Karnofsky performance level of >= 70% [or ECOG =< 2], and children < 16 years old must have a Lansky performance of >= 70%)','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin (Hgb) >= 9.0 g/dL','Total bilirubin < 1.5 x institutional upper limit of normal (with the exception of those with Gilbert syndrome, and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) within =< 3 x upper limit of normal)','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) within =< 3 x upper limit of normal','AST (serum glutamic oxaloacetic transaminase [SGOT])/ALT (serum glutamate pyruvate transaminase [SGPT]) < 3.0 x institutional upper limit of normal','Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 60 mL/min/1.73 m^2 by either Cockcroft-Gault formula or analysis normal serum creatinine based on age described below:\r\n* =< 5 years, 0.8 mg/dL\r\n* 5 < age =< 10 years, 1.0 mg/dL\r\n* 10 < age =< 15 years, 1.2 mg/dL\r\n* > 15 years, 1.5 mg/dL','Patients will be eligible if tumor is metastatic, unresectable, progressive, or if complete tumor resection is not considered to be feasible without substantial risk or morbidity','Patients may be treated on this trial without having received prior medical therapy directed at their GIST, patients who have had prior GIST-directed surgery may enroll provided they have measurable disease','There will be no limit to number of prior myelosuppressive regimen for GIST or other tumor manifestations associated with NF1','Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, imatinib or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the plexiform neurofibromas (PN) and patients who received previous GIST-directed therapy must either demonstrate progression as defined by RECIST, or be unable to tolerate their previous therapy; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v4 before entering this study','Cytotoxic chemotherapy last dose must have been received at least 28 days prior to enrollment, their last dose of biological therapy, immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment','Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment','At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy','At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healing','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 weeks after dosing with selumetinib ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform her treating physician immediately; please note that the selumetinib manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle','Ability to understand and the willingness to sign a written informed consent document','Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated','Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study, as these may affect selumetinib metabolism','Patients with evidence of another malignancy or benign tumor requiring chemotherapy or radiation therapy are excluded; however, those patients with a plexiform neurofibroma requiring treatment will be eligible as selumetinib has documented activity in plexiform neurofibromas','Patients with a diagnosis of NF1 and GIST who do not meet other eligibility criteria may enroll on the NF1 natural history study, and will be followed on this study; should they require therapy for GIST based on evidence of progression, they may then enroll on study','Patients who are receiving any other investigational agents','Prior therapy with selumetinib or another specific mitogen-activated protein kinase kinase (MEK) inhibitor is not permitted','History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or other agents used in study','Previous MEK, retrovirus associated sequence (RAS), or RAF inhibitor use','Patients who anticipate the need for surgical intervention within the first three cycles (3 months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable','Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events','Patients with the following cardiac conditions are excluded:\r\n* Uncontrolled hypertension (adults: blood pressure [BP] of >= 150/95 despite medical support/management; participants 18 years of age and younger should have a blood pressure =< 95th percentile for age, height and gender; preexisting hypertension in adults should be controlled [either with pharmacological or non-pharmacological methods] at the time of enrollment)\r\n* Acute coronary syndrome within 6 months prior to starting treatment\r\n* Uncontrolled angina – Canadian Cardiovascular Society grade II-IV despite medical support/management\r\n* Heart failure New York Heart Association (NYHA) class II or above\r\n* Prior or current cardiomyopathy including but not limited to the following:\r\n** Known hypertrophic cardiomyopathy\r\n* Known arrhythmogenic right ventricular cardiomyopathy\r\n* Baseline left ventricular ejection fraction (LVEF) =< 55%\r\n* Previous moderate or severe impairment of left ventricular systolic function (LVEF < 50% on echocardiography or equivalent on Multi-Gated Acquisition Scan [MUGA]) even if full recovery has occurred\r\n* Severe valvular heart disease\r\n* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest\r\n* QT interval corrected according to Fridericia’s formula (QTcF) interval > 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) are excluded.; the use of medication(s) that can prolong QTc interval is prohibited while treated on this study','Ophthalmological conditions as follows:\r\n* Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR) or retinal vein occlusion\r\n* Intraocular pressure (IOP) > 21 mmHg or uncontrolled glaucoma (irrespective of IOP)\r\n* Evidence of optic glioma, malignant glioma, malignant peripheral nerve sheath tumor,\r\n* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal PN (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study\r\n* Subjects with any other significant abnormality on ophthalmic examination (performed by an ophthalmologist) should be discussed with the study chair for potential eligibility','Inability to swallow capsules, since capsules cannot be crushed or broken','Patients with refractory nausea and vomiting, chronic gastrointestinal (GI) diseases (e.g., inflammatory bowel disease) or significant bowel resection that may significantly alter the absorption of study agent','Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), CYP1A3, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), CYP2C19, cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), UDP glycosyltransferase 1 family, polypeptide A1 (UGT1A1), P-glycoprotein, or breakpoint cluster region pseudogene (BCRP) are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','No supplementation with vitamin E is permitted because the selumetinib capsules contain vitamin E','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with selumetinib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated','Ongoing radiation therapy, chemotherapy, hormonal therapy, immunotherapy, or biologic therapy directed at the tumor; those patients with a plexiform neurofibroma requiring treatment will be eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study'
NCT02844816,https://www.clinicaltrials.gov/ct2/show/record/NCT02844816?term=NCT02844816&rank=1,'Patients must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration; the carcinoma must be stage T1 high-grade, stage CIS, or stage Ta high-grade','Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible','Patients must have had all visible tumor resected completely within 60 days prior to registration; CIS disease is not expected to be completely excised; all patients must have tumor tissue from the histologic diagnosis of recurrence available for central pathology review submission; failure to submit these materials will make the patient ineligible for this study','Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration; (CIS disease is not expected to have been completely excised)','Patients must have had cytology within 21 days prior to registration; cytology for patients with CIS component is not expected to be negative for malignant cells; if the cytology for patients with only Ta/T1 disease is positive for malignant cells, patient must have had a biopsy of the prostatic urethra within the previous six months','All patients with T1 urothelial carcinoma must undergo re-transurethral resection of bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT; tissue from the re-resection must be submitted; the TURBT that identified the recurrent T1 disease may have taken place more than 60 days prior to registration','Patients must not have had urothelial carcinoma in the prostate or upper urinary tract within the previous 24 months, or muscle invasive urothelial carcinoma of the bladder at any time; patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis to rule out upper tract malignancy and intra-abdominal metastases within 90 days prior to registration','Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of care for these patients; the reason for patients not to undergo cystectomy will be clearly documented','Patients must be BCG-unresponsive; a patient is BCG-unresponsive if they meet one or more of the following criteria:\r\n* Patient has persistent or recurrent high-grade Ta/CIS urothelial carcinoma after completing therapy with at least induction BCG (>= 5 doses) and first round maintenance or second induction BCG (>= 2 doses)\r\n* Patient has high grade T1 urothelial carcinoma after induction BCG (>= 5 doses) only or after induction BCG (>= 5 doses) and first round maintenance or second induction BCG (>= 2 doses)\r\n* Patient is disease-free at 6 months after starting BCG (i.e., complete response) but then experiences a high-grade recurrence within 6 months after the last BCG dose','All adverse events associated with any prior surgery and intravesical therapy must have resolved to grade =< 2 prior to registration','Patients must not have had systemic chemotherapy or immunotherapy, including, but not limited to interferon alfa-2b, high dose interleukin 2 (IL-2), pegylated interferon (PEG-IFN), anti-programmed cell death protein 1 (PD-1), anti-PD-L1, intra-tumoral, or vaccine therapies within 6 weeks prior to cycle 1, day 1; patients must not have received or be planning to receive any of the prohibited therapies during protocol treatment; prior intravesical interferon therapy is allowed','Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other therapy while on this protocol','Patients must not have received any prior radiation to the bladder for bladder cancer','Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 4 weeks prior to cycle 1, day 1; exceptions: (1) patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea); (2) the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients must not have received of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Patients must not require treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab','Absolute neutrophil count (ANC) >= 1,500 microliter (mcL)','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2 x IULN','Alkaline phosphatase =< 2 x IULN','Serum creatinine =< 1.5 ULN OR measured or calculated creatinine clearance >= 30 mL/min','Patients must have Zubrod performance status =< 2','Patients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registration','Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis','Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to registration; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Patients must not have severe infections within 28 days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia','Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis','Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation','Patient must not have active tuberculosis','Patients must not have active hepatitis B (chronic or acute) or active hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA','Patients positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','No other prior malignancy is allowed except, for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years','Patients must not be pregnant or nursing; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Patients must not be known to be allergic to Chinese hamster egg or ovaries','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies','As a part of the oncology patient enrollment network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02887521,https://www.clinicaltrials.gov/ct2/show/record/NCT02887521?term=NCT02887521&rank=1,'Patient is scheduled to undergo non-small cell lung cancer (NSCLC) resection: video assisted thoracoscopy (VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy; surgery must not be scheduled to take place < 3 weeks after registration','Patient has a doctor diagnosis of COPD','Patient is a current or ex-smoker with a smoking history of >= 10 pack years'
NCT02900976,https://www.clinicaltrials.gov/ct2/show/record/NCT02900976?term=NCT02900976&rank=1,'Patient must have a history of solid organ transplantation','Patients must have biopsy-proven newly diagnosed polymorphic or monomorphic PTLD using the World Health Organization (WHO) classification and that is:\r\n* CD20 positive\r\n* EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining','There must be measurable disease at study entry\r\n* Note: a measurable node must have an LDi (longest diameter) greater than 1.5 cm; a measurable extranodal lesion should have an LDi greater than 1.0 cm; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters)','Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1\r\n* Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Patients must have a life expectancy of >= 8 weeks','Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study','Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study','Must not have received therapy with anti-CD20 monoclonal antibodies within 90 days of entry onto this study','Must not have received any prior radiation to any sites of measurable disease','Must not have received any prior stem cell transplant','Must not have received investigational therapy within 30 days of entry onto this study','Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study','Must not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this study','Burkitt morphology','Central nervous system (CNS) involvement; CNS status must be confirmed by lumbar puncture\r\n* Note: lumbar puncture can be performed at the time of diagnosis and does not need to be repeated unless there is a change in neurological status or it was performed more than 14 days prior to study entry','Bone marrow involvement (> 25%)\r\n* Note: bone marrow aspiration/biopsy can be performed at the time of diagnosis and does not need to be repeated unless there is a change in peripheral blood counts or it was performed more than 14 days prior to study entry','Fulminant PTLD defined as: fever > 38 degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following: \r\n* Bone marrow (including pancytopenia without any detectable B-cell proliferation) \r\n* Liver (coagulopathy, transaminitis and/or hyperbilirubinemia)\r\n* Lungs (interstitial pneumonitis with or without pleural effusions)\r\n* Gastrointestinal hemorrhage','Any documented donor-derived PTLD','Hepatitis B or C serologies consistent with past or current infections','Severe and/or symptomatic refractory concurrent infection other than EBV','Pregnant females are ineligible','Lactating females are not eligible unless they have agreed not to breastfeed their infants','Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained','Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and until six months after completion of study therapy','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02849496,https://www.clinicaltrials.gov/ct2/show/record/NCT02849496?term=NCT02849496&rank=1,'Patients must have histologically documented unresectable stage III or IV triple negative breast cancer (TNBC) and a known BRCA 1/2 mutation present; TNBC patients must be Her-2 negative, estrogen receptor (ER) negative (defined as less than 3% ER by immunohistochemistry [IHC]) and progesterone receptor (PR) negative breast cancer (defined as less than 3% PR staining by IHC)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Prior chemotherapy is allowed, including platinum therapy; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events from any prior chemotherapy (other than alopecia); patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment','Prior radiation therapy is allowed; patients must not have received minimal radiation therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation of study treatment; otherwise, patients must not have received radiation therapy (> 5% of their total marrow volume) within 4 weeks prior to the initiation of study treatment; patients who have received prior radiation to 50% or more of their total marrow volume will be excluded','Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met: minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose, and no history of severe immune-related adverse effects from anti-CTLA-4 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) is allowed, provided the following is met: minimum of 2 weeks prior to cycle 1, day 1; patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled; the use of corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) is allowed, provided the following is met: minimum of 6 weeks prior to cycle 1, day 1','Patients taking bisphosphonate therapy for symptomatic hypercalcemia are NOT allowed; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events of these therapies (other than alopecia); prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody is NOT allowed','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 6 months','Absolute neutrophil count >= 1,500/mcL','Leukocytes >= 3,000/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 8 g/dL','Total bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x upper limit of normal (ULN) if no liver metastasis; =< 5 x upper ULN if liver metastasis present','Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)','Creatinine clearance >= 51 mL/min/1.73 m^2 by Cockcroft-Gault','International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)','No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear','Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies (with a third biopsy upon evidence of disease progression)','Women of child-bearing potential and men must agree to use highly effective contraception for appropriate methods of contraception) prior to study entry, for the duration of study participation, and for at least 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use two highly effective forms of contraception in combination prior to the study, for the duration of study participation, and for at least 5 months (150 days) after completion of atezolizumab and/or olaparib administration; women of child-bearing potential: negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1\r\nPostmenopausal or evidence of non-childbearing status for women of childbearing potential; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)','Ability to understand and the willingness to sign a written informed consent document','Subject is able to swallow and retain oral medication and does not have uncontrolled emesis or gastrointestinal disorders likely to interfere with absorption of the study medication','Patients crossing over from monotherapy to combination therapy do not have to be fully rescreened; however, they do need to meet performance status, organ function, and blood parameters and not meet any of the exclusion criteria','Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based test','Patients with prior allogeneic bone marrow transplantation, double umbilical cord blood transplantation (dUCBT) or prior solid organ transplantation','Patients with known brain metastases should be excluded from this clinical trial except as those described below','Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\r\n* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\r\n** Evaluable or measurable disease outside the CNS\r\n** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)\r\n** No history of intracranial hemorrhage or spinal cord hemorrhage\r\n** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted\r\n** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1\r\n* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\r\n** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study\r\n** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1\r\n** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and atezolizumab; patients with a known hypersensitivity to olaparib or any of the excipients of the product','Prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA','History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, lichen sclerosis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted if recovered','Major surgical procedure within 28 days prior to cycle 1, day 1 and patients must have recovered from any effects of any major surgery; anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression, superior vena cava syndrome, symptomatic congestive heart failure, unstable angina pectoris, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent and would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with olaparib and atezolizumab','Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1','Patients with active seizures or a history of uncontrolled seizure disorder, including focal or generalized seizure within the past year','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab','Resting electrocardiogram (ECG) with corrected QT (QTc) > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome','Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil); the required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product'
NCT02862275,https://www.clinicaltrials.gov/ct2/show/record/NCT02862275?term=NCT02862275&rank=1,'Histologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effective','Prior ACT infusion within 6 months of study enrollment (cohorts include ACT with tumor infiltrating lymphocytes [TIL], human leukocyte antigen [HLA]-class I T cell receptor [TCR]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor [CAR]-engineered T cells)','Prior ACT therapy should be completed, and residual disease documented by either radiographic progression or active disease observed on biopsy (i.e. hematologic or solid tumor malignancy must be deemed active by the treating investigator); the investigator may deem that the disease is active on the basis of a pre-treatment biopsy demonstrating viable tumor cells or clinical progression of disease (i.e. RECIST progression is not required)','Solid tumor patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 15 mm (>= 1.5 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam\r\n* Leukemia and non-Hodgkin’s lymphoma patients must have measurable disease according to the revised response criteria for malignant lymphoma','Disease suitable for assessment by pre- and post-biopsies','There is no limit to the number of lines of prior therapy; prior anti-programmed cell death (PD)-1 or anti-PD-ligand (L)1 therapy and other immunotherapies are allowed','Prior anti-PD-1 or anti-PD-L1 therapy may not be administered after ACT and before study atezolizumab (MPDL3280A) administration','All ACT related toxicities resolved to grade 1 with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade 2','No prior other anti-cancer therapy, including ACT, for 28 days prior to study administration of atezolizumab','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','Absolute neutrophil count >= 1,000/mcL','Platelets >= 75,000/mcL (>= 50,000 for patients with hematologic malignancies)','Hemoglobin >= 8 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN (AST and/or ALT =< 5 x ULN for patients with liver involvement)','Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault','International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1','Patients who have received prior treatment with anti-CTLA-4 antibody may be enrolled, provided the following requirements are met:\r\n* > 6 weeks from the last dose\r\n* No history of severe immune-related adverse effects from anti-CTLA-4 antibody (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)','Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1','Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day 1','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, premedication for a radiologic contrast allergy) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\r\n* Patients who receive low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\r\n* Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\r\n** There are no more than 3 lesions, =< 1 cm in size each\r\n** Evaluable or measurable disease outside the CNS\r\n** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)\r\n** No history of intracranial hemorrhage or spinal cord hemorrhage\r\n** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted\r\n** No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1\r\n* Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\r\n** Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study\r\n** No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1\r\n** Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','Patients with known clinically significant liver disease (have previously tested positive), including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease that threatens vital organ function, including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis\r\n* Patients with a prior history of immune related events to anti-CTLA-4 may be eligible after discussion with the sponsor; however, patients with a history of grade 3 and 4 pulmonary, CNS and renal events attributed to anti-CTLA-4 agents will be excluded\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab','Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients who have previously tested positive for human immunodeficiency virus (HIV) are NOT excluded from this study (please note: testing of all patients wishing to enroll is NOT required), but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with atezolizumab'
NCT02867592,https://www.clinicaltrials.gov/ct2/show/record/NCT02867592?term=NCT02867592&rank=1,'Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)','Patients must have a body surface area >= 0.35 m^2','Patients must have recurrent or refractory disease, or newly diagnosed disease with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:\r\n* Ewing sarcoma \r\n* Rhabdomyosarcoma (RMS)\r\n* Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS])\r\n* Osteosarcoma\r\n* Wilms tumor \r\n* Rare tumors \r\n** Medullary thyroid carcinoma (MTC)\r\n** Renal cell carcinoma (RCC)\r\n** Hepatocellular carcinoma (HCC)\r\n** Hepatoblastoma \r\n** Adrenocortical carcinoma\r\n** Pediatric solid tumors (including central nervous system [CNS] tumors) with known molecular alterations in the targets of XL184 (i.e., MET amplification, overexpression, activating mutation, MET translocation, MET exon skipping mutations, activating RET mutations, RET rearrangement, overexpression or activation of AXL); documentation of the alteration from a Clinical Laboratory Improvement Act (CLIA) certified laboratory will be required','Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)\r\n* Note: The following do NOT qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) \r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement parameters noted above','Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study','Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)','At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim','Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent','Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1','>= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of M-Iodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Subjects should not have any clinically relevant ongoing complications from prior radiation therapy (i.e., radiation esophagitis or other inflammation of the viscera)','No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant','Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib); there are no limits on number of prior therapeutic regimens; patients who have been treated with prior VEGF pathway, or RET inhibitors (except XL184) may be eligible','Peripheral absolute neutrophil count (ANC) >= 1000/uL for patients with solid tumors without bone marrow involvement','Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) for patients with solid tumors without bone marrow involvement','Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) for patients with solid tumors without bone marrow involvement','Peripheral absolute neutrophil count (ANC) >= 750/uL for patients with solid tumors and known bone marrow metastatic disease','Platelet count >= 50,000/uL for patients with solid tumors and known bone marrow metastatic disease','Hemoglobin >= 8.0 g/dL for patients with solid tumors and known bone marrow metastatic disease','Transfusions are permitted to meet both the platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* 2 to < 6 years of age\r\n** Male and female: 0.8 (maximum serum creatinine [mg/dL])\r\n* 6 to < 10 years of age\r\n** Male and female: 1 (maximum serum creatinine [mg/dL])\r\n* 10 to < 13 years of age\r\n** Male and female: 1.2 (maximum serum creatinine [mg/dL])\r\n* 13 to < 16 years of age\r\n** Male 1.5 (maximum serum creatinine [mg/dL])\r\n** Female: 1.4 (maximum serum creatinine [mg/dL])\r\n* >= 16 years of age\r\n** Male: 1.7 (maximum serum creatinine [mg/dL])\r\n** Female: 1.4 (maximum serum creatinine [mg/dL])','Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3 x ULN) (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2.8 g/dL','No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)','No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment','QTc =< 480 msec; Note: Patients with grade 1 prolonged QTc (450- 480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications)','Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled','CNS toxicity =< grade 2','A blood pressure (BP) =< the 95th percentile for age, height, and gender for pediatric patients < 18 years old and =< 140/90 mmHg for patients >= 18 years old; patients should not be receiving medication for treatment of hypertension (except patients with Wilms tumor and RCC who may be eligible if on stable doses of no more than one anti-hypertensive medication with a baseline BP =< ULN for pediatric patients and =< 140/90 for adult patients); please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP','International normalized ratio (INR) =< 1.5','Serum amylase =< 1.5 ULN','Serum lipase =< 1.5 ULN','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control- a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control-during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control','Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)','Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial','Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John’s wort','Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen','Patients must not have received enzyme–inducing anticonvulsants within 14 days prior to enrollment','Patients who are receiving drugs that prolong QTc are not eligible','Patients who are unable to swallow intact tablets are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible','Patients with active bleeding are not eligible; specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment; patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible (patients with evidence of resolving hemorrhage will be eligible); in patients with CNS tumors, an MRI with ECHO gradient sequences would be required to exclude presence of petechial hemorrhages','Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* Surgical or other wounds must be adequately healed prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy','Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible','Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible'
NCT02879695,https://www.clinicaltrials.gov/ct2/show/record/NCT02879695?term=NCT02879695&rank=1,'PRE-REGISTRATION ELIGIBILITY CRITERIA','Patients must have suspected refractory or relapsed pre-B cell ALL or mixed phenotype acute leukemia (MPAL), or if newly diagnosed, the patient must be 60 years of age or older','Bone marrow and/or peripheral blood specimens will be submitted for correlative studies; patients who have a dry tap will still be eligible','REGISTRATION ELIGIBILITY CRITERIA','Patients must have histologically or cytologically confirmed by the local institution CD19+ precursor B-acute lymphoblastic leukemia (pre-B cell ALL) OR CD19+ mixed phenotype acute leukemia (MPAL): a) with relapse following or refractory to at least one prior line of therapy if older than 21 years; b) in second or higher relapse or refractory to at least two prior lines of therapy if 21 years old and younger (16-21); c) or they must have a new diagnosis of pre-B cell ALL or CD19+ MPAL but are >= 60 years old and are either not a candidate for or do not wish to receive traditional induction chemotherapy','The evidence of CD19+ expression on leukemia cells must be confirmed by pathology review of the bone marrow and/or peripheral blood specimens (flow cytometry and/or immunohistochemistry) collected at the time of current relapse and prior to the initiation of therapy','Patients with Philadelphia chromosome (Ph) positive (+) pre-B cell ALL OR Ph+ MPAL will be eligible if they have been refractory to or intolerant of treatment with at least 1 second-generation or third-generation tyrosine kinase inhibitor (TKI)','Patients who were treated with blinatumomab in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells and did not experience unacceptable toxicities with prior blinatumomab administration; patients who were treated with chimeric antigen receptor (CAR)-modified T cells targeting CD19 in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells','Patients with a history of allogeneic hematopoietic stem cell transplantation (HSCT) will be eligible if they are more than 90 days removed from the date of stem cell infusion, have no evidence of acute graft-versus-host disease (GVHD) or active chronic (grade 2-4) GVHD, and are off of all transplant-related immunosuppression for at least 2 weeks','Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0-2 (Karnofsky >= 60%)','Life expectancy of greater than 12 weeks','Total bilirubin =< 2.0 mg/dL (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x upper limit of normal (ULN)','Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)','Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of treatment on the study; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab +/- ipilimumab and blinatumomab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\r\n* Note: women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately','Oxygen saturation >= 90% when ambulating and not requiring supplemental oxygen','Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) will be eligible if:\r\n* They are generally healthy from an HIV perspective and on a stable anti-retroviral regimen for > 6 months\r\n* They have had no AIDS-defining conditions in the past 12 months other than historically low CD4+ cell counts\r\n* They have an undetectable viral load on standard assays','Patients with a known history of hepatitis C (HCV) will be eligible if they have an undetectable viral load; if the patient received treatment for HCV, then that treatment must have been completed at least three weeks prior to enrollment','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows: chemotherapy, radiotherapy or surgery =< 3 weeks prior to entering the study, targeted therapy (e.g., TKI) =< 1 week prior to entering the study; autologous HSCT =< 6 weeks prior to entering the study; investigational drug or immunotherapy (e.g. rituximab) =< 4 weeks prior to entering the study; prophylactic intrathecal chemotherapy within one week of enrollment allowed; patients will be allowed to receive cytoreduction with hydroxyurea, 6-mercaptopurine, corticosteroids (dexamethasone, prednisone or similar) or cyclophosphamide provided that it is discontinued at least 24 hours prior to the initiation of study treatment; pre-phase treatment with dexamethasone 10 mg/m^2 (maximum total 24 mg per day) for up to 5 days is required for patients with bone marrow blasts more than 50%, peripheral blood blasts of 15,000/uL or higher, or elevated lactate dehydrogenase suggesting rapidly progressing disease as per investigator’s assessment; pre-phase treatment must be stopped at least 24 hours prior to the initiation of blinatumomab','Patients who are receiving any other investigational agents','Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways','Patients with active central nervous system leukemia are excluded from this clinical trial; patients with a history of central nervous system (CNS) leukemia but no active disease at the time of enrollment are eligible; the absence of CNS disease must be confirmed by flow cytometric and cytologic examination of the cerebrospinal fluid (CSF) within 7 days of study enrollment','Active leukemia in the testes or isolated extramedullary relapse; patients with a history of treated leukemia in testes but no active disease at the time of enrollment are eligible','History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, ipilimumab, or blinatumomab','History of severe hypersensitivity reaction to any monoclonal antibody','Uncontrolled intercurrent illness including, but not limited to, active, uncontrolled infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements; patients with infection under treatment and controlled with antibiotics are eligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nivolumab and ipilimumab; these potential risks may also apply to blinatumomab','History of any chronic hepatitis including alcoholic, non-alcoholic steatohepatitis (NASH), drug related, autoimmune, chronic viral positive tests for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) in the absence of hepatitis B surface antibody (anti-HBs), or a positive hepatitis C (HCV) viral load; these patients are excluded','Subjects with active autoimmune disease, a history of known or suspected autoimmune disease or a history of a syndrome requiring systemic corticosteroids (> 10 mg daily of prednisone equivalent) except for the treatment of malignancy with the exception of:\r\n* Isolated vitiligo\r\n* Resolved childhood atopy\r\n* History of a positive antinuclear antibody (ANA) titer without associated symptoms or history of symptoms of an autoimmune disorder\r\n* Controlled thyroid disorders\r\n* Type I diabetes mellitus\r\n* Psoriasis, Sjogren’s syndrome, and arthropathies not requiring systemic treatment\r\n* Autoimmune diseases: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, autoimmune vasculitis, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded','Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen), or as pre-phase treatment for cytoreduction; patients will receive steroids with blinatumomab to reduce cytokine release syndrome (CRS) as specified in the protocol','Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study','Patients who have a history of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, psychosis, or other significant CNS abnormalities; a history of treated CNS leukemia will be allowed if recent CNS studies confirm the absence of active CNS disease at the time of study entry (screening)','Patients with a known concurrent malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ of the cervix','Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity'
NCT02883062,https://www.clinicaltrials.gov/ct2/show/record/NCT02883062?term=NCT02883062&rank=1,'Patients must have histologically confirmed new diagnosis of breast cancer','Estrogen receptor (ER) and progesterone receptor (PR) < Allred score of 3 or =< 5% positive staining cells in the invasive component of the tumor (provided the patient is being treated as triple negative breast cancer)','Human epidermal growth factor receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+ according to National Comprehensive Cancer Network (NCCN) guidelines','Clinical stage T2-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging','Eligible for neoadjuvant chemotherapy','No prior therapy for this disease','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Leukocytes >= 2,500/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 150,000/mcL','Hemoglobin >= 10 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN','Alkaline phosphatase =< 2.5 x ULN','Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault','International normalized ratio (INR) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)','Activated partial thromboplastin time (aPPT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 180 days after the last dose of paclitaxel; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign an Institutional Review Board (IRB) approved written informed consent document','Known metastatic disease','Invasive cancer in the contralateral breast','Patients with a previous history of non-breast malignancy are eligible only if they meet the following criteria for a cancer survivor: (1), and (2)\r\n* Has undergone potentially curative therapy for all prior malignancies\r\n* Has been considered disease-free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix)','Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation','Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., osteoporosis) is allowed','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study with the exception of the planned breast cancer surgery that is part of the trial design','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only; patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (including symptomatic sinus bradycardia), or psychiatric illness/social situations that would limit compliance with study requirements','Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with atezolizumab'
NCT02888743,https://www.clinicaltrials.gov/ct2/show/record/NCT02888743?term=NCT02888743&rank=1,'Patients must have histologically or cytologically confirmed non-small cell lung cancer (cohort 1) or colorectal cancer (cohort 2)','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1.5 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Patients in both cohorts must have progressive disease following prior therapy; specifically:\r\n* Cohort 1 (NSCLC): Patients must have evidence of radiologic or clinical disease progression during previous treatment with systemic PD-1 directed therapy and/or have been deemed not to derive clinical benefit from PD-1 directed treatment; this includes patients who demonstrated an initial response and subsequent progression; no prior treatment with chemotherapy or targeted agents are required; intervening therapy is allowed between previous PD-1 directed treatment and there is no required interval from prior PD-1 treatment required; PD-1 directed treatment includes treatment with antibodies targeting the PD-1 receptor such as pembrolizumab or nivolumab, as well as PD-L1 targeted antibodies such as MEDI4736 (durvalumab), atezolizumab and avelumab; these agents may have been administered as part of a clinical trial\r\n* Cohort 2 (colorectal cancer): Patients must have progressed on >= one line chemotherapy','At least 21 days must have elapsed from prior systemic therapy (chemotherapy or radiation)','Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%) and life expectancy greater than 6 months; furthermore, enrollment of patients with greater than 10 measurable lesions is discouraged','Patients must have normal organ and marrow function independent of transfusion for at least 7 days prior to screening and independent of growth factor support for at least 14 days prior to screening','Hemoglobin (Hgb) >= 9 g/dl','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin =< 1.5 x normal institutional limits; this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = < 2.5 x institutional upper limit of normal; for patients with hepatic metastases, ALT and AST =< 5 x ULT','Measured creatinine clearance (CL) > 40 mL/min OR calculated creatinine clearance (CL) > 40 mL/min as determined by Cockcroft-Gault (using actual body weight)','Patients must have at least one lesion that has not previously been irradiated (and is not within a previously radiated field) and for which palliative radiation is potentially indicated and could be safely delivered at the radiation doses specified in this protocol; this lesion must not be the only measurable lesion so that it is still possible to determine the response rate outside of the radiation treatment field; this lesion must not be within the central nervous system (CNS) (brain or spinal cord) or requiring urgent or emergent palliative radiation given the timing of radiation specified on this protocol; furthermore, this lesion: \r\n* For cohort 1 (NSCLC cohort) – the lesion to be irradiated must be in the lung, lymph nodes, adrenal gland or liver \r\n* For cohort 2 (colorectal cohort) – the lesion to be irradiated must be in the liver','Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients is required; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced oophorectomy with last menses > 1 year ago, had chemotherapy-induced menopause with > 1 year interval since last menses, or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)','Females of childbearing potential who are sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; female patients should also refrain from breastfeeding throughout this period','Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; male patients should refrain from sperm donation throughout this period','Female partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period','Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability of a patient or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document','Body weight > 30 kg','Must have a life expectancy of at least 12 weeks','Cohort 1 (NSCLC cohort) \r\n* Ability to undergo a fresh tumor biopsy for the purpose of screening for this clinical trial (including able and willing to give valid written consent) to ability or to provide an available archival tumor sample taken less than 3 months prior to study enrollment (and not obtained prior to progression on a PD-1/PD-L1 inhibitor) if a fresh tumor biopsy is not feasible with an acceptable clinical risk; tumor lesions used for fresh biopsies should be the same lesions to be irradiated when possible and should not be the same lesions used as Response Evaluation Criteria in Solid Tumors (RECIST) target lesions, unless there are no other lesions accessible; additional, optional archival tumor tissue is also requested from before the prior PD-1 directed therapy','Cohort 2 (colorectal cohort) \r\n* Ability to undergo a fresh tumor biopsy for the purpose of screening for this clinical trial (including able and willing to give valid written consent) to ability or to provide an available archival tumor sample taken less than 3 months prior to study enrollment if a fresh tumor biopsy is not feasible with an acceptable clinical risk; tumor lesions used for fresh biopsies should be the same lesions to be irradiated when possible and should not be the same lesions used as RECIST target lesions, unless there are no other lesions accessible \r\n* Microsatellite stable (MSS) tumor as documented by either: \r\n** Immunohistochemistry (IHC) testing that does not suggest loss of MLH-1, MSH-2, PMS2 or MSH6 \r\n** Polymerase chain reaction (PCR) testing that does not suggest microsatellite instability (MSI)','Patients who have had systemic (chemotherapy, biologic therapy or radiotherapy) within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study','Receipt of prior radiotherapy or condition for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician','Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1)','Patients who are receiving any other investigational agents','Patients with untreated brain metastases, spinal cord compression, or leptomeningeal carcinomatosis should be excluded from this clinical trial; patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases; these imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression); in addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =< 10 mg/day of prednisone or its equivalent (and anti-convulsants) for at least 14 days prior to the start of treatment','History of allergic reactions attributed to compounds of similar chemical or biologic composition to tremelimumab and MEDI4736 or previous toxicity attributed to MEDI4736 or other PD-1 or PD-L1 directed therapy that led to drug discontinuation','Prior exposure to immune-mediated therapy, including durvalumab and tremelimumab, except for anti-PD-1 or anti-PD-L1 therapy (including durvalumab) in NSCLC patients; this includes anti-CTLA-4 agents (prior treatment with these agents is NOT allowed in either cohort) and, excludes therapeutic anticancer vaccines, excluding therapeutic anticancer vaccines; exposure to other investigational agents may be permitted after discussion with the study principal investigator (PI)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MEDI4736 (durvalumab), tremelimumab and radiation','Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy, whichever is later','Human immunodeficiency virus (HIV)-positive patients are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated','Any concurrent chemotherapy, immune therapy, biologic, hormonal therapy for cancer treatment','Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned IP; the following are exceptions to this criterion:\r\n* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\r\n* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent \r\n* Steroids as pre-medication for hypersensitivity reactions (e.g., CT scan pre-medication)','Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP; Note: local surgery of isolated lesions for palliative intent is acceptable','History of allogeneic organ transplantation','Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis [with the exception of diverticulosis]; sarcoidosis syndrome, or other serious gastrointestinal [GI] chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves disease; rheumatoid arthritis; hypophysitis; uveitis, sarcoidosis syndrome, etc.) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: \r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet alone','History of another primary malignancy except for \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)','Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from electrocardiograms (ECGs) using Fridericia’s correction; abnormal ECGs should be repeated','History of active primary immunodeficiency','Known history of previous clinical diagnosis of tuberculosis','Active infection including hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg]) result or, hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA); negative serologies documented over the past year are sufficient evidence of this','Receipt of live, attenuated vaccine within 30 days prior to the first dose of investigational treatment; Note: patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of investigational treatment','Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational treatment or interpretation of patient safety or study results','Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician','Cohort 1 (NSCLC cohort) \r\n* In regards to administration of prior anti-PD-1 or anti PD-L1 antibodies, a patients:\r\n** Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy\r\n** All adverse events (AEs) while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study\r\n** Must not have experienced a >= grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy; NOTE: subjects with endocrine AE of =< grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic\r\n** Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day\r\n* Eligibility for Food and Drug Administration (FDA)-approved agents targeting the EGFR, ROS1 or ALK pathway, which should be evaluated as per standard of care; exceptions to this requirement may be considered on a case-by-case basis by the principal investigator if the patient was previously treated with another targeted agent'
NCT02890329,https://www.clinicaltrials.gov/ct2/show/record/NCT02890329?term=NCT02890329&rank=1,'Subjects with evidence of relapsed or refractory acute myeloid leukemia (AML) OR treatment naive AML who are 75 years or older OR relapsed or refractory myelodysplastic syndrome (MDS)\r\n* For subjects with relapsed AML: evidence of >= 5% blasts in the bone marrow; or reappearance of blasts in the peripheral blood; or development of extramedullary disease (according to 2003 IWG criteria) who relapse after:\r\n** Allogeneic hematopoietic stem cell transplant, or\r\n** After one cycle of standard cytotoxic chemotherapy or two cycles of any hypomethylating agent-based therapy\r\n* For subjects with refractory AML: =< 2 prior induction regimens (example: patients who receive 7+3 followed by 5+2 would count as one induction regimen) or a minimum of two cycles of any hypomethylating agent-based therapy\r\n* For subjects with treatment-naive AML: must be 75 years and older with de novo or secondary AML to be considered eligible\r\n* For subjects with relapsed MDS: disease recurrence after CR, partial remission (PR) or hematologic improvement with bone marrow blasts >= 5% who relapse after:\r\n** Allogeneic hematopoietic stem cell transplant, or\r\n** After four cycles of any hypomethylating agent-based therapy\r\n* For subjects with refractory MDS: disease progression at any time after initiation of hypomethylating agent treatment or persistent bone marrow blasts >= 5% despite a minimum of four cycles of hypomethylating agent therapy','Allowed prior allogeneic hematopoietic stem cell transplantation (allo-HCT) regardless of stem cell source; patients must be at least 3 months post allo-HCT (at time of treatment start); mismatched transplantations would be allowed','Patients must be off systemic immunosuppressive medications > 2 weeks prior to treatment start; if patients are in systemic corticosteroids and must be on a dose of prednisone 5 mg/day or less (or equivalent), then patients must be on this reduced dose for > 1 week prior to treatment start; topical steroids are allowed','If post allo-HCT, then patient must have baseline donor T cell chimerism of >= 20% (from peripheral blood); evaluation can be made within 4 weeks of treatment start','No limitations on prior therapies','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilbert’s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN','Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) =< 3.0 x local institutional ULN','Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) =< 3.0 x local institutional ULN','Serum creatinine =< 2.0 x local institutional ULN','Negative serum pregnancy test for women who are of child bearing potential (test must be repeated if performed > 72 hours from treatment start); women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration','Patients with known active human immunodeficiency virus (HIV) infection; patients with chronic HIV with a CD4 > 250, undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of highly active anti-retroviral therapy (HAART) therapy would be eligible','Ability to understand and the willingness to sign a written informed consent document','Participants who have had chemotherapy or radiotherapy within 2 weeks prior to treatment start or those who have not recovered from adverse events due to agents administered more than 2 weeks prior to treatment start; hydroxyurea is allowed for symptomatic leukocytosis during screening, lead in, and cycle 1 only if clinically necessary; a total white blood cell (WBC) count < 25 x 10^9/L prior to first dose of decitabine on trial is required; prior leukapheresis and/or prior or concurrent treatment with hydroxyurea to achieve this level are allowed','Prior hypomethylating agent (HMA) therapy is allowed, however this study excludes: (1) patients whose relapse occurred on HMA-based therapy immediately prior to this study and (2) patients who experience disease progression (see definition below) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study; disease progression is defined as either: (1) patients with MDS who have evidence of initial progression to AML (defined by the presence of >= 20% blasts in peripheral blood or bone marrow) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study; OR (2) patients with AML who have evidence of progressive disease according to European Leukemia Net (ELN) 2017 criteria (e.g. > 50% increase in marrow blasts over baseline or > 50% increase in peripheral blasts to > 25 x10^9/L [> 25,000/uL] [in absence of differentiation syndrome]) while receiving HMA-based therapy within the last 12 weeks prior to treatment start on study\r\n* (Note: Patients who relapse post-transplant who received HMA treatment prior to transplant are eligible for study)','Donor lymphocyte infusion within 8 weeks prior to treatment start if post-transplant','Patients with prior history of severe (grade III or IV) acute GVHD even if resolved if post-transplant','Patients with a history of prior treatment with anti-CTLA-4, anti-PD 1 antibody, or anti-PDL1 antibody','Participants who are receiving any other investigational agents','Participants with known central nervous system (CNS) involvement with leukemia or who are receiving intrathecal chemotherapy that is either prophylactic or therapeutic; history of CNS involvement that has been completely treated (no longer receiving intrathecal chemotherapy) will be allowed','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the patient or impair the assessment of study results; if patients are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection control, then they will be considered eligible for study','Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with a history of autoimmune disease (specifically including: diabetes mellitus, vitiligo, Hashimoto’s thyroiditis) who are asymptomatic, do not require immune suppression or steroids, and do not have threatened vital organ function from these conditions may be considered after discussion with the principal investigator (PI)','No concurrent active malignancies are allowed on study for >= 2 years prior to treatment start with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast','Patients with known active hepatitis B virus (HBV) infection should be excluded; however, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he/she would be eligible for study','Patients with known active hepatitis C virus (HCV) infection; patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ipilimumab'
NCT02893917,https://www.clinicaltrials.gov/ct2/show/record/NCT02893917?term=NCT02893917&rank=1,'Patients must have histologically confirmed progressive, metastatic castration resistant prostate adenocarcinoma by meeting ALL the following:\r\n* Pathology of prostate gland or metastatic disease must confirm the diagnosis of prostate adenocarcinoma; mixed histology with other variants including but not limited to small cell or neuroendocrine differentiation must be discussed with the study principal investigator (PI) \r\n* Metastasis must be documented by radiographic evidence\r\n* Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/d (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to cycle 1, day 1 and must be continued throughout the study\r\n* Progression must be evidenced and documented by any of the following parameters\r\n** Two consecutively rising PSA values, above the baseline, at a minimum of 1-week intervals; the minimal value to enter the study is 1.0 ng/ml or greater; the reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met, if values 3A or #4 are 1 ng/mL or higher (Prostate Cancer Working Group 3)\r\n** Appearance of one or more new lesions on bone scan\r\n** Progressive disease by RECIST 1.1','Must have a tumor lesion safely accessible for biopsy per the investigator’s discretion; while a soft tissue metastasis is preferred for a biopsy, a bone metastasis is allowed for biopsy as long as enough cores can be obtained; a biopsied lesion cannot be used for target lesion for response assessment','Must be agreeable to the mandatory research tumor biopsies (pre-treatment and on-treatment); tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression','Must have received at least two one prior line of therapy for mCRPC; a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless patient develops disease progression within 12 months from the last dose chemotherapy','Must have a life expectancy greater than or equal to 16 weeks','If patient is currently on prednisone or other corticosteroids for palliation, the dose must be less than or equal to 10 mg a day or its equivalent dose and it must have been started at least 4 weeks prior to cycle 1 day 1','Patients must have measurable disease by RECIST v1.1, or evaluable disease with bone metastases demonstrated by Tc99 bone scan; patients with bone metastases only are allowed (NOTE: nodes >= 1.5 cm (not >= 2 cm) in the short axis are considered measurable, per The Prostate Cancer Working Group 3 [PCWG3])','Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; patients with long-standing stable grade 2 neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 70%)','Within 28 days prior to administration of study treatment: White blood count (WBC) > 3 x 10^9/L','Within 28 days prior to administration of study treatment: Absolute neutrophil count >= 1,500/mcL','Within 28 days prior to administration of study treatment: Platelets >= 100,000/mcL','Within 28 days prior to administration of study treatment: Hemoglobin >= 10 g/dL with no pack red blood cell transfusion in the past 28 days','Within 28 days prior to administration of study treatment: Creatinine Clearance > 50 mL/min, calculated using Cockcroft-Gault formula','Within 28 days prior to administration of study treatment: Urine protein: creatinine ratio (UPC) of =< 1','Within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)','Within 28 days prior to administration of study treatment: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 times institutional ULN unless liver metastases are present in which case they must be < 5 x ULN','Within 28 days prior to administration of study treatment: Coagulation parameters (international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed, or except patients on anticoagulation','Patients must be able to swallow oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib','Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; patients can be on thyroid hormone replacement medication; asymptomatic patients with elevated thyroid-stimulating hormone (TSH) with normal T4/T3 are allowed to enroll, and recommended to follow with routine thyroid function test especially if they are randomized to cediranib/olaparib arm','Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol','Patients must be willing and able to check and record daily blood pressure readings when randomized to cediranib containing arm','Patients must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months prior to registration if they have any of the following risk factors for cardiac toxicities:\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment \r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months prior to registration\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* Prior history of other significant impaired cardiac function','Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:\r\n* Condom with spermicide and one of the following:\r\n** Oral contraceptive or hormonal therapy (e.g. hormone implants)\r\n** Placement of an intra-uterine device\r\n* Acceptable non-hormonal birth control methods include:\r\n** Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period\r\n** Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia\r\n** Tubal occlusion plus male condom with spermicide\r\n** Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded\r\n* Acceptable hormonal methods:\r\n** Etonogestrel implants (eg, Implanon, Norplan) + male condom with spermicide\r\n** Normal and low dose combined oral pills + male condom with spermicide\r\n** Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide\r\n** Intravaginal device + male condom with spermicide (eg, EE and etonogestrel)\r\n** Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy, hormonal therapy (except LHRH agonist or antagonist), immunotherapy, radioisotope therapy, or RT within 21 days prior to start of the study agents','Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue','Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1','Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans are excluded from this clinical trial; while screening brain MRI is not required, it should be performed if clinically indicated at the discretion of the treating investigator; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study','For patients with known and treated brain metastases is allowed in this study if they fulfill ALL of the following criteria:\r\n* The lesions have remained radiologically stable for at least six weeks after completion of brain irradiation or stereotactic brain radiosurgery, and must remain stable at the time of study entry\r\n* There is no mass effect present radiologically and no steroids requirement for symptom control for more than 4 weeks','Patients who have received a prior inhibitor of vascular endothelial growth factor (VEGF) signaling inhibitor, or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor administered','History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib','Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir), moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil), strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil); a minimum washout period of 2 weeks prior to cycle 1 day 1 is required for strong inhibitors, and at least one week for moderate inhibitors; a minimum washout period of 4 weeks prior to cycle 1 day 1 is required for CYP3A inducers; a minimum washout period of 5 weeks prior to cycle 1 day 1 is required for enzalutamide or phenobarbital; dihydropyridine calcium-channel blockers are permitted for management of hypertension','Current use of natural herbal products or other “folk remedies”; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed','Patients with concomitant or prior invasive malignancies within the past 5 years; subjects with limited stage basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast, or non-muscle invasive bladder cancer, are eligible as long as they received curative intent therapy','\\Uncontrolled intercurrent illness including, but not limited to, uncontrolled seizures ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Resting ECG with corrected QT (QTc) > 470 msec on two or more time points within a 24 hour period, noted within 14 days of treatment, or family history of long QT syndrome','History of myocardial infarction within 6 months of the randomization','History of stroke or transient ischemic attack within 6 months of the randomization','NYHA classification of III or IV','Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows','History of hypertensive crisis or hypertensive encephalopathy within 3 years of the randomization','Clinically significant peripheral vascular disease or known abdominal aortic aneurysm ( > 5 cm in diameter) or history of aortic dissection; patients with known history of abdominal aortic aneurysm (AAA) with >= 4 cm in diameter, a repeat ultrasound (US) within the last 6 months prior to randomization will be required to document that it is =< 5 cm, and patient must be asymptomatic from the aneurysm, and the blood pressure must be well controlled as required in this protocol','A major surgical procedure, open biopsy, or significant traumatic injury within 3 months prior to cycle 1 day 1 (percutaneous/endobronchial/endoscopic biopsies are allowed)','History of bowel obstruction within 1 month prior to starting study drugs','History of hemoptysis within the last 1 month prior to randomization','Presence of cavitation of central pulmonary lesion, or radiographic evidence of pneumonitis or other extensive bilateral lung disease such as interstitial lung disease','Any history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PI','Current dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)','Known coagulopathy or bleeding diathesis; those on therapeutic anticoagulation or anti-platelet agent are permitted only after discussing with the study PI','Patients with history of intra-abdominal bleeding or retroperitoneal bleeding within the last 3 years are excluded','Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), or features suggestive of MDS/AML','Patients with known active human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; patients with a history of hepatitis B or hepatitis C, who are deemed cured and no longer require treatment may be allowed to enroll after consultation with the respective specialist and the study PI','Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)','Whole blood transfusions in the last 120 days prior to entry to the study','Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)','Previous enrollment in the present study'
NCT02893930,https://www.clinicaltrials.gov/ct2/show/record/NCT02893930?term=NCT02893930&rank=1,'Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment','Refractory disease to treatment with an mTOR inhibitor','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent','Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma','Patients must have measurable disease','Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment\r\n* NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)','Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment','Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously\r\n* NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable','Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1','Patients must be able to swallow intact capsules','Within less than or equal to 14 days prior to registration: Leukocytes >= 3,000/mm^3','Within less than or equal to 14 days prior to registration: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L','Within less than or equal to 14 days prior to registration: Hemoglobin >= 10 g/dL','Within less than or equal to 14 days prior to registration: Platelets >= 100 x 10^9/L','Within less than or equal to 14 days prior to registration: Total serum bilirubin =< institutional upper limit of normal (ULN)','Within less than or equal to 14 days prior to registration: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN','Within less than or equal to 14 days prior to registration: Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation','Within less than or equal to 14 days prior to registration: Glycosylated hemoglobin (HbA1c) < 7.0%','Within less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dL','Within less than or equal to 14 days prior to registration: Fasting triglycerides =< 300 mg/dL','Diabetics are allowed if:\r\n* Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L),\r\nOR\r\n* HbA1c =< 7%','Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 7 days of registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 90 days (for female patients) and 120 day (for male patients) after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug','Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity','Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start','Patient must NOT have had previous treatment with any PI3K or AKT inhibitor','NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start','Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions:\r\n* Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR\r\n* Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years','No more than 3 prior systemic treatment regimens for advanced PNET','Patients with a history of the following within =< 6 months of study entry are NOT eligible:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism','Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* QT syndrome, or torsades de pointes\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long','Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE','Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:\r\n* Brain metastases which have been treated\r\n* No evidence of disease progression for >= 3 months before the first dose of study drug\r\n* No hemorrhage after treatment\r\n* Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228\r\n* No ongoing requirement for dexamethasone or anti-epileptic drugs','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELIGIBLE','NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug','NO patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug','Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug','Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care'
NCT03115333,https://www.clinicaltrials.gov/ct2/show/record/NCT03115333?term=NCT03115333&rank=1,'Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery\r\n* Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation)','Karnofsky performance status >= 60','Women must not be pregnant or breast-feeding','Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to administer bevacizumab, either as single therapy or in conjunction with other chemotherapeutic regimens, in order to treat tumor progression/recurrence per the treating physician; patients receiving bevacizumab primarily for reduction of edema (i.e. alleviation of symptoms) rather than for tumor treatment are excluded','Patients who have not previously received a bevacizumab-containing regimen (i.e., this must be the first bevacizumab-containing therapy administered to the patient)','Patient must not have planned treatment with immunotherapies (vaccines, checkpoint inhibitors, T-cells); if the patient’s most recent recurrence occurs while on immunotherapy, this must be judged as true recurrence using Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria','For patients with intratumoral hemorrhage (acute, subacute, or chronic) seen on hemosiderin-sensitive (gradient-echo) MRI, there must be at least 10 x 10 x 10 mm \"measurable enhancement\" that is not obscured or distorted by magnetic susceptibility blooming artifact','Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm, and at least 10 mm in the 3rd orthogonal direction','Patient must be cleared for bevacizumab administration with respect to any recent surgeries, and post-surgical scans must confirm the presence of measurable residual disease','Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections\r\n* Ability to withstand 22-gauge intravenous (IV) placement\r\n* No history of untreatable claustrophobia\r\n* No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies\r\n* No contraindication to intravenous contrast administration\r\n** Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* Weight compatible with limits imposed by the MRI scanner table','Patient must be scheduled to receive treatment with a bevacizumab containing chemotherapy regimen; patient can be treated with bevacizumab alone or in combination with other chemotherapies; patient may also be receiving treatment with Optune'
NCT02899728,https://www.clinicaltrials.gov/ct2/show/record/NCT02899728?term=NCT02899728&rank=1,'Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer with no prior systemic treatment','Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','White blood cell count (WBC) >= 3 x 10^9/L','No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear','Within 28 days prior to administration of therapy: Absolute neutrophil count >= 1,500/mcL','Within 28 days prior to administration of therapy: Platelets >= 100,000/mcL','Within 28 days prior to administration of therapy: Hemoglobin >= 10 g/dL with no blood transfusion within 28 days of initiation of therapy','Within 28 days prior to administration of therapy: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Within 28 days prior to administration of therapy: Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x institutional ULN, unless liver metastases are present and then =< 5 x institutional ULN is acceptable','Within 28 days prior to administration of therapy: Creatinine clearance >= 50 mL/min','Within 28 days prior to administration of therapy: Proteinuria - urine protein:creatinine ratio (UPC) of =< 1 OR =< 2+ proteinuria on two consecutive urinalysis/dipstick tests taken no less than 1 week apart; patients with 2+ proteinuria on dipstick must also have a UPC of =< 0.5 on 2 consecutive samples','Urine protein: creatinine ratio (UPC) of =< 1; UPC is the preferred test','Ability to swallow and retain oral medication','Women of child-bearing potential and male patients and their partners who are sexually active must agree to use two highly effective forms of contraception in combination for the duration of study participation and for 3 months after completion of olaparib and cediranib administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Postmenopausal or evidence of non-pregnant status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to the start of therapy; postmenopausal status is defined as:\r\n* Age >= 60 years, or\r\n* Age < 60 with any one or more of the conditions below:\r\n** Amenorrheic for >= 1 year in the absence of chemotherapy and/or hormonal treatments,\r\n** Luteinizing hormone and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range,\r\n** Radiation-induced oophorectomy with last menses > 1 year ago,\r\n** Chemotherapy-induced menopause with > 1 year interval since last menses,\r\n** Surgical sterilization (bilateral oophorectomy or hysterectomy)','Ability to understand and the willingness to sign a written informed consent document','Participants must have archival tumor tissue available for analysis (minimum 20 5 um slide) or be able to undergo a baseline fresh tumor tissue biopsy','Adequately controlled blood pressure; (defined as systolic blood pressure [SBP] of < 140 mmHg and diastolic blood pressure [DBP] of < 90 mmHg) on maximum of three antihypertensive medications; participants must have a blood pressure (BP) of < 140/90 taken in the clinic or hospital setting by a medical professional within 2 weeks prior to starting on study; it is strongly recommended that participants who are on 3 antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on study','Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; patients can be on thyroid hormone replacement medication; asymptomatic patients with elevated thyroid stimulating hormone (TSH) with normal T4/T3 are allowed to enroll, and recommended to follow with routine thyroid function test','Patients who have had major surgery or trauma within 28 days prior to entering the study; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment','Patients who have had radiotherapy within 14 days prior to entering the study','Patients with a non-healing wound, fracture, or ulcer','Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or baseline, with the exception of alopecia)','Patients who are receiving any other investigational agents','Patients with symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; exceptions include patients with previously-treated CNS metastases or those with are asymptomatic, subcentimeter metastases, and have no requirement for steroids or anti-seizure medication for at least one week prior to study entry; screening with CNS imaging studies (CT scan or MRI) is required','History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib, cediranib, carboplatin, cisplatin, or etoposide','Patients with a history of myelodysplastic syndrome (MDS)','Patients with a history of acute myeloid leukemia (AML), or patients with a history of any other primary malignancy within 3 years prior to initiation of treatment on this study; exceptions include: patients with a history of malignancies (other than AML) that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin; and completely resected carcinoma in situ of any type','Patients with clinically significant gastrointestinal abnormalities including, but not limited to:\r\n* Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment\r\n* History of intra-abdominal abscess within 3 months prior to starting treatment\r\n* History of gastrointestinal (GI) perforation within 6 months prior to starting treatment\r\n* Evidence of abdominal fistula within 6 months prior to starting treatment; history of abdominal fistula will be considered eligible if the fistula was surgically repaired, and there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula','Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months; Note: Participants with recent DVT who have been treated with therapeutic anti-coagulants for at least 6 weeks are eligible, with the exception of participants being treated with warfarin, which is prohibited on this study; other oral anti-coagulants may be allowed after discussion with overall principle investigator (PI), but short half-life low molecular weight heparins are strongly preferred','Patients with evidence of active bleeding diathesis','Patients with hemoptysis in excess of 2.5 mL within 6 weeks prior to the first dose of study medication','Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A4 are ineligible; the required washout period for strong inhibitors is 2 weeks and at least one week for moderate inhibitors; the required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 4 weeks for other agents','Patients requiring concomitant therapy with phenytoin, phenobarbital, carbamazepine, or valproic acid','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; specifically, patients with any of the following within 6 months prior to starting treatment are excluded:\r\n* Acute myocardial infarction\r\n* Unstable angina\r\n* New York Heart Association functional classification of III or IV\r\n* Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per institutional guidelines, or 55%\r\n* Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation\r\n* Patients with active hepatitis (B or C)\r\n* Patients with active pneumonitis','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with olaparib or cediranib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Patients must be willing and able to check and record daily blood pressure readings if receiving cediranib'
NCT02898207,https://www.clinicaltrials.gov/ct2/show/record/NCT02898207?term=NCT02898207&rank=1,'For the dose escalation cohort, patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective','For the dose escalation cohort, patients may have received any number of prior therapies','For the dose expansion cohort, participants must have histologically or cytologically confirmed diagnosis of either:\r\n* Ovarian, fallopian tube, or primary peritoneal cancer of high grade serous histology which has recurred despite standard therapy; up to 3 prior lines in the platinum resistant setting (i.e. up to 3 lines after patients have become platinum resistant); patients may have received unlimited lines while platinum sensitive\r\n* Triple-negative breast cancer (TNBC) which has recurred despite standard therapy; recurrent TNBC needs to have metastatic disease and patients with an in breast recurrence are not eligible; up to 4 prior lines in the recurrent setting for patients with triple-negative breast cancer are allowed','For the dose expansion cohort, patients with ovarian, fallopian tube or primary peritoneal cancer must have platinum resistant disease defined as progression within 6 months after last platinum regimen; platinum refractory disease is allowed','For the dose expansion cohort, patients with triple-negative breast cancer may not be BRCA1/2 germline mutation carriers','There must be availability of a formalin-fixed, paraffin-embedded tumor specimen','Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky > 60%)','Life expectancy of greater than 12 weeks','Leukocytes >= 3,000/mcL','Hemoglobin >= 10 g/dL with no blood transfusion in the past 28 days','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Total bilirubin within normal institutional limits','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal','Creatinine =< the institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Corrected QT using Fridericia's formula (QTcF) =< 450 ms','Any clinically significant electrolyte imbalance, particularly hypokalemia and hypomagnesemia, should be corrected before treatment','Pre-study evaluation must include an ophthalmologic exam by an ophthalmologist (not optometrist) and should minimally include visual acuity testing, slit lamp examination, and funduscopic examination; follow up eye-exams will only be performed if subjects develop/report any visual impairment; visual impairment may include peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; follow up eye-exams will minimally include visual acuity testing, slit lamp examination, and funduscopic examination; additional testing will be based on symptoms, what is observed and ophthalmologist recommendations','For the expansion cohort only: measurable disease by RECIST v1.1 with at least one measurable target lesion','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of study drugs; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of olaparib and/or AT13387 administration','Patients must be able to swallow tablets and have no significant impairment in gastrointestinal absorption','Ability to understand and the willingness to sign a written informed consent document','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =< 1','Patients who are receiving any other investigational agents','Patients with known active or history of brain metastases should be excluded from this clinical trial','History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and AT13387 used in study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with olaparib or AT13387','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible','Known history of QT/corrected QT (QTc) prolongation or torsades de pointes (TdP); patients who are currently receiving treatment with medication with a known risk to prolong the QT interval or inducing torsades de pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drugs','Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or moderate inhibitors of CYP3A4 are ineligible; the study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product','Participants with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)'
NCT03267433,https://www.clinicaltrials.gov/ct2/show/record/NCT03267433?term=NCT03267433&rank=1,'INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)','Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) and with proliferation rate determination, using Ki-67 or MIB-1 immunohistochemistry (=< 30% versus > 30% versus “indeterminate” Ki-67 index)','Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician','Patient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0\r\n* For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); post-induction patients with evidence of clinical disease progression are not eligible for preregistration\r\n* Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy; overall, a partial response needs to have been achieved (using studies at the time of diagnosis as the baseline)\r\n**NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen','Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement','Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence\r\n* NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient’s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment','INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)','Patients must have met eligibility criteria for the screening step','Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:\r\n* Patients are “MRD Indeterminate”: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR\r\n* ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed','Patients must have completed induction therapy within 120 days prior to registration to step 1, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (“day 0”) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given\r\n* Patient must have received at least four (4) cycles of induction therapy \r\n* Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy\r\n** NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen','Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria','Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements','Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2','Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the below criteria:\r\n* HIV is sensitive to antiretroviral therapy\r\n* Must be willing to take effective antiretroviral therapy that has minimal overlapping toxicity and pharmacokinetic interactions with protocol therapy\r\n* No history of HIV-related opportunistic disease or acquired immune deficiency syndrome (AIDS)-defining conditions within past 12 months other than historic CD4+ T-cell counts below 200 cells/mm^3\r\n* Expected long-term survival if lymphoma were not present','Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months','Women must not be pregnant or breast-feeding\r\n* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)','Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months post rituximab treatment'
NCT02975882,https://www.clinicaltrials.gov/ct2/show/record/NCT02975882?term=NCT02975882&rank=1,'Patients must have a body surface area (BSA) of >= 0.2 m^2 at the time of study enrollment','Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)','Patients must have either measurable or evaluable disease','Patient’s current disease state must be one for which there is no known curative therapy','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age \r\n* Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately','Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)','Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment','Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1','Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator','Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)','Stem cell infusions (with or without total body irradiation [TBI]):\r\n* Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion, and no evidence of graft-versus-host disease (GVHD)\r\n* Autologous stem cell infusion including boost infusion: >= 42 days','Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)','X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation','Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy','Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:\r\n* Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible\r\n* Patients who have received prior therapy with ABI-009 are not eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible\r\n* Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8.0 g/dl at baseline (may receive red blood cell [RBC] transfusions)','Patients with known bone marrow metastatic disease will be eligible for the study if they meet the following criteria: \r\n* Peripheral absolute neutrophil count (ANC) >= 750/mm^3\r\n* Platelet count >= 50,000/mm^3 (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions)\r\n* Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions, provided they are not known to be refractory to RBC transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: maximum serum creatinine (mg/dL)\r\n* 1 to < 2 years: 0.6 (male and female) \r\n* 2 to < 6 years: 0.8 (male and female) \r\n* 6 to < 10 years: 1 (male and female) \r\n* 10 to < 13 years: 1.2 (male and female) \r\n* 13 to < 16 years: 1.5 (male), 1.4 (female) \r\n* >= 16 years: 1.7 (male), 1.4 (female)','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L','Serum albumin >= 2 g/dL','Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)','Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled','Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) resulting from prior therapy must be =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible','Serum triglyceride level =< 300 mg/dL','Serum total cholesterol level =< 300 mg/dL','Random or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age','International normalized ratio (INR) =< 1.5','Not currently receiving anticoagulation therapy','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 6 months after participation in this study; abstinence is an acceptable method of contraception','Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment','Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible','Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible','Patients with interstitial lung disease and/or pneumonitis are not eligible','Patients with a history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics, temsirolimus/other mTOR inhibitors, temozolomide or irinotecan are not eligible','Patients with hypersensitivity to albumin are not eligible','Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy','Patients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible','Patients with a history of, or current grade 4 depression are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT02912559,https://www.clinicaltrials.gov/ct2/show/record/NCT02912559?term=NCT02912559&rank=1,'Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve)','Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status','Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)','Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate','Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margins are acceptable so long as en bloc resection was performed. Proximal or distal margin positivity is not permitted','Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary','Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon','No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible','No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','For women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)','Absolute neutrophil count (ANC) >= 1500 mm^3','Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration','Creatinine =< 1.5 x upper limit of normal (ULN) or','Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation','Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease','Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)','Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible','No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn’s disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency','No known active hepatitis B or C\r\n* Active hepatitis B can be defined as: \r\n** Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;\r\n** Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B\r\n** Persistent or intermittent elevation in ALT/AST levels \r\n** Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation\r\n* Active hepatitis C can be defined as: \r\n** Hepatitis C antibody (AB) positive AND \r\n** Presence of hepatitis C virus (HCV) RNA','Excluded if known active pulmonary disease with hypoxia defined as: \r\n* Oxygen saturation < 85% on room air, or\r\n* Oxygen saturation < 88% despite supplemental oxygen','No grade >= 2 peripheral motor or sensory neuropathy','Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests','No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study','No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration','No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins','No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation','No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin'
NCT02921269,https://www.clinicaltrials.gov/ct2/show/record/NCT02921269?term=NCT02921269&rank=1,'Patients must have measurable disease per RECIST 1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; to be considered pathologically enlarged and measurable, a lymph node must be >= 15 mm (>= 1.5 cm) in short axis','Patients must have had one prior systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix (e.g.; paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab), at least one which must have contained bevacizumab\r\n* NOTE: Patients are allowed to receive 1-2 prior regimens for management of recurrent, persistent or metastatic carcinoma of the cervix; patients who have received more than two prior systemic regimens for management of recurrent, persistent or metastatic carcinoma of the cervix are NOT eligible\r\n* NOTE: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy (e.g., paclitaxel and carboplatin for up to 4 cycles)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN','Alkaline phosphatase =< 2.5 x ULN','Creatinine =< 1.5 x ULN','International normalized ratio (INR) and activated partial thromboplastin time aPTT =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)','Urine protein must be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment','Patient must have recurrent, persistent or metastatic cervical cancer including squamous cell, adenocarcinoma and adenosquamous histologies; mesonephric carcinoma, minimal deviation/adenoma malignum, clear cell carcinoma and gastric type are excluded','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab; fertile women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Tumors within previous radiated field will be designated “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy','Willingness to undergo a tumor biopsy','Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation','Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)','Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents','Prior treatment with anti-CTLA-4 therapeutic antibody or pathway-targeting agents','Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1','Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day 1','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Patients with known brain metastases should be excluded from this clinical trial','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or atezolizumab','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with atezolizumab and/or bevacizumab','Malignancies other than the cervical cancer within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast','Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1','Patients with clinically significant cardiovascular disease are excluded\r\n* Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] >= 160 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg despite antihypertensive medication)\r\n* History of cerebrovascular accident (CVA) within 6 months\r\n* Myocardial infarction or unstable angina within 6 months\r\n* New York Heart Association class II or greater congestive heart failure \r\n* Serious and inadequately controlled cardiac arrhythmia\r\n* Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)\r\n* Clinically significant peripheral vascular disease','History of abdominal/pelvic fistula, gastrointestinal perforation and/or intraabdominal abscess within 6 months prior to day 1','Evidence of bleeding diathesis or clinically significant coagulopathy','Serious or non-healing wound, active ulcer or bone fracture','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab'
NCT02923778,https://www.clinicaltrials.gov/ct2/show/record/NCT02923778?term=NCT02923778&rank=1,'Newly diagnosed and histopathologically confirmed (by central pathology review) potentially resectable soft tissue sarcomas of the extremity and trunk of the following subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma\r\n* An incisional or core biopsy is the preferred method for diagnosis; fine needle aspiration is not acceptable\r\n* Sites permissible for biopsy include\r\n** Extremities: upper (including shoulder) and lower (including hip)\r\n** Trunk: body wall','Patients must have localized disease with a primary tumor >= 5 cm by magnetic resonance imaging (MRI) or computed tomography (CT) scan','Patients must have histologically confirmed grade 2 or 3 tumors by the French Federation of Cancer Centers Sarcoma Group (FNCLCC) sarcoma grading system','Patients must have a primary tumor that are determined by multidisciplinary team (medical oncology, orthopedic/surgical oncology, and radiation oncology) to require radiation therapy for optimal management prior to surgical resection','Patients must have a sarcoma in the extremity or trunk in location, which is accessible to direct or ultrasound guided injections','Karnofsky performance score >= 70','Absolute neutrophil count (ANC) >= 1500/uL','Absolute lymphocyte count (ALC) >= 800/uL','Platelets >= 100,000/uL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Calculated creatinine clearance > 70 mL/min/1.73 m^2','Patient must have a life expectancy of at least 3 months with appropriate therapy','Patients must agree to use contraception during study treatment and for 4 months after the end of treatment\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Willingness to provide mandatory tissue and blood samples for correlative studies','Patients with localized sarcomas that are not of the extremity or trunk wall (including head/neck, retroperitoneum, visceral organs, peritoneum, pelvis within the confines of the bony pelvis, and tumors arising in bone)','Patients who have had prior treatment with anti-PD1 or anti-CTLA4 therapy','Patients with grade 1 non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) tumors of any size are not eligible','Patients with evidence of active bleeding or bleeding diathesis will be excluded (patients with excess of 2.5 mL of hemoptysis are not eligible)','Patients requiring therapeutic anticoagulation','Patients must have had no prior radiotherapy to tumor-involved sites','Patients with gross total resection of the primary tumor prior to enrollment are not eligible; patients who have experienced tumor recurrence after gross total tumor resection are not eligible','History of serious or non-healing wound, ulcer, or bone fracture','Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1)','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of talimogene laherparepvec (T-VEC) and during the study','Previous treatment with talimogene laherparepvec (T-VEC) or any other oncolytic virus','Patients with metastatic disease','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to talimogene laherparepvec (T-VEC) or any of its components','History or evidence of active autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other); or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) within 2 months of enrollment; (replacement therapy [e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency] is not considered a form of systemic treatment for autoimmune disease)\r\n* Evidence of clinically significant immunosuppression such as\r\n** Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n** Concurrent opportunistic infection\r\n** Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment','Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis)','Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an anti-herpetic drug, other than intermittent topical use (e.g., acyclovir)','Other viral infections\r\n* Known to have acute or chronic active hepatitis B or hepatitis C infection\r\n* Known to have human immunodeficiency virus (HIV) infection\r\n* Prior therapy with viral-based tumor vaccine\r\n* Received live vaccine within 28 days prior to enrollment','Patients who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec (T-VEC) treatment and through 30 days after the last dose of talimogene laherparepvec (T-VEC)','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients who are pregnant, breastfeeding or plan to become pregnant; sexually active patients and their partners must be willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of T-VEC'
NCT02981628,https://www.clinicaltrials.gov/ct2/show/record/NCT02981628?term=NCT02981628&rank=1,'Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease\r\n* NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study','Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing >= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method','Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended) \r\n* In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen','Patient with and without Down syndrome are eligible and must have one of the following:\r\n* Second or greater relapse;\r\n* Primary refractory disease with at least 2 prior induction attempts;\r\n* First relapse refractory to at least one prior re-induction attempt\r\n* Any relapse after HSCT\r\n* First relapse with no prior re-induction attempt in setting of Down syndrome\r\n* Note: Patients with Down syndrome are eligible with any disease status including first relapse with no prior re-induction attempt; patients without Down syndrome are NOT eligible if in first relapse with no prior re-induction attempt','Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)','Patients must have fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study\r\n* Myelosuppressive chemotherapy:\r\n** No waiting period will be required for patients receiving standard \"maintenance-like\" chemotherapy including oral mercaptopurine, weekly low-dose oral methotrexate, and intermittent vincristine; otherwise, at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exceptions of hydroxyurea or corticosteroids used for cytoreduction\r\n** Intrathecal cytotoxic therapy: No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone; intrathecal chemotherapy given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* At least 7 days must have elapsed since completion of therapy with a biologic agent (including tyrosine kinase inhibitors); for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab; patients must have been off blinatumomab infusion for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria \r\n* >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion; patient must have had no more than one previous HSCT and currently have no evidence of active graft versus (vs.) host disease (GVHD)\r\n* At least 30 days must have elapsed from the last chimeric antigen receptor (CAR)-T cell infusion','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)\r\n* 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)\r\n* 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)\r\n* 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)\r\n* 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)','Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and','Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L','Patients with any prior history of SOS irrespective of severity','Patients with isolated central nervous system (CNS), testicular, or other extramedullary site of relapse','Patients who have been previously treated with inotuzumab ozogamicin','History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study','Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement','Patients who are currently receiving another investigational drug','Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy and intrathecal chemotherapy)','Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD medications (meds)','Patients who are currently receiving or plan to receive corticosteroids except as described below \r\n* Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, as a premedication for InO and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications','Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient','Patients who have an active uncontrolled infection defined as: \r\n* Positive bacterial blood culture within 48 hours of study enrollment; \r\n* Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability\r\n* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\r\n* Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (c.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline\r\n* Active viral or protozoal infection requiring IV treatment','Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome','Women of childbearing potential should be advised to avoid becoming pregnant while receiving InO; women should not breast-feed during treatment with InO and for at least 2 months after the final dose\r\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days of starting protocol therapy\r\n* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of InO\r\n* Men with female partners of childbearing potential should use effective contraception during treatment with InO and for at least 5 months after the last dose of InO\r\n* Lactating females are not eligible unless they agree not to breastfeed their infants'
NCT02936752,https://www.clinicaltrials.gov/ct2/show/record/NCT02936752?term=NCT02936752&rank=1,'Pathologically confirmed myelodysplastic syndrome (MDS) diagnosis (regardless of initial International Prognostic Scoring System [IPSS] risk category) or oligoblastic acute myeloid leukemia (AML) with 21-30% bone marrow (BM) blasts in whom DNMTi have failed; patients who have developed AML after DNMTi therapy can be enrolled as long as they have initiated DNMTi therapy while they were in the MDS or oligoblastic AML (20-30% BM blasts) phase and the study chair agrees; failure of DNMTis is defined as: failure to achieve a complete response (CR), partial response (PR) or hematologic improvement (HI) after at least 4 cycles of DNMTi or progressed after such therapy','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Calculated creatinine clearance by Modification of Diet in Renal Disease (MDRD) (CrCl) >= 60 ml/min/1.73 squared meter','Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x upper limit of normal (ULN)','Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of first cycle of therapy','Patients must have no clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia','Patients must have no serious or uncontrolled medical conditions','Women of child-bearing potential and men who are sexually active with women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men who are sexually active with women of childbearing potential, treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of entinostat and MK3475 (pembrolizumab) administration','Ability to understand and the willingness to sign a written informed consent document','Patients, who relapsed 6 months after bone marrow transplant and have no evidence of active graft versus host disease and are off systemic immunosuppressant medications for at least 2 months and have received hypomethylating agents (HMA) therapy before or after transplant and meet other eligibility criteria of progression after at least 4 months of DNMTi therapy, are eligible to be enrolled in this clinical trial','Any patients eligible for allogeneic stem cell transplantation (allo-SCT) and willing to undergo allo-SCT as determined at time of screening for trial; patients who are ineligible or not interested in undergoing allo-SCT will be eligible for the trial','Any serious medical condition, uncontrolled intercurrent illness (e.g., active infection, symptomatic congestive heart failure [CHF], unstable angina, cardiac arrhythmias, laboratory abnormalities, or psychiatric illness and/or biopsychosocial conditions that may limit compliance','Patients with known active cancers who are on therapy for those cancers at time of screening','Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:\r\n* They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective\r\n* They must have a CD4 count of greater than 250 cells/mcL\r\n* They must not be receiving prophylactic therapy for an opportunistic infection','Patients with a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment','Pregnant or breast feeding females (lactating females must agree not to breast feed while taking the study drugs)','Use of any other experimental drug or therapy within 21 days of baseline - patients who have had chemotherapy or radiotherapy within 4 weeks of entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier','Known hypersensitivity to MK-3475 (pembrolizumab) or history of allergic reactions to compounds of similar chemical or biologic composition to anti-PD1 or PD-L1 antibodies or entinostat','Prior treatment with any anti-PD-1 blocking therapies or histone deacetylase inhibitors (HDACi), or anti-CTLA-4 antibody, CD137 agonist or other immune activating therapy such as anti-CD 40 antibody within the last 3 months of enrollment in the study','Any history of active or severe autoimmune disease: inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, rheumatoid arthritis, systemic progressive scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), CNS or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis); patients with hypothyroidism with stable hormone replacement therapy dosing are allowed on study'
NCT02305654,https://www.clinicaltrials.gov/ct2/show/record/NCT02305654?term=NCT02305654&rank=1,'Histologically-proven squamous cell carcinoma of the penis','Stage:\r\n* any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, or;\r\n* any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0, or;\r\n* any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0','Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) criteria','Performance status Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2','Patient is fit to receive the randomization options for which he is being considered','Hematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomization options and parameters should be in line with considerations specified in the summary of product characteristics; hematological parameters should not be supported by transfusion to enable entry into the trial; liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomized to receive paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACT-neoadjuvant but may be considered for arm A','Willing and able to comply with follow-up schedule','Written informed consent','Pure verrucous carcinoma of the penis','Non-squamous malignancy of the penis','Squamous carcinoma of the urethra','Stage M1','Previous chemotherapy or chemoradiotherapy outside of the InPACT trial','Concurrent malignancy (other than squamous cell carcinoma [SCC] or basal cell carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years','Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)'
NCT03007147,https://www.clinicaltrials.gov/ct2/show/record/NCT03007147?term=NCT03007147&rank=1,'For patients enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled\r\n* For patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe\r\n* In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment','Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR','Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy','Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine','Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2','Direct bilirubin =< 2.0 mg/dL','Shortening fraction of >= 27% by echocardiogram','Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram','Corrected QT interval, QTc < 480 msec\r\n* Note: Repeat echocardiogram is not required if echocardiogram was obtained within 21 days of study enrollment','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2','Serum creatinine within normal limits based on age/gender, as follows:\r\n* 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)\r\n* 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)\r\n* 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)\r\n* 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)\r\n* 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)\r\n* >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)','Known history of chronic myelogenous leukemia (CML)','ALL developing after a previous cancer treated with cytotoxic chemotherapy','Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation','Down syndrome','Pregnancy and breast feeding\r\n* Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential\r\n* Lactating females who plan to breastfeed their infants\r\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation','Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block','Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib','All patients and/or their parents or legal guardians must sign a written informed consent','All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met'
NCT02954874,https://www.clinicaltrials.gov/ct2/show/record/NCT02954874?term=NCT02954874&rank=1,'STEP 1 REGISTRATION','Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2 negative and HER2 equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weekly ER or PR positive disease, defined as ER and/or PR < 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam\r\n* NOTE: Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast in order to be eligible','Patients must not have metastatic disease (i.e., must be M0); patients must not have locally recurrent disease','It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response; patients must have a complete axillary lymph node dissection after neoadjuvant chemotherapy in the following situations (exceptions will be granted for patients participating in the Alliance A11202 trial):\r\n* Patients had documented pathologic involvement of the axillary nodes (fine needle aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)\r\n* Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy\r\n** NOTE: Patients who undergo sentinel node biopsy before starting neoadjuvant treatment and do not undergo post neoadjuvant assessment of the axillary nodes or who have negative axillary nodes on post neoadjuvant assessment must have >= 1 cm residual invasive cancer in the breast after completion of neoadjuvant chemotherapy','Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to determine PD-L1 expression) the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide\r\n* NOTE: Initial order for specimen kits should be placed at least two weeks prior to registering the first patient at each site','Patients must be offered the opportunity to participate in specimen banking','Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC] followed by dose-dense paclitaxel; weekly paclitaxel x 12 followed or preceded by cyclophosphamide-adriamycin-fluorouracil [FAC], fluorouracil-epirubicin-cytoxan [FEC], AC or dose dense AC; docetaxel either followed or preceded by FEC/FAC or AC; carboplatin-containing neoadjuvant chemotherapy is also allowed); patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed','Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed; patients that have received adjuvant chemotherapy must be registered to screening within 35 days after completing treatment','Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:\r\n* 90 days prior to screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR\r\n* 270 days prior to screening registration for patients who have received post-operative (adjuvant) chemotherapy\r\nPatients who receive postoperative chemotherapy may receive radiation therapy before or after the chemotherapy; a short course of reduced dose chemotherapy concomitant with radiation for radiation sensitization is not considered to be adjuvant chemotherapy; positive margins are allowed only if the surgical team of the patient deems further resection impossible','Patients for whom radiation therapy (RT) to the affected breast or chest wall and regional nodal areas is clinically indicated as per NCCN treatment guidelines, should receive RT after randomization when possible, and receive MK-3475 (pembrolizumab) concurrent with RT, if randomized to the experimental arm; however, RT administered, or initiated, prior to registration is also allowed; pembrolizumab may be added to ongoing radiation, or started after its completion, if randomized to the experimental arm, provided there are no > grade 2 radiation-related skin toxicities; patients who have not yet started radiation must specify at the time of screening registration whether or not they will receive RT and the extent of intended RT','Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study','Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy','Patients must have Zubrod performance status =< 2','Patients must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis','Patients must not have an active infection requiring systemic therapy','Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment','Patients must not have received live vaccines within 30 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed','Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration; patients who have completed curative therapy for HCV are eligible; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet each of the following 3 criteria:\r\n* CD4 counts >= 350 mm^3\r\n* Serum HIV viral load of < 25,000 IU/ml and\r\n* Treated on a stable antiretroviral regimen','No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer; stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years','Patients must have complete history and physical examination within 28 days prior to registration','Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system','STEP 2 REGISTRATION','Patients must not be registered to step 2 until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 days of receiving the e-mail notification confirming submission was evaluable for PD-L1 status','Absolute neutrophil count (ANC) >= 1,500 microliter (mcL), obtained within 28 days prior to step 2 registration','Platelets >= 100,000/mcL, obtained within 28 days prior to step 2 registration','Hemoglobin >= 9 g/dL, obtained within 28 days prior to step 2 registration','A serum thyroid-stimulating hormone (TSH) must be obtained within 28 days prior to step 2 registration to obtain a baseline value','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior to step 2 registration','Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN, obtained within 28 days prior to step 2 registration','Alkaline phosphatase =< 2.5 x IULN, obtained within 28 days prior to step 2 registration','Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min, obtained within 28 days prior to step 2 registration','Women of childbearing potential must have a negative urine or serum pregnancy test within 28 day prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or vasectomy; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing','Site must verify that there is no known change in the step 1 eligibility since initial registration'
NCT03373760,https://www.clinicaltrials.gov/ct2/show/record/NCT03373760?term=NCT03373760&rank=1,'Patients must have been assigned to S1400F','Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. patient has not received any platinum-based chemotherapy for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; patients must have experienced disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment; prior PD-1/PD-L1 combination therapy is not permitted','Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)','Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration','Patients must not have any prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, immune-mediated alopecia, Grave’s disease, or psoriasis requiring systemic treatment within the past 2 years are not eligible; patients with hypothyroidism (e.g. post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible','Patients must not have any history of primary immunodeficiency','Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy','Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy','Patients must not have any history of organ transplant that requires use of immunosuppressives','Patients must not have any known allergy or reaction to any component of the durvalumab (MEDI4736) and/or tremelimumab formulation','Patients must not have clinical signs or symptoms of active tuberculosis infection','Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration','Patients must not have known human immunodeficiency virus (HIV), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed','Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior to sub-study registration','Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens'
NCT03180268,https://www.clinicaltrials.gov/ct2/show/record/NCT03180268?term=NCT03180268&rank=1,'PRIOR TO STEP 1 REGISTRATION:','The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria','Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings','Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection','For step 1 registration the operating neurosurgeon must provide the modified Simpson grade','GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis','The patient or a legally authorized representative must provide study-specific informed consent prior to study entry','If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study','NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization','PRIOR TO STEP 2 REGISTRATION:','Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration','History/physical examination, including neurologic examination within 60 days prior to step 2 registration','Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration','If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception','Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma','Definitive evidence of metastatic meningioma','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)','Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas','Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration\r\n* Transmural myocardial infarction within the last 6 months prior to step 2 registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration\r\n* Type II neurofibromatosis (NF2)\r\n* Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration\r\n* Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia','Pregnancy and/or nursing females'
NCT02965716,https://www.clinicaltrials.gov/ct2/show/record/NCT02965716?term=NCT02965716&rank=1,'Patients must have pathologically confirmed stage IV or unresectable stage III melanoma; patients must not have disease that is suitable for local therapy, administered with curative intent','Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; contrast-enhanced computed tomography (CT) scans of the neck, chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patients chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)','Cohort A: Patients must have at least one measurable visceral lesion (per RECIST 1.1); a visceral lesion is any solid organ except for skin, lymph node, and musculoskeletal tissue; at least one of these visceral lesions must be measurable per RECIST 1.1','Cohort B: Patients must not have any visceral lesions','Patients must, in the opinion of the treating physician, be candidates for intralesional administration into cutaneous, subcutaneous, or nodal lesions; patients must have at least 2 injectable lesions','Patients may have brain metastases if all lesions have been treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy with no evidence of progression (demonstrated by identical imaging modality for 2 consecutive assessments/scans [magnetic resonance imaging (MRI) or CT scans], at least 4 weeks apart) and have not required steroids for at least 14 days prior to registration','Patient must have had prior treatment with anti-PD-1 or anti-PD-L1 agents and have documented disease progression on these agents prior to registration; patient must have received anti-PD-1 or PD-L1 based therapy as the immediate previous line of treatment and within 56 days prior to registration','Patients must not have had surgery, biologic therapy, or hormonal therapy within 14 days prior to registration; patients must not have had chemotherapy, targeted small molecule therapy, or radiation therapy within 28 days (42 days for nitrosoureas or mitomycin C) prior to registration; patients must not have had an investigational agent or monoclonal antibodies, except anti-PD1/L1 antibodies, within 28 days prior to registration\r\n* Patients must have recovered from all adverse events due to prior anti-cancer therapy (residual toxicity =< grade 1) prior to registration, with the exception of patients with =< grade 2 neuropath or =< grade 2 alopecia\r\n* If patients received major surgery, they must have recovered adequately from toxicity and/or complications from the intervention prior to registration','Patients must not have received prior treatment with talimogene laherparepvec (T-VEC) or other oncolytic virus agents','Patients must not have received any live vaccine within 30 days prior to registration; seasonal flu vaccines that do not contain live virus are permitted','Patients must not be planning to receive other biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other therapy while on this protocol; palliative radiation therapy or surgery can be considered for symptomatic non-target lesions after discussions with the study team','Patients must have Zubrod performance status =< 2','Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration','Hemoglobin >= 9 g/dL within 28 days prior to registration','Platelets >= 100,000/mcL within 28 days prior to registration','Albumin >= 2.5 g/dL within 28 days prior to registration','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except patients with documented Gilbert’s syndrome within 28 days prior to registration','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both < 2.5 x IULN within 28 days prior to registration','Serum creatinine < 2.0 x IULN within 28 days prior to registration','Patients must have prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) =< 2.0 x institutional upper limit of normal (IULN) unless the patient is on anticoagulant therapy within 28 days prior to registration (if the patient is receiving anticoagulant therapy, PT, and a PTT must be within therapeutic range of intended use of anticoagulants)','Activated partial thromboplastin time (aPTT) =< 2.0 x IULN if not using anticoagulants within 28 days prior to registration; if using anticoagulants, then the value must be within therapeutic range according to the condition for which the patient is being treated within 28 days prior to registration','Patients must have lactate dehydrogenase (LDH) obtained prior to registration','Patients must have complete physical examination and medical history obtained within 28 days prior to registration','Patients must not require use of systemic corticosteroid within 14 days prior to registration or during protocol treatment; patients with preexisting severe autoimmune disease requiring systemic corticosteroids or ongoing immunosuppression are not eligible','Patients must not have known history of hepatitis B, hepatitis C, human immunodeficiency virus (HIV); the use of physiologic doses of corticosteroids may be approved after consultation with the study chair','Patients must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis','Patients must not have an active infection requiring systemic therapy nor a viral infection requiring intermittent treatment with an antiherpetic drug, other than intermittent topical use','Patients must not have active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis) which requires intermittent or chronic treatment with an anti-herpetic drug other than intermittent topical use','Patients must not have organ allografts','Patients must not have an uncontrolled intercurrent illness including, but not limited to, nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy, or psychiatric illness/social situations which would limit compliance with study requirements','Patients must not have history or evidence of active autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other); or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) within 2 months of registration; replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease','Patient must not have evidence of any clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease;\r\n* Concurrent opportunistic infection;\r\n* Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years','Patients must not be pregnant or nursing; women of reproductive potential must have a negative serum pregnancy test within 7 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method while on study and for 120 days after last study treatment; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures','Patients must be willing to submit blood and tissue specimens for translational medicine','Patients must be offered the opportunity to participate in specimen banking for future research','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT02971501,https://www.clinicaltrials.gov/ct2/show/record/NCT02971501?term=NCT02971501&rank=1,'Non-small cell lung cancer (NSCLC) with an activating EGFR mutation (exon 19 deletion, L858R point mutation, or any other mutation known to be associated with EGFR TKI sensitivity); presence of an activating EGFR mutation may be documented in tumor tissue or by plasma testing if performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory; AND','The presence of an EGFR T790M mutation after progression on a first- or second-generation EGFR TKI; presence of an EGFR T790M mutation may be documented from biopsy material from any site of disease (intra- or extra-cranial) or from plasma testing if performed in a CLIA-certified laboratory; for patients who have disease progression in the CNS only (with otherwise stable disease systemically), T790M positivity is not required','Disease progression on a first- or second-generation EGFR TKI (i.e. erlotinib, gefitinib, or afatinib); patient may have also received prior chemotherapy or immunotherapy but this is not required','Patients must have at least one measurable CNS lesion that is asymptomatic, untreated, and does not require local therapy at the time of enrollment; measurable CNS disease is defined as a brain metastasis that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 5 mm (>= 0.5 cm) with brain magnetic resonance imaging (MRI); if the lesion is 5-10 mm in size and is the only measurable disease, MRI imaging must be performed with 1.5 mm slice thickness or less; a history of previously treated brain metastases is allowed, however any lesion present at the time of whole brain radiotherapy or included in the stereotactic radiotherapy field (or within 2 mm of the treated lesion) will NOT be considered “untreated” unless it is new or documented to have progressed unequivocally since treatment','Patients are not required to have measurable systemic (i.e. non-CNS) disease; if present, measurable systemic disease must be able to be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, MRI, or calipers by clinical exam','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Life expectancy of greater than 3 months','The use of anti-convulsants is allowed, as long as the patient is on a stable dose with no seizure activity for at least 2 weeks prior to initiating trial therapy','Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child- bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n* Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation','Fertile men should be willing to use barrier contraception during and for 4 months after AZD9291 (osimertinib), and fertile women must agree to use adequate contraceptive measures during and for 6 weeks after AZD9291 (osimertinib); fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Symptomatic brain metastases','Patients with brain metastases for whom complete surgical resection is clinically appropriate','Prior treatment with a third-generation EGFR TKI (i.e. rociletinib)','Prior treatment with agents targeting the VEGF pathway, including bevacizumab','The use of corticosteroids to control cerebral edema or treat neurologic symptoms will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 3 days without recurrence of symptoms prior to starting trial therapy; corticosteroids for other indications is allowed','Presence of leptomeningeal disease','Patients may not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within five half-lives of the compound or 3 months, whichever is greater','Treatment with an EGFR TKI (i.e. erlotinib, gefitinib or afatinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment','Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 platinum-therapy related neuropathy','Concurrent, active malignancies in addition to that being studied (other than cutaneous squamous cell carcinoma or basal cell carcinoma)','Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices)','Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease','History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9291 (osimertinib) or bevacizumab','Urine protein should be screened by urine analysis; if protein is 2+ or higher, 24-hour urine protein should be obtained; patients with 24-hour urine protein >= 1000 mg are excluded','Serious or non-healing wound, ulcer or bone fracture','History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1','Invasive procedures defined as follows:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy\r\n* Anticipation of need for major surgical procedures during the course of the study\r\n* Core biopsy within 7 days prior to day 1 (D1) therapy','Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1','Patients with clinically significant cardiovascular disease are excluded\r\n* Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] > 160 mmHg and/or diastolic blood pressure [DBP] > 90 mmHg despite antihypertensive medication)\r\n* History of cerebrovascular accident (CVA) within 6 months (see additional requirement for adjuvant protocols)\r\n* Myocardial infarction or unstable angina within 6 months (see additional requirement for adjuvant protocols)\r\n* New York Heart Association grade II or greater congestive heart failure \r\n* Serious and inadequately controlled cardiac arrhythmia\r\n* Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)\r\n* Clinically significant peripheral vascular disease','Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (Fridericia's correction formula [QTcF]) > 470 ms ms obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived corrected QT (QTc) value\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval','Evidence of bleeding diathesis or coagulopathy (including clinically significant hemoptysis)','Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291 (osimertinib)','Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4','Any evidence of severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV); screening for chronic conditions is not required','History of hypersensitivity active or inactive excipients of AZD9291 (osimertinib) or drugs with a similar chemical structure or class to AZD9291 (osimertinib)','Absolute neutrophil count < 1.5 x 10^9/L','Platelet count < 100 x 10^9/L','Hemoglobin < 90 g/L','Alanine aminotransferase > 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases; aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases','Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases','Serum creatinine > 1.5 times ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)—confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN','Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements'
NCT02974621,https://www.clinicaltrials.gov/ct2/show/record/NCT02974621?term=NCT02974621&rank=1,'Unequivocal evidence of progressive disease on contrast-enhanced brain computed tomography (CT) or MRI as defined by Response Assessment in Neuro-Oncology (RANO) criteria, or have documented recurrent glioblastoma on diagnostic biopsy','Previous therapy with at least radiotherapy and temozolomide','Must be 12 weeks from radiotherapy; if patients are within 12 weeks of radiotherapy, then the progressive lesion must be outside of the high-dose radiation target volume or have unequivocal evidence of progressive tumor on a biopsy specimen','Only first and second recurrences of GBM are eligible','From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from investigational agents, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other systemic anti-tumor therapies; treatment on study may start one day after discontinuation of the optune device','All adverse events grade > 1 related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved, except for alopecia','Willingness to release archival tissue sample for research purposes, if available','Karnofsky performance status >= 60','Life expectancy of at least 3 months','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal','Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal','Urine protein: creatinine (UPC) ratio < 1 or urine dipstick for proteinuria =< 2+ (note: if the UPC ratio is >= 1.0 then a 24-hour urine collection should be performed and this must demonstrate =< 1g of protein in 24 hours)','CT or MRI within 14 days prior to start of study drug','Corticosteroid dose must be stable or decreasing for at least 5 days prior to the baseline MRI scan','Female subjects must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1; Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of olaparib + cediranib administration','Ability to understand and the willingness to sign a written informed consent document','Participants should not have received any other investigational agents nor have participated in an investigational trial within the past 4 weeks','Participants may not have had prior use of PARP inhibitors; patients may not have received prior treatment affecting the VEGF pathway including but not limited to thalidomide, bevacizumab, sunitinib, or sorafenib','Patients who are receiving any other investigational agents','History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib, cediranib or bevacizumab','Participants may not have any evidence of ongoing inadequately controlled hypertension (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90 mmHg); patients with hypertension may not be on more than three antihypertensive medications for management of their blood pressure (medications that combine two anti-hypertensives into one are considered as two medications); it is strongly recommended that patients who require three antihypertensive medications for baseline management of pre-existing hypertension be actively followed by a cardiologist or blood pressure specialist for management of BP while on protocol','Participants may not have had any prior history of hypertensive crisis or hypertensive encephalopathy','Participants may not have had history of abdominal fistula or gastrointestinal perforation within the past 6 months','Participants may not have had a history of intra-abdominal abscess within the past 6 months; anticipation of need for major surgical procedures during the course of the study also excludes patients from the trial','Patients may not have a known or confirmed history of pneumonitis','Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs','Participants may not have a dependency on IV hydration or total parenteral nutrition (TPN)','Patients with myelodysplastic syndrome/acute myeloid leukemia','Participants with any concomitant or prior invasive malignancies are ineligible with the following exceptions:\r\n* Treated limited-stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Prior cancer treated with curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence','Participants with any of the following:\r\n* History of myocardial infarction within six months\r\n* Unstable angina\r\n* History of cerebrovascular accident (CVA) within 6 months\r\n* New York Heart Association grade II or greater congestive heart failure\r\n* Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)\r\n* Clinically significant peripheral vascular disease','If cardiac function assessment is clinically indicated or performed: participants will be ineligible if left ventricular ejection fraction (LVEF) is less than normal per institutional guidelines, or < 55%, if the threshold for normal is not otherwise specified by institutional guidelines','Participants may not have corrected QT (QTc) > 470 msec or family history of long QT syndrome','Participants may not have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib','Participants should not have any uncontrolled intercurrent illness including, but limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or moderate inhibitors of CYP3A4 are ineligible; the study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; dihydropyridine calcium-channel blockers are permitted for management of hypertension; patient drug information handout and wallet card should be provided to patients','Pregnant women are excluded; breastfeeding should be discontinued if the mother is treated with cediranib and olaparib','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis.\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, S. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto or ginseng)\r\n* Raloxifene is allowed for patients taking it for bone health','Participants should not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted'
NCT03274687,https://www.clinicaltrials.gov/ct2/show/record/NCT03274687?term=NCT03274687&rank=1,'PRIOR TO STEP 1 REGISTRATION','Adenocarcinoma of the prostate treated primarily with radical prostatectomy\r\n* Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted; there is no time limit for the date of radical prostatectomy','One of the following pathologic T-classifications: pT2 or pT3\r\n* Patients with positive surgical margins are eligible','One of the following pathologic N-classifications: pN0, pNX\r\n* If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus (vs.) extended lymph node dissection) should be noted whenever possible','No clinical evidence of regional lymph node metastasis\r\n* Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration\r\n* Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1 cm in the short axis','A post-radical prostatectomy study entry PSA >= 45 days after prostatectomy and within 30 days prior to step 1, < 2.0 ng/mL','No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration\r\n* Patients with equivocal or questionable DRE findings should have an MRI of the pelvis to exclude the presence of a prostate fossa mass\r\n* Patients with equivocal or questionable exam findings by DRE or MRI are eligible if a biopsy of the lesion is negative for tumor','No evidence of bone metastases (M0) on bone scan (Na F positron emission tomography (PET)/CT is an acceptable substitute) within 120 days prior to step 1 registration\r\n* Equivocal bone scan findings are allowed if plain films and/or MRI are negative for metastasis','Zubrod performance status 0-1 within 60 days prior to step 1 registration','The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration','Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire','Only English and French-speaking patients are eligible to participate','PRIOR TO STEP 2 REGISTRATION','The EPIC-26 must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization','A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7','pT2 with a negative surgical margin and PSA < 0.1 ng/mL','Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration; \r\n* Note: The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to prostatectomy is acceptable','Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)','Neoadjuvant chemotherapy before or after prostatectomy','Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed','Previous chemotherapy for any other disease site if given within 3 years prior to step 1','Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes','Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration\r\n* Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease\r\n* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol\r\n* End-stage renal disease (ie, on dialysis or dialysis has been recommended)','Prior allergic reaction to the study drugs involved in this protocol','History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason'
NCT02978625,https://www.clinicaltrials.gov/ct2/show/record/NCT02978625?term=NCT02978625&rank=1,'Patients must have histologic or cytologic diagnosis of non-melanoma skin cancer (NMSC) or lymphomas other than B-cell lymphomas; as both of those terms are categories rather than specific diagnoses, specific guidance on eligible tumor types is provided below','Included tumor types\t\r\n* T cell and NK cell lymphomas, including, but not limited to: cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas\r\n* Merkel cell carcinoma\r\n* Squamous cell carcinoma of the skin, including keratoacanthomas, vulvar squamous carcinoma, and mixed histology tumors, such as basosquamous carcinoma, and squamous cell carcinoma of unknown primary consistent with skin origin\r\n* Other non-melanoma skin cancers\r\n** Basal cell carcinoma\r\n** Malignant sweat gland tumors, including porocarcinoma, hidradenocarcinoma, spiradenocarcinoma, cylindrocarcinoma, microcystic adnexal carcinoma and related entities, squamoid eccrine ductal carcinoma, cutaneous adenoid cystic carcinoma, digital papillary adenocarcinoma, primary cutaneous mucinous carcinoma, endocrine mucin-producing sweat gland carcinoma, primary cutaneous signet ring cell carcinoma, cutaneous apocrine gland carcinoma, and extraocular sebaceous carcinoma\r\n** Adnexal carcinoma\r\n** Trichilemmal carcinoma\r\n** Extramammary Paget’s disease\r\n** Any other rare tumor of the skin with approval of principle investigator (PI)','Patients with T cell and natural killer (NK) cell lymphomas must be refractory to, be intolerant of, have relapsed following, or have refused all standard life-prolonging therapies','Patients with non-melanoma skin cancers (NMSC) must have advanced or refractory tumors\r\n* Advanced/unresectable is defined by at least 1 of the following criteria: tumors 2 cm or more, tumors considered unresectable, tumors invading deep tissues such as muscle, cartilage or bone, tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes and/or distant sites\r\n* Refractory is defined by persistent or recurrent tumor despite prior therapy consisting of at least 1 of the following: surgery, radiation therapy, intralesional therapy, topical therapy, or systemic therapy','Subjects must have at least 1 cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing','Subjects must have radiographically or clinically measurable disease, defined as at least one lesion that is >= 10 mm in diameter in at least 1 dimension, or an aggregate of lesions that measures >= 10 mm in diameter in at least 1 dimension','Subjects must be able and willing to undergo serial biopsies of injected lesion(s) and, when applicable and clinically feasible, non-injected lesions','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Absolute neutrophil count (ANC) >= 1.2 x 10^9/L','Hemoglobin >= 9 g/dL without transfusion in the preceding 7 days','Platelets >= 75 x 10^9/L','Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome with a total bilirubin < 3.0 mg/dL)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN, unless the subject is on anticoagulant therapy; (if the subject is receiving anticoagulant therapy, PT, and activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants)','Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence from heterosexual intercourse) prior to study entry, during the study participation, and for 7 months after the last dose of the drug; WOCBP must have a negative serum pregnancy test within 14 days prior to randomization; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree to use adequate contraception prior to study entry, during the study participation and for 7 months after the last dose of the drug','Ability to understand and the willingness to sign a written informed consent document','Excluded tumor types\r\n* Melanoma\r\n* Bone sarcomas\r\n* Soft tissue sarcomas, including angiosarcoma, primary cutaneous leiomyosarcoma, dermatofibrosarcoma protuberans\r\n* Leukemias\r\n* Myeloid sarcoma, leukemia cutis, and chloroma\r\n* Hodgkin’s lymphoma\r\n* B cell lymphoma','Patients who have had systemic therapy or radiotherapy within 3 weeks prior to the first dose of study therapy','Untreated central nervous system (CNS) involvement','Previous treatment with talimogene laherparepvec or other herpes virus based therapy; (prior therapy with checkpoint inhibitors and/or other immunotherapy is allowed)','Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1 excepting alopecia, peripheral sensory neuropathy, and stable endocrine insufficiencies such as thyroid and adrenal insufficiency)','Second primary malignancy, only if it would affect the safety of the treatment or the subject’s ability to complete study-related procedures','History or evidence of active autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other); or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) within 2 months of enrollment; (replacement therapy [e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency] is not considered a form of systemic treatment for autoimmune disease)','Evidence of clinically significant immunosuppression such as the following:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* Receiving systemic immunosuppressive therapy including prednisone > 10 mg per day (or equivalent), tacrolimus, everolimus, sirolimus, mycophenolate mofetil, etanercept, infliximab, etc. \r\n* Recipients of solid organ, bone marrow, or stem cell transplants; auto transplant recipients are allowed\r\n* Notes: Oral steroid doses =< 10 mg/day of prednisone (or equivalent) are not considered immunosuppressive and are permitted; inhaled and intraarticular corticosteroids are permitted','Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis)','Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use','Other viral infections:\r\n* Known to have acute or chronic active hepatitis B or hepatitis C infection\r\n* Known to have human immunodeficiency virus (HIV) infection\r\n* Prior therapy with viral-based tumor vaccine\r\n* Received live vaccine within 28 days prior to enrollment','Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus 1 (HSV-1) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec','Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 7 months after the last dose of treatment; female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 7 months after the last dose of treatment; sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to talimogene laherparepvec or any of its components or nivolumab, or history of severe hypersensitivity reaction to any monoclonal antibody'
NCT03188393,https://www.clinicaltrials.gov/ct2/show/record/NCT03188393?term=NCT03188393&rank=1,'The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines','The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1','Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing','Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible','Patients must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy','Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)','Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI','Patients must be undergoing breast conserving therapy','Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy','Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen','Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated','Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible','Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible','T4 tumors including inflammatory breast cancer','Patients with metastatic disease','Patients with any history of prior radiation therapy in the affected breast','Patients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)','Patients with invasive lobular carcinoma','Patients who have multicentric disease','Patients treated with neoadjuvant hormonal therapy only are not eligible','Patients who are medically unfit to undergo surgical resection','Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy','Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography)','Patients with one or more of the following imaging criteria from any of the 3 imaging modalities after completion of neoadjuvant chemotherapy (NCT) are not eligible:\r\n* Mammogram with malignant appearing calcifications or mass > 1 cm; or\r\n* Ultrasound with a hypoechoic area > 2 cm; or\r\n* Breast MRI demonstrating a residual mass with rapid rise and washout type III kinetics.','Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results','Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration)'
NCT03300544,https://www.clinicaltrials.gov/ct2/show/record/NCT03300544?term=NCT03300544&rank=1,'Patients must have histologically or cytologically confirmed A) low lying (i.e. =< 6 cm from the anal verge) rectal adenocarcinoma eligible for concurrent chemoradiation therapy to rectal tumor, B) if the treatment is palliative in the metastatic setting, no additional requirements for tumor size or nodal involvement is needed; C) if the treatment is in the neoadjuvant setting, the tumor must ALSO be high-risk locally advanced rectal cancer defined as T3-4, N+, and/or at risk for a positive radial margin (as determined by the surgeon)','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L','Hemoglobin >= 9 g/dL','Platelets >= 100,000 x 10^9 /L','Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who can have total bilirubin < 3 mg/DL)','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min','Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional unless the subject is on anticoagulant therapy (if the subject is receiving anticoagulant therapy, PT, and activated partial thromboplastin time [aPTT] must be within therapeutic range of intended use of anticoagulants)','Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary; patients must be made aware of their other treatment options','Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; WOCBP must have a negative serum pregnancy test within 14 days prior to randomization and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Ability to understand and the willingness to sign a written informed consent document','Patients who have had radiotherapy within < 4 weeks are ineligible','Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) except alopecia are ineligible','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of talimogene laherparepvec (T-VEC) and during the study are ineligible','Patients who have previously been treated with T-VEC, any other oncolytic virus or pelvic radiation are ineligible','Patients with known active central nervous system (CNS) metastases are ineligible; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases','Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to T-VEC or any of its components, capecitabine, fluorouracil (5-FU) and / or oxaliplatin are ineligible','Patients with a history or evidence of active autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other); or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) within 2 months of enrollment are ineligible; (replacement therapy [e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency] is not considered a form of systemic treatment for autoimmune disease)','Patients with evidence of clinically significant immunosuppression such as the following are ineligible:\r\n* Primary immunodeficiency state such as severe combined immunodeficiency disease\r\n* Concurrent opportunistic infection\r\n* Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment','Patients with active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis) are ineligible','Patients with viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use are ineligible','Patients with other viral infections are ineligible:\r\n* Known to have acute or chronic active hepatitis B or hepatitis C infection\r\n* Known to have human immunodeficiency virus (HIV) infection\r\n* Prior therapy with viral-based tumor vaccine\r\n* Received live vaccine within 28 days prior to enrollment','Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec are ineligible','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are ineligible','The study treatment must be excluded in the following patients:\r\n* Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec\r\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 4 months after the last dose of T-VEC\r\n* Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with T-VEC','Patients that unable to swallow oral medications are ineligible','Patients with a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of therapy, or anticipation of need for major surgical procedure during the course of the study other than that defined by protocol are ineligible','If patients require anticoagulation while on protocol, they should be switched from warfarin to another alternative anticoagulant such as low molecular weight heparin or oral direct factor Xa inhibitors as deemed appropriate by the treating physician for the duration they are on capecitabine (must be switched at least 1 week prior to starting capecitabine) to avoid drug-drug interaction of warfarin with capecitabine','Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency are ineligible'
NCT03250299,https://www.clinicaltrials.gov/ct2/show/record/NCT03250299?term=NCT03250299&rank=1,'Patients must have histologically-proven GBM','Patients must have recovered from the immediate post-operative period','Patients must have tumor MGMT methylation status of unmethylated as determined by local pathologist using a Clinical Laboratory Improvement Act (CLIA)-approved diagnostic test; results of routinely-used methods for MGMT methylation testing (e.g. methylation-specific [MS]- polymerase chain reaction [PCR] or quantitative PCR) are acceptable','Patients must be able to undergo magnetic resonance imaging (MRI) of the brain with gadolinium','Patients must not have received prior radiation therapy (RT), chemotherapy, immunotherapy or therapy with a biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor; corticosteroid therapy is allowed','Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM, completed and signed by a pathologist','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Absolute neutrophil count >= 1,500/uL','Platelets >= 100,000/uL','Hemoglobin >= 9 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for patients with known Gilbert’s syndrome who must have normal direct bilirubin)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN','Creatinine =< 1.5 x ULN OR','Creatinine clearance >= 60 mL/min/1.73 m^2','Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x ULN','Sodium >= the institutional lower limit of normal','Patients must be able to provide written informed consent','Patients must have baseline MRI performed within the 21 days prior to starting treatment','Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of BAL101553; women of childbearing potential must agree to use highly-effective contraceptive methods for the duration of study participation and for an additional 90 days after the last dose of study drug; highly-effective contraceptive methods include male or female sterilization (bilateral tubal occlusion or vasectomy); intrauterine device (IUD); combined (estrogen- and progesterone-containing) hormonal contraception (oral, vaginal ring or transdermal patch) with an ethinylestradiol dose of at least 30 ug, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap; or total sexual abstinence; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; male patients must agree not to donate sperm from the first dose of study drug until 90 days after the last dose of study drug; male patients, without a vasectomy and with a partner of childbearing potential, must agree to use condoms during the study and for at least 90 days after the last dose of study drug; the patient should be instructed that their female partner should use another form of contraception for the duration of the study and continue this use for at least 90 days after the last dose of study drug','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= 5 years','Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI','Patients must be able to swallow whole capsules','Patients receiving any other investigational agents are ineligible','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to BAL101553 are ineligible','Patients on drugs that are strong inhibitors and/or inducers of CYP2C9, CYP2C19 or CYP3A4 (including enzyme-inducing anti-epileptic drugs [EIAEDs]), are not eligible for treatment under this protocol; patients taking non-EIAEDs are permitted to take part in the study; patients previously treated with any of the prohibited concomitant medications listed above may be enrolled if they have been off of the medication for >= 10 days prior to the first dose of BAL101553','Patients may not be on coumarin anti-coagulants (warfarin, etc.); heparin, low-molecular weight heparin (LMWH), or other antithrombotic medications are permitted','Patients with gastrointestinal disease, or those who have had a procedure that is expected to interfere with the oral absorption or tolerance of BAL101553 (e.g., functionally-relevant gastrointestinal obstruction, or frequent vomiting unresolved upon anti-emetic supportive care), are ineligible','Patients with peripheral neuropathy >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 are ineligible','Patients with ataxia >= CTCAE grade 2 are ineligible','Patients with known acute or chronic hepatitis B or hepatitis C infection are ineligible','Patients with systolic blood pressure (SBP) >= 140 mmHg or diastolic blood pressure (DBP) >= 90 mmHg at the screening visit are ineligible; patients with an initial clinic blood pressure (BP) >= 140/90 mmHg may be included if SBP < 140 mmHg and DBP < 90 mmHg is confirmed in two subsequent BP measurements on the same day','Patients with BP combination treatment with more than two antihypertensive medications are ineligible','Significant cardiac disease or abnormality, including any one of the following:\r\n* Left ventricular ejection fraction < 50% at screening (assessed by echocardiography, cardiac MRI or multigated acquisition [MUGA])\r\n* Corrected QT Fridericia's correction formula (QTcF) > 470 ms on screening electrocardiogram (ECG), or a clinically-relevant ECG abnormality\r\n* Congenital long QT syndrome\r\n* History of sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes\r\n* Presence of atrial fibrillation with tachyarrhythmia (ventricular response rate > 100 beats per minute [bpm])\r\n* Bradycardia (heart rate < 50 bpm)\r\n* Complete left bundle branch block\r\n* Bifascicular block (complete right bundle branch block and anterior or posterior left hemiblock)\r\n* Myocardial infarction, acute coronary syndrome (including unstable angina), coronary revascularization procedures, or coronary arterial bypass grafting within the 6 months prior to starting study drug\r\n* Cardiac troponin (either troponin T or troponin I) > ULN\r\n* Congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with BAL101553','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'
NCT02993146,https://www.clinicaltrials.gov/ct2/show/record/NCT02993146?term=NCT02993146&rank=1,'Patients must have histologically confirmed malignancy with brain metastases and are being recommended palliative WBRT','Life expectancy of greater than 2 months to allow completion of study treatment and assessment of dose-limiting toxicity','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Leukocytes >= 3,000/mcL','Absolute neutrophil count >= 1,000/mcL','Platelets >= 100,000/mcL','Calculated creatinine clearance >= 45 mL/min/1.73 m^2','Total bilirubin:\r\n* If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN)\r\n* If known liver metastases, then: total bilirubin < 2.5 x ULN','Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]):\r\n* If no known liver metastases: AST/SGOT and ALT/SGPT both < 2 x ULN\r\n* If known liver metastases, then: AST/SGOT and ALT/SGPT both < 5 x ULN','Human immunodeficiency virus (HIV) positive (+) patients with CD4 counts >= 250 cells/mm^3 on anti-viral therapy are eligible for the study','Negative urine or serum pregnancy test result for females of child bearing potential only; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of IPdR administration','Ability to understand and the willingness to sign a written informed consent document','Presence of diffuse lepto or pachy meningeal carcinomatosis (focal/localized involvement from limited meningeal based metastases acceptable), greater than 1 cm mid-line shift, uncal herniation, or severe hemorrhage/hydrocephalous (small intra-lesional hemorrhage or anticipated surgical cavity is acceptable); patients with seizure at presentation who have been started on levetiracetam and have been stable for 48 hours prior to study registration are eligible at the discretion of treating physician','Patients who have received systemic cytotoxic chemotherapy or approved oral targeted therapy or immunotherapy for 2 weeks, or other investigational agents for 3 weeks (4 half-lives for any oral targeted agents), or radiotherapy to a non-brain site for 2 weeks before initiation of IPdR therapy; patients who have recovered from serious (Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more higher) to grade 1 or less adverse events from the previous therapies are eligible; prior/current/future hormonal therapy and/or bisphosphonates are permitted with no minimum interval to initiation of study therapy; if indicated, patients can receive palliative radiation therapy to a non-brain site concurrent or immediately post-study treatment with no minimum interval to initiation of study therapy','Patients must not have received prior whole brain radiation therapy; previous SRS/SRT done at least 3 weeks from the planned start of IPdR therapy is acceptable; SRS/SRT/fractionated boosts or neurosurgery can be performed once the dose limiting toxicity (DLT) assessment has been completed, if felt clinically necessary','Patients with primary tumors including germ cell tumor, or lymphoma/leukemia','Patients who are receiving any other investigational agent','Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the study’s principal investigator, Dr Mohindra at the University of Maryland','History of allergic reactions attributed to compounds of similar chemical or biologic composition to IPdR','Uncontrolled intercurrent illness if it would increase the risk of toxicity or limit compliance with study requirements; this includes, but is not limited to, ongoing uncontrolled serious infection requiring intravenous (i.v.) antibiotics, progressive congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IPdR'
NCT03150693,https://www.clinicaltrials.gov/ct2/show/record/NCT03150693?term=NCT03150693&rank=1,'REGISTRATION ELIGIBILITY CRITERIA (STEP 1)','Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (World Health Organization [WHO] criteria) are eligible; patients with Burkitt type ALL are NOT eligible','Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet','No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible','No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC','Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy','Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 8 days prior to registration is required','Eastern Cooperative Oncology Group (ECOG) performance status 0-2','Patients with down syndrome are excluded from this study','Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver','Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver','Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault','RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)','Completion of remission induction therapy','Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized\r\n* Rating: M0, M1; Blast Cells (%): 0-5.0\r\n* Rating: M2; Blast Cells (%): 5.1-25.0\r\n* Rating: M3; Blast Cells (%): > 25-50\r\n* Rating: M4; Blast Cells (%): > 50.0\r\n* The term “blast cell” includes any cell that cannot be classified as a more mature normal element, and includes “leukemic cells,” pathologic lymphocytes, and stem cells','Absolute neutrophil count (ANC) >= 750/mm^3','Platelet count >= 75,000/mm^3','Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert’s syndrome','AST =< 8 x upper limit of normal (ULN)'
NCT03186898,https://www.clinicaltrials.gov/ct2/show/record/NCT03186898?term=NCT03186898&rank=1,'Pathologically (histologically or cytologically) or radiographically-proven (based on the American Association for the Study of Liver Diseases [AALSD] criteria) unresectable or locally recurrent hepatocellular cancer prior to registration','Appropriate stage for study entry based on the following diagnostic workup:\r\n* All patients must have computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan prior to registration; if CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen is permitted\r\n* Participants must have measurable disease at study entry, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 2 cm with conventional techniques or as > 1 cm with spiral CT scan\r\n* Patient must have 3 or fewer single or multinodular tumors; for patients with a single lesion, lesion must be 15 cm or less in greatest dimension; for patients with two lesions, no lesion may be greater than 10 cm in greatest dimension; for patients with three lesions, no lesion may be greater than 6 cm in greatest dimension; portal vein involvement or thrombosis combined with a single lesion that is >= 4 cm and =< 15 cm in greatest dimension is allowed','Zubrod performance status 0-1 within 30 days prior to registration','Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry','Absolute neutrophil count (ANC) >= 1,000 cells/mm^3','Platelets >= 50,000 cells/mm^3','Hemoglobin >= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)','Total bilirubin < 4 x institutional upper limit of normal (ULN)','Transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) < 6 x institutional ULN','Albumin >= 2.5 g/dl','Creatinine < 2 mg/dl','Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable','Must have Child-Turcotte-Pugh (CTP) A or B7','The patient or a legally authorized representative must provide study-specific informed consent prior to study registration','PRIOR TO STEP ONE RANDOMIZATION:','Definitive clinical or radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm','Uncontrolled prior invasive malignancy, excluding the current diagnosis','Systemic chemotherapy for the study cancer < 2 weeks prior to registration','Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception','HIV positive with CD4 count < 200 cells/microliter; note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter prior to registration; note also that HIV testing is not required for eligibility for this protocol','Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90)','Prior liver transplant','PRIOR TO STEP TWO RANDOMIZATION:','Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment'
NCT03216499,https://www.clinicaltrials.gov/ct2/show/record/NCT03216499?term=NCT03216499&rank=1,'Patients must have histologically confirmed glioblastoma that is progressive or recurrent following radiation therapy and temozolomide according to the Response Assessment in Neuro-Oncology (RANO) criteria with:\r\n* New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids\r\n* Increase by >= 25% in the sum of the products of perpendicular diameters between the postradiotherapy scan with the smallest tumor measurement and a scan at least 12 weeks from completion of radiation therapy (RT) + temozolomide (TMZ), on stable or increasing doses of corticosteroids\r\n** Note: clinical deterioration not attributable to concurrent medication or comorbid conditions is sufficient to declare progression on current treatment but not for entry onto a clinical trial for recurrence','Tumor O(6)-methylguanine-DNA-methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction, MSPCR, or quantitative polymerase chain reaction [PCR]) are acceptable','Patients must have a tumor tissue form indicating availability of archived tissue from a previous surgery for glioblastoma, completed and signed by a pathologist','Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment','Patients must be able to undergo MRI of the brain with gadolinium; patients must be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI','Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide','Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)','Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 9 g/dL','Total bilirubin =< institutional upper limit of normal','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 4 x institutional upper limit of normal','Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73m^2 for patients with creatinine levels above institutional normal','Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal','Patients must be able to provide written informed consent','Women of childbearing potential must have a negative serum pregnancy test prior to study start; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug','Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years','Patients must be able to swallow tablets','Patients receiving any other investigational agents are ineligible','Patients must not have received prior anti-VEGF therapy including bevacizumab (i.e. patients must be bevacizumab naive)','Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PT2385 are ineligible','Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol; patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of PT2385','Patients with a history of bleeding diathesis are ineligible','Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible','Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible','Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with PT2385','Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible due to potential drug-drug interactions with PT2385'
NCT03269669,https://www.clinicaltrials.gov/ct2/show/record/NCT03269669?term=NCT03269669&rank=1,'Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible','Patients must not have clinical evidence of central nervous system involvement by lymphoma; if performed, any laboratory or radiographic tests performed to assess central nervous system (CNS) involvement must be negative','Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration','Patients must have bone marrow biopsy performed within 42 days prior to registration','All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form','Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing first line bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of bendamustine; relapsed patients must not have received any intervening chemotherapy; patients must have received at least 3 cycles of bendamustine as first line therapy; (note that no minimum dose of bendamustine is required); patients who additionally received any maintenance anti-CD-20 antibody based therapy or consolidative radioimmunotherapy within 2 years of the last dose of the bendamustine therapy are eligible; involved field or involved site radiation is not considered a line of therapy; patients who previously received anthracycline based therapy are excluded; examples of eligible 1st line treatment regimens (note this list is not all inclusive):\r\n* Bendamustine rituximab x 4 cycles\r\n* Bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance\r\n* Bendamustine obinutuzumab x 3 cycles','For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registration','Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide','Patients must have blood and tissue specimens collected prior to registration and submitted for translational medicine; note that patients without adequate diagnostic specimens will not be eligible; with patient consent, residuals from the mandatory submission will be banked for future research','All patients must have a Zubrod performance status of 0, 1 or 2','Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration','Platelets >= 75,000/mcL within 28 days prior to registration','Patients must have adequate renal function as documented by a calculated creatinine clearance >= 60 mL/min, within 28 days prior to registration','Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert’s syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration','Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (=< 5 x IULN secondary to lymphoma) within 28 days prior to registration','Patients must have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 42 days prior to registration with a cardiac ejection fraction >= 45%','Patients with hepatitis B virus infection must have undetectable hepatitis B virus (HBV) on suppressive therapy and no evidence of HBV-related hepatic damage; patients with hepatitis C virus infection are eligible if complete eradication therapy has been successfully completed, and there is no detectable hepatitis C virus (HVC) or related hepatic damage; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria:\r\n* Patient must have no history of acquired immune deficiency syndrome (AIDS)-related complications, other than a history of low CD4+ T-cell count (< 200/mm3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low\r\n* Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia\r\n* Patient must have serum HIV viral load of < 200 copies/mm^3\r\n* Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy; (recommend a regimen of the integrase inhibitor dolutegravir combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine)\r\n* Protease inhibitors and once daily formulations containing cobicistat are NOT allowed\r\n* Stavudine and zidovudine (AZT) are NOT allowed','Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients must also be willing to receive pneumocystis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamidine, in the event that they are randomized to TGR-1202; patients unable or unwilling to take any listed prophylaxis are NOT eligible','Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202; patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer)','No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years','Patients must have a complete history and physical examination within 28 days prior to registration','Patients must have the following components of Follicular Lymphoma International Prognostic Index (FLIPI) available from diagnosis, and collected again at time of registration:\r\n* Age\r\n* Lactate dehydrogenase (LDH)\r\n* Number of nodal groups involved\r\n* Serum or plasma hemoglobin \r\n* Ann Arbor stage\r\nAdditionally, patients must have beta-2-microglobulin collected at time of registration','Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal or post ovulation methods] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: 1) has achieve menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT03018249,https://www.clinicaltrials.gov/ct2/show/record/NCT03018249?term=NCT03018249&rank=1,'Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration; central pathology review will be required as part of the study but not for registration purposes','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1);\r\n* Further protocol-specific assessments','The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment','Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration','A formalin-fixed, paraffin-embedded tumor block (or 16 unstained sections [charged, 4 um]) of the biopsy or curettage must be submitted along with the corresponding pathology report; patients without such material, but willing to undergo repeat biopsy or curettage, are eligible; repeat biopsy must occur after consent but prior to randomization','Platelets >= 100,000/ul','Granulocytes (ANC) >= 1,500/mcl','Creatinine =< 1.6 mg/dl','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal','Bilirubin within institutional normal limits','The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry','Any patients of childbearing potential must have a negative pregnancy test','Patients with predominant (> 30%) non-endometrioid histology (such as serous, clear cell, or carcinosarcoma)','Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowed','Patients with ECOG performance grade of 3 or 4','Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders','Patients who have previously received systemic, radiation or other treatment for uterine cancer','Patients for whom a formalin-fixed, paraffin-embedded tumor block (or 16 unstained sections [charged, 4 um]) of the biopsy or curettage are unavailable and patient is unwilling to undergo repeat biopsy or curettage','Patients must not have previously received a histone deacetylase (HDAC) inhibitor in a clinical trial setting (entinostat, romidepsin, belinostat, panobinostat, vorinostat)','Patients must not be currently taking or have ever taken vorinostat (Zolinza, Merck), panobinostat (Farydak, Novartis) or romidepsin (Istodax, Gloucester Pharmaceuticals)'
NCT03033576,https://www.clinicaltrials.gov/ct2/show/record/NCT03033576?term=NCT03033576&rank=1,'Patients must have pathologically confirmed melanoma that is either stage IV or unresectable stage III; patients may have primaries of cutaneous, mucosal or unknown origin; patients with uveal (ocular) primary are not eligible','Patients must have measurable disease per RECIST 1.1; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; if the only measurable disease is cutaneous or subcutaneous, lesions must be at least 10 mm in greatest dimension and able to be serially recorded using calipers and photographs; tests used to assess non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form','Patients with central nervous system (CNS) metastases must have all lesions adequately treated with stereotactic radiation therapy, craniotomy, gamma knife therapy, or whole brain radiotherapy, with no subsequent evidence of CNS progression; patients must not have required steroids for at least 14 days prior to registration','Patients must have had prior treatment with anti-PD1 or anti-PD-L1 agents and had documented disease progression either while on these agents or after stopping therapy with these agents without intervening therapy; patients must have discontinued anti-PD-1 or anti-PD-L1 therapy at least 21 days prior to registration','Patients must not have achieved a confirmed partial or complete response to the anti-PD-1 or anti-PD-L1 agents prior to progression','Patients must not have had systemic therapy, excluding anti-PD-1 or anti-PD-L1 agents, within 21 days prior to registration','Patients must not have had prior radiation therapy within 14 days prior to registration','Patients must not have had:\r\n* Prior treatment with ipilimumab or other CTLA-4 antagonists\r\n* Systemic therapy between progression on the anti-PD-1 or anti-PD-L1 agents and registration\r\n* Note: Systemic therapy (including BRAF-targeting agents) prior to anti-PD-1 or anti-PD-L1 therapy is allowed','Patients must not be planning to require any additional form of systemic anti-tumor therapy while on protocol treatment','Patients must have Zubrod performance status of =< 2','Patients must have complete history and physical examination within 28 days prior to registration','Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration','Hemoglobin >= 8 g/dL within 28 days prior to registration','Platelets >= 100,000/mcL within 28 days prior to registration','Total bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s syndrome) within 28 days prior to registration','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 5 x IULN within 28 days prior to registration','Serum creatinine =< 2.0 x IULN within 28 days prior to registration','Patients with a known history of human immunodeficiency virus (HIV) must have CD4 count >= institutional lower limit of normal within 28 days prior to registration','Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration','Patients must not have an active infection requiring systemic therapy at time of registration','Patients must not have organ allografts','Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to registration; inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease','Patients must not have a history of immune-mediated pneumonitis or colitis that required interruption of therapy or treatment of steroids','Patients with a known history of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications, or with a clinical history suggestive of the above must have an electrocardiography (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment','Patients with new symptoms of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), or exposure to cardiotoxic medications must have a cardiology consultation, creatinine phosphokinase (CPK), and troponin testing at prestudy and as clinically indicated','No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years','Patients must not be pregnant or nursing; females of reproductive potential must have negative serum pregnancy test within 2 days prior to registration and agree to use an effective contraceptive method throughout the study and for 5 months after completion of protocol treatment; a woman is considered to be of “reproductive potential” if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, “effective contraception” also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; if at any point a previously celibate patient chooses to become heterosexually active during or within 5 months after protocol treatment, she is responsible for beginning effective contraceptive measures','Males who are sexually active with women of reproductive potential must have agreed to use birth control throughout the study and for 7 months after completion of protocol treatment; in addition to routine contraceptive methods, “effective contraception” also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); if at any point a previously celibate patient chooses to become heterosexually active during or within 7 months after completion of protocol treatment, he is responsible for beginning effective contraceptive measures','Patients must be offered the opportunity to submit archival tissue for translational medicine; patients must also be willing to undergo biopsies and submit fresh tissue and blood for translational medicine','Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines','As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'
NCT03377556,https://www.clinicaltrials.gov/ct2/show/record/NCT03377556?term=NCT03377556&rank=1,'Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)','Patients must be assigned to S1400G; S1400G biomarker eligibility defined as homologous recombination repair deficiency (HRRD) positive is as follows\r\n* Biomarker-positive group\r\n** HRRD by FMI\r\n*** Homologous recombination repair deficiency by Foundation Medicine Inc., criteria\r\n* Alteration type\r\n** Truncating mutation, frameshift deletions, indels missense and nonsense mutations predicted to have functional consequence in any of the specified genes\r\n* Eligible alteration\r\n** Mutation in any one of the following critical HRR pathway genes: ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF, FANCM, NBN (NBS1), PALB2, RAD51, RAD51B (RAD51L1), RAD54L, RPA1','Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib [BMN 673]) as its primary pharmacology','Patients must have achieved stable disease, a partial response, or a complete response at their first disease assessment after initiating first-line platinum-based chemotherapy; patients determined to have progressed (in the opinion of the treating physician) at their first disease assessment are not eligible','Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (BMN 673) (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease); patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis (within 12 months of sub-study registration)','Patients must be able to take oral medications; patients must be able to swallow capsules whole without crushing or altering them in any way','Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors, P-gp inducers, or breast cancer resistance protein (BCRP) inhibitors','Patients must agree to have blood specimens submitted for pharmacokinetic analysis'
NCT03067181,https://www.clinicaltrials.gov/ct2/show/record/NCT03067181?term=NCT03067181&rank=1,'Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be < 50 years of age at enrollment','Standard risk 1: Patient must be < 11 years of age at enrollment','Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment','Newly diagnosed patients must have histologic verification of a primary extracranial germ cell tumor in any of the categories outlined; elevation of serum tumor markers without histologic confirmation is not sufficient for entry on the trial\r\n* NOTE: for low risk patients, materials for rapid surgical central review must be sent within 7 days of study enrollment','Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma, (no pathological evidence of mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; age (years) < 50','Low risk stage I MCGT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 50','Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 11','Standard risk 2 (SR2)\r\n* Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) >= 11 and < 25\r\n* Site: testicular; stage: COG stage II-IV, AJCC stage II, III, International Germ Cell Consensus Classification (IGCCC) good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); tumor markers: for IGCCC good risk: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 1.5 x normal; age (years) >= 11 and < 25\r\n* Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed) age (years) >= 11 and < 25','Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2','A serum creatinine based on age/gender as follows: (mg/dL)\r\n* 1 month to < 6 months male: 0.4 female: 0.4\r\n* 6 months to < 1 year male: 0.5 female: 0.5\r\n* 1 to < 2 years male: 0.6 female: 0.6\r\n* 2 to < 6 years male: 0.8 female: 0.8\r\n* 6 to < 10 years male: 1 female: 1\r\n* 10 to < 13 years male: 1.2 female: 1.2\r\n* 13 to < 16 years: male: 1.5 female: 1.4\r\n* >= 16 years male: 1.7 female: 1.4','Total bilirubin =< 1.5 x upper limit of normal (ULN) for age','Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L)','No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication or determination; pulmonary function tests (PFTs) are not required','Eligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument \r\nNote: participants in group 1 will not receive protocol-directed therapy','>= 11 and < 25 years old at enrollment','Able to fluently speak and read English','Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor','Followed for cancer or survivorship care at one of the following institutions: \r\n* Dana Farber/Harvard Cancer Center\r\n* Hospital for Sick Children\r\n* Children’s Hospital of Eastern Ontario\r\n* Oregon Health and Science University\r\n* Seattle Children’s Hospital\r\n* Yale University','Has experienced prior or ongoing hearing impairment due to chemotherapy or radiotherapy as defined by one of the following: \r\n* Society of Pediatric Oncology (SIOP) grade 1 hearing loss\r\n* Subjective (patient-reported) hearing difficulties\r\n* Subjective (patient-reported) tinnitus','Patients with any diagnoses not listed including:\r\n* Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\r\n* Pure dysgerminoma and pure seminoma\r\n* Pure mature teratoma\r\n* Pure immature teratoma COG stage I with alpha-fetoprotein (AFP) >= 1000 ng/mL\r\n* Pure immature teratoma COG stage II - IV or FIGO stage IC to IV\r\n* Poor risk disease (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or\r\n* Primary central nervous system (CNS) germ cell tumor','Patients must have had no prior systemic therapy','Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)','SR1 and SR2 patients:','Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential','Lactating females who plan to breastfeed their infants','Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation'
NCT03180502,https://www.clinicaltrials.gov/ct2/show/record/NCT03180502?term=NCT03180502&rank=1,'STEP 1 REGISTRATION','Tumor tissue must be available for submission for central pathology review','Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma','Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories and be uploaded prior to Step 2 registration','Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within 60 days prior to registration\r\n* Magnetic resonance imaging (MRI) of the brain with contrast within 30 days prior to registration','Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages','The patient or a legally authorized representative must provide study-specific informed consent prior to study entry','History and physical exam, and Karnofsky performance status of >= 70 within 30 days prior to registration','Absolute neutrophil count (ANC) >= 1,500 cells/mm^3','Platelets >= 100,000 cells/mm^3','Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)','Bilirubin =< 1.5 upper limit of normal (ULN)','Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN','CD4 lymphocyte count is highly encouraged','Blood urea nitrogen (BUN) < 30mg/dl','Serum creatinine < 1.5 mg/dl','Women of childbearing age must have a negative serum pregnancy test within 14 days prior to registration','Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning and must be 30 days prior to the start of radiation therapy; enrolling sites are not mandated although highly encouraged to obtain thin-slice (< 1.5 mm) 3 dimensional (D) axial T2/FLAIR and T1 pre and post contrast sequences for planning purposes','Patients must be able to swallow capsules','Definitive clinical or radiologic evidence of metastatic disease; if applicable','Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity or cervix are permissible)','Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist','Prior chemotherapy or radiotherapy for any brain tumor','Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I)','Definitive evidence of multifocal disease','Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)','Patients with infra-tentorial tumors are not eligible','Prior history of neurologic or psychiatric disease believed to impact cognitive function','The use of memantine during or following radiation is NOT allowed','Severe, active co-morbidity defined as follows:\r\n* Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment\r\n* Transmural myocardial infarction within the last 6 months prior to registration; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)\r\n* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration\r\n* Serious and inadequately controlled arrhythmia at step 2 registration\r\n* Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol\r\n* Any other severe immunocompromised condition\r\n* Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity\r\n* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)\r\n* Any other major medical illnesses or psychiatric treatments that in the investigator’s opinion will prevent administration or completion of protocol therapy','Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction); note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia','Patients known to have hypersensitivity to dacarbazine (DTIC) are not eligible','PRIOR TO STEP 2 REGISTRATION','Histologically proven diagnosis of supratentorial, World Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation confirmed by central review','The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidiata RAVE System for evaluation by Dr. Wefel; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the research associate (RA) to proceed to step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors)','Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration','Financial clearance for proton therapy treatment prior step 2 registration'
NCT03148275,https://www.clinicaltrials.gov/ct2/show/record/NCT03148275?term=NCT03148275&rank=1,'Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; baseline imaging must be obtained within 30 days of day 1 of study','Patients must have histologically confirmed epithelioid hemangioendothelioma which is metastatic or locally advanced (unresectable)','Patients must have evidence of disease progression per RECIST 1.1 prior to enrollment or have evidence of cancer-related pain requiring symptom management with narcotic analgesics','Patients previously untreated or treated with drug therapy for epithelioid hemangioendothelioma (EHE) are eligible; there is no limit on the number of prior regimens used to be eligible','Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)','Life expectancy of greater than 6 months','Able to swallow orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or small bowel','All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5) grade =< 1 (except alopecia) at the time of enrollment','Absolute neutrophil count (ANC) >= 1 x 10^9/L within 30 days of day 1 of study','Hemoglobin >= 9 g/dL, patients may receive transfusion to meet criterion within 30 days of day 1 of study','Platelets >= 75 x 10^9/L within 30 days of day 1 of study','Albumin >= 2.5 g/dL within 30 days of day 1 of study','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert’s disease are eligible to participate in the study','Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN within 30 days of day 1 of study','Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min within 30 days of day 1 of study','Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 30 days of day 1 of study','Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately','Human immunodeficiency virus (HIV)-patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, however HIV-positive patients must meet the following criteria:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based test','Prior systemic therapy with a MEK inhibitor','History of another malignancy\r\n* Exception: patients who have been disease-free for 3 years or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements specified above','History of interstitial lung disease or pneumonitis requiring supplemental oxygen or treatment with oral or intravenously administered corticosteroids','Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity (e.g. doxorubicin), biologic therapy, or immunotherapy within 21 days prior to enrollment and/or daily or weekly chemotherapy (e.g. sunitinib, sorafenib and pazopanib) without the potential for delayed toxicity within 14 days prior to enrollment','Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study','Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression','Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO)','Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)','History or current evidence/risk of retinal vein occlusion (RVO)','History or evidence of cardiovascular risk including any of the following:\r\n* LVEF < LLN (lower limit of normal range)\r\n* A QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec\r\n* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n* History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Treatment-refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy\r\n* Patients with intra-cardiac defibrillators\r\n* Known cardiac metastases','Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)','Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures','The study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)','Inability to comply with protocol-required procedures'
NCT03233204,https://www.clinicaltrials.gov/ct2/show/record/NCT03233204?term=NCT03233204&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621H based on the presence of an actionable mutation','Patients must have a body surface area >= 0.65 m^2 at enrollment','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age\r\n* Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131iodine [I]-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to olaparib, veliparib, niraparib, rucaparib, talazoparib or other poly adenosine diphosphate ribose polymerase inhibitors (PARPi)','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts in (may receive platelet or packed red blood cells [pRBC] transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female\r\n* Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female\r\n* Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female\r\n* Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female\r\n* Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female\r\n* Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female','Patients with solid tumors: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Patients with solid tumors: serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)','Patients with solid tumors: serum albumin >= 2 g/dL','Activated partial thromboplastin time (aPTT) =< 1.5 x ULN','International normalized ratio (INR) =< 1.5','Patients must be able to swallow intact tablets','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; women of child-bearing potential and their partners should agree to use two (2) highly effective forms of contraception throughout study participation and for at least one (1) month after the last dose of olaparib; male study participants should avoid fathering a child or donating sperm during the study and for three (3) months after the last dose of olaparib','Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A/CYP3A4 agents: patients who are currently receiving drugs that are strong and moderate inducers or inhibitors of CYP3A or CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 21 days prior to enrollment to the end of the study','Patients who have an uncontrolled infection are not eligible','Patient who are known to be serologically positive for human immunodeficiency virus (HIV)','Patients with known active hepatitis (i.e. hepatitis B or C)','Patients who have received a prior solid organ transplantation are not eligible','Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to enrollment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days','Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T) syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (asymptomatic carriers are acceptable)','Major surgery must not have occurred within 2 weeks prior to enrollment and patients must have recovered from any effects of any major surgery','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03206047,https://www.clinicaltrials.gov/ct2/show/record/NCT03206047?term=NCT03206047&rank=1,'Women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with platinum-resistant disease (defined as having relapsed within 6 months of last platinum-containing regimen because we would like to include both primary and secondary resistance); patients are allowed to have had more than 2 prior cytotoxic treatment regimens; all patients should have received standard of care agents, which confer clinical benefit','Presence of biopsiable disease and patient able to undergo pre-treatment and on-treatment biopsy','Tissue available from primary and/or recurrent disease to evaluate tumor expression of NY-ESO-1 or PDL1 by immunohistochemistry (IHC) and/or reverse transcriptase-polymerase chain reaction (RT-PCR), and for measurement of DNA methylation','No requirement for tumor expression of NY-ESO-1','Life expectancy > 6 months as assessed by study physician','Eastern Cooperative Oncology Group (ECOG) performance status =< 2','Have been informed of other treatment options','Have measurable disease outside of biopsy site present per immune related (ir)RECIST criteria','Patients may have received previous NY ESO 1 vaccine therapy; patients who received bevacizumab or other experimental therapies are eligible for enrollment provided they have discontinued therapy (at least 4 weeks) prior to randomization and recovered from toxicities to less than grade 2','Leukocytes >= 2,500/mcL','Absolute neutrophil count >= 1,500/mcL','Platelets >= 100,000/mcL','Hemoglobin >= 10 g/dL','Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)','Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x ULN (AST and/or ALT =< 3 x ULN for patients with liver involvement)','Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)','Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault','International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN','Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately','Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure','Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation','Patients who have had chemotherapy or radiotherapy including complementary and alternative medicine treatments (CAMs) within 4 weeks prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier','Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents\r\n* Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:\r\n** Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose\r\n** No history of severe immune-related adverse effects from anti-CTLA-4 (NCI CTCAE grade 3 and 4)','Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1','Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day 1','Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed','Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed','Concomitant systemic treatment with chronic use of anti-histamine or non-steroidal anti-inflammatory drugs and other platelet inhibitory agents and patients on oral anticoagulant (e.g. warfarin)','Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded','Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies','History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins','History of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in this study','Subjects who have received prior therapy with hypomethylating agents (5-azacytidine, decitabine, SGI-110)','Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study','Lack of ability of a patient for immunological and clinical follow-up assessment','Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator’s opinion will prevent completion of protocol therapy or follow-up','Pregnant or nursing female patients are excluded from this study','Unwilling or unable to follow protocol requirements','Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug. (i.e., any significant medical illness or abnormal laboratory finding that would increase the patient’s risk by participating in this study)','Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)','History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)','History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted','Patients with active tuberculosis (TB) are excluded','Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia','Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1','Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible','Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study','Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\r\n* Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study and until 5 months after the last dose of atezolizumab','Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements','Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:\r\n* A stable regimen of highly active anti-retroviral therapy (HAART)\r\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\r\n* A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests','Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab'
NCT03233191,https://www.clinicaltrials.gov/ct2/show/record/NCT03233191?term=NCT03233191&rank=1,'Women of childbearing potential must not be known to be pregnant or lactating','Patients must be scheduled for, or have intent to schedule, a screening mammogram','Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol','Patients must be willing and able to provide a written informed consent','Patients must not have symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam; patients with breast pain are eligible as long as other criteria are met','Patients must not have had a screening mammogram within the last 11 months prior to date of randomization','Patients must not have previous personal history of breast cancer including ductal carcinoma in situ','Patients must not currently have breast enhancements (e.g., implants or injections)','ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK','To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:\r\n* Patients are pre-menopausal; OR\r\n* Post-menopausal aged 45-69 with any of the following three risks factors:\r\n** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or\r\n** Family history of breast cancer (first degree relative with breast cancer), or, participant positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or\r\n** Currently on hormone therapy; OR\r\n* Post-menopausal ages 70-74 with either of the following two risk factors:\r\n** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or\r\n** Currently on hormone therapy','Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter','All other postmenopausal women are eligible for inclusion in the biennial screening regimen','For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND for whom a prior mammogram interpretation is not available, breast density will be determined by the radiologist’s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic 2D portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population','Breast density will be determined by prior mammography reports, when available, or by radiologist review of prior imaging; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report'
NCT03213652,https://www.clinicaltrials.gov/ct2/show/record/NCT03213652?term=NCT03213652&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F based on the presence of an actionable mutation','Patients must have a body surface area >= 0.5 m^2 at enrollment','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age\r\n* Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >=14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or','A serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female\r\n* Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female\r\n* Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female\r\n* Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female\r\n* Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female\r\n* Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Patients must be able to swallow intact capsules','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib','Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study\r\n** Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03220035,https://www.clinicaltrials.gov/ct2/show/record/NCT03220035?term=NCT03220035&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621G based on the presence of a BRAF V600 mutation','Patients must have a body surface area >= 0.37 m^2 at enrollment while the 120 mg strength tablet supply is available; patients < 0.73 m^2 must follow the dosing nomogram; patients >= 0.73 m^2 at enrollment must follow the dosing nomogram','Patients enrolled after the drug supply of the 120 mg strength has been exhausted must have a body surface area >= 0.73 m^2 at enrollment and follow the dosing nomogram','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease: \r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation\r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total-body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to a BRAF inhibitor (e.g. vemurafenib, dabrafenib or encorafenib)','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts in above criteria (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6\r\n* Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8\r\n* Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1\r\n* Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2\r\n* Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4\r\n* Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Corrected QT (QTc) interval =< 480 milliseconds; Note: Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause Torsades De Pointes; if possible, alternative agents should be considered; patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available','Patients must be able to swallow intact tablets','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method, for the duration of study treatment and for 6 months after the last dose of vemurafenib','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients who are currently receiving drugs that are moderate to strong inducers or inhibitors of CYP3A4 are not eligible; moderate to strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed','Patients who are currently receiving drugs that are inhibitors or inducers of p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G, member 2 (ABCG2 [BCRP]) are not eligible','Patients with known active cutaneous squamous cell carcinoma (includes keratoacanthoma or mixed keratoacanthoma subtype) are not eligible; patients who have fully excised lesions with dermatologic confirmation of absence of disease are eligible','Patients with low grade glioma patients (World Health Organization [WHO] grades I and II) are not eligible','Patients who have an uncontrolled infection are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03213665,https://www.clinicaltrials.gov/ct2/show/record/NCT03213665?term=NCT03213665&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621C based on the presence of an actionable mutation','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease:\r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation\r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have had prior exposure to tazemetostat or other inhibitor(s) of EZH2','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: male: 0.6 mg/dL; female: 0.6 mg/dL \r\n* Age 2 to < 6 years: male: 0.8 mg/dL; female: 0.8 mg/dL\r\n* Age 6 to < 10 years: male: 1 mg/dL; female: 1 mg/dL\r\n* Age 10 to < 13 years: male: 1.2 mg/dL; female: 1.2 mg/dL\r\n* Age 13 to < 16 years: male: 1.5 mg/dL; female: 1.4 mg/dL\r\n* Age >= 16 years: male: 1.7 mg/dL; female: 1.4 mg/dL','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Corrected QT (QTc) interval =< 480 milliseconds','Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled','Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [V] 4.0) resulting from prior therapy must be =< grade 2','International normalized ratio (INR) =< 1.5','For subjects with CNS involvement (primary tumor or metastatic disease): Subjects must not have any active bleeding, or new intratumoral hemorrhage of more than punctate size on screening MRI or known bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment','Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid','Patients who are currently receiving another investigational drug are not eligible','Patients who are currently receiving other anti-cancer agents are not eligible','Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; Note: Dexamethasone for CNS tumors or metastases, on a stable dose, is allowed','Patients who have an uncontrolled infection are not eligible','Patients who have received prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03213678,https://www.clinicaltrials.gov/ct2/show/record/NCT03213678?term=NCT03213678&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621D based on the presence of an actionable mutation; note that treatment assignment may be to primary cohort A for patients with TSC1 or TSC2 loss of function mutations, primary cohort B for patients with other PI3K/MTOR pathway mutations, a histology specific biomarker positive expansion cohort if the criteria to open such a cohort are met, or a biomarker negative expansion cohort if the criteria to open such a cohort are met','Patients accruing to dose level 1 must have a body surface area >= 0.52 m^2 at the time of study enrollment; patients accruing to dose level 2 must have a body surface area >= 0.37 m^2 at the time of study enrollment; patients accruing to dose level -1 must have a body surface area >= 0.75 m^2 at the time of study enrollment','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n** Bone lesions without an associated soft tissue mass >= 10 mm in greatest diameter; bone lesions with an associated soft tissue mass >= 10 mm in greatest diameter imaged by computed tomography (CT) or MRI are considered measurable','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY3023414\r\n* Patients must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor)','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6\r\n* Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8\r\n* Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1\r\n* Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2\r\n* Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4\r\n* Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Patients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw','Patients must have a serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; if an initial random draw (i.e. non-fasting) is out of range, it is acceptable to repeat this test as a fasting draw','Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled','Nervous system disorders (by Common Terminology Criteria for Adverse Events version 5.0 [CTCAE V 5.0]) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible','Corrected QT (QTc) interval =< 480 milliseconds','Patients must be able to swallow intact tablets','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while receiving study treatment and for 3 months after the last dose of LY3023414','Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial','Patients who have an uncontrolled infection are not eligible','Patients who have insulin dependent diabetes are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients with subependymal giant cell astrocytomas (SEGAs) are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03213691,https://www.clinicaltrials.gov/ct2/show/record/NCT03213691?term=NCT03213691&rank=1,'Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621E based on the presence of an actionable mutation\r\n* Note: patients with BRAF V600 actionable mutations of interest (aMOIs) will be preferentially assigned to APEC1621G (vemurafenib) if that study is open and they are otherwise eligible for it','Patients must have a body surface area >= 0.5 m^2 at enrollment','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: the following do not qualify as measurable disease: \r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iodine I 131 metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to selumetinib (AZD6244 hydrogen sulfate)','For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)','Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6\r\n* Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8\r\n* Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1\r\n* Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2\r\n* Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4\r\n* Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4','Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)','Serum albumin >= 2 g/dL','Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study','A blood pressure (BP) =< the 95th percentile for age, height, and gender measured; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP; patients with hypertension controlled on antihypertensive medications will be allowed if otherwise eligible','Patients must be able to swallow intact capsules whole','All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines','Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment; males with sexual partners who are pregnant or who could become pregnant (ie, women of child-bearing potential) should use effective methods of contraception for 12 weeks after completing the study to avoid pregnancy and/or potential adverse effects on the developing embryo','Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study\r\n* CYP2C19 agents: patients who are currently receiving drugs that are strong CYP2C19 inducers (eg, rifampin, ritonavir) or inhibitors (eg., fluoxetine, fluvoxamine, ticlopidine) are not eligible','Patients who have an uncontrolled infection are not eligible','Patients with known significant ophthalmologic conditions (uncontrolled glaucoma, history of retinal vein occlusion or retinal detachment, excluding patients with longstanding findings secondary to existing conditions) are not eligible','Patients with low grade glioma are not eligible','Patients who have received a prior solid organ transplantation are not eligible','Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible'
NCT03155620,https://www.clinicaltrials.gov/ct2/show/record/NCT03155620?term=NCT03155620&rank=1,'ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses [e.g. Langerhans cell histiocytosis (LCH), juvenile xanthogranuloma (JXG), histiocytic sarcoma], and central nervous system [CNS] tumors) are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-HCG','ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have a formalin fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto pediatric MATCH for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas)','ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621 screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol; patients must be enrolled onto a subprotocol within 8 weeks (56 days) of treatment assignment','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice\r\n* Note: The following do not qualify as measurable disease:\r\n** Malignant fluid collections (e.g., ascites, pleural effusions)\r\n** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n** Elevated tumor markers in plasma or CSF \r\n** Previously radiated lesions that have not demonstrated clear progression post radiation \r\n** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:\r\n* Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n** Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n*** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n** Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n** Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n** Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n** Stem cell infusions (with or without TBI):\r\n*** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of GVHD\r\n*** Autologous stem cell infusion including boost infusion: >= 42 days\r\n** Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n** X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n** Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6\r\n* Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8\r\n* Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1\r\n* Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2\r\n* Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4\r\n* Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: serum glutamate pyruvate transaminase (SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned','GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols','GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method','GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications\r\n* Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible','GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible','GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ transplant are not eligible','GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols'
NCT03213704,https://www.clinicaltrials.gov/ct2/show/record/NCT03213704?term=NCT03213704&rank=1,'APEC1621SC: Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621A based on the presence of an actionable mutation','Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG)+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice; Note: The following do not qualify as measurable disease: \r\n* Malignant fluid collections (e.g., ascites, pleural effusions)\r\n* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma\r\n* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma\r\n* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n* Previously radiated lesions that have not demonstrated clear progression post radiation \r\n* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1','Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score','Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\t\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have el