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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 | true | 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 | true | 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 | true | 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 | true | No previous chemotherapy or radiation therapy | true | Corticosteroids should not be used during chemotherapy administration as an antiemetic | true | 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) | true | 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 | true | 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 | true | No other experimental therapy is permitted while on study | true | 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) | true | Total bilirubin < 1.5 x upper limit of normal (ULN) for age | true | 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 | true | Absolute neutrophil count (ANC) >= 1,000/uL | true | Platelets >= 100,000/uL (untransfused) | true | Hemoglobin >= 8 g/dl (may be transfused) | true | 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 | true | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 1 | NCT00632853 | https://www.clinicaltrials.gov/ct2/show/record/NCT00632853?term=NCT00632853&rank=1 | Histologically or cytologically confirmed small cell lung cancer | true | 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 | true | 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 | true | 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 | true | No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for small cell lung cancer (SCLC) | true | No prior mediastinal or thoracic radiotherapy | true | Patients with complete surgical resection of disease are not eligible | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2 | true | No patients that are known to be pregnant or nursing | true | Granulocytes >= 1,500/ul | true | Platelet count >= 100,000/ul | true | Total bilirubin =< 1.5 x upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 x ULN | true | Serum creatinine =< 1.5 times ULN OR calculated creatinine clearance >= 70 mL/min | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 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 | true | 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 M�llerian epithelial adenocarcinoma | true | 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 | true | 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) | true | Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 | true | Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen | true | 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.) | true | 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) | true | Patients must complete all pre-entry assessments | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | 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 | true | Patients with GOG performance grade of 3 or 4 | false | 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 | false | 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) | false | Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma | false | 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 | false | Patients with a life expectancy of less than one year | false | Patients with body mass index (BMI) < 20 kg/m^2 | false | Vegan vegetarians | false | Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue | false | Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2 | true | Patients must have an estimated survival greater or equal to 3 months | true | 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 | true | Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1 | true | Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min | true | Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1) | true | Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1) | true | Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1) | true | Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1 | true | Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry | true | Patients who have met the pre-entry requirements | true | Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization | true | Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes | false | Patients who have received previous vaginal, pelvic, or abdominal irradiation | false | Patients who received chemotherapy directed at the present recurrence | false | Patients with septicemia or severe infection | false | Patients who have circumstances that will not permit completion of this study or the required follow-up | false | Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields | false | 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 | false | 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 | false | 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 | false | Patients with history of active collagen vascular disease | false | Patients with GOG performance grade of 3 or 4 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | true | Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI) | true | Any stage for mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL) | true | 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) | true | Human immunodeficiency virus (HIV) negative | true | Not pregnant or nursing | true | 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 | true | Bilirubin < 1.5 mg/dl | true | Absolute neutrophil count (ANC) > 1000 unless impairment is due to lymphoma or immune-mediated mechanism caused by lymphoma | true | Platelets > 100,000 unless impairment is due to lymphoma or immune-mediated mechanism caused by lymphoma | true | 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% | true | No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety | true | No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer | true | Ability to give informed consent | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 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 | true | 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 | true | 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 | true | Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines | true | 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) | true | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 12 weeks | true | Absolute neutrophil count (ANC) >= 1,500/mcL | true | Platelets (PLT) >= 100,000/mcL | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN); if liver metastases are present, =< 5 x ULN | true | Bilirubin =< 1.5 x ULN | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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) | true | 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 | false | Patients may not have received any other investigational agents within 4 weeks of study entry | false | 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) | false | 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 | false | Patients with uncontrolled seizures | false | 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 | false | Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen) | false | 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 | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888 | false | Patients who are unable to reliably tolerate and/or receive oral medications | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 6 | 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 | true | 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 | true | 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) | true | 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 | true | Absolute neutrophil count >= 1500/mcL | true | Hemoglobin >= 9.0 g/dL | true | Platelets >= 100,000/mcL | true | Total bilirubin =< 1.5 x the upper limit of normal (ULN) | true | 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 | true | Creatinine =< 1.5 x ULN | true | International normalized ratio (INR) =< 1.4 unless receiving therapeutic doses of coumadin | true | Partial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN) | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 | true | Ability to provide informed consent | true | Willingness to return to enrolling institution for follow up | true | Life expectancy >= 12 weeks | true | 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 | true | Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential only | true | Able to swallow and absorb the medication | true | Known standard therapy for the patient�s disease that is potentially curative or definitely capable of extending life expectancy | false | Prior treatment with a PARP inhibitor or topotecan | false | 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 | false | 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 | false | Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment | false | New York Heart Association classification III or IV | false | 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 | false | 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 | false | 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 | false | Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive | false | Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm | false | 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 | false | History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 7 | 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 | true | 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 | true | 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 | true | Zubrod performance status 0-1 | true | Absolute granulocyte count (AGC) >= 1,500/mm� | true | Platelet count >= 100,000/mm� | true | Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) | true | Total bilirubin < 2 x institutional upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN | true | Serum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula | true | Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential | true | 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 | true | Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control | true | 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 | true | 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 | false | 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 | false | Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Prior allergic reaction to cetuximab | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 8 | NCT00887146 | https://www.clinicaltrials.gov/ct2/show/record/NCT00887146?term=NCT00887146&rank=1 | PRE-REGISTRATION INCLUSION CRITERIA: | true | 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 | true | 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 | true | REGISTRATION INCLUSION CRITERIA: | true | 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 | true | 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 | true | 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 | true | 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 | true | Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration | true | Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration | true | Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration | true | Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration | true | Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration | true | Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only | true | Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance) | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 | true | Written informed consent | true | 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 | true | 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 | true | 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 | false | 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 | false | 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 | false | Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study | false | 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 | false | 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 | false | Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm | false | 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 | false | History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias | false | Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 9 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Participant willing to provide a written informed consent | true | Patient who is pregnant and/or breastfeeding | false | Patient with sinonasal carcinoma | false | Patient with tumors in the head and neck that are not SCC | false | Patient with salivary gland malignancies | false | Patient with thyroid cancers | false | Patient with advanced skin cancers | false | Patient with nasopharyngeal carcinoma | false | 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 | false | Patient not a candidate for surgery (neck dissection) because of an underlying medical condition | false | Patient who weighs more than the weight limit for the PET table | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 10 | 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) | true | 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) | true | 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) | true | Zubrod performance status 0-1 | true | Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 | true | Platelets >= 100,000 cells/mm^3 | true | Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) | true | White blood cell count >= 4000 cells/mm^3 | true | Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry | true | Bilirubin =< 1.5 times normal 14 days prior to study entry | true | Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry | true | 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 | true | 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) | true | Patient must provide study-specific informed consent prior to study entry | true | 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) | false | Patients can not have any neuroendocrine histology in pathology | false | Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable | false | Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields | false | 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 | false | Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin | false | Patients who have gross residual disease or distant metastatic disease | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 11 | 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 | true | 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 | true | The participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy | true | 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 | true | 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 | true | 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 | true | 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 | true | Zubrod performance status =< 1 | true | White blood cell count (WBC) >= 4,000/ml | true | Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 | true | Platelets >= 100,000 cells/mm^3 | true | Hemoglobin >= 10.0 g/dL (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) | true | If the patient is to be treated with cisplatin, the serum creatinine should be =< 1.5 mg% | true | If the patient is to be treated with cisplatin, the serum bilirubin of =< 2.0 mg% | true | Glomerular filtration rate (GFR) > 25 ml/min (for patients receiving cisplatin, GFR >= 60 ml/min) | true | 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 | true | Patient must be able to provide study-specific informed consent prior to study entry | true | Evidence of tumor-related hydronephrosis | false | Evidence of distant metastases or histologically or cytologically proven lymph node metastases | false | Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable | false | 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 | false | Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT | false | Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside) | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Prior allergic reaction to the study drugs (cisplatin, mitomycin, fluorouracil [5FU]) involved in this protocol | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 | NCT00980460 | https://www.clinicaltrials.gov/ct2/show/record/NCT00980460?term=NCT00980460&rank=1 | Patients must be newly diagnosed with histologically-proven hepatoblastoma | true | 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 | true | Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines | true | 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 | true | 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) | true | 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 | true | Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment | true | Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy | true | 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) | true | Total bilirubin < 1.5 x upper limit of normal (ULN) for age | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN for age | true | Absolute neutrophil count (ANC) > 750/uL | true | Platelet count > 75,000/uL | true | Shortening fraction >= 27% by echocardiogram | true | 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 | true | Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L) | true | Serum cholesterol level =< 300 mg/dL (7.75 mmol/L) | true | 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 | true | 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 | true | Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled | true | Prothrombin time (PT) < 1.2 x ULN | true | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | 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 | false | 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 | false | Patients who have received any prior chemotherapy are not eligible | false | Patients who are currently receiving another investigational drug are not eligible | false | Patients who are currently receiving other anticancer agents are not eligible | false | Patients who have previously received a solid organ transplant are not eligible | false | Patients who have an uncontrolled infection are not eligible | false | Females who are pregnant or breast feeding are not eligible for this study | false | Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained | false | Males and females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method | false | Patients receiving corticosteroids are not eligible; patients must have been off corticosteroids for 7 days prior to start of chemotherapy | false | Patients who are currently receiving enzyme inducing anticonvulsants are not eligible | false | 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 | false | Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) are not eligible | false | Patients who are currently receiving angiotensin-converting enzymes (ACE) inhibitors are not eligible | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||
| 13 | 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) | true | 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 | true | 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 | true | Zubrod performance status 0 or 1 | true | 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) | true | 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 | true | 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) | true | Absolute neutrophil count (ANC) >= 1,500/mm^3 | true | Platelets >= 100,000/mm^3 | true | Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable) | true | Post resection serum cancer antigen (CA)19-9 =< 180 units/mL AND prior to any systemic treatment | true | 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) | true | 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) | true | 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) | true | Negative serum pregnancy test for women of childbearing potential within 14 days of study registration | true | 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 | true | Signed study-specific informed consent | true | Consultation, agreement, and documentation in the patient�s chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol | true | Women of childbearing potential and male participants must practice adequate contraception | true | 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 | true | 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 | false | Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy | false | 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 | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | 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 | false | Pregnant or lactating women | false | Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 14 | 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 | true | Sexually active males must be strongly advised to use an accepted and effective method of contraception | true | Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< grade 1 | true | 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 | true | Patient must not have a concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes [MDS]) | true | Patient must not have an active, uncontrolled infection | true | ADDITIONAL INDUCTION ELIGIBILITY CRITERIA: | true | 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 | true | ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if >= 70 years of age) | true | 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 | true | Patients must not have blastic transformation of chronic myelogenous leukemia | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture; those with documented CNS involvement will be excluded | true | Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (> 10^9/l) from peripheral blood | true | Patients who have received previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine will be excluded | true | Patients with known human immunodeficiency virus (HIV) infection are excluded | true | HLA typing should be performed at registration, if possible | true | Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing | true | CONSOLIDATION CRITERIA: | true | NOTE: All patients achieving CR or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit | true | NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment | true | Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi | true | Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant) | true | Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi | true | Patients must have an ECOG performance status of 0-2 | true | 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 | true | Any significant medical complications related to induction must have resolved | true | Patients must have a creatinine and AST =< grade 1 | true | MAINTENANCE CRITERIA: | true | 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 | true | 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 | true | Patients must have an ECOG performance status of 0 -2 | true | Patients must have resolved any serious infectious complications related to consolidation cycle 2 | true | Any significant medical complications related to consolidation cycle 2 must have resolved | true | 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 | true | Serum creatinine =< grade 1 | true | 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 | true | 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 | true | ALLOGENEIC TRANSPLANTATION: | true | 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�) | true | 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 | true | Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1 | true | 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 | true | Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance | true | 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 | true | Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease | true | No known hypersensitivity to Escherichia (E.) coli-derived products | true | No human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies | true | Creatinine =< grade 1 | true | Bilirubin =< grade 1\r\n* If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligible | true | AST =< grade 1 | true | ||||||||||||||
| 15 | 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] | true | 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 | true | Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 | true | Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control | true | 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 | true | Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 | true | Platelet greater than or equal to 100,000/mcl | true | Creatinine no greater than the institutional upper limits of normal | true | Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1) | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1) | true | Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) | true | Neuropathy (sensory and motor) less than or equal to CTCAE grade 1 | true | No signs of clinically significant hearing loss | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | 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 | true | 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 | true | 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 | true | Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs) | false | Patients with apparent stage I disease who have not undergone a staging procedure | false | 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 | false | Woman who are pregnant or breastfeeding | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 16 | 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 | true | 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 | true | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | 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 | false | Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible | false | No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment | false | Pregnant female patients are not eligible for this study | false | Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained | false | Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method | false | Lactating females may not participate unless they have agreed not to breastfeed a child while on this study | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 17 | 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 | true | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status 0-2 | true | 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 | true | 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 | true | Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control | true | Absolute neutrophil count (ANC) >= 1000/uL | true | Platelet count >= 100,000/uL | true | Serum creatinine =< 2 mg/dL | true | Bilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert�s disease | true | AST =< 2 x upper limit of normal | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 18 | 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 | true | 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 | true | Absolute neutrophil count (ANC) >= 1,500/mcl | true | Platelets >= 100,000/mcl | true | Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min | true | Bilirubin =< 1.5 x normal | true | Alkaline phosphate =< 3 x normal | true | Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal | true | Gynecologic Oncology Group (GOG) performance status 0, 1, 2 | true | Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery | true | Patients who have met the pre-entry requirements | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins | false | Patients with septicemia or severe infection | false | Patients with intestinal obstruction or gastrointestinal bleeding | false | Patients with postoperative fistula | false | Patients with cervix cancer who have received any previous radiation or chemotherapy | false | Patients whose circumstances do not permit completion of the study or the required follow-up | false | Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.) | false | Patients with GOG performance status of 3 or 4 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 19 | NCT01141231 | https://www.clinicaltrials.gov/ct2/show/record/NCT01141231?term=NCT01141231&rank=1 | Able to give informed consent | true | Must be able to read, write and understand English | true | Must have a diagnosis of head/neck cancer | true | 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 | true | Must have received external beam radiation with curative intent | true | Must have completed radiotherapy at least 12 months prior to entry | true | 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 | true | Have never had acupuncture for xerostomia | true | Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 | true | History of xerostomia, Sjogren�s disease or other illness known to affect salivation prior to head/neck radiation | false | Suspected or known closure of salivary gland ducts on either side | false | 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 | false | Have received any investigational new drug within the past 30 days or planning to receive such during the study period | false | Active systemic infection or skin infection at or near the acupuncture sites | false | Receiving chemotherapy during study period | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 20 | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 12 weeks | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Hemoglobin >= 8.0 g/dL | true | 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: | true | Total bilirubin =< 5 x upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 10 x ULN | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | Patients may not be receiving any other investigational agents | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study | false | Peripheral neuropathy of severity greater than grade 1 | false | Inability to take oral medications on a continuous basis | false | Evidence of bleeding diathesis | false | 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 | false | 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 | false | 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 | false | 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 | false | Patients with both hepatic and renal dysfunction will also be excluded | false | Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible | false | Active seizure or history of seizure disorder | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 21 | 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 | true | Patients must have measurable or evaluable disease | true | 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 | true | 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 | true | The Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60 %) | true | Life expectancy > 3 months | true | Absolute neutrophil count (ANC) >= 1,500/uL | true | Platelet count >= 100,000/uL | true | Total bilirubin within =< 1.5 normal institutional limits (patients with Gilbert�s syndrome with total bilirubin up to 2.5 mg/dL is allowed) | true | 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) | true | Creatinine < 1.5 x ULN OR creatinine clearance measured >= 60 mL/minute for patients with creatinine levels >= 1.5 x upper limit of normal | true | 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 | true | Breastfeeding should be discontinued if the mother is treated with indenoisoquinolines | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients receiving any other investigational agents | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 22 | 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 | true | Inoperable tumor or residual disease after resection | true | No prior chemotherapy or radiation therapy for HGG or DIPG is permitted; prior chemotherapy or radiation therapy for treatment of other malignancies is permitted | true | Able to swallow whole capsules | true | 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 | true | Absolute neutrophil count >= 1,000/mcL assessed within seven (7) days prior to the start of therapy | true | Platelets >= 100,000/mcL assessed within seven (7) days prior to the start of therapy | true | Total bilirubin < 1.5 x upper limit of normal assessed within seven (7) days prior to the start of therapy | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal assessed within seven (7) days prior to the start of therapy | true | Creatinine below age-adjusted maximum limits in the table below OR creatinine clearance >= 60 mL/min/1.73 m^2 assessed within seven (7) days prior to the start of therapy\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) | true | Females only:\r\n* Urine or serum pregnancy test negative assessed within seven (7) days prior to the start of therapy | true | No overt renal, hepatic, cardiac or pulmonary disease | true | 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 | true | 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 | true | 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 | true | Assignment of DPA to a family member or guardian should be offered to all patients 18 years of age or older | true | Signed informed consent according to institutional guidelines must be obtained | true | Patients who have had prior chemotherapy for this tumor | false | Patients with an HGG that was completely resected with good margins | false | Patients with a body surface area (BSA) =< 0.4 m^2 are excluded | false | 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 | false | Patients who have had a thromboembolic event that is not line-related are excluded | false | 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 | false | Patients with a history of toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome are excluded | false | Patients receiving any other investigational agents | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (i.e. thalidomide) | false | Patients with known hypersensitivity to anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide | false | Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | Patients identified as needing spinal radiation at diagnosis (e.g. spinal metastasis or malignant cells identified on cerebrospinal fluid [CSF] cytology) are excluded | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 23 | 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 | true | 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 | true | 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 | true | Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer | true | Patients must not have received prior chest radiation therapy for NSCLC | true | 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 | true | Patients must have Zubrod performance status 0-1 | true | 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 | true | Absolute neutrophil count >= 1,500/mcl | true | Platelets >= 100,000/mcl | true | Hemoglobin >= 9.0 g/dl | true | Total bilirubin within institutional upper limit of normal (IULN) | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN | true | 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" | true | Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula | true | 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 | true | Patients may not be planning to receive any other investigational agents | true | Patients must not have more than 10% weight loss in the past 6 months | true | 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 | true | 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 | true | 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 | true | 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) | true | Patients must not have a history of seizures | true | 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 | true | Patients must be able to swallow whole capsules | true | Prestudy history and physical must be obtained within 28 days prior to registration | true | 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 | true | 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 | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: | true | 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) | true | 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 | true | 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 | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count >= 1,500 mcl | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets >= 100,000/mcl | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin >= 9.0 g/dl | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN | true | REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1 | true | ||||||||||||||||||||||||||||||||||||||||||||
| 24 | 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 | true | 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 | true | Parent/legal guardian and child > 7 years old able to read English or Spanish | true | Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations | true | 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 | true | 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 | true | Able and willing to sign informed consent/assent | true | Signed Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization | true | Off treatment > 14 years | false | Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < 70) | false | Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease | false | Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia, or prolonged corrected QT interval (QTc) | false | History of stroke or head injury associated with loss of consciousness within 12 months of registration | false | History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or monoamine oxidase inhibitor (MAO) inhibitors within 30 days of registration | false | 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 | false | 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 | false | Participants with known hypersensitivity to modafinil, armodafinil, or any of its components | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 25 | 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 | true | B-ALL patients must have an initial white blood cell count < 50,000/uL | true | 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 | true | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met | true | 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 | false | 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 | false | B-ALL patients with testicular leukemia are not eligible for AALL0932 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 26 | 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 | true | Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist | true | 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 | true | 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) | true | Total bilirubin < 1.5 x upper limit of normal (ULN) for age | true | 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 | true | Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram | true | 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 | false | Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible | false | Patients with pathologic diagnoses other than Ewing sarcoma will be excluded | false | 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 | false | 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 | false | All patients and/or their parents or legal guardians must sign a written informed consent | false | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 27 | 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 | true | 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) | true | 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 | true | Patients must not have inflammatory breast cancer and must not have metastatic disease | true | 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 | true | 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 | true | 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 | true | Patients must have a complete history and physical examination within 28 days prior to registration | true | Patients must have a performance status of 0-2 by Zubrod criteria | true | Patients must be able to receive taxane and/or anthracycline based chemotherapy | true | Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration | true | Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents | true | 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 | true | 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" | true | 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 | true | 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) | true | 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 | true | 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 | true | STEP 2 REGISTRATION | true | Recurrence score (RS) by Oncotype DX must be =< 25 | true | 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 | true | 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) | true | 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 | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 28 | 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 | true | 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 M�llerian 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 | true | 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 | true | 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) | true | Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable) | true | Patients with a GOG Performance Status of 0, 1, or 2 | true | 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 | true | Patients who are able to complete the assessments | true | Patients who are able to comply with the anti-emetic therapy | true | Patients must have met pre-entry requirements | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | Patients who are known to be hypersensitive to aprepitant, granisetron or any of the components of the patch or to dexamethasone | false | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 29 | 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 | true | 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 | true | 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" | true | 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 | true | 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 | true | Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration | true | Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group | true | Patients must be offered the opportunity to consent to the use of specimens for future research | true | 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 | true | Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma | true | Patients must have a complete history and physical examination within 28 days prior to registration | true | Zubrod performance status 0-2 | true | 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) | true | Serum creatinine =< 2 x institutional upper limit of normal (IULN), unless due to lymphoma, within 42 day prior to registration | true | Patients must have aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x IULN, unless due to lymphoma, within 42 days prior to registration | true | Platelet count >= 100,000 cells/mcL | true | Absolute neutrophil count (ANC) >= 1,000 cells/mcL within 42 days prior to registration | true | Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration | true | 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 | true | Patients must not be known to be human immunodeficiency virus (HIV)-positive | true | 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 | true | 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" | true | 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 | true | 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 | true | SECOND REGISTRATION (STEP 2) | true | Patients must have completed 3 cycles of R-CHOP with no evidence of disease progression | true | Interim PET/CT scans must have been submitted for centralized review | true | 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 | true | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 30 | 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 | true | 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 | true | 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 | true | 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 | true | Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration | true | 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 | true | Zubrod performance status 0-1 (unless otherwise specified) | true | Within 60 days prior to registration on study: Absolute neutrophil count (ANC) >= 1,500/mm^3 | true | Within 60 days prior to registration on study: Platelets >= 100,000/mm^3 | true | 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) | true | Patient must be able to provide study specific informed consent prior to study entry | true | 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 | false | Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer | false | Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy | false | 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) | false | 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 | false | Use of finasteride within 30 days prior to registration | false | Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration | false | Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable | false | Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | Patients who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Prior allergic reaction to the hormones involved in this protocol | false | Patients status post a negative lymph node dissection are not eligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 31 | 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 | true | Participants must have measurable or evaluable disease | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Absolute neutrophil count >= 1,500/mm^3 | true | Hemoglobin (Hgb) > 9.0 g/dl | true | Platelets >= 100,000/mm^3 | true | Total bilirubin < 1.5 mg/dl | true | 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 | true | Creatinine =< 1.5 times institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2 | true | Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal | true | 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 | true | 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 | true | Patients must be able to swallow pills | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document; subjects must be willing to adhere to dose and visit schedules | true | 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 | false | 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 | false | Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen) | false | Patients who have previously received SCH727965 | false | 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 | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888 and SCH727965 | false | Patients with prior seizure history who have experienced a seizure within the three months prior to enrollment are excluded | false | Subjects with a known allergy to lidocaine | false | Subjects on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 32 | 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) | true | Patients must have measurable disease (Phase I) | true | 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) | true | 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) | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 | true | Absolute neutrophil count (ANC) >= 1200/mm^3 | true | Peripheral platelet count (PLT) >= 75,000/mm^3 | true | Hemoglobin (HgB) > 8.5 g/dL | true | Bilirubin =< 3.0 x upper limit of normal (ULN) | true | 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) | true | Creatinine =< 1.5 x ULN | true | 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 | true | Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only | true | Provide informed written consent | true | Willing to return to Alliance enrolling institution for follow-up | true | Life expectancy >= 3 months | true | 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 | false | 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 | false | Receiving any other investigational agent | false | 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 | false | Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 100 mmHg on anti-hypertensive medications) | false | 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 | false | New York Heart Association (NYHA) classification III or IV congestive heart failure | false | Received treatment with radiation therapy or investigational therapy =< 28 days prior to registration | false | 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 | false | 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 | false | HCC patients only: Cancer potentially amenable to local modalities of therapy or surgical resection (phase I) | false | Known or suspected allergy or hypersensitivity to any component of TH-302, sorafenib, or any of the sorafenib excipients | false | Any condition that severely impairs patient�s ability to swallow whole pills | false | Corrected QT (QTc) interval > 500 msec on baseline electrocardiogram (EKG) | false | Documented history of prolonged QTc interval =< 6 months prior to registration | false | Receiving any medication that has documented data or is generally accepted as having increased risk of QT prolongation and/or Torsades de Pointes | false | 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 | false | Fibrolamellar histology HCC, mixed hepatocholangiocarcinoma, hepatic sarcomas and other non-HCC primary liver tumors | false | History of lobectomy involving > 50% of lobe | false | Radioembolization within 8 weeks of day 1 dosing of sorafenib | false | PHASE II REGISTRATION - INCLUSION CRITERIA | true | 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) | true | Patients must have measurable disease; must have at least one non-nodal lesion | true | First line advanced HCC (i.e., no prior systemic therapy) | true | Child Pugh class A or B7 liver disease | true | 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 | true | Ability to receive intravenous contrast for the purpose of imaging | true | PHASE II REGISTRATION: EXCLUSION CRITERIA: | false | Cancer potentially amenable to local modalities of therapy or surgical resection | false | ||||||||||||||||||||||||||||||||||
| 33 | 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 | true | 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 | true | 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) | true | 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 | true | Able and willing to use the MEMS� TrackCap� (e.g., not using a pillbox or prescribed liquid 6MP) | true | 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 | true | Patient and parent/caregiver must speak English or Spanish | true | Patients with Down syndrome | false | Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence | false | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 34 | 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 | true | 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 | true | 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) | true | The patient must have access to a telephone and phone number where they can be reached | true | The patient and caregiver must have reading, speaking and listening comprehension of English | true | Patients with pontine glioma are not eligible | false | Patients with an estimated survival of less than one year are not eligible | false | Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible | false | 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 | false | 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 | false | 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) | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 35 | NCT01515787 | https://www.clinicaltrials.gov/ct2/show/record/NCT01515787?term=NCT01515787&rank=1 | Diagnosis of rectal adenocarcinoma | true | Radiologically measurable or clinically evaluable disease | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2 | true | 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 | true | Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon | true | 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 | true | Absolute neutrophil count (ANC) >= 1,500/mm^3 | true | Platelet count >= 100,000/mm^3 | true | Hemoglobin > 8.0 g/dL | true | Total bilirubin =< 1.5 x upper limit of normal (ULN) | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN | true | Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN | true | Creatinine =< 1.5 times ULN | true | Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only | true | 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) | true | Provide informed written consent | true | Willing to return to enrolling medical site for all study assessments | true | Clinical T4 tumors | false | Primary surgeon indicates need for abdominoperineal (APR) at baseline | false | 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) | false | Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible) | false | Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years) | false | Any prior pelvic radiation | false | 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 | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 36 | 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) | true | PROCUREMENT: Patients with life expectancy >= 6 weeks | true | PROCUREMENT: Hemoglobin (Hgb) > 8.0 (transfusions allowed) | true | PROCUREMENT: Patient able to give informed consent | true | 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) | true | TREATMENT: Patients with life expectancy >= 6 weeks | true | TREATMENT: Pulse oximetry of > 95% on room air in patients who previously received radiation therapy | true | TREATMENT: Patients with a Karnofsky/Lansky score of >= 50% | true | TREATMENT: Bilirubin =< 2 x upper limit of normal | true | TREATMNET: Aspartate aminotransferase (AST) =< 3 x upper limit of normal | true | TREATMENT: Hgb > 8.0 g/dL (transfusions allowed) | true | TREATMENT: Creatinine =< 2 x upper limit of normal for age | true | TREATMENT: Patients should have been off other investigational therapy for one month prior to entry in this study | true | TREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab | true | TREATMENT: Patient able to give informed consent | true | 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 | true | PROCUREMENT: Patients with severe intercurrent infection | false | PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw) | false | TREATMENT: Patients with severe intercurrent infection | false | TREATMENT: Patients receiving systemic corticosteroids | false | TREATMENT: Pregnant | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 37 | 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) | true | Men are excluded from this study | true | 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 | true | 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 | true | 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 | true | cN0 or cN1 disease | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 | true | Ability to complete questionnaire(s) by themselves or with assistance | true | Ability to provide written informed consent | true | 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 | true | 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) | false | 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 | false | Surgical axillary staging procedure prior to first definitive breast operation; Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted | false | Clinical or radiographic evidence of metastatic disease | false | Prior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive) | false | cNX, cN2, or cN3 disease | false | Breast implants at time of diagnosis; Note: patients who have had implants previously removed prior to diagnosis are eligible | false | 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) | false | 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 | false | Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed) | false | 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 | false | Planned partial breast radiation | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 38 | 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 | true | Body mass index (BMI) between 18 and 35 kg/m^2 | true | Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy | true | 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 | true | Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months | true | >= 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 | true | Ability to complete questionnaire(s) by themselves or with assistance | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 | true | Willing to provide informed written consent | true | Willing to return to an Alliance enrolling institution for follow-up | true | Willing to provide blood samples for correlative research purposes | true | Laboratory values obtained =< 365* days prior to registration:\r\n* Note: Without medical situations that should change these parameters since they were done | true | Creatinine =< 1.5 x upper limit of normal (ULN) | true | Hemoglobin > 11 g/dL | true | White blood cell (WBC) > 3.0 | true | Platelet count > 100,000 | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN | true | Presence of residual or recurrent cancer (locally or metastatic) | false | Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL | false | History of coronary artery disease (angina or myocardial infarction) | false | Patients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapy | false | Known hypersensitivity to any component of testosterone | false | 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 | false | Receiving any other investigational agent | false | History of a deep venous thrombosis or a thromboembolism | false | Concurrent use of the aromatase inhibitor exemestane | false | Concurrent radiation therapy or chemotherapy | false | Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 39 | 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 | true | Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 3 months | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Hemoglobin >= 9.0 g/dL not requiring transfusions within the past 2 weeks | true | Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); =< 3 x institutional ULN if the patient has Gilbert's syndrome | true | 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 | true | Creatinine =< 1.5 mg/dL | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | true | 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 | true | 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 | false | Patients who are receiving any other investigational agents | false | Patients with active or untreated brain metastases; treated brain metastases must have been stable for at least 2 months | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat | false | 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 | false | 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 | false | Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with vorinostat | false | 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 | false | A second malignancy requiring active therapy | false | 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 | false | Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption | false | Corrected QT interval (QTc) > 475 milliseconds | false | Patients who cannot swallow capsules | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 40 | 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 | true | 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 | true | 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 | true | 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%) | true | Life expectancy of greater than 3 months | true | Absolute neutrophil count >= 1,500/mcL | true | Hemoglobin >= 9.0 mg/dl | true | Platelets >= 100,000/mcL | true | Total bilirubin =< 2 x institutional upper limit of normal | true | 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 | true | Creatinine =< 1.5 x upper limit of normal (ULN) | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | Patients may not be receiving any other investigational agents | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study | false | For Part I: patients with known contraindications to platinum agents are excluded | false | 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 | false | 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 | false | 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 | false | Patients with active seizure or history of seizure are not eligible | false | 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 | false | Patients with prior malignancy successfully treated who are currently stable and on no active treatment are eligible | false | Patients who are unable to swallow pills/capsules are ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 41 | 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� | true | Life expectancy of > 3 months | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Hemoglobin >= 9 g/dL (transfusions and/or erythropoietin are permitted) | true | Absolute neutrophil count (ANC) >= 1.5 x 10^9/L | true | 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) | true | Creatinine =< twice upper limit institutional normal | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients who have received prior romidepsin use are eligible | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | 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 | false | Patients may not be receiving any other investigational agents | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to romidepsin, including cyclic tetrapeptide compounds | false | 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 | false | Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted | false | Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements | false | 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) | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this drug | false | Warfarin is not permitted | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 42 | 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 | true | 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" | true | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 within 7 days of enrollment | true | Participants must have an estimated life expectancy of > 6 weeks | true | White blood cells (WBC) >= 3,000 cells/uL (3.0 x 10^9 L) or | true | Absolute granulocytes >= 1500 cells/uL (1.5 x 10^9 L) | true | Platelets >= 100,000 cells/uL (75 x 10^9 L); and, | true | Hemoglobin >= 8 g/dL (5.0 mmol/L) | true | 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 | true | Estimated creatinine clearance of > 50 ml/min (0.84 mL/s) by the Cockcroft-Gault equation | true | 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) | true | 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) | true | Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 4 weeks prior to enrollment | true | 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 | true | 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) | true | Participants must, in the opinion of the investigator, be capable of complying with the protocol | true | Participants must be able to take oral medications | true | Participants must have a CD4 count performed within 30 days of enrollment | true | Inability to provide informed consent | false | 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 | false | 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 | false | 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) | false | 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 | false | 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 | false | 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 | false | Pregnant or breastfeeding | false | Inability to swallow oral medications | false | Participants with known congestive heart failure (CHF); if known, patients with left ventricular ejection fraction (LVEF) =< 40% are excluded | false | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 43 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky >= 60%) | true | Obtained within 30 days of registration: Leukocytes >= 3,000/mcL | true | Obtained within 30 days of registration: Absolute neutrophil count >= 1,500/mcL | true | Obtained within 30 days of registration: Platelets >= 75,000/mcL or >= 50,000/mcL with documented bone marrow involvement | true | Obtained within 30 days of registration: Total bilirubin within normal institutional limits (may be elevated if direct bilirubin normal) | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | Patients who are receiving any other investigational agents | false | Patients with known brain metastases should be excluded from this clinical trial | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, bortezomib or rituximab | false | 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 | false | 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 | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237 | false | 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 | false | Grade 2 or greater neuropathy | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 44 | 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 | true | Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy | true | Absolute neutrophil count (ANC) >= 1,500/mcl | true | Platelets >= 100,000/mcl | true | Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min | true | Bilirubin =< 1.5 x ULN | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN | true | Alkaline phosphatase =< 3 x ULN | true | Patients judged capable of tolerating a radical course of chemoradiation therapy | true | 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 | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | Patients with a GOG performance status of 0, 1, or 2 | true | Patients with recurrent carcinoma of the vulva regardless of previous treatment | false | Patients who have received prior pelvic radiation or cytotoxic chemotherapy | false | Patients with vulvar melanomas or sarcomas | false | Patients with circumstances that will not permit completion of the study or the required follow-up | false | Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 45 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Peripheral absolute neutrophil count (ANC) >= 1,000/uL | true | Platelet count >= 100,000/uL (transfusion independent) | true | Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) | true | 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) | true | Total bilirubin =< 1.5 times upper limit of normal (ULN) for age | true | Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN | true | Patients with seizure disorder may be enrolled if well controlled | true | Patients must not be in status, coma, or assisted ventilation prior to study enrollment | true | Patients with mature teratoma or completely resected immature teratoma with normal tumor markers are not eligible | false | Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible | false | Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible | false | Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids | false | Female patients who are pregnant are ineligible | false | Lactating females are not eligible unless they have agreed not to breastfeed their infants | false | Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained | false | 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 | false | All patients and/or their parents or legal guardians must sign a written informed consent | false | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 46 | NCT01622868 | https://www.clinicaltrials.gov/ct2/show/record/NCT01622868?term=NCT01622868&rank=1 | Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer | true | 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) | true | 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 | true | History/physical examination within 21 days prior to study entry | true | Karnofsky performance status >= 60 within 21 days prior to study entry | true | Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable) | true | Absolute neutrophil count (ANC) >= 1,200 cells/mm^3, within 21 days prior to study entry | true | Platelets >= 70,000 cells/mm^3, within 21 days prior to study entry | true | 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 | true | Creatinine < 1.5 times institutional upper limit of normal, within 21 days prior to study entry | true | Bilirubin < 1.5 times institutional upper limit of normal, within 21 days prior to study entry | true | 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 | true | Patient must provide study specific informed consent prior to study entry | true | Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry | true | Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion | true | 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 | true | Prior WBRT | false | 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 | false | 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 | false | 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 | false | Leptomeningeal disease | false | 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 | false | 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 | false | Grade 2 or greater rash of any cause at time of study entry | false | Grade 2 or greater diarrhea of any cause at time of study entry | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 47 | NCT01649089 | https://www.clinicaltrials.gov/ct2/show/record/NCT01649089?term=NCT01649089&rank=1 | Patient must consent for the appropriate surgery | true | 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 | true | All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm | true | 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 | true | Patients who have met the pre-entry requirements | true | Patients must have signed an approved informed consent and authorization permitting release of personal health information | true | Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 | true | Patients with stage IA1 disease who are LVSI negative | false | Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm | false | Patients with >= stage IB2 disease | false | Patients with clear cell or neuroendocrine cell types | false | Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP) | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 48 | 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 | true | 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) | true | 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 | true | 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 | true | 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) | true | 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 | true | 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 | true | Absolute neutrophil count (ANC) >= 1,500/mL within 28 days prior to registration | true | Hemoglobin >= 9 g/dL within 28 days prior to registration | true | Platelet count >= 100,000/mL within 28 days prior to registration | true | Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome) within 28 days prior to registration | true | Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 1.5 x institutional upper limit of normal (IULN) within 28 days prior to registration | true | Alkaline phosphatase =< 1.5 x IULN within 28 days prior to registration | true | Serum creatinine level =< IULN within 28 days prior to registration | true | 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 | true | Patients must have a complete history and physical examination within 28 days prior to registration | true | Patients must have a performance status of 0-2 by Zubrod criteria | true | 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 | true | Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration) | true | 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 | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | 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" | true | 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 | true | 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 | true | 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 | true | 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 | true | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 49 | 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 | true | 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\r\n* All tests for establishing high risk 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 | true | Patients with non-secretory MM or known amyloidosis are not eligible | true | Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy) | true | 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 | true | 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 | true | Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 without growth factor support | true | Within 14 days prior to registration: 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% | true | Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) | true | Within 14 days prior to registration: Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.5 x IULN | true | 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 | true | 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 | true | 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 | true | Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture | true | Patients must have Zubrod performance status =< 2 | true | 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 | true | Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) | true | 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 | true | 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 | true | 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 | true | Patients must have history and physical examination within 28 days prior to registration | true | Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol | true | 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) | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 50 | NCT01711541 | https://www.clinicaltrials.gov/ct2/show/record/NCT01711541?term=NCT01711541&rank=1 | PHASE I: | true | Patients who are treatment na�ve, 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 | true | PHASE II: | true | Patients who are treatment na�ve, 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 | true | PHASE I AND II: | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status 0-1 | true | Patients must be able to swallow the drug | true | Ability to understand and the willingness to sign a written informed consent document | true | Leukocytes >= 3,000/mm^3 | true | Absolute neutrophil count >= 1,500/mm^3 | true | Platelets >= 100,000/mm^3 | true | Total bilirubin =< 1.5 institutional upper limit of normal (ULN) | true | 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 | true | Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN as calculated by Cockcroft-Gault | true | Patients who are receiving any other investigational agents are not eligible | true | Patients with active seizure or a history of seizure are not eligible | true | 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 | true | 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 | true | 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 | true | 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 | true | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are not eligible | true | 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 | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 51 | 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 | true | Patients must have high-risk neuroblastoma | true | 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 | true | 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 | true | 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 | true | Patients must have a life expectancy of at least 6 weeks | true | Lansky (=< 16 years) or Karnofsky (> 16 years) score of at least 50 | true | Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment | true | 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 | true | 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 | true | 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 | true | A minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapy | true | 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 | true | All cytokines or hematopoietic growth factors must be discontinued a minimum of 7 days prior to protocol therapy | true | Patients must not be receiving any other anti-cancer agents or radiotherapy at the time of study entry or while on study | true | Absolute phagocyte count (APC = neutrophils and monocytes): >= 1000/mm^3 | true | Absolute neutrophil count: >= 750/mm^3 | true | Platelet count: >= 50,000/mm^3, transfusion independent (no platelet transfusions within 1 week) | true | Hemoglobin >= 8.0 (may transfuse) | true | 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 | true | 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 | true | =< grade 2 hematuria (criteria applicable only for dose levels that include isotretinoin) and =< grade 2 proteinuria | true | Total bilirubin =< 1.5 x upper limit of normal for age | true | 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) | true | Sinusoidal obstruction syndrome (SOS) if present, must be stable or improving clinically | true | 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 | true | No dyspnea at rest | true | 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) | true | =< grade 2 hypercalcemia (applicable only for dose levels that include cis retinoic acid [RA]) | true | Skin toxicity =< grade 1 | true | 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 | true | Patients with other ongoing serious medical issues must be approved by the study chair prior to registration | true | 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 | false | Breast feeding women are not eligible | false | Patients who have an active or uncontrolled infection are excluded | false | 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) | false | Patients with a history of venous or arterial thrombosis personally before the age of 40 years unless associated with a central line | false | 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 | false | Inability to swallow lenalidomide capsules whole; capsules of 13-isotretinoin may be opened | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||
| 52 | 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 | true | >= 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 | true | 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 | true | Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician | true | Ability to complete questionnaire(s) by themselves or with assistance | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3 | true | Provide informed written consent | true | Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) | true | Stable dose of corticosteroid >= 14 days prior to registration | true | 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 | false | History of hypersensitivity to other psychostimulants | false | History of steroid psychosis | false | 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 | false | 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 | false | Anticipating surgery, history of hypothyroidism, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or clinical depression per physician discretion | false | Active or a history of Tourette�s syndrome or tic disorder | false | History of or active glaucoma | false | History of intractable epilepsy, or uncontrolled seizure disorder | false | 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 | false | 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) | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 53 | 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 | true | 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 | true | No patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS) | true | No patients with bilateral breast cancer | true | No patients with known deleterious mutations in breast cancer (BRCA) genes | true | No history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed | true | Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible | true | No patients scheduled to receive partial breast irradiation following breast conserving surgery | true | 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 | true | 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 | true | 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 | true | No prior MRI of study breast within the 12 months prior to registration | true | 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 | true | Signed study-specific informed consent prior to registration | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 54 | 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) | true | 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 | true | 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 | true | Zubrod performance status 0-2 within 28 days prior to study entry | true | Absolute neutrophil count (ANC) >= 1,500 cells/mm^3; obtained within 14 days prior to study entry | true | Platelets >= 60,000 cells/mm^3; obtained within 14 days prior to study entry | true | 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 | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 6 times upper limit of normal (ULN); obtained within 14 days prior to study entry | true | Serum creatinine =< 1.2 x ULN or creatinine clearance >= 60 mL/min; obtained within 14 days prior to study entry | true | Patients must have Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 28 days prior to study entry | true | Child-Pugh score A within 14 days prior to study entry | true | 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) | true | Unsuitable for resection or transplant or radiofrequency ablation (RFA) | true | 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) | true | Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria | true | Patient must be able to provide study-specific informed consent prior to study entry | true | 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) | false | 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 | false | Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields | false | Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time | false | 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 | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Maximal diameter of any one hepatocellular carcinoma > 15 cm | false | Total sum of maximum diameters of each definite parenchymal hepatocellular carcinomas within the liver or maximum diameter of a single conglomerate HCC > 20 cm | false | More than 5 discrete intrahepatic parenchymal foci of definite HCC | false | Direct tumor extension into the stomach, duodenum, small bowel or large bowel | false | Measureable common or main branch biliary duct involvement with HCC | false | 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 | false | Prior liver transplant | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 55 | NCT01349881 | https://www.clinicaltrials.gov/ct2/show/record/NCT01349881?term=NCT01349881&rank=1 | STEP 0: REGISTRATION (Optional) | true | 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 | true | STEP 1: REGISTRATION | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease | true | 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 | true | 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) | true | 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 | true | Patients must have a Zubrod performance status of 0-1 | true | Patients must not be expecting to receive radiation or additional chemotherapy | true | Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, 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; inhaled steroids (i.e. for asthma or related conditions) are allowed | true | Patients must have the ability to swallow oral medication | true | 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 | true | Total white blood cells (WBC) >= 4.0 x 10^3/mcL within 28 days prior to registration | true | Platelets >= 100,000/mcL within 28 days prior to registration | true | Hemoglobin > 11.0 g/dL within 28 days prior to registration | true | A total WBC >= 3.1 x 10^3/mcL is allowed for non-Hispanic black males (NHBM) and total WBC >= 3.4 x 10^3/mcL for non-Hispanic black females (NHBF) \r\n* Exception: If the WBC is lower than the above levels, the patient may be enrolled IF the absolute neutrophil count (ANC) is >= 1.3 for NHBM, >= 1.4 for NHBF, or >= 1.5 for all. | true | Serum bilirubin =< 2.0 mg/dL within 28 days prior to registration | true | 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) within 28 days prior to registration | true | Serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration | true | 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 | true | 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" | true | SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA | true | Patients must be offered the option to participate in submission of specimens for banking for future translational medicine studies | true | Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis | true | Patients must be offered the option to participate in the Diet and Lifestyle Substudy | true | REGULATORY CRITERIA | true | 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 | true | 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 | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 56 | NCT01789684 | https://www.clinicaltrials.gov/ct2/show/record/NCT01789684?term=NCT01789684&rank=1 | SITE INCLUSION CRITERIA: | true | Providing surgical treatment for newly diagnosed breast cancer patients | true | 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 | true | 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 | true | PATIENT INCLUSION CRITERIA: | true | 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 | true | Able to read and write in English or Spanish | true | SITE EXCLUSION CRITERIA: | false | On-site genetics professionals as defined by the Commission on Cancer | false | PATIENT EXCLUSION CRITERIA: | false | Any previous diagnosis of cancer except for non-melanoma skin cancer | false | Stage IV breast cancer | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 57 | 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 | true | 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 | true | STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization) | true | STEP I: Untransfused platelet count >= 75,000 cells/mm^3 (obtained within 28 days prior to randomization) | true | STEP I: Absolute neutrophil count >= 1000 cells/mm^3 (obtained within 28 days prior to randomization) | true | STEP I: Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior to randomization) | true | STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization) | true | 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) | true | 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 | true | 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 | true | STEP I: Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months | true | 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 | true | STEP I: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (performance status [PS] 3 allowed if secondary to pain) | true | STEP I: Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible | true | STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | true | STEP I: Patients must not have active, uncontrolled infection | true | 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 | true | STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months | true | 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) | true | 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 | true | 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 | true | STEP I: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women | true | 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 | true | 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 | true | 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 | true | STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy | true | STEP II: Patients must not have received any non-protocol therapy outside of the assigned induction therapy including stem cell transplant | true | STEP II: ECOG performance status 0, 1, or 2 (PS 3 allowed if secondary to pain) | true | STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or less | true | STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II) | true | STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II) | true | STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II) | true | STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II) | true | STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II) | true | STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II) | true | 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 | true | 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 | true | STEP II: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||
| 58 | 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 | true | 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 | true | 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 | true | 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 | true | Able to swallow and absorb the medication | true | Obtained =< 7 days prior to registration: Absolute neutrophil count (ANC) >= 1500/mm^3 | true | Obtained =< 7 days prior to registration: Platelets (PLT) >= 100,000/mm^3 | true | Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) | true | Obtained =< 7 days prior to registration: Creatinine =< 1.5 x institutional ULN | true | Obtained =< 7 days prior to registration: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional ULN | true | Obtained =< 7 days prior to registration: Hemoglobin (Hgb) > 9.0 mg/dl | true | Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 | true | Ability to provide informed written consent | true | Life expectancy >= 12 weeks | true | Women of childbearing potential only: negative pregnancy test done =< 7 days prior to registration | true | 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 | false | 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 | false | 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 | false | 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 | false | Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment | false | 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) | false | 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 | false | 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) | false | 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 | false | Receiving any other investigational agent that would be considered a treatment for the primary neoplasm | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 59 | NCT01806129 | https://www.clinicaltrials.gov/ct2/show/record/NCT01806129?term=NCT01806129&rank=1 | Female patients presenting with initial diagnosis of any type of cancer | true | Patients must not have initiated chemotherapy or radiation prior to registration to this study | true | Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of any method | true | Patients must be pre-menopausal patients within the reproductive age range | true | 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 | true | Pregnant women are eligible to participate in this study | true | Patients must have the cognitive ability to participate in the study | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 60 | 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 | true | 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 | true | Patients must have a performance status of 0 or 1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) scale | true | 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 | true | 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 | true | Cardiac ejection fraction >= 50% as determined by screening echocardiogram | true | 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 | true | 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 | true | Patients treated with prior Interleukin-2 will be allowed to be in this study | true | Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable | false | ECOG performance status of 2 or greater | false | 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 | false | Patients taking steroids for disease control or pain management | false | 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 | false | 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 | false | 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 | false | Patients that have undergone Tyrosinase immunotherapy | false | Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy | false | Absolute neutrophil count < 1.5 x 10^9/L | false | Platelet count < 100 x 10^9/L | false | Serum bilirubin > 1.5 x upper limit of normal (ULN) | false | Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 x ULN | false | Serum alkaline phosphatase (ALP) > 2 x ULN | false | Serum Albumin < 2.5 g/dL | false | International Normalized Ratio (INR) > 1.5 | false | Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (< 50mL/min) | false | Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics | false | 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) | false | Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start | false | Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) | false | Known hypersensitivity to any of the components of the study drugs | false | Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 61 | 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 | true | 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 | true | Patients are allowed prior VEGFR-tyrosine kinase inhibitor (TKI); patients will be stratified based on prior VEGFR-TKI therapy | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky > 70%) | true | Life expectancy > 3 months | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Total bilirubin =< 1.5 times upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal | true | Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal | true | Hemoglobin >= 9 g/dL | true | Serum albumin >= 2.8 g/dL | true | Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis | true | Urine protein/creatinine ratio (UPCR) =< 1 | true | Serum phosphorus calcium, magnesium and potassium >= lower limit of normal (LLN) | true | 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 | true | Patients must be able to swallow whole tablets; tablets must not be crushed or chewed | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment | false | The subject has received radiation therapy within 4 weeks (=< 2 weeks for palliative radiation therapy) | false | 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 | false | 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 | false | Patients with refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that could interfere with absorption | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib | false | 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 | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | 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) | false | 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 | false | The subject has radiographic evidence of cavitating pulmonary lesion(s) | false | The subject has tumor invading or encasing any major blood vessels | false | 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 | false | 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 | false | The subject is unable to swallow tablets | false | 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 | false | The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee | false | The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment | false | Patients should not have any clinical evidence of an active infection at the time of enrollment | false | ||||||||||||||||||||||||||||||||||||||||||
| 62 | 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 | true | 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.) | true | 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 | true | 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 | true | 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 | true | At least 14 days must have elapsed since completion of myelosuppressive therapy | true | At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid | true | 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 | true | 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 | true | Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met | true | 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 | true | 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 | true | Peripheral absolute neutrophil count (ANC) >= 750/uL | true | Platelet count >= 75,000/uL (transfusion independent) | true | 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 | true | Creatinine clearance or estimated radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or | true | 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 | true | Total bilirubin =< 1.5 x ULN for age AND | true | 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 | true | 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 | true | Shortening fraction of >= 27% by echocardiogram (ECHO) OR | true | Ejection fraction >= 50% by ECHO or gated radionuclide study | true | Adequate coagulation defined as:\r\n* Prothrombin time (PT) =< 1.2 x upper limit of normal | true | 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 | true | 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 | false | Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study | false | 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 | false | 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 | false | Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma | false | Patients with symptoms of congestive heart failure are not eligible | false | Patients must not have >= grade 2 diarrhea | false | Patients must not have uncontrolled infection | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 63 | 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 | true | All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration | true | Patients must start therapy within 7 calendar days of registration | true | 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 | true | All patients must meet the following inclusion and exclusion criteria; NO EXCEPTIONS WILL BE GIVEN | true | 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 | true | 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 | true | 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 | true | 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 | true | NF-1 patients with radiographic evidence of a progressive, recurrent or refractory low grade glioma, with or without pre-treatment tumor tissue | true | Patients with progressive, recurrent or refractory optic pathway glioma, with or without pre-treatment tumor tissue | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | 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 | true | Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration | true | 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 | true | Corticosteroids: patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration | true | 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 | true | Patients must have a body surface area (BSA) >= 0.55 m^2 | true | Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration | true | Patients must be able to swallow capsules | true | 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 | true | Absolute neutrophil count >= 1,000/uL (unsupported), within 14 days of registration and within 7 days of the start of treatment | true | Platelets >= 100,000/L (unsupported), within 14 days of registration and within 7 days of the start of treatment | true | Hemoglobin >= 8 g/dL (may be supported), within 14 days of registration and within 7 days of the start of treatment | true | 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 | true | 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 | true | Albumin >= 3 g/dL, within 14 days of registration and within 7 days of the start of treatment | true | Serum sodium and potassium within the institutional limits of normal, within 14 days of registration and within 7 days of the start of treatment | true | 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 | true | 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 | true | Left ventricular ejection fraction (LVEF) >= 55% | true | Corrected QT (QTc) interval =< 450 msecs | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines | true | 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 | false | Patients who are receiving any other anticancer or investigational agents | false | Patients with uncontrolled seizures | false | Previous mitogen-activated protein kinase kinase (MEK) inhibitor use such as PD-0325901; CI1040; AS73026; GDC 0973; ARRY43182; GSK110212 | false | Prior treatment with a BRAF inhibitor such as vemurafenib or dabrafenib (previous treatment with sorafenib is allowed) | false | 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 | false | Required use of a concomitant medication that can prolong the QT interval | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 | false | ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY | true | 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 | true | 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 | true | Patients must have bi-dimensionally measureable disease defined as at least one lesion that can be accurately measured in at least two planes | true | 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 | true | ||||||||||||||||||
| 64 | 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 | true | The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 | true | 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 | true | 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 | true | 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 | true | 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 | true | Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen | true | 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 | true | 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 | true | 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 | true | Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible | true | Patient who have undergone either a total mastectomy or a lumpectomy are eligible; (patients who have had a nipple-sparing mastectomy are eligible) | true | 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) | true | For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor | true | 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 | true | The patient must have recovered from surgery with the incision completely healed and no signs of infection | true | If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved | true | Definitive clinical or radiologic evidence of metastatic disease | false | T4 tumors including inflammatory breast cancer | false | Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone | false | N2 or N3 disease detected clinically or by imaging | false | Patients with histologically positive axillary nodes post neoadjuvant therapy | false | Patients with microscopic positive margins after definitive surgery | false | Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible) | false | 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) | false | 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 | false | Any radiation therapy for the currently diagnosed breast cancer prior to randomization | false | 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 | false | Prior breast or thoracic radiation therapy (RT) for any condition | false | 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 | false | 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) | false | Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up | false | Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 65 | 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 | true | 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 | true | Stage II, III or IV disease as defined by the Ann Arbor Staging System | true | 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 | true | Normal baseline cardiac ejection fraction >= 50% | true | Serum creatinine of =< 1.5 mg/dL; if creatinine > 1.5 mg/dL, creatinine clearance must be >= 60 mL/minute | true | Absolute neutrophil count (ANC) >= 1000/uL | true | Platelets >= 75,000/uL unless related to bone marrow involvement by HIV-cHL | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Karnofsky performance status > 30% (given the aggressiveness of this disease and the often severely debilitated nature of the patients at initial presentation) | true | 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 | true | Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible | true | CD4 count >= 50 cells/ul | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients with prior anthracycline therapy will be excluded | false | 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 | false | 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 | false | 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 | false | Grade 2 or greater peripheral neuropathy | false | Evidence of progressive multifocal leukoencephalopathy (PML) identified on the pretreatment magnetic resonance imaging (MRI) | false | Central nervous system disease | false | 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 | false | Cirrhosis secondary to any cause will be excluded | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 66 | 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" | true | Surgical resection with curative intent within 8 weeks prior to registration | true | 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 | true | Zubrod performance status 0-1 | true | Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 | true | Platelets >= 100,000 cells/mm^3 | true | Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) | true | Serum creatinine < 2.0 mg/dl | true | Total bilirubin < 2 x the institutional upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN | true | Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential | true | Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment | true | All patients must have a Medical Oncology evaluation within 4 weeks prior to registration | true | Patients must be deemed able to comply with the treatment plan and follow-up schedule | true | Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review | true | Patients with residual macroscopic disease after surgery | false | 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) | false | Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Significant pre-existing hearing loss, as defined by the patient or treating physician | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 67 | 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 | true | NOTE: use of luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin) is not allowed | true | Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast | true | 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 | true | 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 | true | 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 | true | Plan to treat with anastrozole for at least 12 months | true | Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 | true | 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 | true | 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) | true | Patients must not have a prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years | true | 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" | true | Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 68 | 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 | true | 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 | true | 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) | true | 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 | true | Zubrod performance status of 0-1 within 14 days prior to registration | true | Absolute granulocyte count (AGC) >= 1,500 cells/mm^3 | true | Platelets >= 100,000 cells/mm^3 | true | Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) | true | Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration | true | Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration | true | 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 | true | Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential | true | 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 | true | Patients with feeding tubes are eligible for the study | true | Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control | true | 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 | true | 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 | false | 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 | false | Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | 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 | false | Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4): | false | 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 | false | Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L) | false | Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels | false | Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels | false | Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Prior allergic reaction to cetuximab | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 69 | 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) | true | 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 | true | 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 | true | 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 | true | 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 | true | All patients and/or their parents or legal guardians must sign a written informed consent | true | All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | true | Patients with a previous or current line infection are ineligible until 14 days after the completion of antibiotics | false | Patients with only totally implanted CVCs or ports are ineligible | false | Patients with a known allergy or hypersensitivity to CHG are ineligible | false | Patients with chronic, severe, generalized skin breakdown (such as generalized blistering, burns, severe graft versus host disease [GVHD] with open sores, etc.) are ineligible | false | 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 | false | 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 | false | Patients receiving sorafenib at the time of enrollment and those who are scheduled to receive sorafenib as part of a treatment plan are ineligible | false | 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 | false | Patients previously enrolled on this trial are ineligible | false | Females who are pregnant or breastfeeding are ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 70 | 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 | true | 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) | true | Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment | true | 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 | true | Karnofsky performance status >= 60% | true | Life expectancy of greater than 3 months | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Total bilirubin < 1.5 x institutional upper limit of normal | true | 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 | true | Creatinine < 1.5 institutional upper limit of normal OR | true | Creatinine clearance >= 60 mL/min for patients with creatinine levels above 1.5 x institutional upper limit of normal | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients should not be receiving any other investigational agents | true | 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 | false | History of allergic reactions attributed to fluoropyrimidines (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 71 | NCT01822496 | https://www.clinicaltrials.gov/ct2/show/record/NCT01822496?term=NCT01822496&rank=1 | Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC | true | 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) | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | The institution�s pre-enrollment biomarker screening at a CLIA certified lab documents absence of T790M mutation in the EGFR TK domain | true | 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 | true | Zubrod performance status 0-1 within 14 days prior to registration | true | Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 | true | Platelets >= 100,000 cells/mm^3 | true | Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) | true | Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration | true | Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) within 14 days prior to registration | true | Bilirubin within normal institutional limits within 14 days prior to registration | true | Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential | true | Patient must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue | true | 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) | false | Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable | false | Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields | false | Atelectasis of the entire lung | false | Contralateral hilar node involvement | false | Exudative, bloody, or cytologically malignant effusions | false | 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 | false | Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception | false | Prior allergic reaction to the study drug(s) involved in this protocol | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 72 | NCT01822509 | https://www.clinicaltrials.gov/ct2/show/record/NCT01822509?term=NCT01822509&rank=1 | Histologically or cytologically confirmed hematologic malignancy | true | 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) | true | Life expectancy of greater than 3 months | true | Must have undergone allogeneic hematopoietic stem cell transplantation (HSCT) (regardless of stem cell source) | true | Must have baseline donor T cell chimerism of >= 20% | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 | true | 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) | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN | true | Creatinine =< 1.5 x institutional ULN | true | Prednisone dose =< 5 mg/day and off all other systemic immunosuppressive medications for at least 4 weeks prior to study entry | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | Patients with prior history of or active severe (grade 3 or 4) acute graft-versus-host disease (GVHD) | false | 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 | false | Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to registration | false | 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 | false | Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 73 | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 12 weeks | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | 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) | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal | true | Creatinine =< 1.5 x ULN | true | Creatinine clearance >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal | true | Hemoglobin >= 9 g/dL | true | Serum albumin >= 2.8 g/dL | true | Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis | true | Urine protein/creatinine ratio (UPCR) =< 1 | true | Serum phosphorus >= lower limit of normal (LLN) | true | Calcium >= LLN | true | Magnesium >= LLN | true | Potassium >= LLN | true | A cluster of differentiation (CD)4+ lymphocyte count > 50/mcL will be required within 2 weeks of study participation | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Participants must in the opinion of the investigator be capable of complying with this protocol | true | Prior treatment with cabozantinib (XL184) | false | The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment | false | 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 | false | The participant has received any other type of investigational agent within 28 days before the first dose of study treatment | false | 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) | false | The participant has a primary brain tumor | false | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | The participant has radiographic evidence of cavitating pulmonary lesion(s) | false | The participant has tumor invading or encasing any major blood vessels | false | 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 | false | 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 | false | 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 | false | The participant is unable to swallow tablets that are whole (do not crush or chew or administer via nasogastric [NG]-tube) | false | 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 | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib (XL184) | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib | false | ||||||||||||||||||||||||||||||||
| 74 | 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 | true | Patients should be capable of achieving imaging without the need for sedation or anesthesia | true | Karnofsky performance status >= 50 for patients >= 12 years of age; for children < 12 years of age, the Lansky play scale >= 50% can be substituted | true | 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 | true | Patients receiving glucocorticoids and/or anti-seizure medications are eligible for this study | true | Clinically active infection; an active infection may alter the biodistribution of 18F-FLT | false | 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 | false | Serious intercurrent medical illness | false | Patients requiring emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 75 | 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 | true | 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) | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Hemoglobin >= 9 g/dL | true | Total bilirubin =< institutional upper limit of normal | true | 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 | true | Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal | true | Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal | true | Patients must be able to provide written informed consent | true | Patients must have magnetic resonance imaging (MRI) within 21 days of starting treatment | true | 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 | true | 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 | true | Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment | true | Patients must be able to swallow whole capsules | true | PHASE I PATIENTS: | true | Must have histologically proven glioblastoma | true | Must have recovered from the immediate post-operative period | true | 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 | true | 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 | true | INTRATUMORAL DRUG DISTRIBUTION STUDY PATIENTS: | true | Patients must have prior histologically proven glioblastoma that is progressive or recurrent following radiation therapy +/- chemotherapy | true | Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers | true | 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 | true | Patients may have an unlimited number of prior therapy regimens | true | 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.) | true | Patients receiving any other investigational agents are ineligible | false | 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 | false | 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) | false | 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 | false | Patients may not be on anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH) | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD1775 (MK-1775) | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 76 | 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 | true | No inflammatory breast cancer | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy | true | No neoadjuvant radiation therapy | true | No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy | true | 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 | true | No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis | true | No history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowed | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 | true | INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA | true | 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 | true | 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 | true | 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 | true | POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA | true | 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) | true | 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 | true | 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) | true | 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+) | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 77 | 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 | true | 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 | true | Patients enrolling in the expansion cohorts must have disease amenable to biopsy and be willing to undergo pre-and post-treatment biopsies | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Phase I), =< 1 (Phase II) | true | Life expectancy of greater than 3 months | true | Absolute neutrophil count >= 1,500/mcL | true | Hemoglobin >= 10 g/dL without transfusion within 4 days prior to enrollment | true | Platelets >= 100,000/mcL | true | Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients must be able to swallow whole tablets or capsules; nasogastric or gastrostomy tube (G-tube) administration is not allowed | true | Ability to understand and the willingness to sign a written informed consent document and to undergo tumor biopsies in the expansion phase | true | Patients who are actively receiving any other investigational agents | false | 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 | false | 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 | false | 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 | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or TMZ | false | 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 | false | 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 | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | HEALTHY VOLUNTEER BLOOD DONORS | true | Age > 18 years | true | Hemoglobin >= 12 g/dL | true | No history of bleeding problems; not taking aspirin or any medication that may affect erythrocyte biochemistry | true | Willingness to sign the healthy volunteer informed consent form | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 78 | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 3 months | true | Absolute neutrophil count >= 1.5 x 10^9/L | true | Platelets >= 100 x 10^9/L | true | Total bilirubin =< 1.5 x upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 X institutional upper limit of normal | true | Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal | true | Hemoglobin >= 90 g/L | true | Serum albumin >= 28 g/L | true | Lipase < 2.0 x ULN; no radiologic/clinical evidence of pancreatitis | true | Urine protein/creatinine ratio (UPCR) =< 1 | true | Serum phosphorus, calcium, magnesium and potassium >= lower limit of normal (LLN) | true | 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 | true | 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) | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | Prior treatment with cabozantinib | false | 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 | false | The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment | false | 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 | false | The subject has received any other type of investigational agent within 28 days before the first dose of study treatment | false | 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) | false | 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 | false | Patients with known brain metastases should be excluded from this clinical trial | false | 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 | false | 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 | false | The subject requires chronic concomitant treatment of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John�s wort) | false | 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 | false | The subject has tumor in contact with, invading or encasing any major blood vessels | false | 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 | false | 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) | false | 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 | false | 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 | false | 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 | false | The subject is unable to swallow tablets | false | The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms =< 7 days before the first dose of study treatment | false | The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to XL184 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with XL184 | false | Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | ||||||||||||||||||||||||||||||||||||
| 79 | NCT01881867 | https://www.clinicaltrials.gov/ct2/show/record/NCT01881867?term=NCT01881867&rank=1 | Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) | true | Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment | true | 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 | true | Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy | true | No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 days | true | 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 | true | Absolute neutrophil count (ANC) >= 1500/uL | true | Bilirubin < 1.5 x upper limit of normal (ULN) | true | Hemoglobin >= 10 g/dL | true | Platelets >= 100,000/mcL | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN | true | Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation | true | Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists or s/p orchiectomy) | true | Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky performance status of >= 80% | true | Life expectancy of at least 6 months | true | Prior local radiation therapy must be completed at least 30 days prior to enrollment and the patient must have recovered from all toxicity | true | Prior �systemic� radiopharmaceuticals (strontium, samarium, radium 223 dichloride) must be completed >= 8 weeks prior to enrollment | true | Patients must agree to use 2 methods of adequate contraception for the duration of study participation, and for four months after discontinuing therapy | true | Ability to understand and the willingness to sign a written informed consent document | true | Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed | false | Prior investigational immunotherapy | false | Prostate cancer pain requiring regularly scheduled narcotics | false | Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression | false | 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 | false | Known central nervous system metastases | false | 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 | false | 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 | false | 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 | false | 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) | false | 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 | false | Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder; HIV-positive patients on combination antiretroviral therapy are ineligible | false | Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness | false | 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 | false | History of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107 | false | Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment | false | Active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy) | false | Patients who have received hepatotoxic drugs less than 7 days prior to enrollment | false | Patients who have received prior biologic agents less than 30 days prior to enrollment | false | 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 | false | Patients who have a history of any hematopoietic malignancy | false | 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) | false | ||||||||||||||||||||||||||||||||||||||||||
| 80 | 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 | true | Patients must have measurable or evaluable disease | true | Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is being enrolled prior to patient enrollment | true | 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 | true | Karnofsky performance status >= 60% | true | Life expectancy of greater than 3 months | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Total bilirubin =< 1.5 X institutional upper limit of normal | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients should not be receiving any other investigational agents | true | Ability to swallow liquids | true | 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 | true | 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 | false | 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 | false | History of allergic reactions attributed to fluoropyrimidine (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine | false | Malabsorption syndrome or other conditions that would interfere with intestinal absorption | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 81 | 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 | true | Patients must have at least one 1.5 cm bidimensional measurable lesion | true | Relapsed or refractory after at least 1 front-line therapy | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 12 weeks | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 75,000/mcL | true | Direct bilirubin =< 1 mg/dL | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal | true | Creatinine =< 2 x institutional upper limits of normal | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | true | Patients who have had chemotherapy, radiation therapy, or other investigational agents within 3 weeks prior to entering study, 6 weeks for nitrosoureas or mitomycin | false | Patients with known brain metastases should be excluded from this clinical trial | false | 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 | false | 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 | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MLN8237 and/or romidepsin | false | 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 | false | Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 82 | 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) | true | 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 | true | 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 | true | 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 | true | 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) | true | Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2 | true | 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 | true | 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) | true | 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 | true | Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air | true | 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 | true | Absolute neutrophil count (ANC) >= 1500/mcL (1.5 x 10^9/L) obtained within 2 weeks prior to registration | true | Platelets >= 75,000/mcL (75 x 10^9/L) obtained within 2 weeks prior to registration | true | Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) obtained within 2 weeks prior to registration | true | 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 | true | Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min obtained within 2 weeks prior to registration | true | 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 | true | Patient must have no current or prior history of central nervous system (CNS) involvement | true | 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 | true | No history of Steven�s Johnson�s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy | true | 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 | true | 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 | true | Patients must not have grade 2 or greater peripheral sensory neuropathy | true | 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 | true | Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab | true | Patients must not have a serious medical or psychiatric illness likely to interfere with study participation | true | Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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) | true | RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2 | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L), obtained within 2 weeks prior to registration | true | RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L), obtained within 2 weeks prior to registration | true | RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN), obtained within 2 weeks prior to registration | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min, obtained within 2 weeks prior to registration | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): No history of Steven�s Johnson�s syndrome, TENs syndrome, or motor neuropathy | true | 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 | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab | true | RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation | true | 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 | true | 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 | true | RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents | true | 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 | true | ||||||||
| 83 | NCT01902173 | https://www.clinicaltrials.gov/ct2/show/record/NCT01902173?term=NCT01902173&rank=1 | PHASE I PORTION ELIGIBILITY CRITERIA | true | 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 | true | 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 | true | Patients must have a complete physical examination and medical history within 28 days prior to registration | true | 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) | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients may have received prior radiation therapy; all adverse events associated with prior radiation therapy must have resolved to =< grade 1 prior to registration | true | 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 | true | 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 | true | Patients must have Zubrod performance status =< 1 | true | Absolute neutrophil count (ANC) >= 1,200/ul | true | Platelets >= 100,000/ul | true | Hemoglobin >= 9 g/dL | true | Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert�s syndrome) | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases) | true | Serum albumin >= 2.5 g/dL | true | Serum creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance >= 50 mL/min | true | 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 | true | Patients must not have a corrected QT (QTc) interval >= 480 msecs within 28 days prior to registration | true | 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 | true | Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration | true | 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) | true | Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range | true | 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) | true | Women of childbearing potential must have a negative pregnancy test within 14 days of registration | true | 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" | true | 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 | true | Patients must not have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection | true | 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) | true | 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 | true | 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 | true | 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 | true | Patients must have a serum albumin >= 2.5 g/dL within 28 days prior to registration | true | 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 | true | 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) | true | PHASE II PORTION ELIGIBILITY CRITERIA | true | Patients must have histologically confirmed melanoma with BRAF^V600 mutation; patients must have stage IIIC or stage IV disease | true | 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 | true | 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) | true | Patients must have Zubrod performance status =< 2 | true | 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 | true | ||||||||||||||||||||||||||||||||
| 84 | NCT01953588 | https://www.clinicaltrials.gov/ct2/show/record/NCT01953588?term=NCT01953588&rank=1 | Eastern Cooperative Oncology Group (ECOG) performance status 0-2 | true | 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 | true | Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy | true | 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 | true | 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 | true | 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 | true | 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 | true | Absolute neutrophil count (ANC) > 1,000/mm^3 | true | Platelet count > 100,000/mm^3 | true | Total bilirubin < 1.5 x upper limits of normal (ULN) | true | Creatinine < 1.5 x ULN | true | Serum alanine aminotransferase (ALT) < 2.5 x ULN | true | 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 | true | Premenopausal status | false | 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) | false | An excisional biopsy of this breast cancer | false | Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration | false | Tumor ER Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0 | false | Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted | false | 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 | false | Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion | false | Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry | false | History of invasive breast cancer or contralateral DCIS | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 85 | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) | true | Life expectancy of greater than 6 months | true | 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 | true | Absolute neutrophil count (ANC) >= 1.5 x 10^9/L | true | Hemoglobin >= 9 g/dL | true | Platelets >= 100 x 10^9/L | true | Albumin >= 2.5 g/dL | true | Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN | true | 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 | true | Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN | true | Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA) | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (any G12, G13, Q61) confirmed by Clinical Laboratory Improvement Act (CLIA)-certified testing | true | The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis | true | 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 | false | History of interstitial lung disease or pneumonitis | false | Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment | false | 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 | false | 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 | false | 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) | false | History or current evidence/risk of retinal vein occlusion (RVO) | false | 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 | false | 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 | false | 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 | false | 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) | false | HIV-positive patients on combination antiretroviral therapy are ineligible | false | 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) | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 86 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Patients must have Zubrod performance status 0-2 | true | 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 | true | 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) | true | 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 | true | 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 | true | 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) | true | Patients must have serum creatinine =< 2 x institutional upper limits of normal (IULN) within 7 days prior to registration | true | Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated) | true | Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration | true | Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN within 7 days prior to registration | true | Patients with a history of a serious allergic or anaphylactic reaction to humanized monoclonal antibodies are not eligible | true | 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 | true | Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome | true | 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 | true | Patients must not have a myocardial infarction within 6 months prior to registration | true | 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 | true | 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 | true | Patients must not have a history of chronic liver disease (or cirrhosis) | true | 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 | true | 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 | true | Patients must have complete history and physical examination within 28 days prior to registration | true | 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" | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 87 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Body surface area (BSA) >= 1.04 m^2 | true | 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 | true | Life expectancy of greater than 8 weeks | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Total bilirubin < 1.5 X institutional upper limit of normal | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal | true | 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 | true | Corrected QT interval (QTc) must be < 500 msec | true | Pediatric patients: normal left ventricular function with ejection fraction > 55% or shortening fraction >= 27% | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients should not be receiving any other investigational agents | true | Prior therapy with anti-angiogenic agents is permitted | true | 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 | false | Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine) | false | Patients who are unable to swallow tablets | false | Mean QTc > 500 msec (with Bazett�s correction) in screening electrocardiogram or history of familial long QT syndrome | false | Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD2171 | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 88 | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Life expectancy of greater than 3 months | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | 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 | true | 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 | true | 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 | true | 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 | true | 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) | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Prior therapy with belinostat | false | Patients may not be receiving any other investigational agents | false | Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to belinostat, including hydroxamate compounds or arginine | false | Patients should not have taken valproic acid, another histone deacetylase (HDAC) inhibitor, for at least 2 weeks prior to enrollment | false | 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 | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with belinostat | false | 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 | false | 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 | false | HIV-positive patients on combination antiretroviral therapy are ineligible | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 89 | 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 | true | 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 | true | 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 | true | 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 | true | The Eastern Cooperative Oncology Group (ECOG) performance status =< 2 | true | Life expectancy > 3 months | true | Absolute neutrophil count >= 1,500/uL | true | Platelets >= 100,000/uL | true | Total bilirubin within =< 1.5 x institutional upper limit of normal | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients receiving any other investigational agents | false | 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 | false | 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 | false | Patients with untreated spinal cord metastases or metastases close to vital organs (as determined by the principal investigator) are excluded | false | Patients with a history of deep vein thrombosis must be on anti-coagulation therapy prior to enrollment; patients requiring prophylactic anti-coagulation are eligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 90 | 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 | true | PHASE II: >= 2 and =< 18 years; body surface area (BSA) >= 0.55 m^2, and able to swallow whole capsules | true | 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 caf�-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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Absolute neutrophil count >= 1500/ul | true | Hemoglobin >= 9 g/dl | true | Platelets >= 100,000/ul | true | Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome | true | Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) within =< 3 x upper limit of normal | true | 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 | true | 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 | true | 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 | true | 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 | true | Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated | true | 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 | true | 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 | false | 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 | false | Use of an investigational agent within the past 30 days | false | Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy | false | 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 | false | Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study | false | Inability to swallow capsules, since capsules cannot be crushed or broken | false | 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 | false | Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption | false | Prior treatment with selumetinib or another specific mitogen-activated protein kinase (MEK)1/2 inhibitor (unless the subject meets criteria for re-treatment) | false | Evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy | false | 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 | false | Patients not achieving adequate blood pressure in spite of antihypertensive therapy for control of blood pressure | false | 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 | false | 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 | false | 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 | false | Recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access | false | Any unresolved chronic toxicity with CTCAE grade >= 2, from previous anti-NF1 therapy, except for alopecia | false | Clinical judgement by the investigator that the patient should not participate in the study | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||
| 91 | 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 | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery | true | Patients age 16-17 years are eligible only if they have a body surface area (BSA) >= 1.7 m^2 or weigh >= 60 kg | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 | true | Life expectancy of greater than 3 months | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Hemoglobin >= 9 g/dL | true | Total serum bilirubin within normal institutional limits | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal | true | Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal | true | Corrected QT interval (QTc) < 480 msec (with Bazett�s correction) in screening electrocardiogram | true | 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 | true | 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 | true | Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal | true | Strong 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 | true | 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 | true | Patients who are nursing infants: breastfeeding should be discontinued if the mother is treated with the study agents | true | Ability to understand and the willingness to sign a written informed consent document | true | Patients must be able to swallow whole tablets and capsules | true | Patients must not have received prior treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed | false | Patients may not be receiving any other investigational agents | false | Major surgery within 4 weeks prior to entry into the study, or a surgical incision that is not fully healed | false | History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation | false | Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible | false | Warfarin and its derivatives are not allowed; patient can be receiving low molecular weight heparin if clinically indicated | false | 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 | false | 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 | false | 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 | false | 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 | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 92 | 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 | true | 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 | true | 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]) | true | 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 | true | 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 | true | Serum creatinine of =< 1.5 X the upper limit of normal | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x the upper limit of normal | true | Absolute neutrophil count >= 1,500/mm^3 | true | Platelets >= 100,000/mm^3 | true | Karnofsky performance status >= 70% or Eastern Cooperative Oncology Group (ECOG) =< 1 | true | 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 | true | 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 | false | 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 | false | Life expectancy of less than 3 months | false | Patients with more than 30% replacement of hepatic parenchyma by tumor or any history of drug related hepatic encephalopathy | false | History of complex ventricular or supraventricular arrhythmias | false | Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, or hepatitis C infection | false | 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 | false | A positive hepatitis C serology is an exclusion criterion | false | Concurrent anticancer therapy (including other investigational agents), with the exception of hormone therapy for prostate cancer | false | Active CNS metastases | false | History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible) | false | 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 | false | 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) | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 93 | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky > 60%) | true | Life expectancy of greater than 3 months | true | Leukocytes >= 3,000/mcL | true | Absolute neutrophil count >= 1,500/mcL | true | Platelets >= 100,000/mcL | true | Hemoglobin > 9 g/dL | true | Total bilirubin =< 1.5 x institutional upper limit of normal | true | Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal | true | 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 | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | true | Patients who are receiving any other investigational agents | false | 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 | false | 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 | false | 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 | false | 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 | false | Pregnant women are excluded from this study | false | Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy are ineligible | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 94 | 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 | true | 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 | true | 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 | true | 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 | true | TUMOR BIOPSY SEQUENCING: Karnofsky performance status >= 70% | true | TUMOR BIOPSY SEQUENCING: Life expectancy > 3 months | true | TUMOR BIOPSY SEQUENCING: Absolute neutrophil count >= 1,000/uL (mcL) | true | TUMOR BIOPSY SEQUENCING: Platelets >= 100,000/uL (mcL) | true | TUMOR BIOPSY SEQUENCING: Total bilirubin < 1.5 x institutional upper limit of normal | true | 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 | true | 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 | true | 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 | true | 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 | true | 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) | true | TUMOR BIOPSY SEQUENCING: Women who are pregnant or breastfeeding | false | 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 | false | 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 | false | 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 | false | TUMOR BIOPSY SEQUENCING: Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | 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 | false | TREATMENT: Patient must have predefined targeted mutation in tumor biopsy | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | TREATMENT: Karnofsky performance status >= 70% | true | TREATMENT: Absolute neutrophil count >= 1,000/uL (mcL) | true | TREATMENT: Platelets >= 100,000/uL (mcL) | true | TREATMENT: Total bilirubin < 1.5 x institutional upper limit of normal | true | TREATMENT: AST (SGOT)/ALT (SGPT) =< 3 x institutional upper limit of normal | true | 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 | true | TREATMENT: Life expectancy > 3 months | true | 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 | true | TREATMENT: Breastfeeding should be discontinued while the patient is on this trial and for 30 days following last dose of study drug | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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) | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | TREATMENT: Patients with known hypersensitivity reaction to dacarbazine are ineligible to receive temozolomide | true | TREATMENT: Women who are pregnant or breastfeeding | false | 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 | false | 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 | false | 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 | false | 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 | false | TREATMENT: HIV-positive patients on combination antiretroviral therapy are ineligible | false | 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 | false | 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 | false | 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 | false | 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 | false | TREATMENT: Patients requiring chronic treatment with corticosteroids or other immunosuppressive agents are ineligible to receive everolimus (topical or inhaled corticosteroids are allowed) | false | TREATMENT: Patients who have received live attenuated vaccines within 1 week of the start are ineligible to receive everolimus | false | 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 | false |
| 95 | 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 | true | Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment | true | 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 | true | 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 | true | Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 | true | Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) | true | Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or | true | 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) | true | Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age | true | 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 | true | 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 | true | Serum albumin >= 2 g/dL | true | Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled | true | Corrected QT interval (QTc) =< 480 msec | true | 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 | true | 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 | false | 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 | false | Patients receiving corticosteroids are eligible for this trial | false | Patients who are currently receiving another investigational drug are not eligible | false | Patients who are currently receiving other anti-cancer agents are not eligible | false | Patients must not currently be receiving enzyme inducing anticonvulsants | false | 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 | false | 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 | false | 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 | false | Any known hypersensitivity or contraindication to the components of the study drug AZD1775 | false | Patients must not receive metformin for at least 5 days prior to enrollment and for the duration of study treatment | false | Patients must be able to swallow capsules; nasogastric or gastrostomy feeding (G) tube administration is not allowed | false | Patients who have an uncontrolled infection are not eligible | false | Patients who have received a prior solid organ transplantation are not eligible | false | 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 | false | 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 | false | 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 | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 96 | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Stratum 1: patients must not have received radiation therapy | true | 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 | true | 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 | true | 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 | true | 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 | true | Absolute neutrophil count (ANC) >= 1000/ul (unsupported) | true | Platelets >= 100,000/ul (unsupported) | true | Hemoglobin (Hg) >= 8g/dL (unsupported) | true | Alanine aminotransferase (ALT) =< 2.5 x the upper limit of institutional normal | true | Total bilirubin =< x 1.5 upper limit of institutional normal | true | 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) | true | 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 | true | 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) | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | Stratum 1 patients: must not have had > 3 surgical debulking procedures/resections | false | Patients may not have received prior interferon, either systemic or intra-cystic | false | Patients must not have evidence of metastatic tumor or other cancer | false | Patients must not be on steroids other than for physiologic replacement | false | Patients must not have a severe psychiatric illness, including major depression or any previous suicide attempts | false | Patients must not be on phenytoin, warfarin or methadone | false | 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 | false | Subjects with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 97 | 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 | true | 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% | true | 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 | true | Pomalidomide naive disease | true | 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 | true | 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) | true | 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 | true | No other chemotherapy or radiation therapy within 14 days prior to registration | true | No investigational therapy within 14 days prior to registration | true | No major surgery within 28 days prior to registration | true | No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria | true | No platelet transfusions within 7 days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status 0-2 | true | Absolute neutrophil count (ANC) >= 1.0 x 10^9/L | true | Platelet count >= 50 x 10^9/L | true | Calculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection | true | Total bilirubin < 1.5 x upper limits of normal (ULN) | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limits of normal (ULN) | true | Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria | true | 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 | true | =< grade 2 peripheral neuropathy | true | 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 | true | 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 | true | 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 | true | 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 | true | 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% | true | 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 | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status 0-2 | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Absolute neutrophil count (ANC) >= 1.0 x 10^9/L | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L | true | 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 | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN) | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN) | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria | true | RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy | true | 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 | true | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 98 | 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 | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) | true | Absolute neutrophil count (ANC) >= 1.2 x 10^9/L | true | Hemoglobin >= 9 g/dL | true | Platelets >= 100 x 10^9/L | true | Albumin >= 2.5 g/dL | true | Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert�s syndrome | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN | true | Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min | true | 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 | true | Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) | true | 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 | true | 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 | true | 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 | true | 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 | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | false | 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 | false | Study participants with a history of prior treatment with BRAF or MEK inhibitors | false | 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 | false | 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, Sj�gren�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) | false | 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 | false | 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 | false | 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 | false | 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 | false | Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO) | false | 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 | false | Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible | false | 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) | false | 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 | false | 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 | false | Any condition which in the investigator�s opinion makes the subject unsuitable for study participation | false | History of retinal vein occlusion (RVO) | false | History of interstitial lung disease or pneumonitis | false | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 99 | 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 | true | 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) | true | 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 | true | 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 | true | Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or Karnofsky\r\n>= 60% | true | Life expectancy of greater than 2 months | true | 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 | true | Absolute neutrophil count (ANC) >= 1.2 x 10^9/L, within 2 weeks of the first dose of study treatment | true | Hemoglobin >= 9 g/dL, within 2 weeks of the first dose of study treatment | true | Platelets >= 100 x 10^9/L, within 2 weeks of the first dose of study treatment | true | 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 | true | Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN, within 2 weeks of the first dose of study treatment | true | 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 | true | 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 | true | Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO), within 2 weeks of the first dose of study treatment | true | Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study treatment | true | 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 | true | Ability to understand and the willingness to sign a written informed consent document | true | 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 | true | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | 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 | false | 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) | false | 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 | false | 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 | false | Brain metastases that are symptomatic or requiring corticosteroids (except inhaled); subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks | false | 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 | false | Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO) | false | Medical or psychiatric illness/social situations that would limit compliance with study requirements | false | Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with dabrafenib | false | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 100 | 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) | true | Scheduled to receive chemotherapy with an anthracycline (doxorubicin [doxorubicin hydrochloride] or epirubicin [epirubicin hydrochloride]) | true | Patients that are receiving or have received chemotherapy regimens are allowed | true | Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment | true | Able to hold breathe for 10 seconds | true | Eastern Cooperative Oncology Group (ECOG) 0 or 1 | true | Patients with breast implants are usually permitted to have an magnetic resonance imaging (MRI); check with the MRI technician to confirm | true | 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 | true | Alanine aminotransferase level (ALT) =< 3 x the upper limit of normal (ULN), within 30 days prior to enrollment | true | Aspartate aminotransferase level (AST) =< 3 x ULN, within 30 days prior to enrollment | true | Total bilirubin =< 2.0, within 30 days prior to enrollment | true | Thyroid stimulating hormone (TSH) =< 1.5 times ULN, within 30 days prior to enrollment | true | Creatinine kinase =< 2.5 x the ULN, within 30 days prior to enrollment | true | 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 | true | 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 | false | 40 to 75 years of age with diabetes per American College of Cardiology (ACC)/American Heart Association (AHA) ACC/AHA 2013 guidelines | false | Significant ventricular arrhythmias (> 20 premature ventricular contractions [PVCs]/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response | false | Current use of statin therapy | false | Current or history of hepatic dysfunction | false | Uncontrolled hypothyroidism | false | Recent extended history of constant-recurrent substance abuse or another medical condition that might compromise safety or the successful completion of the study | false | Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices | false | 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 | false | Current use of rifampin and digoxin | false | Unable to provide informed consent | false | Symptomatic claustrophobia | false | 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 | false | 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 | false |