CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity* Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
No prior mediastinal or thoracic radiotherapy
Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
Patients must complete all pre-entry assessments
Patients with body mass index (BMI) < 20 kg/m^2
Vegan vegetarians
Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Patients who have met the pre-entry requirements
Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
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)
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
History of allergic reactions attributed to the following: * Camptothecin derivatives (e.g., topotecan [topotecan hydrochloride], irinotecan, or exatecan [exatecan mesylate]) * Any ingredients contained within the liquid irinotecan solution (e.g., sorbitol) or* Any antiemetics or antidiarrheals appropriate for administration with study therapy (e.g., loperamide or dexamethasone)
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)
Known standard therapy for the patients disease that is potentially curative or definitely capable of extending life expectancy
Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)
Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
Patients can not have any neuroendocrine histology in pathology
Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment (transurethral resection bladder tumor [TURBT] and intravesical bacillus Calmette-Guerin [BCG] immunotherapy) or on initial presentation with a T1 high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in severe, active co-morbidity or because the patient refuses BCG therapy
The participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy
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
Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines
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
HLA typing should be performed at registration, if possible
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 * 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)* Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and DQB1* 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
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
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
Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):            * Positive capillary-lymphovascular space involvement and one of the following:                ** Deep third penetration** Middle third penetration, clinical tumor >= 2 cm** Superficial third penetration, clinical tumor >= 5 cm* Negative capillary-lymphatic space involvement                ** Middle or deep third penetration, clinical tumor >= 4 cm
Patients who have met the pre-entry requirements
Patients with postoperative fistula
Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
Have never had acupuncture for xerostomia
Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment
Have received any investigational new drug within the past 30 days or planning to receive such during the study period
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
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
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
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
Patients with a known coagulation disorder are excluded; patients with a first-degree relative with a history of venous thrombosis before age 50 years (yrs) or an arterial thrombosis before age 40 yrs must have the following testing performed prior to enrollment to exclude a heritable disorder; patients with a suspected disorder will be excluded
Patients who have had a thromboembolic event that is not line-related are excluded
Patients must not have more than 10% weight loss in the past 6 months
Signed Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization
Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < 70)
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* Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
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* 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
Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
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* 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
Recurrence score (RS) by Oncotype DX must be =< 25
Patients receiving the initial course of chemotherapy including * Paclitaxel 135 mg/M2 IV over 3 hours on day 1 and * Cisplatin 75 mg/M2 IP on day 2  OR  * Paclitaxel 80 mg/m2 IV days 1, 8 and 15 and * Carboplatin AUC 6 IP on day 1
Patients who are able to comply with the anti-emetic therapy
Patients must have met pre-entry requirements
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
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
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
Study entry PSA should not be obtained during the following time frames:             * 10-day period following prostate biopsy* Following initiation of hormonal therapy* Within 30 days after discontinuation of finasteride* Within 90 days after discontinuation of dutasteride
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days prior to the date of registration
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
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
Fibrolamellar histology HCC, mixed hepatocholangiocarcinoma, hepatic sarcomas and other non-HCC primary liver tumors
History of lobectomy involving > 50% of lobe
Radioembolization within 8 weeks of day 1 dosing of sorafenib
Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required
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)
Able and willing to use the MEMS TrackCap (e.g., not using a pillbox or prescribed liquid 6MP)
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT* Note: COG therapeutic study participation is not required for ACCL10P1 enrollment
Patients with an estimated survival of less than one year are not eligible
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
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)
PROCUREMENT: Diagnosis of Hodgkins or non-Hodgkins lymphoma:* GROUP A: ** With active disease *** In second or subsequent relapse*** In first relapse for indolent lymphoma after first line therapy for relapse*** Or first relapse if immunosuppressive chemotherapy contraindicated*** Primary refractory disease or if persistent disease after first line therapy of relapse** 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* GROUP B:** After autologous or syngeneic stem cell transplant (SCT) (as adjuvant therapy)
TREATMENT: Diagnosis of Hodgkins or non-Hodgkins lymphoma:* GROUP A: ** With active disease *** In second or subsequent relapse*** In first relapse for indolent lymphoma after first line therapy for relapse*** Or first relapse if immunosuppressive chemotherapy contraindicated*** Primary refractory disease or if persistent disease after first line therapy of relapse** 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* GROUP B:** After autologous or syngeneic SCT (as adjuvant therapy)
Men are excluded from this study
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
Breast implants at time of diagnosis; Note: patients who have had implants previously removed prior to diagnosis are eligible
Body mass index (BMI) between 18 and 35 kg/m^2
Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen
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* 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
Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator* 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
Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted
Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry; confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry; please reference the AMC-068 Manual of Procedures (MOP) for further instructions on documenting the diagnosis; the site pathologist for non-Hodgkin lymphoma (NHL) must be approved through the AMC's external quality assurance (EQA) process
Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 4 weeks prior to enrollment
Participants must have a CD4 count performed within 30 days of enrollment
Patients judged capable of tolerating a radical course of chemoradiation therapy
Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
Patients with vulvar melanomas or sarcomas
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
Prior WBRT
All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm
Patients who have met the pre-entry requirements
Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)
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
Patients (at National Cancer Institute [NCI] Community Oncology Research Program [NCORP] Institutions only) must be offered the opportunity to participate in the S1207-E01 Behavioral and Health Outcomes study (BAHO); NOTE: patients who have already started endocrine therapy are eligible for the BAHO study
Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture
Patients must be registered to the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program and must be willing and able to comply with the requirements of the Revlimid REMS program
Patients must have high-risk neuroblastoma
Absolute phagocyte count (APC = neutrophils and monocytes): >= 1000/mm^3
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)
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
>= 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
History of steroid psychosis
History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report
Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed
History of or active glaucoma
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):* Technical contraindications: arteriovenous fistula, including surgical portosystemic shunt or spontaneous portosystemic shunt* Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion* Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease* Presence of extrahepatic disease* 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* Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be > 28 days from study entry* 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)
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Total sum of maximum diameters of each definite parenchymal hepatocellular carcinomas within the liver or maximum diameter of a single conglomerate HCC > 20 cm
More than 5 discrete intrahepatic parenchymal foci of definite HCC
Measureable common or main branch biliary duct involvement with HCC
Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
Minimum provider participation requirements met; this includes participation in the study intervention of a minimum of the following: Site Coordinator and Site Clinician Investigator/study champion
Site Coordinator identification and contact with as many as possible of the sites 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
On-site genetics professionals as defined by the Commission on Cancer
Received HBOC genetic counseling or mutation testing prior to diagnosis; if the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible
The SunCoast Community Clinical Oncology Program (CCOP) Research Base does not exclude patients who are participating in other investigational studies; refer to the local Institutional Review Board (IRB) guidelines
STEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted
STEP I: Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible
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
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
Patients must be pre-menopausal patients within the reproductive age range
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
Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable
Patients that have undergone Tyrosinase immunotherapy
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
The subject has radiographic evidence of cavitating pulmonary lesion(s)
Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible
Patients 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
Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration
All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration
Patients must have received treatment on PBTC-029 or PBTC-029B for a minimum of 12 courses with at least stable disease, or had a sustained response (partial response [PR]/ complete response [CR]) but remained on treatment < 12 courses
Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible
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
Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible
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
Cirrhosis secondary to any cause will be excluded
Patients must not be currently taking (or have taken in the past 6 months) medication for active, chronic conditions, including rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles; this includes analgesic medications or medications being taken with the purpose of treating pain or that may have an effect on pain (e.g. anti-depressants for help with pain or neuropathy, corticosteroid shots for arthritis); (Note: patients taking daily low dose aspirin are allowed to participate in this trial)
Patients must 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 patients 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
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
Patients with only totally implanted CVCs or ports are ineligible
Patients currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study
Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim [TMP]/sulfamethoxazole [SMX]) or encapsulated organisms (penicillin) are eligible
History of allergic reactions attributed to fluoropyrimidines (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine
Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
Atelectasis of the entire lung
Exudative, bloody, or cytologically malignant effusions
Must have baseline donor T cell chimerism of >= 20%
Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to registration
The participant has radiographic evidence of cavitating pulmonary lesion(s)
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
Patients should be capable of achieving imaging without the need for sedation or anesthesia
Must have recovered from the immediate post-operative period
INTRATUMORAL DRUG DISTRIBUTION STUDY PATIENTS:
Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
HEALTHY VOLUNTEER BLOOD DONORS
Willingness to sign the healthy volunteer informed consent form
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
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment
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
History of allergic reactions attributed to fluoropyrimidine (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine
According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration; these guidelines may change pending results from an ongoing food effects study
Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients 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
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
Premenopausal status
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
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
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)
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:* Patient is in second salvage or more and B1931022 has been considered and ruled out as a treatment option; OR* Patient was treated on the standard of care arm of B1931022 and failed therapy
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
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
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine)
Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
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
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 patients medication cannot be switched, the patients eligibility will be determined following a review of their case by the principal investigator
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):* Six or more caf-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)* Freckling in axilla or groin* Optic glioma* Two or more Lisch nodules* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)* A first-degree relative with NF1
Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
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
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible)
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte antigen 4 [CTLA-4]) therapy that has been completely resolved for more than 4 weeks
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
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
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 tumors mutation/aberrant pathway
TREATMENT: Patients who have received prior carboplatin or AZD1775 (MK-1775) would not be excluded unless the two drugs were administered in combination; patients who have received prior carboplatin in combination with AZD1775 (MK-1775) would still be eligible to receive other study treatment regimens based on identified genetic mutation(s), other than carboplatin plus AZD1775 (MK-1775)
TREATMENT: Patients who have 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
Subjects must have completed at least 3 half-life periods from the last dose of monoclonal antibody prior to registration * 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
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
Patients must have evidence of radiographic progression as defined below:* 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* Stratum 2: ** 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** 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
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
The tumor is considered to be radioactive-iodine refractory by any of the following criteria:* Total lifetime dose of radioactive iodine > 600 mCi* 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)* Progression of disease (by imaging or thyroglobulin) within 6 months of radioactive iodine treatment* Fludeoxyglucose F 18 (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= 3) on a FDG-positron emission tomography (PET) scan
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
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* If labs are drawn non-fasting and LDL levels are >= 190 mg/dl the lipid profile should be repeated fasting to determine eligibility
Uncontrolled hypothyroidism
Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Current use of rifampin and digoxin
Symptomatic claustrophobia
Patients with non-malignant pleural effusion are eligible* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:** When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative** Exudative pleural effusions are excluded, regardless of cytology** Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible
Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Hemoglobin >= 10 g/dL (may be transfused but must be stable without clinical evidence of ongoing blood loss or hemolysis)
Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)
Patients who weigh < 10 kg are not eligible
PRE-REGISTRATION
Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations
Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet
RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)
Patients who have adenocarcinomas of the ampulla, distal bile duct, and duodenum
Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
Sexually active fertile men not using effective birth control if their partners are WOCBP
Patients must NOT be taking metformin or have been on metformin in the past 6 months
Biopsy-proven HSIL (anal intraepithelial neoplasia 2 [AIN2] with a positive p16 stain, AIN 2-3, or AIN3) of the anal canal at either the squamocolumnar junction or distal anus, documented within 60 days prior to enrollment, but not less than 7 days prior to randomization
HSIL comprising 2 or more lesions, or anal HSIL in at least 2 octants, or anal HSIL that has recurred or is persistent after prior ablative treatmentNote: HSIL should be in the anal canal at either the squamocolumnar junction or distal anus on HRA at screening or randomization; the extent of HSIL should be based on available biopsy results and visual appearance
Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of HSIL at any point, use of intra-anal or topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of condyloma within 6 months prior to randomization or perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5% within 6 months prior to randomization
Extensive concurrent perianal or lower vulvar HSIL or condyloma requiring a different treatment modality than the study treatment, or treatment that cannot be deferred in observation arm, per examining provider
Condyloma occupying more than 50% of the circumference of the anal canal or that obscures a satisfactory exam
Treatment for anal or perianal HSIL, low-grade squamous intraepithelial lesion (LSIL) or condyloma within 4 months of randomization; please note that infrared coagulation (IRC) or electrocautery of a biopsy site to stop bleeding does not constitute treatment
Patients must be off all non-cytotoxic chemotherapies or biologic agents (e.g. azacitidine, decitabine, histone deacetylase inhibitors, tyrosine kinase inhibitors, hematopoietic growth factors, interferon, but excluding hydroxyurea and cyclophosphamide) for at least 2 weeks prior to starting induction chemotherapy
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs in the past
Patients have failed at least one previous induction course of intravesical BCG, defined as histologically confirmed persistent or relapsing tumor present on post-BCG endoscopic evaluation; all BCG failures will be considered for inclusion into the study, including BCG-refractory, -resistant, and -relapsing; for the purposes of the study, BCG-refractory and BCG-resistant subjects will be considered to have BCG-persistent disease
Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
Patients unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day 1 vaccination: (a) children =< 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczematoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV)
Proteinuria =< +1 on dipstick or =< 1 gram/24 hours
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk
Potassium > 3 and < 5.5 mEq/L
Patients with history of activating RAS mutation positive tumors regardless of interval from current study; however, patients may have concurrent BRAFV600 and RAS mutations in the tumor to be treated with protocol therapy
Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
Radioactive iodine (RAI)-refractory disease defined as 1 or more of the following:* Patients who have received greater than 600 mCi of radioactive iodine in their lifetime OR* RAI-avid metastatic lesion which remained stable in size or progressed despite RAI treatment within 9 months of RAI treatment OR* 10% or more increase in serum thyroglobulin (on thyroid-stimulating hormone [TSH]-suppression) within 9 months of RAI treatment OR* Index metastatic lesion non-RAI avid on a diagnostic RAI scan OR* Presence of fluorodeoxyglucose (FDG) avid metastatic lesions on positron emission tomography (PET)/CT scan (standardized uptake values [SUV]max > 5 of any single lesion)
Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form
SUB-STUDY REGISTRATION:
Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible
Patients with B-lymphoblastic lymphoma (B-LL) are not eligible
Patients with undetectable pre-treatment plasma EBV DNA
Biopsy-proven anal HSIL at baseline (anal intraepithelial neoplasia [AIN]2 with a positive cyclin-dependent kinase inhibitor 2A [p16] stain, AIN2-3, or AIN3)
At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study
Men randomized to the treatment arm should not father a baby while receiving topical treatment during this study; men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
Treatment or removal of HSIL less than 6 months prior to randomization
Participant has symptoms related to HSIL and would benefit more from immediate treatment than from entry into the study and potential for randomization to active monitoring arm
Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
Participant plans to relocate away from the study site to a location that does not have an Anal Cancer/HSIL Outcomes Research (ANCHOR) study site during study participation
Patients with cataracts on ophthalmologic examination
Patient must have relapsed or refractory myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria for symptomatic myeloma (although new or worsening end organ damage is not required to be eligible) as defined below:* Presence of clonal bone marrow plasma cells* Presence of serum and/or urinary measurable monoclonal protein or light chains* Evidence of any end organ damage criteria listed below (at any time) attributed to the patients myeloma:** Hypercalcemia: serum calcium > 11.5 mg/dL or** Renal insufficiency: serum creatinine > 2 mg/dL** Anemia > 2 g/dL below the lower limit of normal or a hemoglobin value < 10 g/dL** Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
Patients must agree not to donate blood, sperm/ova during the course of taking protocol therapy and for at least 4 weeks after stopping treatment
In both the above cases, the lesion considered at highest risk for recurrence based on the investigator's discretion will be used for eligibility determination
Documented germline mutation in BRCA1 or breast cancer 2, early onset (BRCA2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); local germline (g)BRCA testing results, if available, will be used for establishing eligibility; if local gBRCA testing results are not available, central testing will be provided for those patients who otherwise appear to be eligible
Involvement in the planning and/or conduct of the study
Patients who do not have deleterious or suspected deleterious gBRCA1 and/or 2 mutations but only have BRCA1 and/or BRCA2 mutations that are considered to be non-detrimental (e.g., variants of uncertain clinical significance or variant of unknown significance or variant, favor polymorphism or benign polymorphism etc.)
Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients
Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index* Favorable genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above* Unfavorable genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)* Only patients with MYCN non-amplified tumors are eligible for this study
Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:* No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise* No prior tumor resection, tumor biopsy ONLY* Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1
Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
All metastases not resected must be amenable to SBRT
The patient must meet ONE of the three following criteria:* 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR* 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR* 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed
Metastases with indistinct borders making targeting not feasible
Prior palliative radiotherapy to metastases
T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
Patients may be treated with bone modifying agents such as bisphosphonates or RANK-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
Patients must have no known allergies to exemestane, entinostat, or medications that have a benzamide structure (e.g., tiapride, remoxipride, clebropride)
Patient must have 1 lesion with a maximum AXIAL diameter of 12 cm; up to 3 satellite lesions are permitted; satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (GTV) are permitted; the satellite lesions are NOT included in the AXIAL diameter measurement; regional lymph node involvement within the porta hepatis (as medial as superior mesenteric vein [SMV] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. fludeoxyglucose F 18 [FDG] avid)
Multiple lesions that dont meet the criteria as satellite lesions
Extrahepatic metastases or malignant nodes beyond the periportal region; celiac, pancreaticoduodenal and para-aortic nodes > 2 cm are ineligible; note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
Maximum diameter exceeding 12 cm (maximum diameter does not include satellite lesion)
Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Patients must agree to participate in the translational medicine studies
ARM I ONLY: For patients with presumed localized disease (any T, N0, M0), a multiparametric MRI (standard of care at the National Institutes of Health [NIH] Clinical Center) must be performed within 4 months of the 18F-DCFBC injection with findings suggestive for prostate cancer and a prostate lesion at least 6 mm or greater; must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Patients must be undergoing surgery that is clinically indicated as determined by their care providers
HbA1c =< 7.0%
For Dose Expansion Cohort: HCC patients only: HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria; all of the following criteria must be met or a biopsy is required:* Known cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection* Hypervascular liver masses > 2 cm, and either serum alpha-fetoprotein (AFP) > 400 ng/ml* AFP > three times normal and doubling in value in the antecedent 3 months* In the expansion cohort, prior treatment with sorafenib as first-line therapy allowed
Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients with Burkitt's (L3) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have relapsed or refractory diagnoses* NOTE: Relapsed/refractory Ph-positive patients or Ph-like patients with dasatinib-sensitive mutations or kinase fusions who have previous exposure to either dasatinib or another 2nd or 3rd generation TKI will begin protocol therapy with Cohort 2: re-induction cycle 1
Cohort I, Ph-negative Patients Only
It is preferred, but not required, that corticosteroids and hydroxyurea should start only after all diagnostic samples have been obtained; however, if the patient was previously on corticosteroids and/or hydroxyurea, this is allowable provided that the patient still has measurable disease at time of the bone marrow aspirate* Corticosteroids and/or hydroxyurea, as well as any of the other therapies mentioned (with the exception of IV cyclophosphamide), may continue to be administered, at physician discretion, until 1 day prior to blinatumomab administration** IV cyclophosphamide must be discontinued at least 7 days prior to blinatumomab administration
Cohort 2, Ph-positive and Ph-like DSMKF Patients Only
Patients must agree to have specimens submitted for blinatumomab immunogenicity testing if subsequently moved to a blinatumomab containing treatment regimen on protocol
The tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
As of Amendment 2, if the registering site is a photon center (registering patients to group I), the patient must agree to participate in the advanced imaging sub-study
Recurrent or multifocal malignant gliomas
Any site of distant disease (for example, drop metastases from the GBM tumor site)
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration
Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter
RAI-refractory disease on structural imaging, defined as any one of the following:* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed prior to enrollment in the current study, or* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion* The presence of at least one fluorodeoxyglucose (FDG) avid lesion
Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration; those that have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been cleared after the last intravenous contrast administration
Glycosylated hemoglobin (HbA1c) < 7.0%
Concurrent use of herbal supplements and other non-traditional medications; all herbal supplements and other non-traditional medications must be stopped before time of registration
History of any of the following within 6 months prior to start of MLN0128:
Requirement of inotropic support (excluding digoxin)
Presence of unstable atrial fibrillation (ventricular response > 100 beats per minute)
History of arrhythmia requiring an implantable cardiac defibrillator
Placement of a pacemaker for control of rhythm
Use of hematopoietic colony-stimulating growth factors (e.g. filgrastim [G-CSF], sargramostim [GMCSF], lanimostim [M-CSF]) =< 2 weeks prior to starting study drug; erythropoietin, darbepoetin and erythropoietin-biosimilars are allowed for as long as they have been initiated at least 2 weeks prior to study enrollment
Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody [ANA], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
Patients with nodular lymphocyte-predominant HL
ELIGIBLE SITES:* Extremities: upper (including shoulder) and lower (including hip)* Trunk: body wall
After completing one cycle of therapy, patients will be registered for randomization between intermittent and continuous dosing, provided that they were eligible for the initial step 1 registration and satisfy the following criteria
Patients must be registered to step 2: randomization within +/- 5 days of starting cycle 2; patients MUST NOT be registered prior to the day 56 disease assessment
Serum albumin must be planned to be collected after admission, but prior to treatment
Patients must consent and provide both their contact information and that of their representative for a monthly 24-hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab
No history of cornea abnormalities
Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment; tumor may have originated in any primary site* NOTE: in rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established; this would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels [HCG >= 500; AFP >= 500] and typical pattern of metastases)
Must have adequate recovery from prior surgery (e.g., healed scar, resumption of diet, etc.)
No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression
Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib
The patient must have met all eligibility criteria (except as detailed below) at the time of crossover* RECIST defined measurable disease is not required* Only prior systemic therapy as part of step 1 is allowed; patients who received allowed systemic therapy in the adjuvant setting prior to Step 1 and were eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other eligibility criteria* Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment* History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy* Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who underwent surgery or SRS to CNS metastases need not be off of steroids to start treatment * There is no restriction on serum LDH at crossover* Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover
Male and female patients must agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenic purpura (ITP) resulting in (or as evidenced by) declining platelet or hemoglobin (Hgb) levels within the 4 weeks prior to first dose of study drug
Presence of transfusion-dependent thrombocytopenia
Maximum diameter of individual metastasis in any dimension =< 5 cm
There are no restrictions on distance between the metastases
Metastases with indistinct borders making targeting not feasible* NOTE: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physicians judgment will be required
Exudative, bloody, or cytological proven malignant effusions
The subject has radiographic evidence of cavitating pulmonary lesion(s)
Prior participation in this study
Full anti-coagulant therapy Coumadin; patients may be receiving therapeutic Lovenox, Fragmin, or other heparin product that does not require laboratory monitoring
A single, biopsy-proven SISCCA as defined by the LAST criteria (=< 3 mm depth of invasion, horizontal spread of =< 7 mm, and completely excised with at least 1 mm margin clear of cancer irrespective of the amount of HSIL) documented per investigator assessment in combination with the pathology report within 16 weeks before Segment B enrollment
Clinician believes that eradication of concomitant HSIL is reasonable and feasible based on the extent of disease and overall medical condition of the participant
Prior to Segment B enrollment, participants on combination anti-retroviral therapy (cART) will be required to have a minimum CD4 count of >= 200 and participants not on cART will be required to have a minimum CD4 count of >= 350 to be eligible for the study; participants not currently on cART who have a CD4 count >= 200 and who agree to start cART immediately will be eligible for participation; laboratory data should be obtained within 16 weeks prior to Segment B enrollment
Participants must have organ and marrow function within the following parameters within 16 weeks before Segment B enrollment:
Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
The participants SISCCA must not have been ablated
Concurrent anal canal or perianal HSIL or condyloma that in the judgment of the clinician cannot be cleared or can only be cleared with undue morbidity to the participant
Participant plans to relocate away from the study site during study participation
Prior treatment, involving interferon, anakinra, imatinib, steroids, chemotherapy with, but not limited to cladribine, vinblastine, 6-mercaptopurine and etoposide, or other medications used empirically for the treatment of ECD, will be acceptable; these therapies should have been completed and discontinued 4 weeks or more prior to enrollment in this study
Patients with history of rat sarcoma (RAS) mutation-positive tumors are not eligible regardless of interval from the current study; Note: RAS testing and absence of RAS mutation are required for eligibility
Inability to travel to the National Institutes of Health (NIH) Clinical Center
Patients with wild type BRAF gene molecular results on ECD affected tissue
Patients must have high grade upper tract urothelial carcinoma proven by one of the following:* Biopsy;* Urinary cytology with a 3-dimensional upper urinary tract mass on cross-sectional imaging; or* Urinary cytology and a mass visualized during upper urinary tract endoscopy
Patients with concomitant primaries of the bladder/urethra are allowed, as long as these sites are surgically resected and non-invasive cancers (< cT1N0)
Patients who have been previously treated with MET or vascular endothelial growth factor receptor (VEGFR) inhibitors (except for patients on renal cell cancer [RCC] cohort) are not eligible for the expansion cohorts but can enroll in the phase I portion
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
Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
Patients must not be planning to receive any other investigational agents during the course of protocol treatment
After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible:* Score >= 8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)-Anxiety/Depression Scale OR* Score >= 4 on the Distress Thermometer OR* Score > 5 on the Modified Cancer Acceptance Scale
Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
Any change in psychotropic medications in past 30 days
No prior carboplatin unless given in neoadjuvant/adjuvant setting for curative intent and more than 6 months have elapsed since last carboplatin dose; in the case of relapsed ovarian cancer, patients are eligible if more than 6 months have elapsed since last carboplatin dose
Has a study site-specific nurse available to act as a PN or has a (study site-specific or shared) nurse available to act as a clinical consultant to a study site-specific, non-nurse navigator* Study sites randomized to the Intervention Arm are not eligible to register subjects (nor administer the protocol intervention), until the sites identified PN(s) has/have completed the protocol-specific navigation training
STUDY PARTICIPANT ELIGIBLITY:
African American or Black race
Recently diagnosed (i.e., within 70 days of enrollment) with clinically suspicious or biopsy-proven early stage (i.e., stage I-II) NSCLC; the inclusion criteria will be operationalized as follows:* Recently diagnosed (i.e., within 70 days of definitive tissue biopsy) biopsy-proven NSCLC* Recently diagnosed (i.e., within 70 days of clinical diagnosis) probable NSCLC where probable NSCLC is defined as a suspicious lung nodule for which the patient was referred for** Invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR** Surgical or radiation oncology consultation and date of clinical diagnosis is defined as (whichever comes first)** Date of referral for invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR** Date of referral for surgical or radiation oncology consultation* Study sites should enroll patients that meet either of the above inclusion criteria as early as possible during the diagnostic work-up (i.e., if the patient meets the criteria for recently diagnosed, clinically suspicious NSCLC, definitive tissue biopsy is not required for eligibility)
Evaluated/treated for NSCLC at an eligible study site
Currently in hospice care
Failure to respond to corticosteroids, defined as:* Progression of chronic GVHD despite optimal first line therapy (> 0.5 mg/kg/day of prednisone dose equivalent [PDE] for two weeks) or* No improvement after 4-8 weeks of sustained therapy; sustained therapy should include 2 weeks of > 0.5 mg/kg/day of PDE or* Inability to taper steroid dosage to less than 0.5 mg/kg/day of PDE without worsening of chronic GVHD or * Need for second or third line therapy beyond corticosteroids and calcineurin inhibitors or sirolimus, irrespective of other criteria
Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study
The following baseline neurocognitive assessments must be completed prior to Step 2 registration: HVLT-R, TMT, and COWA; the neurocognitive assessment will be uploaded into the NRG RAVE System for evaluation by Dr. Wefel; once the upload is complete, within one business day a notification will be sent to proceed to Step 2; NOTE: completed baseline neurocognitive assessments can be uploaded at the time of Step 1 registration
Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg/dL, then BUN up to 30 mg/dL is permitted)
Current alcohol or drug abuse (may exacerbate lethargy/dizziness with memantine)
Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan
Participants must have biopsy-proven KS involving skin with or without visceral involvement
Participants must have cutaneous lesion(s) amenable to four (4) 5-mm tumor biopsies during the study (either 4 separate lesions measuring >= 5 mm each OR 2 separate lesions measuring >= 10 mm each) and at least five additional lesions measurable for assessment with no improvement over the past month
Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications
Glycosylated hemoglobin measurement (HbA1c) < 7.0%
Women of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN0128 (TAK-228)*Female patients must:** Be postmenopausal for at least 1 year before the screening visit, OR** Be surgically sterile, OR** If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g., United States product insert [USPI], summary of product characteristics [SmPC], etc.;]) after the last dose of study drug, OR ** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR ** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)** AND agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
Arm B (first stage of phase II of TRC102 and pemetrexed): patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline; intervening treatment is allowed
Prior pemetrexed is allowed except Arm A dose level 4 (cisplatin 75 mg/m^2)
All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:* By pathologic evaluation, primary tumor must be pT1-3* By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b* If pN0, pathological tumor must be >= 3.0 cm
All races and ethnic groups are eligible for this study
Patients of childbearing or child fathering potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity while being treated on this study and for 6 months after the last dose of study medication
Clinical picture indicative of leukostasis or evidence of disseminated intravascular coagulopathy
Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration
Participants must have disease that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains or by minimal residual detection; measurable disease is defined as one or more of the following:* Serum M protein > 0.5 G/DL, or* Urine M protein > 200 MG/24H, and/or* Serum free light chain (FLC) assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio* >= 50 plasma cells detectable by multicolor flow cytometry, at a sensitive level of 10^-4 (determined by central review)
History of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide, or similar drugs
Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor [AI], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed
Medically stable as judged by patients physician
The PN must be inoperable, defined as a PN that cannot be surgically completely removed without risk for substantial morbidity due to: encasement of or close proximity to vital structures, invasiveness, or high vascularity of the PN; the PN either causes morbidity or it is growing and has the potential to cause morbidity such as (but not limited to): head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or are significantly disfiguring, and lesions of the extremity that cause limb hypertrophy or loss of function or pain; PN growth will be defined as a >= 20% increase in PN volume within approximately 3 years prior to enrollment on this trial
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (patients who are wheelchair bound because of paralysis secondary to a plexiform neurofibroma should be considered ambulatory when they are up in their wheelchair; similarly, patients with limited mobility secondary to need for mechanical support (such as an airway PN requiring tracheostomy or continuous positive airway pressure [CPAP] will also be considered ambulatory for the purpose of the study)
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Supplementation with vitamin E greater than 100% of the daily recommended dose
Participants with clinical or radiographic evidence of pancreatitis are excluded
Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms; in addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded
Concurrent treatment with any anticancer agent outside of this protocol
Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer associated disseminated intravascular coagulation [DIC])
Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in dwelling catheters
Patients receiving bisphosphonates
Hemoglobin A1C (HBA1C) < 7.0%
Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields
Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed
Patients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consent
Patients must NOT have absorption issues that would limit the ability to absorb study agents
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
Patients who cannot tolerate pneumocystis jirovecii pneumonia (PJP) prophylaxis (i.e., known Bactrim and pentamidine allergies)
Recent initiation of bone modifying therapy with a bisphosphonate or denosumab unless it has been started more than 4 weeks prior to the first dose of the study regimen; patients who are already enrolled in this study can initiate bone modifying therapy after the first set of re-staging scans (>= 8 weeks from cycle 1, day 1)
Hemoglobin A1C (HbA1C) < 7.0%
Relapse after SCT is allowed but no active graft-versus-host disease (GVHD) as per treating physician; also must not exceed the number of prior induction regimens listed above; SCT does not count as line of therapy
There are no prohibitions of specific medications on the basis of anticipated drug-drug interactions
Glycosylated hemoglobin (Hb A1c) =< 7%
Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of registration and must agree to:* Practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 120 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc.;]) after the last dose of study drug, OR* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together
Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:* Practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together* Not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
Consumption of grapefruit or grapefruit juice is not permitted during the study; patients should not consume food or beverages containing the fruit or juice of grapefruits or Seville oranges within 7 days before the first dose of study drug and throughout the study
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
Have contraindications to functional testing or yoga participation according to the treating physician or the physician's designee
Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
Be planning to start yoga on their own during the time they are enrolled in the study
Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable
Any history or evidence of opportunistic infection within 6 months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
Patients with a weight of < 39 kg
Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized
A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation
Symptomatic brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where symptomatic is defined as:* New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits* Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg daily for 1 week
Blood urea nitrogen measurement (BUN) < 30 mg/dL
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration;* High-grade neuroendocrine carcinoma or combined SCLC and non-small cell lung cancer (NSCLC) is permitted
The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (parts A and B), and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, within 3 business days, a notification will be sent to the site to proceed to Step 2 registration; at minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible
Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall. as determined by central assessment by the Neurocognitive Co-Chair, Dr. Wefel
AST (SGOT)/ALT(SGPT) (only if elevated liver function tests [LFTs] are due to disease) =< 5.0 x institutional upper limit of normal
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10  14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below
Patients with uncontrolled hyperglycemia
Patients with uncontrolled hyperlipidemia
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* There will be no exclusion of patients with known visual impairment or symptoms, including by not limited to peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; patients will have a baseline ophthalmologic exam to serve as a point of comparison and further exams as needed should visual symptoms develop; no pretreatment eye exam findings or ocular symptoms have been associated with an increased risk of ocular toxicity seen with AT13387
History of noncompliance to medical regimens
Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration
Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) resulting in (or as evidenced by) declining platelet or hemoglobin (Hgb) levels within the 4 weeks prior to first dose of study drug
Presence of transfusion-dependent thrombocytopenia
Prior exposure to ibrutinib or other ITK inhibitors
Biopsy-proven intermediate or high-grade non-Hodgkins lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):* In partial remission* Relapsed after initial complete remission* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)* In complete remission with high-risk features as specified by the International Prognostic Index
Biopsy-proven advanced stage mantle cell lymphoma with proliferation-related Ki-67 antigen (Ki-67) > 10% in first complete remission (timeline 8 months prior to enrollment)
Biopsy-proven Hodgkins lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment)* In first, or greater relapse after initial complete remission* In partial remission* Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease)
Biopsy-proven Burkitts lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment):* In second complete remission after relapse following initial complete remission* Failed induction therapy, but responds (very good partial remission, complete remission, or near complete remission) to salvage therapy (i.e., chemosensitive disease)
Must be on a multi-drug anti-HIV regimen (excluding zidovudine [AZT, ZDV, Retrovir], or agents containing zidovudine [e.g., Combivir and Trizivir], and efavirenz [Sustiva], or agents containing efavirenz [e.g., Atripla]), and have an HIV-1 viral load < 50 copies/mL by reverse transcriptase-polymerase chain reaction (RT-PCR) within 6 months prior to study enrollment; for patients who have had negative viral loads in the past 6 months and no known HIV viral load (VL) > 500 copies/mL within the past 6 months, minor fluctuations of viral load (isolated escalations up to 500 copies/mL) are acceptable; the participant's history of negative viral loads may be documented with recent laboratory results and/or a record from the participant's HIV care provider; participants on zidovudine [AZT, ZDV, Retrovir; including Combivir and Trizivir] and efavirenz [Sustiva; including Atripla] must switch to an alternative regimen without anticipated drug-drug interactions or myelosuppressive properties based on known viral resistance patterns and/or ART history, such as raltegravir and Truvada (emtricitabine and tenofovir) at least two weeks prior to the transplant
Participants with CD4 counts > 50/microL are eligible for this study if their viral load is < 50 copies/mL by reverse transcription polymerase chain reaction (RT-PCR) since majority of the participants have received aggressive chemotherapy that can potentially decrease the CD4 counts despite the ART therapy; timeline: within 3 weeks prior to start of trial
Participants with hepatitis B should be on appropriate anti-viral therapy at the time of the transplant, and their viral load should be negative; timeline: within 3 weeks prior to enrollment
Participants with unexplained anemia, and/or thrombocytopenia
Participants with clear evidence of myeloproliferative disorders, or myelodysplastic disorders in the marrow
Active cytomegalovirus (CMV) retinitis, or other active CMV-related organ dysfunction
Dementia of any kind
Any medical or physical contraindication, or other inability to undergo hematopoietic progenitor cell (HPC) collection
Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity
Patients with 1-3 brain metastases, each < 3 cm by contrast MRI, with stable systemic disease and ECOG score of 0-2, who would otherwise be eligible for SRS/stereotactic radiation therapy (SRT) alone should not be enrolled into this study unless WBRT is recommended due to any medical reasons or logistic limitations as determined by the treating physician; patients who develop recurrence post-SRS/SRT or surgery alone and are recommended WBRT will be eligible for the protocol
Presence of diffuse leptomeningeal carcinomatosis (focal/localized involvement is acceptable), > 1 cm mid-line shift, uncal herniation or significant hemorrhage/hydrocephalous (small intra-lesional hemorrhage is acceptable); patients with seizure at presentation who have been started on levetiracetam and have been stable for 48 hours prior to study registration are eligible at the discretion of treating physician
Patients must not have received prior WBRT (previous SRS/SRT done at least 4 weeks from the planned start of WBRT is acceptable); patients planned upfront to undergo SRS/SRT/fractionated boosts or neurosurgery after WBRT are not eligible; however, these treatments/procedures can be performed once the dose limiting toxicity (DLT) assessment has been completed, if felt clinically necessary
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the studys principal investigator, Dr Mohindra at the University of Maryland
Classical Hodgkin lymphoma* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin nave but is ineligible or unable to receive brentuximab vedotin; and* May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)
On an effective combination cART regimen, generally a 3-drug regimen based on Department of Health and Human Services (DHHS) treatment guidelines* Patients must be on cART >= 4 weeks; and* Evidence of viral suppression defined as HIV viral load < 200 copies/mL; and * No symptomatic AEs > grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) criteria probably or definitely attributed to cART; and* No laboratory AEs noted on protocol defined screening laboratories > grade 1 by CTCAE criteria probably or definitely attributed to cART, with exceptions noted below* Note: if cART is modified during the screening period, patients must be on an effective new regimen for >= 2 weeks and otherwise meet eligibility criteria* Most patients have viral loads that are suppressible to < 50 copies/mL, but about 25% of patients will occasionally have blips up to 400500 copies/mL, which do not appear to correlate with lack of viral suppression in most studies; thus, an HIV viral load of =< 400 copies/mL for an occasional blip will be allowed, if there is documentation of an HIV viral load < 200 on the same regimen and no significant treatment interruption
Patients must have marrow function and organ function as defined below* Note: to remain on treatment, any abnormal lab values allowed by the PI must remain stable or improve during treatment; similar off treatment rules will be applied to all patients, except the following: the grade of any abnormal laboratory (lab) value allowed by the protocol principal investigator (P.I.) at enrollment will be considered the patients baseline for potentially resuming therapy after modification/holding of therapy when off treatment criteria are applied
Creatine kinase < 5 X institutional ULN
Blood urea nitrogen (BUN) < 25 mg/dL
Patients must have adequate tissue available and must agree to have specimens submitted for germline BRCA deoxyribonucleic acid (DNA) sequencing and other correlative studies* NOTE: Blood for BRCA mutation testing is to be collected and submitted after registration but before treatment
The preoperative Memorial Sloan-Kettering (MSK) nomogram estimates the patients likelihood of freedom from metastatic recurrence within the first 12 years following radical or partial nephrectomy to be =< 80%
Scheduled to undergo nephrectomy as part of treatment plan, per assessment through an MSK urologic surgeon listed as investigator on this trial
Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
Neutrophils >= 1000/uL
To be eligible for the dose-finding phase: (the dose-finding phase completed in 12/2016) * Relapsed patients** Patients must be in first relapse, and** Patients must not have received prior re-induction therapy* Refractory patients** Patients must not have received more than one attempt at remission induction, which may consist of up to two different therapy courses; Children Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is an example* Treatment-related AML (t-AML)** Patients must be previously untreated for secondary AML
To be eligible for the phase 2 efficacy phase:* Relapse patients:** Patients must be in first marrow relapse, and ** Patients must not have received prior re-induction therapy; donor lymphocyte infusion (DLI) is considered a re-induction attempt
Patients with prior allergy to daunorubicin and/or cytarabine
Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required; (subjects with bilateral total mastectomies do not require imaging)
No diabetes mellitus currently treated with insulin or sulfonylureas
No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement; moderate arthritis that does not preclude physical activity is not a reason for ineligibility
BMI >= 27 kg/m^2 documented within 56 days prior to study registration; the most recent body mass index (BMI) obtained must be used for eligibility; if most recent BMI is < 27 then the patient is not eligible to enroll
Self-reported ability to walk at least 2 blocks (at any pace)
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment* Note: A list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
NON-PROGRESSED DIPG (STRATUM 2): BSA* Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2* Patients must have a BSA >= 0.65 m^2 for doses of 10mg/m^2 - 22 mg/m^2* Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2 - 36 mg/m^2
Children are excluded from this study, but will be eligible for future pediatric trials
Prior exposure to gemcitabine
Documentation of HTLV infection (enzyme linked immunosorbent assay [ELISA]) in individual with confirmation of HTLV-1 infection (by immunoblot or polymerase chain reaction [PCR]) or a consistent clinical picture (including two of the following: 1) CD4+ leukemia or lymphoma, 2) hypercalcemia, and/or 3) Japanese, Caribbean or South American birthplace)
Current or prior HTLV-1 associated inflammatory diseases, including but not limited to myelopathy, uveitis, arthropathy, pneumonitis, or a Sjogrens disease-like disorder
CLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazetts formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation
(STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
Patients must have been assigned to S1400I
Chronic diarrhea as defined by loose or watery stools occurring more than 3 times daily at baseline lasting more than 4 weeks or not abating on condition-appropriate therapy prior to study enrollment
Patients must have measurable or evaluable disease; NOTE: All patients with greater than 10% abnormal CD4+ homogeneous CD3^low strongly CD25+ expressing cells, or greater than 5% Sezary/T-PLL cells, among the peripheral blood mononuclear cells (PBMCs) in the peripheral blood will be deemed to have evaluable disease
Abnormal T cells must be CD52+ as assessed by flow cytometry or immunohistochemistry
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible)
Patients with smoldering and lymphomatous ATL
Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Males and females must weigh >= 40 Kg
Uncorrected primary obstructive or severe regurgitative valvular disease:* Nondilated (restrictive); or* Hypertrophic cardiomyopathy; or* Significant systemic ventricular outflow obstruction
Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device
Bradycardia: heart rate < 50 beats per minute (BPM)
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment
Gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Centers Glycemic Target Goals is hemoglobin A1C < 7%)
Patients must be enrolled within 1 year after diagnosis
Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
Diabetic patients (type I or II diabetes mellitus) must have baseline hemoglobin (Hb)A1c levels NOT higher than 8.5% at study entry
Concurrent diagnosis of pheochromocytoma
Grapefruit and grapefruit juice (CYP3A4 inhibitor), Seville oranges and star fruit consumption is not permitted during the study
Anti-arrhythmic therapy other than beta blockers or digoxin
Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies
Concomitant radiotherapy
Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization* If biopsy was performed as part of patients standard care, and will not be performed during step 0 proceed directly to randomization
Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or (if preoperative biopsy was uninformative) - unknown histology; RCC must have been confirmed by biopsy within 4 months prior to randomization; if the biopsy clearly demonstrated a benign condition or a different type of cancer, the patient is not eligible to be randomized
Patients must have no clinical or radiological evidence of distant metastases (M0)
No uncontrolled adrenal insufficiency
Patients must not have received prior intravesical BCG or intradermal BCG
Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml); for PPD readings done outside of 48-72 hour window, patients must have PPD test and reading repeated to confirm eligibility
Patients with a history of allergy to medications that have a benzamide structure (e.g., metoclopramide, procarbazine, domperidone, cisapride etc.) are not eligible
History of allergic reactions to SGI-110 or decitabine
Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy.
Cutaneous metastasis of NSCLC.
Patients with malignant pleural effusions that do not resolve after first-line systemic therapy. Patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line systemic therapy.
Patients with major skull defects (such as missing bone without replacement) are not eligible
Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed
Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters
Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
Patients that do not qualify for one of the histologic cohorts may be considered for registration in the Not Otherwise Categorized Rare Tumors cohort with confirmation of at least one of the study chairs via email
Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
Prior radiotherapy to the abdomen or pelvis
Patients must have substantial cutaneous neurofibroma burden causing distress to the patient by disfigurement or itching; patients must have >= 9 measurable cutaneous neurofibromas; for the purpose of this study measurability will be defined for each of the lesions selected as target lesions as a neurofibroma with a longest diameter >= 4 mm in the longest diameter
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
No supplementation with vitamin E is permitted
For a clinical diagnosis of NF1 patients must have at least two of the diagnostic criteria for NF1 listed below:* Six or more cafe-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)* Freckling in axilla or groin* A neurofibroma or plexiform neurofibroma* Optic glioma* Two or more Lisch nodules* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)* A first-degree relative with NF1
Progressive disease: GIST has demonstrated progression as defined by RECIST v1.1 within the past 12 months; patients whose tumors do not meet this criterion, and have a diagnosis of NF1, may enroll on the NF1 natural history study
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Patients with a diagnosis of NF1 and GIST who do not meet other eligibility criteria may enroll on the NF1 natural history study, and will be followed on this study; should they require therapy for GIST based on evidence of progression, they may then enroll on study
No supplementation with vitamin E is permitted because the selumetinib capsules contain vitamin E
Patients must have had cytology within 21 days prior to registration; cytology for patients with CIS component is not expected to be negative for malignant cells; if the cytology for patients with only Ta/T1 disease is positive for malignant cells, patient must have had a biopsy of the prostatic urethra within the previous six months
Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of care for these patients; the reason for patients not to undergo cystectomy will be clearly documented
Patients must be BCG-unresponsive; a patient is BCG-unresponsive if they meet one or more of the following criteria:* Patient has persistent or recurrent high-grade Ta/CIS urothelial carcinoma after completing therapy with at least induction BCG (>= 5 doses) and first round maintenance or second induction BCG (>= 2 doses)* Patient has high grade T1 urothelial carcinoma after induction BCG (>= 5 doses) only or after induction BCG (>= 5 doses) and first round maintenance or second induction BCG (>= 2 doses)* Patient is disease-free at 6 months after starting BCG (i.e., complete response) but then experiences a high-grade recurrence within 6 months after the last BCG dose
Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection
Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study
Burkitt morphology
Fulminant PTLD defined as: fever > 38 degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following: * Bone marrow (including pancytopenia without any detectable B-cell proliferation) * Liver (coagulopathy, transaminitis and/or hyperbilirubinemia)* Lungs (interstitial pneumonitis with or without pleural effusions)* Gastrointestinal hemorrhage
Any documented donor-derived PTLD
Prior ACT infusion within 6 months of study enrollment (cohorts include ACT with tumor infiltrating lymphocytes [TIL], human leukocyte antigen [HLA]-class I T cell receptor [TCR]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor [CAR]-engineered T cells)
Patients with Philadelphia chromosome (Ph) positive (+) pre-B cell ALL OR Ph+ MPAL will be eligible if they have been refractory to or intolerant of treatment with at least 1 second-generation or third-generation tyrosine kinase inhibitor (TKI)
Patients who were treated with blinatumomab in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells and did not experience unacceptable toxicities with prior blinatumomab administration; patients who were treated with chimeric antigen receptor (CAR)-modified T cells targeting CD19 in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells
Clinical stage T2-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging
Females of childbearing potential who are sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; female patients should also refrain from breastfeeding throughout this period
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; male patients should refrain from sperm donation throughout this period
Body weight > 30 kg
If post allo-HCT, then patient must have baseline donor T cell chimerism of >= 20% (from peripheral blood); evaluation can be made within 4 weeks of treatment start
Donor lymphocyte infusion within 8 weeks prior to treatment start if post-transplant
Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:* Condom with spermicide and one of the following:** Oral contraceptive or hormonal therapy (e.g. hormone implants)** Placement of an intra-uterine device* Acceptable non-hormonal birth control methods include:** Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period** Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia** Tubal occlusion plus male condom with spermicide** Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded* Acceptable hormonal methods:** Etonogestrel implants (eg, Implanon, Norplan) + male condom with spermicide** Normal and low dose combined oral pills + male condom with spermicide** Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide** Intravaginal device + male condom with spermicide (eg, EE and etonogestrel)** Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill
Current use of natural herbal products or other folk remedies; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed
Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
History of hemoptysis within the last 1 month prior to randomization
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Patient must not have planned treatment with immunotherapies (vaccines, checkpoint inhibitors, T-cells); if the patients most recent recurrence occurs while on immunotherapy, this must be judged as true recurrence using Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria
Patient must be cleared for bevacizumab administration with respect to any recent surgeries, and post-surgical scans must confirm the presence of measurable residual disease
Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months; Note: Participants with recent DVT who have been treated with therapeutic anti-coagulants for at least 6 weeks are eligible, with the exception of participants being treated with warfarin, which is prohibited on this study; other oral anti-coagulants may be allowed after discussion with overall principle investigator (PI), but short half-life low molecular weight heparins are strongly preferred
Pre-study evaluation must include an ophthalmologic exam by an ophthalmologist (not optometrist) and should minimally include visual acuity testing, slit lamp examination, and funduscopic examination; follow up eye-exams will only be performed if subjects develop/report any visual impairment; visual impairment may include peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; follow up eye-exams will minimally include visual acuity testing, slit lamp examination, and funduscopic examination; additional testing will be based on symptoms, what is observed and ophthalmologist recommendations
Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) and with proliferation rate determination, using Ki-67 or MIB-1 immunohistochemistry (=< 30% versus > 30% versus indeterminate Ki-67 index)
Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician
Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:* Patients are MRD Indeterminate: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR* ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
Patients must have a sarcoma in the extremity or trunk in location, which is accessible to direct or ultrasound guided injections
Patients who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec (T-VEC) treatment and through 30 days after the last dose of talimogene laherparepvec (T-VEC)
Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing >= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
Patients with any prior history of SOS irrespective of severity
Hematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomization options and parameters should be in line with considerations specified in the summary of product characteristics; hematological parameters should not be supported by transfusion to enable entry into the trial; liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomized to receive paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACT-neoadjuvant but may be considered for arm A
Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
Patients must not be registered to step 2 until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 days of receiving the e-mail notification confirming submission was evaluable for PD-L1 status
Patients must have been assigned to S1400F
Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)
For step 1 registration the operating neurosurgeon must provide the modified Simpson grade
Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
Cohort B: Patients must not have any visceral lesions
Patients must, in the opinion of the treating physician, be candidates for intralesional administration into cutaneous, subcutaneous, or nodal lesions; patients must have at least 2 injectable lesions
Patients must not have organ allografts
Alanine aminotransferase > 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases; aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
Only first and second recurrences of GBM are eligible
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
The EPIC-26 must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization
pT2 with a negative surgical margin and PSA < 0.1 ng/mL
Subjects must have at least 1 cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing
Second primary malignancy, only if it would affect the safety of the treatment or the subjects ability to complete study-related procedures
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus 1 (HSV-1) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy
Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary; patients must be made aware of their other treatment options
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec are ineligible
Patients who are unable to get MRIs due to any reason including pacemakers or automatic implantable cardioverter-defibrillator (AICD) are ineligible
Patients must have recovered from the immediate post-operative period
Presence of diffuse lepto or pachy meningeal carcinomatosis (focal/localized involvement from limited meningeal based metastases acceptable), greater than 1 cm mid-line shift, uncal herniation, or severe hemorrhage/hydrocephalous (small intra-lesional hemorrhage or anticipated surgical cavity is acceptable); patients with seizure at presentation who have been started on levetiracetam and have been stable for 48 hours prior to study registration are eligible at the discretion of treating physician
Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT will not be eligible to participate in the study; however, patients will be allowed entry into the study if it is medically safe to reduce the daily dose of dexamethasone to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such patients may be increased beyond 8 mg per day during the course of treatment if medically necessary; this increased need for dose should be communicated to the studys principal investigator, Dr Mohindra at the University of Maryland
Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet
Completion of remission induction therapy
Definitive clinical or radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm
Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment
Tumor O(6)-methylguanine-DNA-methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction, MSPCR, or quantitative polymerase chain reaction [PCR]) are acceptable
Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing first line bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of bendamustine; relapsed patients must not have received any intervening chemotherapy; patients must have received at least 3 cycles of bendamustine as first line therapy; (note that no minimum dose of bendamustine is required); patients who additionally received any maintenance anti-CD-20 antibody based therapy or consolidative radioimmunotherapy within 2 years of the last dose of the bendamustine therapy are eligible; involved field or involved site radiation is not considered a line of therapy; patients who previously received anthracycline based therapy are excluded; examples of eligible 1st line treatment regimens (note this list is not all inclusive):* Bendamustine rituximab x 4 cycles* Bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance* Bendamustine obinutuzumab x 3 cycles
Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202; patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer)
Patients must have the following components of Follicular Lymphoma International Prognostic Index (FLIPI) available from diagnosis, and collected again at time of registration:* Age* Lactate dehydrogenase (LDH)* Number of nodal groups involved* Serum or plasma hemoglobin * Ann Arbor stageAdditionally, patients must have beta-2-microglobulin collected at time of registration
Granulocytes (ANC) >= 1,500/mcl
Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders
Patients must not be currently taking or have ever taken vorinostat (Zolinza, Merck), panobinostat (Farydak, Novartis) or romidepsin (Istodax, Gloucester Pharmaceuticals)
Patients must not have organ allografts
Patients must be assigned to S1400G; S1400G biomarker eligibility defined as homologous recombination repair deficiency (HRRD) positive is as follows* Biomarker-positive group** HRRD by FMI*** Homologous recombination repair deficiency by Foundation Medicine Inc., criteria* Alteration type** Truncating mutation, frameshift deletions, indels missense and nonsense mutations predicted to have functional consequence in any of the specified genes* Eligible alteration** Mutation in any one of the following critical HRR pathway genes: ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF, FANCM, NBN (NBS1), PALB2, RAD51, RAD51B (RAD51L1), RAD54L, RPA1
SR1 and SR2 patients:
Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
CD4 lymphocyte count is highly encouraged
Blood urea nitrogen (BUN) < 30mg/dl
Prior history of neurologic or psychiatric disease believed to impact cognitive function
The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidiata RAVE System for evaluation by Dr. Wefel; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the research associate (RA) to proceed to step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors)
Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration
Inability to comply with protocol-required procedures
No requirement for tumor expression of NY-ESO-1
Have been informed of other treatment options
Subjects who have received prior therapy with hypomethylating agents (5-azacytidine, decitabine, SGI-110)
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
Patients who are currently receiving drugs that are inhibitors or inducers of p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G, member 2 (ABCG2 [BCRP]) are not eligible
Patients who have insulin dependent diabetes are not eligible