Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registration
SUB-STUDY REGISTRATION:
Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registration
Patients must not have had prior radiation therapy within 14 days prior to registration
None of the following conditions:\r\n* Grade 3 or greater infection, or infection requiring intravenous systemic treatment within 28 days prior to registration; patients should be off antibiotics at the time of registration.\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days prior to registration\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days prior to registration\r\n* History of surgery as follows:\r\n** Major surgery (as an example, surgery requiring anesthesia and a > 24 hour hospital stay) within 3 months prior to registration, with wound healing at least 28 days prior to registration\r\n** Minor surgery within 28 days prior to registration with complete wound healing at least 10 days prior to registration\r\n** Minor procedures within 7 days prior to registration such as thoracentesis, paracentesis, or 18 g or smaller needle biopsy of tumor\r\n** Patients with clinically relevant ongoing complications from prior surgery are not eligible
Patient history: patients who have any of the following are NOT eligible:\r\n* Central nervous system (CNS): Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Heme: Active bleeding or bleeding diathesis\r\n* Gastrointestinal (GI):\r\n** Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration\r\n** Acute GI bleed within 28 days of registration\r\n* Diabetes mellitus: Patients with diabetes mellitus with inadequate control, based on either a glycosylated hemoglobin (Hgb A1c) of > 7.0 or fasting blood glucose above or equal to 130 mg/dL\r\n* Cardiac and vascular disorders:\r\n** History of congenital long QT syndrome or torsades de pointes\r\n** Any arrhythmia that is currently not rate-controlled (rate between 60 and 100)\r\n** Prolongation of corrected QT interval via Fridericia’s formula (QTcF) > 480 msec\r\n** Ongoing unstable angina\r\n** Symptomatic peripheral vascular disease\r\n** Arterial thrombosis within 28 days of registration including transient ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI)\r\n** Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) must be on a stable dose of anticoagulation for 14 days prior to registration\r\n** Uncontrolled hypertension, defined as blood pressure (BP) > 140/90\r\n** Multi gated acquisition scan (MUGA) with ejection fraction (EF), 50% or echocardiogram (echo) with low EF\r\n** Class III or IV congestive heart failure (CHF) within 28 days of registration
Use of finasteride within 30 days prior to registration
For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registration
No other chemotherapy or radiation therapy within 14 days prior to registration
All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
Patients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registration
Charlson modified co-morbidity score =< 3 for patients under 60 and =< 4 for patients 60 and over 21 days prior to registration
Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
Patients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration, with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until 1 day prior to start of study therapy (C1, D1); IV cyclophosphamide may be administered at doses of 1 g/m^2 or less until up to 7 days prior to registration
Comorbid conditions\r\n* No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) =< 8 weeks prior to registration\r\n* No evidence of intracranial hemorrhage =< 4 weeks prior to registration\r\n* Patients who have experienced thromboembolic event within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 4 weeks prior to registration\r\n* No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration\r\n* No current unstable angina or uncontrolled arrhythmia\r\n* No uncontrolled hypertension at time of registration (blood pressure [BP] > 150/95 despite antihypertensive therapy)\r\n* No known history of prolonged QT syndrome\r\n* No known history of ventricular arrhythmia within 6 months of registration\r\n* No known history of uveitis or iritis =< 4 weeks prior to registration\r\n* No known history of or evidence of retinal pathology that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration within 12 months of registration
Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to registration with the following exceptions:\r\n* Monoclonal antibodies must not have been received for 1 week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for 28 days prior to registration\r\n* Steroids, hydroxyurea, vincristine, 6-mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration; Food and Drug Administration (FDA)-approved tyrosine kinase inhibitors may also be administered until 1 day prior to start of study therapy (cycle 1 [C1], day 1 [D1])\r\n* All drug-related toxicities must have resolved to =< grade 2
Serum HCGbeta and AFP levels must be assessed within 7 days prior to registration
No craniotomy within 21 days of registration
Within 3 weeks prior to study registration: \r\nTotal bilirubin =< 1.5 x the upper limits of normal (ULN) within 3 weeks prior to study registration
Within 3 weeks prior to study registration: \r\nSerum creatinine =< 1.5 x the ULN within 3 weeks prior to study registration
Within 3 weeks prior to study registration: \r\nPlatelet count > 100000 /mm^3 within 3 weeks prior to study registration
Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration; for biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration
At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration
Prior ablative, radiation, resection, or transplant therapies less than 4 weeks before study registration
Protocol treatment plan must include beginning therapy within 5 consecutive days after registration
Chemotherapy less than or equal to 4 weeks prior to registration
Biologic therapy less than or equal to 4 weeks prior to registration
Patients who have had chemotherapy or biological therapy within 4 weeks of registration
Treatment must be scheduled to commence within 14 working days after registration and may not begin prior to registration.
Prior treatment:\r\n* Patients may have received prior radiation therapy to index lesions >= 28 days prior to registration on this protocol if there has been documented progression by RECIST criteria; prior radiation therapy to the non-index lesions is allowed if >= 28 days prior to registration on this protocol\r\n* Prior RAI therapy is allowed if >= 90 days prior to registration on this protocol and evidence of progression (as defined above) has been documented in the interim (a diagnostic study using < 10 mCi of RAI is not considered RAI therapy)\r\n* Prior chemotherapy is allowed if >= 28 days prior to registration on this protocol\r\n* Patient may have received any number of prior lines of therapy\r\n* No prior use of sorafenib or an mammalian target of rapamycin (mTOR) (including phosphoinositide 3-kinase [PI3k] or protein kinase B [AKT]) inhibitor for the treatment of thyroid cancer
Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration; for bevacizumab, patients must have received last dose >= 32 days prior to study registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Absolute neutrophil count: >= 1.5 x 10^9/L (1500/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Platelet count: >= 100 x 10^9/L (100,000/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Serum creatinine: =< 1.5 x ULN within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Absolute neutrophil count: >= 1.5 x 10^9/L (1500/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Platelet count: >= 100 x 10^9/L (100,000/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Serum creatinine: =< 1.5 x ULN within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): LVEF >= institutional LLN within 4 weeks of registration
REGISTRATION
In addition to the pathologic diagnosis, at least ONE of the following cytopenias must be present:\r\n* Hemoglobin < 11 g/dL within 14 days of registration; this includes patients with transfusion dependency\r\n** NOTE: transfusion dependency at screening is defined for this protocol as 1-8 disease-related units red blood cells (RBC) transfused in the previous 8 weeks; patients receiving more than 8 disease-related units of RBCs within 8 weeks of registration are excluded\r\n* Platelet count must be ? 20,000/mm^3 and < 100,000/mm^3 within 14 days of registration\r\n* Absolute neutrophil count (ANC) < 1000/mm^3 within 14 days of registration
PFT (pulmonary function test) with a FEV1 > 0.75 liters/second within 16 weeks prior to study registration.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to registration on the Re-treatment Study or at least six weeks if a nitrosourea\r\n* Biologic agent: Patient must have received their last dose of the biologic agent >= 7 days prior to study registration; for biologic agents and monoclonal antibody treatment, at least three half-lives must have elapsed prior to registration\r\n* Other investigational agents (not fitting into one of the above specified categories): patients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment\r\n* Radiation: Patients must have:\r\n** Had their last fraction of local irradiation to the primary tumor >= 12 months prior to registration; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression;\r\n** Had their last fraction of craniospinal irradiation (> 24Gy) > 3 months prior to registration\r\n* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration\r\n* Growth factors: Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations
Prior Treatment\r\n* Patient must have failed at least one prior systemic therapy that included everolimus; disease progression or treatment intolerance leading to discontinuation is considered treatment failure\r\n* Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, and/or radiation must be completed at least 28 days prior to registration\r\n* Prior treatment with somatostatin analogs is allowed, and continuation of treatment with somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months\r\n* Prior systemic treatment with radionuclide therapy must be completed at least 6 weeks prior to registration\r\n* Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site; prior liver-directed or other ablative treatment must be completed at least 28 days prior to registration\r\n* Prior treatment with cabozantinib is not allowed\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version 5.0, grade 1 or less\r\n* Patients must have completed any major surgery at least 12 weeks prior to registration and any minor surgery (including uncomplicated tooth extractions) at least 28 days prior to registration; complete wound healing from major surgery must have occurred at least 28 days prior to registration, and complete wound healing from minor surgery must have occurred at least 10 days prior to registration
Patient History\r\n* No class III or IV congestive heart failure (CHF) within 6 months of registration\r\n* No clinically significant cardiac arrhythmia within 6 months of registration\r\n* No unstable angina or MI within 6 months of registration\r\n* No thromboembolic events within 6 months of registration (including [incl.] stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary embolism [PE])\r\n* No known history of congenital long QT syndrome\r\n* No uncontrolled hypertension within 14 days of registration (defined as systolic blood pressure [SBP] >= 150 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg despite optimal medical management)\r\n* No clinically significant GI bleeding within 6 months of registration\r\n* No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation\r\n* No GI perforation within 6 months of registration\r\n* No known tumor invading the GI tract within 28 days of registration\r\n* No radiologic or clinical evidence of pancreatitis\r\n* No known cavitary lung lesions\r\n* No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; (CT with contrast is recommended to evaluate such lesions)\r\n* No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration\r\n* No known tumor invading or encasing any major blood vessels\r\n* No history of non-healing wounds or ulcers within 28 days of registration\r\n* No history of fracture within 28 days of registration\r\n* No brain metastases or cranial epidural disease unless adequately treated, stable, and off steroid support for at least 4 weeks prior to registration\r\n* No known medical condition causing an inability to swallow oral formulations of agents\r\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib/placebo\r\n* No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years
REGISTRATION
Prior therapy:\r\n* Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was > 4 weeks prior to registration\r\n* Vaginal brachytherapy may have been administered at any time prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Targeted biologic therapy =< 4 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Any viral or gene therapy prior to registration\r\n* External beam radiotherapy =< 4 weeks prior to registration\r\n** NOTE: Vaginal brachytherapy may be performed at any time prior to registration
Performed within 14 days (+ 3 working days) prior to registration: Creatinine < 1.5 mg/dL
Patients must not have had prior cancer therapy (including biologic, cytotoxic, and experimental therapies, nitrosoureas, and Gliadel wafers or other surgically implantable antitumor treatment) within 21 days of registration; if questions arise, please ask the principal investigator (PI)\r\n* NOTE: Patients must not have Novocure within 24 hours of registration
Any of the following prior therapies:\r\n* Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =< 2 weeks prior to registration\r\n* Immunotherapy (monoclonal antibodies) =< 4 weeks prior to registration\r\n* Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 28 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. PARP inhibitors, =< 7 days or 5 half-lives whichever is shorter)\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.
Recent prior chemotherapy:\r\n* Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions:\r\n** Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy\r\n** Prior chemotherapy directed at a “myeloproliferative neoplasm” like hydroxyurea is not exclusionary\r\n* Previously treated patients (group 2)\r\n** Alkylators (e.g. melphalan, cyclophosphamide) =< 28 days prior to registration\r\n** Anthracyclines =< 28 days prior to registration\r\n** High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< 28 days prior to registration
Receipt of corticosteroids =< 7 days prior to registration, unless patient has been taking a continuous dose of no more than 15 mg/day of prednisone for at least 30 days prior to registration
Systemic chemotherapy within 3 weeks of registration
Presence of radiologically documented disease; all radiology studies must be performed within 28 days prior to registration
Pulmonary conditions - any of the following:\r\n* Respiratory condition that required any oxygen supplementation =< 6 months prior to registration\r\n* Prior or current pneumonitis\r\n* Clinically significant pulmonary hypertension =< 12 months prior to registration\r\n* Lung infection requiring treatment =< 3 months prior to registration\r\n* Pulmonary embolism requiring treatment =< 6 months prior to registration\r\n* Pleural effusion requiring drainage =< 12 months prior to registration
Treatment with biologic therapy within 21 days of registration.
Any of the following prior therapies:\r\n* Chemotherapy =< 3 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 3 weeks prior to registration
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =<14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =<14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration.
Prior GEM therapy is acceptable as long as the last dose was >= 3 months from registration on this study
Subject must have at least 2 of the following risk factors\r\n* Pretreatment edema/tumor ratio (>= 35:1) as contoured on a baseline MRI obtained at most 60 days prior to registration; patients are allowed to have whole brain radiotherapy (WBRT) or corticosteroid use between the time of pretreatment MRI and SRS (as long as the corticosteroids can be safely tapered at least 5 days prior to the treatment planning MRI and WBRT is at least 4 days prior to registration)\r\n* Greater than 40 pack year history of smoking cigarettes\r\n* Whole brain radiotherapy at least 4 days and no more than 1 year prior to registration\r\n* Recursive partitioning analysis (RPA) class III
Staging work-up prior to registration
Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
Any of the following prior therapies:\r\n* Chemotherapy =< 3 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Extensive abdominal surgery if it includes enterotomy(ies) =< 3 weeks prior to registration; this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of registration\r\n* Any viral or gene therapy prior to registration\r\n* Radiation therapy to the abdomen or pelvis
Use of finasteride within 30 days prior to registration
Patients treated on any other therapeutic clinical protocols within 3 weeks of registration
ELIGIBILITY CRITERIA FOR REGISTRATION: Leukocytes >= 3,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: absolute neutrophil count >= 1,500/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: platelets >= 100,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: total bilirubin =< upper normal institutional limits (except for patients with Gilbert’s disease who are eligible despite elevated serum bilirubin level) (within one week of registration if patient postop, otherwise within two weeks of registration)
Patient must begin therapy within 7 calendar days of registration
Serum HCGB and AFP levels must be assessed within 7 days prior to registration
Prohibited treatments and or therapies\r\n* Autologous stem cell transplant (ASCT) =< 12 weeks prior to registration\r\n* Prior chemotherapy =< 2 weeks prior to registration\r\n* Prior treatment with nitrosureas =< 4 weeks prior to registration\r\n* Therapeutic anticancer antibodies =< 2 weeks prior to registration\r\n* Radio- or toxin immunoconjugates =< 4 weeks prior to registration\r\n* Radiation therapy to the injected area =< 2 weeks prior to registration\r\n* Major surgery =< 2 weeks prior to registration
Prior chemotherapy within 3 weeks of study registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration
Prior treatment\r\n* Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents\r\n* Surgery =< 2 weeks prior to registration\r\n* Radiotherapy =< 12 weeks prior to registration\r\n* Treatment with bevacizumab or any cytotoxic chemotherapy =< 8 weeks prior to registration
Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Targeted therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrow
Systemic chemotherapy for the study cancer < 2 weeks prior to registration
The patient must have failed at least one prior therapy - surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy - prior to study registration; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks prior if nitrosourea\r\n* Biologic agent: Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended to beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n** For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration\r\n* Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration\r\n* For bevacizumab, patients must have received last dose >= 32 days prior to study registration\r\n* Bone marrow transplant: Patient must be:\r\n** >= 6 months since allogeneic bone marrow transplant prior to registration\r\n** >= 3 months since autologous bone marrow/stem cell prior to registration
Fiberoptic exam with laryngopharyngoscopy within 28 days prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< 3 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 3 weeks prior to registration
REGISTRATION:
Any of the following prior therapies:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< 6 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration\r\n* Radiation to > 25% of bone marrow \r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to registration; subjects with prostate cancer will be permitted to continue hormone therapy
STUDY ELIGIBILITY CRITERIA FOR OVERALL STUDY PARTICIPATION (INITIAL REGISTRATION FOR COHORT 1; ONLY REGISTRATION FOR COHORTS 1A & 1B):
Any of the following prior therapies:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< 6 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration\r\n* Radiation to > 25% of bone marrow
Any of the following therapies:\r\n* Chemotherapy =< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Bevacizumab =< 12 weeks prior to registration\r\n* Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =< 2 weeks prior to registration\r\n* Radiation therapy =< 6 weeks prior to registration\r\n* Any viral or gene therapy prior to registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration
Patients must not have received nitrosourea or mitomycin C within 42 days prior to sub-study registration
Patients must have an eye exam performed within 28 days prior to sub-study registration; patients with uncontrolled glaucoma or intra-ocular pressure >= 21 mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to registration
Patients must have MUGA/echocardiogram performed within 28 days prior to sub-study registration
Patients must have a Na, K, Cl, Ca, Mg, and HbA1c performed within 7 days prior to sub-study registration
Appropriate for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Further protocol-specific assessments:\r\n** Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy\r\n** Any other prior therapy directed at the malignant tumor including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least three weeks prior to registration\r\n** Investigation agents must be discontinued for at least 30 days prior to registration\r\n** Any prior radiation therapy must be completed at least 4 weeks prior to registration\r\n** At least 4 weeks must have elapsed since any major surgery prior to registration
> 10% lymphoplasmacytic cells (measured within 28 days prior to registration OR
Treatment with chemotherapy within 3 months of registration
All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration
Any of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Radiation to > 25% of bone marrow
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY:
CA19-9 must be performed within 14 days prior to registration
Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration
Patients must have CA19-9 obtained within 14 days prior to registration; if CA19-9 is normal a carcinoembryonic antigen (CEA) must be tested within 14 days prior to registration
Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
Prior surgical treatment for prostate cancer is allowed but must have been completed at least 14 days prior to registration and any toxicity from such therapy must have recovered to ? grade 1 per CTCAE version 4 criteria by the time of registration.
Evaluation by a radiation oncologist within 45 days prior to study registration
Evaluation by a medical oncologist within 45 days prior to study registration
Chemotherapy in the 6 months prior to registration
Prostate biopsy within 180 days prior to registration
No radioimmunotherapy within 2 months prior to registration
Use of finasteride within 30 days prior to registration
Use of dutasteride within 90 days prior to registration
Any of the following prior therapies: \r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< 6 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration
Current use of or use =< 2 weeks prior to registration of exogenous corticosteroids; patients clinically proven to require maintenance steroids will be allowed on the study provided that there has been no change in the corticosteroid dose =< 6 weeks prior to registration
Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm:\r\n* Chemotherapy =< 3 weeks of registration\r\n* Nitrosoureas or mitomycin C =< 6 weeks of registration\r\n* Small molecule cell cycle inhibitors =< 2 weeks prior to registration\r\n* Immunotherapy =< 6 weeks prior to registration\r\n* Monoclonal antibodies =< 3 half-lives prior to registration\r\n* Radiation therapy\r\n** Last fraction of craniospinal irradiation or total body irradiation =< 3 months prior to registration or last fraction of focal irradiation to symptomatic metastatic sites =< 4 weeks prior to registration\r\n* Growth factors\r\n** Colony forming growth factors < 2 weeks prior to registration (i.e., filgrastim, sargramostim, erythropoietin)\r\n** Neulasta < 2 weeks prior to registration
Any of the following:\r\n* Chemotherapy =< 4 weeks prior to registration \r\n* Radiotherapy =< 4 weeks prior to registration\r\n* Nitrosoureas =< 6 weeks prior to registration or\r\n* Mitomycin C =< 6 weeks prior to registration\r\n* Those who have not recovered from adverse events (to grade =< 1 in severity) due to agents administered more than 4 weeks earlier; prior palliative radiotherapy to bone metastases =< 2 weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed > 2 weeks prior to registration)
Any of the following prior therapies with interval since most recent treatment:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Biologic or immunologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration
Prior nitrosourea or mitomycin C =< 6 weeks prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< 21 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 21 days prior to registration\r\n* Radiation to > 25% of bone marrow prior to registration\r\n* Hormonal therapy =< 14 days prior to registration
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* Patients must be off other biologic therapies including hematopoietic growth factors >= 7 days prior to registration\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed larynx cancer prior to registration
Patients who have active local-regional disease prior to registration
Prior radiation therapy =< 14 days prior to registration
REGISTRATION
Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrow
Any of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) =< 28 days prior to registration\r\n* Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy
Recent prior chemotherapy:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide) =< 7 days prior to registration
Patients who had radiosurgery > 3 months prior to registration are eligible
Protocol treatment must begin within 5 consecutive days after registration
REGISTRATION
Any of the following prior therapy: Chemotherapy ? 3 weeks prior to registration. Biologic therapy ? 4 weeks prior to registration. Radiation therapy ? 3 weeks prior to registration
Any radiation therapy =< 28 days prior to registration
Patients may have received palliative radiotherapy to non-target lesions within 14 days prior to registration provided all radiotherapy related toxicities have resolved to =< grade 1 prior to registration; patients must not have received any major surgery within 28 days prior to registration
Any of the following prior therapies for malignancy:\r\n* Systemic chemotherapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration (exceptions noted in the prior bullet); the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease\r\n* Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =< 4 weeks prior to registration; minor surgery =< 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard\r\n* Other investigational agent =< 30 days prior to study treatment
Any of the following prior therapies:\r\n* Chemotherapy =< 4 weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< 6 weeks prior to registration\r\n* Immunotherapy =< 4 weeks prior to registration\r\n* Biologic therapy =< 4 weeks prior to registration\r\n* Radiation therapy =< 4 weeks prior to registration\r\n* Radiation to > 25% of bone marrow prior to registration
Any of the following recent therapies:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< 7 days prior to registration
For purposes of determining prior drug regimens the following should be used as a standard; radiation therapy counts as 1 treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, and rituximab alone is not considered a treatment; all prior therapy must have been completed at least 30 days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (e.g., vorinostat, romidepsin), for at least 30 days prior to registration; patients must have recovered from any toxicities related to therapies prior to registration
Completion of radiation therapy >= 12 weeks prior to registration and prior chemotherapy >= 4 weeks prior to registration (>= 6 weeks from nitrosourea-containing regimens)
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.
Donation of blood within the preceding 60 days prior to study registration.
Patient must begin therapy within 7 calendar days of registration
No methadone within 4 weeks prior to registration
Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration
Patients must not have initiated chemotherapy or radiation prior to registration to this study
Current oral steroid use > 2 weeks prior to registration
Patients must not have had surgery, biologic therapy, or hormonal therapy within 14 days prior to registration; patients must not have had chemotherapy, targeted small molecule therapy, or radiation therapy within 28 days (42 days for nitrosoureas or mitomycin C) prior to registration; patients must not have had an investigational agent or monoclonal antibodies, except anti-PD1/L1 antibodies, within 28 days prior to registration\r\n* Patients must have recovered from all adverse events due to prior anti-cancer therapy (residual toxicity =< grade 1) prior to registration, with the exception of patients with =< grade 2 neuropath or =< grade 2 alopecia\r\n* If patients received major surgery, they must have recovered adequately from toxicity and/or complications from the intervention prior to registration
Minimum interval since completion of radiation treatment at the time of registration is 90 days.
Presence of CRF >= 30 days prior to registration
New use of Ambien and/or other benzodiazepines =< 30 days prior to registration
Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days prior to registration and plans to continue for at least an additional 180 days after registration; patients may have received any number of prior AI therapies, but the first AI therapy must have started no more than 36 months prior to registration:\r\n* Anastrozole (Arimidex) 1 mg daily\r\n* Letrozole (Femara) 2.5 mg daily\r\n* Exemestane (Aromasin) 25 mg daily
Patients must not take MAO-Inhibitors for 14 days before registration or any time during study treatment; concomitant therapy with heparin and warfarin is also not permitted at registration
Use of probiotics =< 2 weeks prior to registration
Use of antibiotics =< 3 days prior to registration
No untreated urinary retention within 6 weeks prior to registration
No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration
Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows:\r\n* Chemotherapy < 3 weeks prior to registration\r\n* Hormone therapy < 2 weeks prior to registration\r\n* Targeted therapy (other than below) < 2 weeks prior to registration (e.g., tyrosine kinase inhibitors)\r\n* Trastuzumab < 6 weeks prior to registration\r\n* Bevacizumab < 6 weeks prior to registration\r\n* Nitrosoureas/mitomycin C < 6 weeks prior to registration\r\n* Radiotherapy < 3 weeks prior to registration (NOTE: a previously irradiated lesion may not be used as a target lesion unless there is evidence of post-radiation progression)\r\n* Surgery < 3 weeks prior to registration\r\n* Other approved or investigational agents < 3 weeks prior to registration unless otherwise noted by the protocol chair\r\n* Patients who have received prior epigenetic (e.g., histone deacetylase [HDAC] inhibitors such as entinostat, panobinostat, vorinostat, romidepsin or demethylating agents such as 5-azacitidine or decitabine) immunomodulatory or other checkpoint inhibitors should only be considered after discussion with the protocol chair\r\n* Those who have not recovered from acute adverse events to grade < 2 or baseline due to agents administered, with exception of alopecia, unless approved by the protocol chair
Patients must not be on narcotics within 14 days of registration
Patients must be receiving stable or increasing doses of morphine for 1-2 weeks prior to registration for protocol therapy; NOTE: switching patient from current pain regimen to morphine equivalent for at least 1-2 weeks prior to registration for protocol therapy is required
Use of probiotics =< 2 weeks prior to registration
Use of antibiotics =< 3 days prior to registration
Digital mammogram within 365 days prior to pre-registration
Patients with a prior thoracotomy within 1 week of study registration
Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration)
No prior MRI of study breast within the 12 months prior to registration
Patients must not have history of chemotherapy for cancer within 6 months prior to registration
No prior MRI of the breasts within the 6 months prior to registration
Required imaging studies obtained within four weeks prior to registration
Have taken antibiotics =< 7 days prior to registration
Complete initial work up earlier than 12 weeks prior to subject registration
Prior biologic therapy:\r\n* Patients must have discontinued all biologic or investigational therapy at least 21 days before registration
Finasteride, bicalutamide and nilutamide discontinued at least 4 weeks prior to registration
Prior therapy: Patients must have discontinued all chemotherapy, investigational therapy or biologic therapy at least 14 days prior to initiating study treatment (with the exception of trastuzumab for patients with HER2+ breast cancer)
Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin), but must have been discontinued at least 30 days prior to the study enrollment; vaginal preparations (e.g., Vagifem or Estring) are allowed
Patients must have discontinued all biologic therapy at least 21 days before participation
Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure
Prior chemotherapy, other investigational agents, or radiation must be discontinued for at least 28 days prior to the first administration of COTI-2. Hormone treatments must be discontinued for at least 28 days prior to the first administration of COTI-2.
All previous cancer therapy (with the exception of hydroxyurea) including donor lymphocyte infusions must have been discontinued at least 2 weeks prior to treatment in this study
Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study; if there is progression of disease on that therapy and all adverse effects have resolved to grade 1 or baseline, in which case 2 weeks is acceptable
Have discontinued all previous cancer therapies (except nonsteroidal aromatase inhibitors for participants in Part B2), and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days
Patients must have discontinued enzalutamide at least 28 days prior to enrollment.
Patients must have discontinued all biologic therapy at least 14 days prior to registration
Participants must have discontinued EGFR targeted therapy prior to the first dose of study drug.
Prior biologic therapy: Patients must have discontinued all biologic therapy at least 21 days before registration
Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.
Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.
Prior frontline therapy for B-CLL must have been discontinued >= 56 days but =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
PHASE I: Any prior radiation therapy must be discontinued at least four weeks prior to enrollment
PHASE II: Any prior radiation therapy must be discontinued at least four weeks prior to enrollment
Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy; for patients receiving ALL maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs; for patients on oral targeted therapies (such as imatinib, dasatinib, ponatinib), - these agents should be discontinued at least 48 hours prior to start of study drugs
Patients on antiplatelet/anticoagulant medication that cannot safely be discontinued 5-7 days prior to the procedure
Received any therapies intended to treat malignancy within 14 days of first receipt of DS-3032b (except for hydroxyurea, which must be discontinued at least 48 hours prior to study treatment).
Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
Patients must have discontinued all previous systemic therapies and recovered from side effects due to systemic treatment for more than 14 days prior to starting on treatment
Patients must have discontinued all previous biologic therapies and recovered from side effects due to biologic treatment for more than 14 days prior to starting on treatment
Prior use of duvelisib if discontinued due to toxicity
For the romidepsin arm of the study, prior therapy with romidepsin if discontinued due to toxicity
Any prior therapy for B-CLL must have been discontinued >= 28-days prior to registration
Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment
Has been permanently discontinued from study treatment in the parent study for any reason.
Patients may have received prior therapy (including chemotherapy, biologic/targeted therapy and immunotherapy) for treatment of endometrial cancer; all therapy must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registration
The subject must have discontinued any endocrine therapy for at least 2 weeks before the first dose of study treatment; in the cases of fulvestrant and leuprolide, these must be discontinued for at least 4 weeks before the first dose of study treatment
Any prior radiation therapy must be discontinued at least four weeks prior to registration
Discontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment.
Treatment with erlotinib must be discontinued at least 3 days prior to first dose of tesevatinib and treatment with afatinib or other tyrosine kinase inhibitor must be discontinued at least 3 days prior to first dose of tesevatinib
Any prior radiation therapy must be discontinued at least four weeks prior to registration.
Bicalutamide (Casodex) and nilutamide discontinued < 6 weeks prior to registration
Prior therapy with romidepsin if discontinued due to toxicity
Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the principal investigator; previous fixed-dose IL-2 therapy that was discontinued prior to 4 weeks is permitted
Any prior radiation therapy must be discontinued at least 4 weeks prior to study treatment initiation
Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study; if there is progression of disease on that therapy and all adverse effects have resolved to grade 1 or baseline, in which case 2 weeks is acceptable
Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued >= 4 weeks prior to randomization
Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study; if there is progression of disease on that therapy and all adverse effects have resolved to grade 1 or baseline, in which case 2 weeks is acceptable
Prior therapy with romidepsin if discontinued due to toxicity
Chemotherapy within 3 weeks prior to screening are excluded (other than hydroxyurea at stable doses and will be discontinued 24 hours prior to starting study drug)
Prior Navelbine allowed provided Navelbine therapy discontinued >= 12 months from day 1 of treatment under this protocol
Any prior radiation therapy must be discontinued at least four weeks prior to registration
Patient may not have been resistant to any other prior TKI therapy; prior TKI therapy must only have been discontinued due to intolerance
Treatment with any of the following hormone replacement therapies, unless discontinued at least 14 days prior to the first dose of study treatment:
Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study’s drugs
Targeted therapy must have been discontinued =< 14 days prior to initiation of study therapy
Use of plaquenil must be discontinued two weeks prior to first study treatment
Treatment with chemotherapy or biologic therapy within 3 weeks, except for hydroxyurea, which must be discontinued prior to treatment on study
Receiving hormone replacement therapy that cannot be discontinued
Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks)
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted\r\n* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration; if the prior therapy was with bevacizumab then at least 4 weeks after treatment discontinuation must have elapsed prior to treatment on this study
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to study entry.
Patients are excluded if they had undergone tumor-­directed therapy within 3 months
Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, and biologic/targeted agents must be discontinued at least 28 days prior to tumor resection for preparing TIL therapy.
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
Current treatment with chemotherapy or radiation therapy; any prior therapy directed at the malignant tumor, including biologic and immunologic agents, must be discontinued at least three weeks prior to registration
PHASE I: Hormonal therapy directed at treatment for the cancer must be discontinued at least one week prior to enrollment; hormone replacement therapy for symptom management is permitted
PHASE I: Any other therapy directed at treating the cancer including chemotherapy, biologic/targeted agents, and immunologic agents, must be discontinued at least three weeks prior to enrollment
PHASE II: Hormonal therapy directed at treatment for the cancer must be discontinued at least one week prior to enrollment; hormone replacement therapy for symptom management is permitted
PHASE II: Any other therapy directed at treating the cancer including chemotherapy, biologic/targeted agents, and immunologic agents, must be discontinued at least three weeks prior to enrollment
All therapy (except hormonal therapy) directed at the malignant tumor must be discontinued at least 21 days prior to registration
Any hormonal therapy directed at the malignant tumor must be discontinued at least 7 days prior to registration; continuation of hormone replacement therapy is permitted
Recovery from effects of any recent surgery, chemotherapy and/or radiation:\r\n* No evidence of active infection requiring antibiotic therapy\r\n* Hormonal therapy being utilized, as an anti-neoplastic treatment must be discontinued at least one week prior to study entry; hormonal replacement therapy for symptom management is allowed\r\n* Any prior therapy directed at the malignancy including biologic or immunologic agents, must have be discontinued at least three weeks prior to study entry
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration (study enrollment); continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian or breast cancer are not exclusionary
Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to first dose of study drug (6 weeks for nitrosoureas or mitomycin C)
Patients must not have received any prior tumor-directed therapy including radiation therapy, chemotherapy (tumor-directed therapy), molecularly targeted agents, or immunotherapy for the treatment of HGG other than surgical intervention
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
Any other prior therapy directed at the malignant tumor, including chemotherapy and immunotherapy, must be discontinued at least three weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registration
Recovery from effects of recent surgery, radiotherapy, or chemotherapy:\r\n* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted and immunologic agents (including small molecules and murine monoclonal antibodies), must be discontinued at least three weeks prior to registration; chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor [VEGF] receptor fusion proteins (including VEGF tartrate-resistant acid phosphatase [TRAP]/aflibercept) must be discontinued for at least 8 weeks prior to registration\r\n* At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video assisted thorascopic surgery [VATS]; minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis)
Prior therapy\r\n* Patients must have recurred or progressed following at least one platinum-based chemotherapy regimen\r\n* Patients may have received an unlimited number of prior therapy regimens\r\n* Patients may not have received all of the five choices in the “standard therapy” arm\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Any other prior therapy directed at the malignant tumor, including chemotherapy and radiation therapy, must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 28 days prior to registration
Any other prior therapy directed at the malignant tumor, including chemotherapy, bevacizumab or other biologic or targeted agents and immunologic agents, must be discontinued at least 21 days (three weeks) prior to registration.
Appropriate for study entry based on the following diagnostic workup:\r\n* History/physical examination within 28 days prior to registration\r\n* Imaging of target lesion(s) within 28 days prior to registration\r\n* Further protocol-specific assessments:\r\n** Recovery from effects of recent surgery, radiotherapy or chemotherapy\r\n** Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\r\n** Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n** Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C) \r\n** Any prior radiation therapy must be completed at least 4 weeks prior to registration\r\n** At least 4 weeks must have elapsed since major surgery
Patients must be off all other anti-tumor therapies (including immunologic agents) for at least four weeks prior to study registration. Patients on hormonal agents require a washout for 10 days.
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
Recovery from effects of recent surgery, radiotherapy, or chemotherapy:\r\n* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least two weeks prior to registration; continuation of hormone replacement therapy is permitted\r\n* Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted and immunologic agents, must be discontinued at least two weeks prior to registration and at least 3 weeks before day 1 on trial
Any hormonal therapy directed at malignant tumor must be discontinued at least one week prior to study treatment initiation
Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted therapy and immunologic therapy, must be discontinued at least 3 weeks prior to study treatment initiation
Patients must be off all other anti-tumor therapies (including immunologic or hormonal agents) for at least four weeks prior to study registration
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Continuation of hormone replacement therapy is permitted
Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration
Any myeloma directed therapy within 12 weeks of registration including plasmapheresis or transfusion
Any hormonal therapy directed at the tumor must be discontinued at least one week prior to initiation of therapy; continuation of hormone replacement therapies is permitted
Any other prior therapy directed at the tumor, including immunologic agents, must be discontinued at least 3 weeks prior to initiation of therapy
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration
Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval
Medications known to lower the seizure threshold must be discontinued or substituted prior to study treatment initiation
Medications known to lower the seizure threshold (see Appendix 1) must be discontinued or substituted at least 4 weeks prior to study entry.
Use of any prohibited concomitant medications within 14 days prior to treatment start, or use of prohibited concomitant medications within the outlined windows\r\n* Note: Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to treatment start
Use of medications known to lower the seizure threshold within 4 weeks prior to study entry
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued prior to study entry
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)
Medications known to lower the seizure threshold
Prior treatment with medications known to lower the seizure threshold within 4 weeks of registration
Concomitant medications that lower seizure threshold
History of seizures or medications known to lower seizure threshold
current use of medication that may lower seizure threshold
Medications which lowers seizure threshold
Concurrent therapy with medications known to have seizure potential (those must have been discontinued or substituted for at least 28 days prior to starting the trial)
No history of seizures or medical conditions which may lower seizure threshold
Use of a medication known to lower the seizure threshold within 28 days of first dose of study drug
Medications known to lower the seizure threshold must be discontinued or substituted prior to study treatment
Previous radiation, hormonal therapy, and surgery must have been discontinued at least 2 weeks prior to treatment in this study and adverse effects must have resolved; lymph node or other diagnostic biopsy within 2 weeks is not considered exclusionary
Previous radiation and/or surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved to grade 1 or baseline; lymph node or other diagnostic biopsies within 2 weeks are not considered exclusionary\r\n* CTCL patients who have received localized radiation therapy (RT) as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK principal investigator
Previous radiation, hormonal therapy, and/or surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved; lymph node or other diagnostic biopsies within 2 weeks are not considered exclusionary
Previous radiation, hormonal therapy, and surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved; lymph node or other diagnostic biopsy within 2 weeks is not considered exclusionary