[c09aa8]: / clusters / clusters342final / clust_191.txt

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Prior chemotherapy is allowed; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Any of the following prior therapies:* Chemotherapy =< 4 weeks prior to registration* Mitomycin C/nitrosoureas =< 6 weeks prior to registration* Immunotherapy =< 4 weeks prior to registration* Biologic therapy =< 4 weeks prior to registration* Radiation therapy =< 4 weeks prior to registration* Radiation to > 25% of bone marrow * 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
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation)
Prior chemotherapy is allowed; patients must not have received chemotherapy for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Patients may have had any number of prior therapies; at least 3 weeks must have elapsed since the last dose of systemic therapy; at least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start
All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:* 12 weeks from the completion of radiation * 6 weeks from a nitrosourea chemotherapy* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., Tarceva, hydroxychloroquine, bevacizumab, etc.)
Prior systemic radiopharmaceuticals (strontium, samarium, radium 223 dichloride) must be completed >= 8 weeks prior to enrollment
Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
Prior therapy requirements:* At least one prior therapy using an agent with the potential for prolonged remission (generally includes interleukin-2, checkpoint-blocking antibodies, or adoptive cell therapy)* At least 4 weeks from last dose of prior chemotherapy or immunomodulator therapy with resolution of the acute toxicities; for patients coming off molecularly-targeted therapy, at least 2 weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria* At least 2 weeks from completion of prior radiation therapy with no residual radiation toxicities* At least 4 weeks from last dose of prior investigational therapy with recovery to meet baseline eligibility criteria* Not receiving any current anticancer therapy* Note: any patient whose tumors carry a B-Raf proto-oncogene, serine/threonine kinase (BRAF) v600 mutation should either be excluded, or may be included after experiencing progression following treatment with BRAF inhibitor regimen or if they consent and agree to forgo Food and Drug Administration (FDA)-approved therapies that increase median survival
Patients must be off radiation therapy or chemotherapy 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting induction chemotherapy
Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
Patient should be randomized in the trial ideally within a maximum of 8 weeks of completion of their last treatment (surgery, chemotherapy or radiotherapy), but in no case longer than 12 weeks
Patients receiving systemic chemotherapy within 3 weeks prior to randomization
Patients receiving adjuvant radiotherapy within 2 weeks prior to randomization
Patients may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:* 12 weeks from the completion of radiation * 6 weeks from a nitrosourea chemotherapy or mitomycin C* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents * 2 weeks from administration of a non-cytotoxic, FDA-approved agent except bevacizumab/vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)* 6 weeks from bevacizumab/VEGFR inhibitors
Patients must be >= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =< grade 1 toxicity or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field
Patients must have recovered from clinically significant toxicity of prior therapy to grade =< 1 or pre-treatment baseline; the following intervals from previous treatments are required prior to day 1 of study therapy:* 12 weeks from the completion of radiation for recurrent GBM unless there is surgical diagnosis of recurrence or a new lesion that was not previously radiated* 6 weeks from a nitrosourea chemotherapy* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from an investigational agent (not Food and Drug Administration [FDA] approved) (or 5 half lives, whichever is shorter)* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.) (or 5 half lives, whichever is shorter)
Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
Patients must not receive any other investigational agents while on study or within four weeks prior to registration
Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration
Recovered from prior toxicities to grade 0-1 at least 2 weeks prior to investigational therapy
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Radiotherapy may be given before or after protocol treatment. when radiotherapy is planned prior to protocol treatment administration, patients must have completed adjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, if applicable
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:* 12 weeks from the completion of radiation* 6 weeks from a nitrosourea chemotherapy* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)* 4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Appropriate for study entry based on the following diagnostic workup:* History/physical examination within 28 days prior to registration* Imaging of target lesion(s) within 28 days prior to registration* Further protocol-specific assessments:** Recovery from effects of recent surgery, radiotherapy or chemotherapy** Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])** 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, 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) ** Any prior radiation therapy must be completed at least 4 weeks prior to registration** At least 4 weeks must have elapsed since major surgery
Patients must not receive any other investigational agents while on study or within four weeks prior to randomization
Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease* NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist* NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment* NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
Patients who have had chemotherapy, immunotherapy, or investigational therapy, within 4 weeks (6 weeks for nitrosoureas or mitomycin C), or palliative radiotherapy within 2 weeks prior to the first dose of the study drug
Use of any investigational product within 4 weeks prior to randomization
Other investigational agent within 3 weeks prior to initiation of study therapy
Prior therapy for metastatic disease permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least 4 weeks prior to registration
Any prior surgeries must have been completed at least 4 weeks prior to randomization
Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows:* Chemotherapy < 3 weeks prior to registration* Hormone therapy < 2 weeks prior to registration* Targeted therapy (other than below) < 2 weeks prior to registration (e.g., tyrosine kinase inhibitors)* Trastuzumab < 6 weeks prior to registration* Bevacizumab < 6 weeks prior to registration* Nitrosoureas/mitomycin C < 6 weeks prior to registration* 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)* Surgery < 3 weeks prior to registration* Other approved or investigational agents < 3 weeks prior to registration unless otherwise noted by the protocol chair* 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* 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 have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration
Patients who have had prior chemotherapy or any other investigational drug within 30 days of registration or prior radiotherapy to the study treatment volume; prior surgery is allowed; there must be at least 6 weeks between mitomycin or nitrosoureas and any new therapy
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
Any prior therapy must have been completed at least 4 weeks prior to entry into the study
Prior treatment with lenalidomide within 8 weeks prior to entering the study
Radiotherapy within 4 weeks of protocol therapy
Patients who are receiving any other investigational agents; all investigational agents other than ibrutinib must have been discontinued at least 4 weeks prior to beginning treatment; prior ibrutinib therapy must have been discontinued at least 2 weeks prior to beginning therapy
Receipt of a stable ART regimen for at least 3 weeks prior to start of trial
At least 2 weeks from end of chemotherapy with resolution of neutropenia to above level
Patients who have had radiotherapy within 4 weeks
Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy) (NOTE: adjuvant chemotherapy and/or radiation is not required)
Patients who have received any systemic corticosteroid therapy within 4 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), with the exception of physiological replacement doses of cortisone acetate or equivalent
Participation in any investigational drug study (excluding non-oncology and/or symptom management studies) within 4 weeks prior to registration.
Participants who have had chemotherapy or radiotherapy within 2 weeks prior to treatment start or those who have not recovered from adverse events due to agents administered more than 2 weeks prior to treatment start; hydroxyurea is allowed for symptomatic leukocytosis during screening, lead in, and cycle 1 only if clinically necessary; a total white blood cell (WBC) count < 25 x 10^9/L prior to first dose of decitabine on trial is required; prior leukapheresis and/or prior or concurrent treatment with hydroxyurea to achieve this level are allowed
Patients with hemoptysis in excess of 2.5 mL within 6 weeks prior to the first dose of study medication
Must be 12 weeks from radiotherapy; if patients are within 12 weeks of radiotherapy, then the progressive lesion must be outside of the high-dose radiation target volume or have unequivocal evidence of progressive tumor on a biopsy specimen
From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from investigational agents, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other systemic anti-tumor therapies; treatment on study may start one day after discontinuation of the optune device
Patients who have had systemic therapy or radiotherapy within 3 weeks prior to the first dose of study therapy
Patients who have had radiotherapy within < 4 weeks are ineligible
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:* 12 weeks from the completion of radiation* 6 weeks from a nitrosourea chemotherapy* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)