[c09aa8]: / clusters / final340numclusters / clust_178.txt

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No prior mediastinal or thoracic radiotherapy
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
Must have completed radiotherapy at least 12 months prior to entry
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)
Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
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 had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier* For Part I, prior adjuvant therapy with gemcitabine or a fluoropyrimidine therapy is permitted if completed > 6 months prior to recurrence; no prior PARP inhibitor therapy is allowed* For Part II, no prior PARP inhibitor therapy is permitted; up to two prior treatment regimens are permitted as follows: 1 adjuvant and 1 metastatic; 1 locally advanced and 1 metastatic; or 2 metastatic, or a variation thereof
Patients who have had (prior to entering the study): major surgery and biologic/antibody therapies (including immunotherapies) are not permitted within 4 weeks of romidepsin administration; anti-cancer therapy including chemotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions), and other investigational agents will not be allowed within 14 days or five (5) half-lives (whichever is longer) prior to the first dose of romidepsin (6 weeks for nitrosoureas or mitomycin C); additionally, participants must have recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(ies) of the previous therapy, with the exception of alopecia, unless approved by the principal investigator
Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
Patients must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry
All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration
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.)
Patients must be off radiation therapy or chemotherapy 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting induction chemotherapy
Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have received no more than 2 prior chemotherapy regimens and/or focal radiotherapy for their brain tumor and fully recovered from the acute treatment related toxicities of all prior therapies prior to entering this study; for those acute baseline adverse events attributable to prior therapy, patients must meet organ function criteria
Radiotherapy: patients must have had their last fraction of: * Focal irradiation > 2 weeks prior to enrollment
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
No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
Prior palliative radiotherapy to metastases
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
Prior Therapy:* Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy* Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)* Patients must have had no prior radiotherapy to tumor-involved sites* Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded
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 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
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
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier; patients who have had prior pelvic radiation may be at increased risk for bowel perforation, and therefore may not have residual inflammatory disease of the bowel or residual bowel toxicity based on baseline imaging and clinical assessment; palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:* Repeat imaging demonstrates no new sites of bone metastases* The lesion being considered for palliative radiation is not a target lesion* Bowel toxicity is not expected from the target field due to increased risk of perforation
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 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
Patients must have received prior radiation therapy and/or chemotherapy and recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed
INCLUSION CRITERIA FOR STRATUM C: Patients must have received prior radiotherapy and/or chemotherapy with the following exceptions:* Patients with secondary CNS cancers after a previous medical problem/malignancy who cannot receive full dose of radiotherapy (> 50 Gy) as long as they meet all other eligibility criteria* Patients with progressive low-grade gliomas and CMMRD or Lynch syndromePatients must have recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed
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 who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patients who have had prior onalespib or AT7519M as a monotherapy will not be excluded
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
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
Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy, Note:* Post-chemotherapy restaging imaging must be completed no earlier than 56 days prior to Step 1 registration� For patients with limited-stage small cell lung cancer who receive thoracic radiotherapy concomitant with chemotherapy, patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy� For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted; if consolidative thoracic radiotherapy is performed prior to study registration, then patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy
Prior treatment with lenalidomide within 8 weeks prior to entering the study
Radiotherapy within 4 weeks of protocol therapy
Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to cycle 1 day 1; patients who have had tyrosine kinase inhibitors (such as Braf or MEK inhibitors) within 15 days of cycle 1 day 1
Patients who 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 must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 prior to enrollment
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those whose adverse events have not resolved to grade 1 or less (except alopecia) from agents administered more than 4 weeks earlier; patients must have completed prior biological therapies and/or targeted therapies >= 2 weeks prior to study enrollment; patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (i.e. radiation to > 25% of bone marrow)
Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
Concomitant radiotherapy
Patients must have recovered from the acute treatment related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Prior Therapies:* There is no maximum number of prior medical therapies* There must be no curative or life prolonging treatments available* Patients who have received other IGF-1R antibodies or inhibitors are eligible, as long as an appropriate washout period has elapsed * Participants must have had their last fraction of external beam radiation therapy that is local and palliative at least 2 weeks prior to enrollment, and had their last substantial bone marrow radiation at least 6 weeks prior to enrollment* Participants must have had their last dose of temozolomide at least 4 weeks prior to enrollment; their last dose of other cytotoxic chemotherapy at least 3 weeks prior to enrollment; their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 3 half-lives prior to enrollment, and their last dose of any investigational agent at least 4 weeks prior to enrollment* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.0) level prior to enrollment (does not apply to alopecia)
Prior radiotherapy to the abdomen or pelvis
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Prior chemotherapy is allowed, including platinum therapy; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events from any prior chemotherapy (other than alopecia); patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows: chemotherapy, radiotherapy or surgery =< 3 weeks prior to entering the study, targeted therapy (e.g., TKI) =< 1 week prior to entering the study; autologous HSCT =< 6 weeks prior to entering the study; investigational drug or immunotherapy (e.g. rituximab) =< 4 weeks prior to entering the study; prophylactic intrathecal chemotherapy within one week of enrollment allowed; patients will be allowed to receive cytoreduction with hydroxyurea, 6-mercaptopurine, corticosteroids (dexamethasone, prednisone or similar) or cyclophosphamide provided that it is discontinued at least 24 hours prior to the initiation of study treatment; pre-phase treatment with dexamethasone 10 mg/m^2 (maximum total 24 mg per day) for up to 5 days is required for patients with bone marrow blasts more than 50%, peripheral blood blasts of 15,000/uL or higher, or elevated lactate dehydrogenase suggesting rapidly progressing disease as per investigator�s assessment; pre-phase treatment must be stopped at least 24 hours prior to the initiation of blinatumomab
Patients who have had systemic (chemotherapy, biologic therapy or radiotherapy) within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
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 who have had radiotherapy within 14 days prior to entering the study
Patients must have had no prior radiotherapy to tumor-involved sites
Previous therapy with at least radiotherapy and temozolomide
Must be 12 weeks from radiotherapy; if patients are within 12 weeks of radiotherapy, then the progressive lesion must be outside of the high-dose radiation target volume or have unequivocal evidence of progressive tumor on a biopsy specimen
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.)
Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
Prior chemotherapy or radiotherapy for any brain tumor