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
Any prior therapy must have been completed >= 4 weeks or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator [PI]’s discretion); patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment); patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center PI, with a screening echocardiogram
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
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
Received chemotherapy or radiotherapy within 3 weeks prior to randomization or those who have not recovered to =< grade 1 adverse events (other than alopecia) due to agents administered more than 3 weeks earlier; herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization; for patients who received prior immunotherapy (eg anti-CTLA-4), at least five drug half-lives must have passed before the patient may enroll on this study; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Palliative radiotherapy for bone metastases >= 2 weeks prior to randomization
Signs or symptoms of infection within 2 weeks prior to randomization
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
At least 4 weeks must have elapsed since completion of antibody-directed therapy
Subjects must be at least 4 weeks post last dose of temozolomide
The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas) of the planned surgery date
The patient has received chemotherapy, radiotherapy (except for palliative reasons), immunotherapy, or targeted therapy for gastric cancer within 3 weeks of study treatment
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
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
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 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
Any prior surgeries must have been completed at least 4 weeks prior to randomization
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 who have not recovered from adverse events to < grade 1 (other than alopecia) due to agents administered more than 3 weeks earlier; however, the following therapies are allowed:\r\n* Hormone replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Prior Therapy:\r\n* Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy\r\n* Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)\r\n* Patients must have had no prior radiotherapy to tumor-involved sites\r\n* 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 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 (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed: \r\n* Hormone-replacement therapy or oral contraception\r\n* Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)\r\n* Palliative radiotherapy for bone metastases > 14 days prior to randomization
All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
Patient has received any of the following treatments within the specified timeframes: a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): 4 weeks (28 days), c. Endocrine therapy or immunotherapy (including biological response modifier therapy): 2 weeks (14 days)
Participants receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used); the patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with olaparib and temozolomide
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks washout period. For patients receiving anticancer immunotherapies such as CTLA-4 antagonists, 6 weeks is indicated as the washout period.
Participants who have had anti-cancer therapy within 2 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 2 weeks earlier; palliative radiation to bony metastases >= 2 weeks prior to study entry is allowed; chronic use (defined as starting at least 3 months prior to registration) of GnRH agonist therapy, such as leuprorelin, at the time of study entry is not exclusionary and participants can continue the GnRH agonist therapy while on study
Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than: Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). One line of cytotoxic chemotherapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). Adjuvant/neoadjuvant radiotherapy (must be completed ? 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve).
Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ? 4 weeks prior Cycle 1 Day -2.
Radiotherapy, unless brief course for palliative therapy, endocrine therapy, target-specific therapy, immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and Mitomycin-C, and 4 weeks for investigational medicinal products) or 4 drug half-lives before first dose of study drug, whichever is greater
Patients must have discontinued active immunotherapy (interleukin [IL]-2, interferon, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], etc.) or chemotherapy at least 4 weeks prior to entering the study and oral targeted therapy at least 2 weeks prior to entering the study; patients must not receive any other investigational anticancer therapy during the period on study or the four weeks prior to entry
Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to study drug administration (Cycle 1 Day 1)
Nitrosourea or mitomycin C within 6 weeks
Chemotherapy, immunotherapy or anticancer agents within 4 weeks
Radiotherapy with a wide field of radiation within 4 weeks,
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to starting radiation treatment
For participants treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field; participants who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and two weeks have passed since the last date of therapy
The patients' last dose of chemotherapy must be at least 3 weeks prior to initiation of study therapy
At least 4 weeks for focal radiation therapy (RT) or >= 6 weeks for craniospinal RT must have elapsed prior to study entry
The subject may have had other systemic chemotherapy for PCNSL during the 90 days since PCNSL diagnosis; prior systemic chemotherapy must have been given at least 4 weeks prior to study entry (6 weeks for nitrosourea agents), with the exceptions of methotrexate and rituximab which may have been given at least 10 days prior; ocular lymphoma treatment may have been given any time prior to study entry; if the subject has undergone treatment for parenchymal disease and the parenchymal disease has progressed on a stable or increasing dose of steroids, the subject is not eligible for enrollment
Prior bladder-directed radiotherapy.
Prior therapy with immune-activating agents within less than 1 cycle length prior to first day of study treatment (e.g. 3 weeks for ipilimumab or pembrolizumab; 2 weeks for nivolumab) (for treatment phase)
Antithymocyte globulin or similar anti-T cell antibody therapy ? 4 weeks prior to Cycle 1 Day 1
Patients must have had their last fraction of: \r\n* Craniospinal irradiation (> 24 GRAY [Gy]) or total body irradiation > 12 weeks prior to enrollment\r\n* Focal irradiation > 2 weeks prior to enrollment\r\n* >= 3 months since autologous bone marrow/stem cell transplant prior to enrollment
Radiotherapy </= 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment
Receipt of cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C) of scheduled C1D1 dosing.
Treatment with any of the following:\r\n* Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment\r\n* Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks or 5 half lives, whichever is shorter, of the first dose of study treatment, except fulvestrant, enzalutamide or hormonal therapy with LHRH analogues for medical castration in patients with breast or prostate cancer, which are permitted\r\n* Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort)\r\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment\r\n* Radiotherapy with a wide field of radiation within 4 weeks of the first dose of study treatment\r\n* AKT inhibitors
Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment; for cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as washout period; for patients receiving anticancer immunotherapies such as CTLA-4 antagonists, 3 weeks is indicated as the washout period
Participants who have received thoracic radiotherapy to lung fields =< 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =< 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment is allowed
RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
Prior palliative radiotherapy must have been completed at least 2 weeks prior to study entry
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
Any of the following therapies prior to registration:\r\n* Chemotherapy =< 3 weeks\r\n* Immunotherapy =< 3 weeks\r\n* Biologic therapy =< 3 weeks\r\n* Hormonal therapy =< 2 weeks\r\n* Monoclonal antibodies =< 3 weeks\r\n* Radiation therapy =< 2 weeks\r\n* CDK 4/6 inhibitors =< 4 weeks\r\n* mTOR inhibitors =< 4 weeks
Signs or symptoms of infection within 2 weeks before initiation of study treatment
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to randomization. IMiDs, PIs and or corticosteroids within 2 weeks prior to randomization. Other investigational therapies and monoclonal antibodies within 4 weeks of randomization. Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to randomization
Patients must not have received myelosuppressive therapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
Participation in other clinical trials within at least 2 weeks of the first ORH-2014 dose;
Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 2 weeks in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
Participation in any other clinical trial within 4 weeks prior to randomization.
Myelosuppressive chemotherapy: must not have received within 4 weeks of registration onto this study (6 weeks if prior nitrosourea)
At least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody prior to registration
Patient has received chemotherapy or radiotherapy within 4 weeks prior to day 1 of study; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been radiated
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 (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
Finasteride, bicalutamide and nilutamide discontinued at least 4 weeks prior to registration
At least 4 weeks must have elapsed from the use of palliative radiation, strontium-89, radium-223, or approved immunotherapy prior to registration
Use of an ESA within the 4 weeks prior to Cycle 1 Day 1.
Minimum interval since last drug therapy:\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing therapy regimen
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\nAlanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) within 3 weeks prior to study registration
Within 3 weeks prior to study registration: \r\nAlkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) 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\nInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN within 3 weeks prior to study registration; subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists ; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care
Within 3 weeks prior to study registration: \r\nPlatelet count > 100000 /mm^3 within 3 weeks prior to study registration
Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include: lenalidomide, fludarabine, or alemtuzumab within 12 months; radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed four (4) weeks prior to first dose of study drug or without complete recovery from all such treatments.
Concurrent administration of any other anti-cancer therapy\r\n* Bisphosphonates and denosumab for bone metastases are allowed as long as these were started at least 4 weeks prior to treatment with study drug\r\n* Octreotide is allowed if dose is stable for > 3 months with no worsening of carcinoid syndrome\r\n* Hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with castrate-resistant prostate cancer is permitted\r\n* Most recent chemotherapy within 3 weeks prior to entering the study\r\n* Therapeutic radiotherapy within the previous 3 weeks if =< 5% of their total marrow volume or 4 weeks if > 5% of their total marrow volume, or unresolved acute or subacute toxicities from prior radiotherapy\r\n* Most recent experimental (non-FDA approved) anti-cancer therapy or immunotherapies =< 30 days or five half-lives of the drug (whichever is less)\r\n* Patients who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 toxicities related to prior therapy (administered more than 3 weeks earlier) or incomplete recovery from previous surgery, unless agreed by the principal investigator (PI) and documented are not eligible to participate in this study with the exception of grade 2 peripheral neuropathy if it has been stable, and not worsening, for at least 28 days, and grade 2 alopecia
Treatment with anticancer/investigational drugs, therapy ? 4 weeks prior to first dose of SC-002
The following time periods must have elapsed prior to the planned start date of study treatment:\r\n* >= 2 weeks or 6 half-lives from any approved tyrosine kinase inhibitors (TKIs) or investigational agent, whichever is shorter\r\n* >= 4 weeks from prior cytotoxic therapy, except >= 3 weeks from last dose of temozolomide and >= 6 weeks from nitrosoureas or mitomycin C\r\n* >= 2 weeks from non-cytotoxic agents\r\n* >= 3 weeks from bevacizumab
Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Recent initiation of bone modifying therapy with a bisphosphonate or denosumab unless it has been started more than 4 weeks prior to the first dose of the study regimen; patients who are already enrolled in this study can initiate bone modifying therapy after the first set of re-staging scans (>= 8 weeks from cycle 1, day 1)
Chemotherapy or stereotactic radiotherapy within the last 2 weeks
Less than four weeks since last radiotherapy (excluding palliative radiotherapy).
Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
Less than 4 weeks since any therapy for MDS
ARM 3: Must have had at least 1 but no more than 3 prior lines of anti-myeloma therapy; exposure to carfilzomib and lenalidomide is allowed but must not be refractory to either drug; must be 6 months from prior therapeutic lenalidomide (> 4 weeks if lenalidomide used as maintenance [dose < 15 mg]) and ?8 weeks from prior carfilzomib
Prior radiation therapy or chemotherapy within 2 weeks or major surgical procedure within 4 weeks of the first dose of study treatment
Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
Any chemotherapy, sipuleucel-T, or investigational drug in prior 4 weeks, or abiraterone or enzalutamide in prior 2 week
More than 2 seizures over the last 4 weeks prior to study entry
Patients who received chemotherapy (including monoclonal antibodies) or radiotherapy, administered for any condition, within 4 weeks prior to registration are not eligible
Mitomycin C/nitrosoureas less than or equal to 6 weeks prior to registration
Biologic therapy less than or equal to 4 weeks prior to registration
Exposure to any other anti-leukemic therapy (except hydroxyurea) within 2 weeks before the first dose of study treatment (including investigational chemotherapy regimens involving approved agents)
Prior radiation therapy or chemotherapy within 2 weeks prior cycle 1, day 1, monoclonal antibody therapy within 4 weeks
Washout time of at least 4 weeks for prior biological, chemotherapeutic, or radiotherapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy prior to participating in this trial\r\n* No prior myelosuppressive chemotherapy for at least 21 days prior to study enrollment\r\n* Must not have received craniospinal radiation therapy within 24 weeks prior to study entry and no involved field radiation therapy for 12 weeks prior to study enrollment\r\n* If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation\r\n* No investigational drugs for 4 weeks prior to study enrollment\r\n* No prior therapy with mTOR inhibitors (including sirolimus, temsirolimus or everolimus)
Any other cancer treatments within 2 weeks of planned study treatment
Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment.
Prior treatment including chemoembolization or other ablative therapy, any cytotoxic, biologic or other investigational agents must have been completed at least 4 weeks prior to study entry
Any major surgery must be completed at least 4 weeks prior to study entry; minor surgical procedures (except insertion of vascular access device) must have been completed at least 2 weeks prior to study entry
No other investigational, biologic or chemotherapy agents, localized ablation or chemoembolization for 4 weeks prior to study entry
Radiation therapy, chemotherapy, and other investigational agents within 3 weeks (6 weeks for nitrosourea or mitomycin C) prior to starting fenretinide + safingol; patients must have recovered from toxicities of prior therapy
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
Myelosuppressive chemotherapy: Must not have received within 4 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Currently receiving any investigational agents within the previous six weeks or received any tumor vaccines within the previous 6 weeks
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Previous chemotherapy/radiotherapy/targeted therapy should have been completed at least 4 weeks prior to start of FID-007 administration
Patients who have had chemotherapy or biological therapy within 4 weeks of registration
Last anti-cancer treatment within 2 weeks prior to study entry
Any prior therapy must have been completed >= 4 weeks (6 weeks for nitrosoureas and mitomycin C) or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion, and should have recovered to grade 1 or baseline from any toxicities
Participants who have had chemotherapy, immune therapy, or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C; five-half lives for any investigational or Food and Drug Administration [FDA]-approved kinase inhibitors) prior to entering the study. Patients who have received prior CHK1 inhibitor therapy are excluded. Exposure to prior PD-L1 antibody will be allowed as long as this was not the most recent treatment prior to enrollment.
Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Previous BRAF/MEK inhibitor use is allowed with no washout period for the phase I and II portions
Prior radiotherapy within 2 weeks of the first dose of study treatment
Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
Blood transfusion within 4 weeks prior to screening
Mitomycin C or a nitrosourea: 6 weeks
Radiotherapy: 6 weeks
Prior radiotherapy is acceptable provided it was applied within 4 four weeks before starting of this trial and the patient recovered from any radiotherapy related acute toxicities.
PHASE II INCLUSION CRITERIA: For patients who do not receive radiotherapy after chemotherapy, the randomization must occur within 6 weeks of the last chemotherapy cycle; the study treatment must start within 2 weeks from randomization; for patients who receive radiotherapy (including prophylactic cranial radiation and/or thoracic radiation) after chemotherapy, the randomization must occur within 9 weeks of the last chemotherapy cycle but at least 2 weeks after completion of radiotherapy and the first dose of 177Lu-DOTA0-Tyr3-octreotate cannot be given within 8 weeks of radiotherapy
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 2 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Participants who have had chemotherapy, biologic therapy, investigational agents, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Has received prior radiotherapy within 2 weeks of therapy.
Treatment with chemotherapy (not including tyrosine kinase inhibitors) or radiotherapy within 4 weeks (6 weeks from nitrosoureas or mitomycin C), or treatment with monoclonal antibody therapy within 4 weeks prior to start of study treatment\r\n* Note: no minimum washout period is required for tyrosine kinase inhibitor therapy (eg, imatinib or sunitinib)
Vaccination within 4 weeks of the first dose of avelumab and while on study.
Radio-immunoconjugate within 12 weeks prior to Day 1 of Cycle 1.
Radiotherapy, chemotherapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1.
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives\r\n* Exceptions:\r\n** There is no time restriction with regard to prior intrathecal chemotherapy (including [incl.] steroids) provided there is complete recovery from any acute toxic effects of such\r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n** Subjects receiving steroid therapy at physiologic replacement doses (=< 5 mg/day of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** For radiation therapy: radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment; bevacizumab within 6 weeks prior to enrollment
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Participants who have had chemotherapy, radiotherapy, or major surgery within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Had immunotherapy, radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4 weeks prior to treatment initiation (or oral therapy within 1 week prior to treatment initiation).
Prior history of external beam radiotherapy >= 5,000 cGy delivered to the tumor at least 4 weeks prior to Office for Human Research Studies (OHRS) registration
received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
Chemotherapy or limited field radiotherapy within 2 weeks, wide field radiotherapy within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks prior to entering the study
Participants who have had radiotherapy within 3 weeks
Time since the last prior therapy to treat underlying malignancy to start of drug:\r\n* Cytotoxic chemotherapy: greater than the duration of the most recent cycle of the previous regimen (with a minimum of two weeks for all)\r\n* Biologic therapy (e.g., antibodies): >= four weeks\r\n* >= 5 x t1/2 of a small molecule therapeutic, not otherwise defined above, with a minimum of 2 weeks (including aromatase inhibitors and tamoxifen)
Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Prior systemic therapy: patients must be at least 2 weeks from prior chemotherapy, biological agents, immunotherapy or any investigational drug product, with adequate recovery of toxicity
Prior focal radiotherapy completed at least 4 weeks prior to study drug administration.
Prior radiotherapy or radiosurgery < 2 weeks prior to starting study treatment
Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
Prior Therapies:\r\n* There is no maximum number of prior medical therapies\r\n* There must be no curative or life prolonging treatments available\r\n* Patients who have received other IGF-1R antibodies or inhibitors are eligible, as long as an appropriate washout period has elapsed \r\n* 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\r\n* 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\r\n* 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)
Patients must have recovered to grade 1 or baseline from adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy, biologic therapy, or definitive radiotherapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or 5 half-lives, whichever is shorter, prior to entering the study; palliative-intent radiotherapy (30 Gy or less) must be completed at least 2 weeks prior to start of treatment, and may not be to a lesion that is included as measurable disease; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion, and should have recovered to grade 1 or baseline from any toxicities
Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
Radiotherapy: >=2 weeks must have elapsed since local palliative radiotherapy (XRT) (small port); >=3 months must have elapsed if prior Traumatic Brain Injury (TBI), craniospinal XRT or if >=50% radiation of pelvis; >=6 weeks must have elapsed if other substantial bone marrow irradiation was given.
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
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 who have had radiotherapy within 4 weeks
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
Patients who have received radiation therapy within 3 weeks before transplant. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
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 if nitrosourea
Radiation: patients must have:\r\n* Had their last fraction of local irradiation to primary tumor >= 12 weeks 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 or total body irradiation >= 12 weeks prior to registration
Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field
Patients who have had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g., cytokines or antibodies) within 3 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose of study treatment
INCLUSION - INFUSION: Patients should have been off other investigational therapy for 4 weeks prior to entry in this study
Patients who have had radiotherapy (except for palliative reasons), immunotherapy or chemotherapy during the previous 4 weeks (6 weeks for nitrosoureas or mitomycin) before treatment, or those who have ongoing toxic manifestations of previous treatments, with the exception of alopecia, of grade higher than 1
Participants who have had chemotherapy, immune therapy, other investigational therapy, major surgery, or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Alemtuzumab or ATG within 2 weeks of enrollment.
Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
Participants who have had chemotherapy, other investigational or biologic therapy, major surgery, or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the planned first dose of prexasertib (LY2606368) therapy.
Estimated survival of at least 12 weeks;
Patients with HGG: Have received anticancer therapies including: radiation therapy to current site of disease within 12 weeks of dose assignment, targeted agent therapy within 2 weeks of dose assignment, nitrosoureas within 6 weeks of dose assignment, procarbazine within 3 weeks of dose assignment, or other cytotoxic agents within 4 weeks of dose assignment
Prior thoracic radiotherapy
Completion of any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of ibrutinib; patients must have completed any prior immunotherapy (e.g., rituximab or PD-1 inhibition) or antibody drug conjugate therapy (e.g. brentuximab vedotin) at least 4 weeks prior to the first dose of ibrutinib in the absence of clear disease progression
Cholangitis that required treatment or intervention within 4 weeks of study enrollment
Blood cell count (CBC)/differential obtained within 8 weeks prior to registration on study
Prior radiotherapy to the upper abdomen
Active gastrointestinal bleed within 2 weeks of study enrollment
Thoracic radiotherapy to lung fields =< 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy =< 2 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting INC280 is allowed
Nitrosourea or mitomycin C within 6 weeks of the first dose
Any investigational medicinal product or other systemic chemotherapy, or antibody therapy within 4 weeks prior to the first dose of study treatment, or within 8 weeks after immunotherapy, whichever is the most appropriate and as judged by the Investigator. Note: androgen-deprivation therapy is permitted for patients with prostate cancer.
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
Small pox vaccination for 4 weeks before study therapy and during study treatment
Has had prior chemoembolization, bland embolization, radioembolization, local ablative therapies, radiation to liver tumors, or major surgery such as liver resection within 4 weeks prior to study enrollment or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to intervention more than 4 weeks earlier
The patient has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug.
Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
Current use of systemic corticosteroids greater than (>) 20 mg prednisone per day (or equivalent), or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure; prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
At least three weeks since the last anticancer therapy, including investigational drugs and radiotherapy, and at least six weeks since nitrosoureas and mitomycin C(systemic).
Treatment with systemic immune modulators 2 weeks before enrollment (day 1)
Radiotherapy: at least 3 weeks since most recent radiotherapy; prior radiated lesions will not be evaluable unless there is documented progression post therapy; palliative radiotherapy to localized painful lesions is acceptable when the patient is on study: at least one week after completion of radiation therapy (RT) and recovery from associated toxicities before restarting ARQ 761; irradiated lesions will not be evaluable for response
Receipt of any chemotherapy, biological therapy or investigational agents within 3 weeks prior to study registration
Radiotherapy within 4 weeks prior to therapy except palliative radiation to target organs other than primary tumor may be allowed up to 2 weeks prior to registration
Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 2 weeks since any prior palliative radiation or cyberknife therapy; patients must have recovered to grade 1 from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment
Biologic therapy (eg, antibodies), other than ADCs: ?4 weeks
Any of the following prior therapies:\r\n* Chemotherapy =< 3 weeks prior to study entry\r\n* Immunotherapy =< 4 weeks prior to study entry\r\n* Biologic therapy =< 4 weeks prior to study entry\r\n* Extensive abdominal surgery if it includes enterotomy(ies) =< 3 weeks prior to study entry; (NOTE: this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of study entry)\r\n* Any viral or gene therapy prior to study entry
No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry
Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks prior to study enrollment or at least six (6) weeks if prior nitrosourea
Patients must have had their last fraction of:\r\n* Craniospinal irradiation >= 3 months prior to enrollment\r\n* Other substantial bone marrow irradiation >= 6 weeks prior to enrollment\r\n* Local palliative radiation therapy (XRT) (small port) >= 2 weeks
INCLUSION CRITERIA FOR STRATUM C: Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks prior to study enrollment or at least six (6) weeks if prior nitrosourea
INCLUSION CRITERIA FOR STRATUM C: Patients must have had their last fraction of:\r\n* Craniospinal irradiation >= 3 months prior to enrollment\r\n* Other substantial bone marrow irradiation >= 6 weeks prior to enrollment\r\n* Local palliative radiation therapy (XRT) (small port) >= 2 weeks
Any therapeutic antibody within 4 weeks of first dose of study drugs.
Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
Patients must not have had standard of care chemotherapy, radiotherapy, or major surgery within the last 2 weeks prior to entering the study; Note: local surgeries for isolated lesions for palliative intent are acceptable; for recent experimental therapies a 28 day period of time must have elapsed before commencing protocol treatment
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
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
Patients who have received:\r\n* Radiation or chemotherapy =< 4 weeks\r\n* Mitomycin C, nitrosureas, or radio-immunotherapy =< 6 weeks, or\r\n* Immunotherapy or targeted therapy (such as kinase inhibitors) =< 2 weeks prior to cycle 1 day 1; patients who are on ibrutinib at study entry are not required to discontinue ibrutinib for any period of time\r\n* Palliative steroids for disease related symptoms are allowed as long as dose is tapered down to an equivalent of =< 10 mg of oral prednisone daily on cycle 1 day 1
Chemotherapy: patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study enrollment in the study or at least six (6) weeks for those receiving nitrosourea
Radiotherapy: patients must have had their last fraction of: \r\n* Focal irradiation > 2 weeks prior to enrollment
Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of UC-961, or at any time during the study
Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, or investigational agents; 6 weeks for mitomycin C)
Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients’ toxicities must have recovered to a grade 1 or less; patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks
Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, targeted molecular therapy (e.g. vemurafenib, other inhibitor of mutant BRAF, MEK, or cKit), or other experimental therapy, or who have received this therapy within the preceding 4 weeks (except as specified). Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study registration. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks are excluded.
A minimum of 4 weeks from prior systemic anti-cancer therapies or 3 weeks for radiation treatment prior to enrollment is required
Anticancer chemotherapy or immunotherapy during the study or within 5-halflives prior to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within 6 weeks before starting to receive study treatment or within 6 weeks of pre-treatment biopsy for biomarker (p-ERK1/2) studies
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy\r\n* Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment\r\n* Patients must be > 7 days since treatment with hematopoetic growth factors (> 14 days for Neulasta)\r\n* Patients must be > 7 days since therapy with a biologic agent and beyond the period for which adverse events of the biologic agent are known to occur if longer\r\n* Patients must be > 3 half-lives since therapy with a monoclonal antibody\r\n* Patients must be > 42 days since completion of any immunotherapy (i.e. tumor vaccines)\r\n* Patients must be greater than 2 weeks since most recent palliative XRT and greater than 6 weeks since substantial bone marrow irradiation\r\n* Patients must be greater than 8 weeks since prior stem cell transplant or infusion and without evidence of active graft versus (vs.) host disease
Currently receiving cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization).The following are allowed: Hydroxyurea for proliferative disease, Corticosteroids, Use of hematopoetic growth factors is permitted at the discretion of the investigator according to published guidelines (e.g., National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), etc.). The following are NOT allowed: Investigational anti cancer drug within 2 weeks prior to the first dose of GSK525762; Major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK525762 Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks. Nitrosourea or mitomycin C within the last 6 weeks
Minimum interval since last drug therapy:\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks (or 5 half-lives, whichever is shorter) prior to entering the study (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Bevacizumab within the last 3 weeks before enrollment on trial
Prior radiation therapy must be completed >= 2 weeks prior to enrollment and the patient must have recovered from all toxicity; prior radiopharmaceuticals (strontium, samarium, alpharadin) must be completed >= 4 weeks prior to enrollment
Patients who have had radiotherapy =< 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
Within 4 weeks prior to study enrollment: Shortening fraction of >= 27% by echocardiogram OR
Within 4 weeks prior to study enrollment: No evidence of dyspnea at rest
treatment with cytotoxic agents, or treatment with biologic agents within 4 weeks prior to treatment with APS001F (6 weeks for mitomycin C or nitrosoureas).
radiotherapy within 4 weeks prior to treatment with APS001F (intensive radiotherapy within 6 weeks or palliative radiotherapy within 2 weeks).
Subjects must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below: \r\n* Myelosuppressive chemotherapy: Subjects must have received the last dose of myelosuppressive therapy at least 3 weeks prior to study registration or at least 6 weeks if therapy included nitrosourea\r\n* Investigational/biological agent: Subjects must have received the last dose of other investigational or biological agent > 7 days prior to study registration; subjects must not have received poly-ICLC in the past\r\n* Radiation therapy (XRT): Subjects must be >= 8 weeks since the completion of radiation therapy\r\n* Study specific limitations on prior therapy: There is no limit on the number of prior treatment regimens or received doses of radiation therapy\r\n* Growth factor(s): Subjects must not have received any hematopoietic growth factors within 7 days of study entry or 21 days for pegfilgrastim\r\n* Prior surgery: Subjects must be >= 2 weeks from prior surgery\r\n* Steroids: Subjects must be on a stable steroid dose for 7 days prior to study entry if they are on steroid treatment
Treatment indicated based on demonstration of at least one of the following no more than 4 weeks from the time of enrollment, and no less than 6 months after prior purine analog and no less than 4 weeks after other prior treatment, if applicable
No other therapy (i.e. chemotherapy, interferon) for 4 weeks prior to study entry, or cladribine for 6 months prior to study entry
Received external beam radiotherapy within the 4 weeks prior to randomization
Patients who have completed focal radiotherapy within 14 weeks from time of enrollment are eligible.
Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of completion of radiotherapy.
Prior radiation: Patients must have received prior treatment with focal radiotherapy as part of initial treatment for DIPG and had their last dose at least 4 weeks prior to and no later than 14 weeks from the first CED treatment. Standard focal radiation therapy will include 54 to 60 Gy by external beam radiotherapy to the brainstem.
A diagnosis of deep vein thromboses in the preceding four weeks of study enrollment.
Time from prior therapy:\r\n* Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter (6 weeks for nitrosoureas or mitomycin C)\r\n* Hormonal therapy is not considered anti-neoplastic therapy\r\n* Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
At time of registration and within 4 weeks prior to initiating on-protocol treatment: Platelets >= 100 x 10^9 /L
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Patients who have received antiandrogens such as flutamide, bicalutamide, or nilutamide for > 6 months immediately before enrollment on this study must be off treatment for 4 weeks (6 weeks for bicalutamide) and demonstrate a continued rise in PSA. Patients on antiandrogens for < 6 months must be off medication for 2 weeks.
Patient who has received radiotherapy =< 4 weeks prior to study entry. Palliative radiotherapy for symptomatic control is acceptable (if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned)
Chemotherapy within 3 weeks of starting study drug (6 weeks if prior nitrosourea)
Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks before enrollment (14 days for non-myelosuppressive therapy). Subjects should be 6 weeks from last dose of nitrosourea, nitrogen mustards or monoclonal antibody, 12 weeks from autologous stem cell transplantation (SCT), and 16 weeks from allogeneic SCT
Treatment with plasmapheresis within 4 weeks before enrollment
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy. The use of live vaccines within 30 days before initiation of therapy. IMiDs, PIs and or corticosteroids within 2 weeks prior to initiation of therapy. Other investigational therapies and monoclonal antibodies (mAb) within 4 weeks of initiation of therapy Prednisone up to but no more than 10 mg orally once daily (q.d.) or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy
Prior therapeutic intervention with any of the following:\r\n* Nitrosoureas or mitomycin C within 6 weeks\r\n* Therapeutic anticancer antibodies (including rituximab) within 4 weeks\r\n* Radio- or toxin-immunoconjugates within 10 weeks\r\n* All other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy
Monoclonal antibodies therapy within 2 weeks before study entry
Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
The last dose of previous therapy must have occurred at least 3 weeks prior to the start of study therapy; palliative radiotherapy is allowed up to 2 weeks before the first LMB-100 infusion
STRATUM A: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
STRATUM B: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
STRATUM C: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
Signs or symptoms of infection within 2 weeks prior to first day of study
Patients must be 4 weeks beyond previous treatment of any chemotherapy or radiotherapy, and must have recovered to =< grade 1 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 who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks, whichever is shorter, from the last day of treatment of non-chemotherapeutic biological agents.
Immunotherapy and/or investigational anticancer therapy with agents including mAbs : ?4 weeks
Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been completed at least 2 weeks prior to treatment; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment
For cohort 4, patients must be at least 4 weeks from radiation therapy; additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from procarbazine, 2 weeks from vincristine and 4 weeks from last bevacizumab administration; patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon) including investigative agents
GENERAL: Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1.
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients who have received chemotherapy in the previous 3 weeks (6 weeks for nitrosoureas or mitomycin); other investigational agents within 3 weeks or a PD1/PDL1 agent within 4 weeks prior to first dose of study treatment
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients who have received chemotherapy in the previous 3 weeks (6 weeks for nitrosoureas or mitomycin); other investigational agents within 3 weeks or a PD1/PDL1 agent within 4 weeks prior to study enrollment
COHORT 3: ENDOMETRIAL CANCER: Patients who have received chemotherapy in the previous 3 weeks (6 weeks for nitrosoureas or mitomycin); other investigational agents within 3 weeks or a PD1/PDL1 agent within 4 weeks prior to study enrollment
COHORT 3: ENDOMETRIAL CANCER: Patients who have undergone radiotherapy within 4 weeks of first dose of study treatment
Wash-out requirements (standard or investigational):\r\n* At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and\r\n* At least 23 days must have passed since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a participant’s most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of CAR T cell infusion with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting CAR T cell therapy
Subjects who have received any prior cytotoxic therapy, immunotherapy, major surgery, antitumor vaccines or monoclonal antibodies in the 4 weeks or 5 half-lives, whichever is shorter, prior to course 1, day 1 (C1D1) (6 weeks prior for checkpoint inhibitors such as anti-CTLA-4 or anti-PD1/PD-L1 and for nitrosoureas or mitomycin C); subjects must not have received radiotherapy in the 2 weeks prior to C1D1; subjects who had grade >= 3 immune-related adverse event (irAE) during previous treatment with one of the checkpoint inhibitors are excluded from the trial; subjects who had grade 1 or 2 irAE that have resolved to grade 1 are eligible
Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Any drug used for GVHD within 4 weeks prior to enrollment
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
Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
At least 3 weeks between last systemic chemotherapy and planned start of study treatment (4 weeks for prior investigational drugs, immunotherapy, radiotherapy, or biologics) for ovarian cancer
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
Within two weeks prior to enrollment: Not refractory to red cell or platelet transfusions
Use of hematopoietic growth factors within 2 weeks prior to initiation of therapy
Any major surgery, radiotherapy, or immunotherapy within the last 21 days (focal radiation does not require a washout period; ?4 weeks for WBRT). Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
Patients may have received prior therapy including vincristine, irinotecan, or temozolomide; patients may not have previously been treated with combination therapy of irinotecan and temozolomide\r\n* Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n** Patients must not have received myelosuppressive chemotherapy within 3 weeks of starting protocol therapy, or a minimum of six weeks must have elapsed since prior nitrosourea chemotherapy\r\n** At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim\r\n** At least 7 must have elapsed since the last administration of any biologic agent\r\n** At least 14 days since the last dose of local palliative radiation therapy; greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation\r\n** Complete resolution of graft versus host disease and no current need for immunosuppressive medication; greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors
Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if nitrosourea
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
Radiotherapy within 2 weeks of first dose of study medications
Any prior radiotherapy to the lung
Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of enrollment (day 1 visit)
No prior investigational therapy within 2 weeks prior to study enrollment
Completion of most recent salvage therapy within 8 weeks of enrollment
Prior therapies\r\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: Must not have received within 3 weeks (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor, 14 days for long- acting (e.g. PEG-filgrastim)\r\n* Biologic (anti-neoplastic agent): At least 7 days or 3 half-lives (whichever is longer) since the completion of therapy with a biologic agent\r\n* Radiation therapy: >= 12 weeks must have elapsed from craniospinal radiation; >= 2 weeks must have elapsed from focal radiation\r\n* Surgery: > 3 weeks from major surgery; if recent craniotomy, adequate wound healing must be determined by neurosurgical team\r\n* Autologous stem cell transplant or rescue: No evidence of active graft versus (vs.) host disease and >= 4 weeks must have elapsed
Hormonal therapy during the study or within 2 weeks of first study enrollment
Radiotherapy to target lesions during study or within 2 weeks of enrollment
Concurrent or recent chemotherapy, radiotherapy, or general anesthesia/major surgery within 3 weeks. Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free \washout\ period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).
Severe infection that in the opinion of the investigator would interfere with the patients safety or compliance on trial within 2 weeks prior to enrollment. Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment
Patients may have received prior radiation therapy in either the metastatic or early-stage setting; radiation therapy must be completed per the following timelines:\r\n* Radiotherapy to the thoracic cavity or abdomen within 4 weeks prior to registration\r\n* Radiotherapy to bone lesions within 2 weeks prior to registration\r\n* Radiotherapy to any other site within 4 weeks prior to registration\r\n* NOTE: In all cases, there must be complete recovery and no ongoing complications from prior radiotherapy
Prior mediastinal radiotherapy
Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
Patients must be off cancer-directed therapy for at least 3 weeks (2 weeks for oral agents) prior to day 1 of the study
Patients who have had radiotherapy within < 4 weeks are ineligible
Administration of intravesical BCG within 4 weeks before cycle 1, day 1
Subjects who have had chemotherapy or radiotherapy within 3 weeks (4 weeks for immunotherapy; 6 weeks for nitrosoureas or mitomycin C) prior to starting the study agent.
Subjects who had major surgery or radiation therapy within 4 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass.
Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
Prior systemic treatment with an azole drug within four weeks of cycle 1 day 1.
Signs or symptoms of infection within 2 weeks prior to first day of study treatment
Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
Signs or symptoms of infection within 2 weeks prior to the first study treatment
Previous cytotoxic therapies, including cytotoxic investigational agents, within 3 weeks (6 weeks nitrosoureas) prior to start of study treatment; previous corticosteroids used with intent to treat amyloidosis within three weeks; (prednisone up to but no more than 10 mg orally once a day [q.d.] or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to study treatment)
Pegvisomant, within 24 weeks
Pasireotide, within 24 weeks
Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery
Patients must discontinue antiandrogen therapy (i.e. bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout\r\n* Bicalutamide: Washout period at least 6 weeks\r\n* Flutamide and nilutamide: Washout period at least 4 weeks
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives\r\n* Exceptions:\r\n** There is no time restriction with regard to prior intrathecal chemotherapy (including [incl.] steroids) provided there is complete recovery from any acute toxic effects\r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n** Subjects receiving steroid therapy at physiologic replacement doses (>= 5 mg/day of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
The subject has received cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within 14 days, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Signs or symptoms of infection within 2 weeks prior to study treatment
Patients must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes:\r\n* Chemotherapy, biological therapy, immunotherapy, or an investigational therapy at least 3 weeks prior to starting cabozantinib\r\n* Corticosteroids at least 3 weeks prior to starting cabozantinib, except for a dose equivalent to dexamethasone of =< 4 mg/day\r\n* Nitrosoureas, nitrogen mustards, mitomycin C, or monoclonal antibodies at least 6 weeks prior to starting cabozantinib\r\n* Autologous stem cell transplantation at least 12 weeks prior to starting cabozantinib\r\n* Allogeneic stem cell transplantation at least 24 weeks prior to starting cabozantinib, and these patients must also not have moderate to severe active acute or chronic graft versus host disease
Patients who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with cabozantinib
Patients who have received chemotherapy in the previous 3 weeks (6 weeks for nitrosoureas or mitomycin)
Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration.
Patients who have had radiotherapy within the last 4 weeks before the first OBP-301 administration.
Prior and concomitant therapy:\r\n* Prior exposure to any PI3 kinase inhibitor\r\n* Exposure to chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to entering the study or lack of recovery from adverse events due to previously administered treatments\r\n* Ongoing chronic pharmacologic immunosuppression, e.g. cyclosporine, or systemic steroids that have not been stabilized to the equivalent of =< 10 mg/day prednisone prior to the start of the study drug\r\n* Other concurrent investigational agents during the study period
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment initiation
Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
Signs or symptoms of active infection within 2 weeks prior to cycle 1 day 1
Patients who have had chemotherapy or radiotherapy within 2 weeks of first dose of zydelig
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drug
At least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
Prior systemic chemotherapy or other investigational therapy must have been completed at least two weeks prior to administration of nivolumab
Prior palliative radiotherapy must have been completed at least 2 weeks prior to registration; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of randomization are strongly encouraged to receive palliative radiotherapy prior to randomization
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
Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, except 8 weeks for bicalutamide);
Patients who have had standard of care chemotherapy, large field radiotherapy, or major surgery must wait 2 weeks prior to entering the study
Has had a prior systemic anti-cancer treatment within the last 8 weeks
(For cohort A only): Time from prior therapy: a. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter. Hormonal therapy is not considered anti-neoplastic therapy. b. Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: Use of any of the following:\r\n* Cytotoxic or lymphotoxic agents (including prednisone > 5 mg/day or equivalent corticosteroid) within 1 week prior to leukapheresis; physiologic corticosteroid replacement, and topical or inhaled corticosteroids are not excluded\r\n* GVHD therapies within 4 weeks prior to leukapheresis (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6R)\r\n* Experimental agents within 4 weeks prior to leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis\r\n* Radiation within 6 weeks prior to leukapheresis unless there is progressive disease in irradiated lesions or there are additional non-irradiated, positron emission tomography (PET)-positive lesions \r\n* Allo-HSCT within 60 days prior to leukapheresis or donor lymphocyte infusion (DLI) within 6 weeks prior to leukapheresis\r\n* Treatment with cladribine within 3 months prior to leukapheresis\r\n* Treatment with alemtuzumab within 3 months prior to leukapheresis
131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)
131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
Must have an anticipated survival of at least 12 weeks.
History of use of another IP within the last 4 weeks prior to enrollment.
Monoclonal antibodies therapy within 2 weeks before study entry
No radiotherapy within 2 weeks
Participants receiving any other investigational agents within 2 weeks of the start of this trial and throughout the duration of this trial; participants receiving anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within 3 weeks prior to first dose of dabrafenib or trametinib; participants receiving proteasome inhibitors or immunomodulatory drugs (–imid), or chemotherapy without delayed toxicity within 2 weeks prior to first dose of dabrafenib or trametinib; treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is observed
Hematocrit >= 28% obtained < 4 weeks prior to starting treatment
Patient who has received thoracic radiotherapy to lung fields =< 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy­related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =< 2 weeks prior to starting the study treatment or has not recovered from radiotherapy­related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment is allowed
Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within the last 3 weeks, or chemotherapy without delayed toxicity within the last 2 weeks preceding the first dose of the combination; prior systemic treatment in the adjuvant setting is allowed
Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of the completion of radiotherapy
Patients must have received prior treatment with focal radiotherapy as part of initial treatment for DIPG and had their last dose at least 4 weeks prior to and no later than 14 weeks from the first CED treatment with liposomal irinotecan; standard focal radiation therapy will include 54 to 60 Gy by external beam radiotherapy to the brainstem
Discontinued all previous treatments for cancer ?4 weeks prior.
Patient has received chemotherapy or radiotherapy within 4 weeks prior to day 1 of study; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been radiated
Prohibited treatments and or therapies\r\n* Autologous stem cell transplant (ASCT) =< 12 weeks prior to first dose of the study drug\r\n* Prior treatments (window prior to registration): \r\n** Chemotherapy =< 2 weeks\r\n** Nitrosureas =< 6 weeks\r\n** Therapeutic anticancer antibodies =< 4 weeks\r\n** Radio- or toxin immunoconjugates =< 10 weeks\r\n** Radiation therapy =< 3 weeks\r\n** Or major surgery =< 2 weeks\r\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways\r\n* Prior allogeneic stem cell transplant (SCT)\r\n* Chest radiation =< 24 weeks prior to registration
Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have had immunotherapy in the past (off within 3 weeks), or general anesthesia/major surgery (within 3 weeks). Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free \washout\ period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).
Has recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: At least 3 weeks since completion (6 weeks for nitrosourea)\r\n* Biologic (anti-neoplastic agent): At least 7 days since completion of therapy with a biologic agent\r\n* Radiation (XRT): ? 1 week must have elapsed from prior palliative XRT to non-target lesions
Last docetaxel or cabazitaxel dose > 6 weeks prior to enrollment
Signs or symptoms of infection =< 2 weeks prior to cycle 1, day 1
Note: Treatment with bicalutamide and nilutamide within 6 weeks prior to enrollment is not allowed; treatment with flutamide within 4 weeks prior to enrollment is not allowed; treatment with all other gonadotrophin-releasing hormone (GnRH) analogues or antagonists is allowed\r\n* Chemotherapy\r\n* Biologic therapy\r\n* Investigational therapy\r\n* Immunotherapy
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Patients must not be receiving concurrent anti-tumor treatment and must have recovered from toxicity of prior treatment. Minimum interval required: 1) > 6 weeks following nitrosourea chemotherapy; 2) > 4 weeks after recovering from any non-nitrosourea drug or systemic investigational agent; 3) > 2 weeks after receiving any non-cytotoxic anti-tumor drug; 4) > 4 weeks after receiving radiation therapy (> 12 weeks following upfront concurrent chemoradiation); 5) > 2 weeks following Optune device use.
Calcium (MM only): corrected calcium < 11.5 mg/dL within 2 weeks prior to study registration
For MM patients only:\r\n* Prior radiotherapy within 2 weeks prior to the administration of study drug\r\n* Surgery within 4 weeks\r\n* Chemotherapy (Chemo) within 3 weeks (6 weeks for melphalan, or monoclonal antibodies)
Participants who have had chemotherapy other than R-EPOCH or R-CHOP, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks
At least 4 weeks since any previous treatment for cancer
Last cycle of most recent salvage therapy within 8 weeks of enrollment
Completion of any prior radiotherapy (Cohort C)
Subjects who had a thromboembolic event ? 4 weeks of C1D1 must be receiving adequate anticoagulation treatment for at least 2 weeks before C1D1 and must continue as clinically indicated post first dose
Patients must be >= 4 weeks beyond previous treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =< grade 1 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 who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks, whichever is shorter, from the last day of treatment of non-chemotherapeutic biological agents
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
At least 4 weeks from prior chemotherapy, radiotherapy or immunotherapy, or prior investigational agents
LYMPHODEPLETION: Treatment with any investigational drug within 14 days (ie, two weeks) prior to lymphodepletion or has received any tumor vaccines within the previous five weeks prior to lymphodepletion
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Patients may not have received chemotherapy or bevacizumab =< 4 weeks (except for nitrosourea [6 weeks] or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide [1 week]) prior to starting the study drug unless patients have recovered from side effects of such therapy
Patients must have completed previous cancer-related treatments before enrollment. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes or hormone replacement therapy] is acceptable). The following intervals between end of the prior treatment and first dose of study drug must be observed:\r\n* Port-a-cath placement: no waiting required\r\n* Minor surgical procedures: >= 7 postoperative days\r\n* Major surgery: >= 4 weeks\r\n* Radiotherapy: >= 4 weeks\r\n* Chemotherapy: >= 4 weeks\r\n* Immunotherapy or investigational anticancer therapy with agents other than monoclonal antibodies (mAbs): >= 4 weeks\r\n* Immunotherapy or investigational anticancer therapy with mAbs: >= 6 weeks\r\n* Immunosuppressive medication: >= 4 weeks with the exceptions of intranasal or inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or equivalent
Hormonal treatment within 2 weeks prior to start of study treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted); radiotherapy within 4 weeks prior to enrolment; palliative radiation to target organs may be allowed up to 2 weeks prior to enrolment, as long as there are other target lesions that can be monitored for response to study treatment
Within 4 weeks since any plasmapheresis
Corrected calcium >= 11.5 mg/dL within 2 weeks of randomization
A minimum of 2 weeks off of enzalutamide or abiraterone, if applicable, prior to registration
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Radiotherapy completed within 2 weeks prior to treatment initiation; radiotherapy completed > 2 weeks prior to treatment initiation is allowed if all procedure-related toxicities resolved
Time interval for last local therapy (radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to registration
Participants in cohort D must have completed systemic therapy AND have completed either consolidation thoracic radiotherapy or PCI or both completed either consolidation thoracic radiotherapy or PCI or both; participants in cohort D must initiate therapy with pembrolizumab within 6 weeks of the last dose of radiation; therapy must not start within 2 weeks from the last dose; consolidation radiotherapy dose must NOT be more than 3000 cGy; participants in cohort D must not have had progression of disease prior to the start of therapy
Must be at least 4 weeks since treatment with standard or investigational chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, and 8 weeks since any monoclonal antibodies or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment
The following minimum intervals are required between prior treatment and initiation of study therapy:\r\n* Cytotoxic chemotherapy: 3 weeks\r\n* Molecularly targeted therapy or immunotherapy: 2 weeks\r\n* Conventional fractionated radiation therapy: 2 weeks\r\n* Stereotactic radiation therapy: 1 week\r\n* Major surgery: 3 weeks
Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within 6 weeks (or within 2 weeks if source definitively treated [eg, radiation therapy or bronchoscopic procedure])
Use of other systemic anticancer treatments or agents within the past 2 weeks (4 weeks if the therapy was a monoclonal antibody)
Inclusion Criteria:\n\n        Main inclusion criteria all patients, Part 1 and Part 2:\n\n          -  Male or female, at least 18 years of age at the time of informed consent\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\n          -  Life expectancy >3 months assessed during Screening\n\n          -  Documented (histologically- or cytologically-proven) epithelial malignancy that is\n             locally advanced or metastatic, having received all therapy known to confer clinical\n             benefit\n\n        Additional inclusion criteria applicable to Part 2 ONLY:\n\n          -  Epithelial malignancy (tumor types to be determined), measurable according to RECIST\n             v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging\n             (MRI) within 4 weeks prior to C1/D1\n\n          -  Willingness to undergo a pre-and post-dosing biopsy (total of 2 biopsies) from primary\n             or metastatic tumor site(s) considered safe for biopsy\n\n        Exclusion Criteria:\n\n          -  Any antineoplastic agent for the primary malignancy (standard or investigational)\n             without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest)\n             prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1.\n\n          -  Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless\n             there is documented progression of the lesion following radiotherapy\n\n          -  Immunosuppressive or systemic hormonal therapy (>10 mg daily prednisone equivalent)\n             within 2 weeks prior to C1/D1 with exceptions\n\n          -  Use of hematopoietic growth factors within 2 weeks prior to C1/D1\n\n          -  Active second malignancy or history of another malignancy within the last 3 years,\n             with allowed exceptions\n\n          -  Central nervous system (CNS) malignancies including:\n\n               1. Primary malignancies of the CNS\n\n               2. Known, untreated CNS or leptomeningeal metastases, or spinal cord compression;\n                  patients with any of these not controlled by prior surgery or radiotherapy, or\n                  symptoms suggesting CNS metastatic involvement for which treatment is required\n\n          -  Inadequate recovery from an acute toxicity associated with any prior antineoplastic\n             therapy\n\n          -  Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any\n             prior surgical procedure\n\n          -  Non-healing wounds on any part of the body\n\n          -  Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within\n             4 weeks prior to C1/D1, unless adequately treated and stable\n\n          -  Active uncontrolled bleeding or a known bleeding diathesis\n\n          -  Significant gastrointestinal abnormalities\n\n          -  Significant cardiovascular disease or condition\n\n          -  Abnormal hematologic, renal or hepatic function
Cytotoxic chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 4 weeks prior to first administration of study treatment and/or other renal cell carcinoma (RCC)-directed systemic therapy =< 2 weeks prior to first administration of study treatment
Radiotherapy for primary HPVOC within 8 weeks, or radiotherapy for any other reason within 3 weeks prior to the first dose of vaccine
Chemotherapy or immunotherapy within 3 weeks prior to the first dose of vaccine
More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells\r\n* Note: Patients may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to grade 1 or less
Radiotherapy for extended field within prior 4 weeks or limited field within prior 2 weeks;
Patients who have had radiotherapy ? 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
Discontinuation of bicalutamide or nilutamide less than 6 weeks, and other antiandrogens less than 4 weeks, abiraterone less than 3 weeks, prior to the start of study medication.
Patients who have had standard of care chemotherapy, large field radiotherapy, or major surgery must wait 2 weeks prior to entering the study; for recent experimental therapies a 28 day period of time must elapse before treatment
The last dose of previous therapy must have occurred at least 3 weeks prior to the start of study therapy; palliative radiotherapy is allowed up to 2 weeks before the first LMB-100 infusion
Prior whole brain radiotherapy or conventional external beam radiotherapy
Administration of any of the following within the specified timeframe prior to the first dose of study drug:\r\n* 4 weeks from TMZ\r\n* 6 weeks from a nitrosoureas\r\n* 3 weeks from a biologic or targeted agent (i.e. small molecule)\r\n* 4 weeks for a VEGF inhibitor (i.e. bevacizumab)
mCRPC EXPANSION COHORT: The patient has received chemotherapy, radiotherapy, biologic agents or enzalutamide within 3 weeks before the first dose of study treatment (nitrosoureas or mitomycin within 6 weeks); however, for patients receiving abiraterone, they must discontinue the medication at least 14 days before the first dose of study treatment
Before study therapy, a minimum of 21 days must have elapsed since any prior chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy
Time interval from last systemic chemotherapy (not including low dose dexamethasone) more than 2 weeks prior to initiation of ABC294640; patients receiving high dose dexamethasone defined as 40 mg dexamethasone a day for 4 days will need 2 weeks washout prior to initiation of ABC294640
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, investigational therapy within 3 weeks prior to the first dose of the study drugs
Prior chemotherapy < 2 weeks prior to study drug treatment and treatment related adverse events that have not recovered to baseline or grade 1 (alopecia excluded); prior radiation therapy < 4 weeks prior to study drug treatment
Prior therapy\r\n* 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 not have received myelosuppressive chemotherapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor\r\n* Biologic (anti-neoplastic agent): At least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if traumatic brain injury (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue without TBI: No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
Patients who have received either immunotherapy within =< 8 weeks; chemotherapy within =< 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
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
Patients must not have received myelosuppressive chemotherapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
At least 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); at least 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); at least 3 months must have elapsed if prior craniospinal XRT was received, if more than 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; at least 6 weeks must have elapsed if other substantial bone marrow irradiation was given
Had alemtuzumab therapy within 12-weeks prior to screening.
Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry
Patient who has had systemic therapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
No restriction based on prior treatments but at least 4 weeks from prior immunotherapy, or prior investigational agents
Subject has received any of the following:\r\n* Chemotherapy, biological therapy, or surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to on-study date\r\n* Radiation therapy, within 10 weeks prior to entering the study or those who have not recovered from adverse events due to radiation administered more than 10 weeks prior to on-study date\r\n* Prior therapy with bevacizumab\r\n* Prior therapy with an anti-programed cell death 1 (PD-1), anti-programed cell death 1-ligand (PD-L)1, anti-PD-L2, anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody\r\n* Prior treatment with an HDAC inhibitor, with the exception of prior or current treatment with valproate\r\n* Any investigational agents or have had any investigational agent within the 30 days prior to on-study date\r\n* A live vaccine within 30 days prior to on-study date\r\n* Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to on-study date
Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for targeted therapies prior to this study entry.
Excluded therapies and medications for cancer\r\n* Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia); anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints; however, subjects with prostate cancer who are receiving depot luteinizing hormone-releasing hormone (LHRH) agonist therapy may continue on this treatment\r\n* Hormonal therapy during the study or within 2 weeks of first study enrollment\r\n* Radiotherapy to target lesions during study or within 4 weeks of first study treatment\r\n* An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation\r\n* Bone marrow transplant or stem cell rescue\r\n* Bisphosphonate therapy during the first 2 cycles of treatment\r\n* Granulocyte colony stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction; erythropoietins are not permitted\r\n* Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drugs and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
A minimum of 3 weeks must have elapsed from last intake of prior standard chemotherapy treatment.
A minimum of 6 weeks must have elapsed from the last dose of nitrosoureas.
More than 12 weeks from completion of chemoradiation, unless RANO criteria for early progression within 12 weeks of chemoradiation are met (See 18.1)
Anticancer therapy within 2 weeks prior to initiating study treatment
Patient received radiotherapy within 2 weeks prior to the first dose of study treatment except localized radiation therapy for symptomatic bone metastasis
Prior locoregional therapy is allowed if completed at least 2 weeks prior to enrollment
Prior chemotherapy is allowed if stopped/completed at least 2 weeks prior to enrollment
Previous therapy with antiandrogens within 4 weeks
CAPMATINIB EXCLUSION CRITERIA: Prior treatment with the following antineoplastic therapies within the following time frame:\r\n* Any prior treatment with capmatinib, crizotinib, or any other cMET or HGF inhibitor\r\n* Thoracic radiotherapy to lung fields =< 4 weeks prior to starting capmatinib; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy =< 2 weeks prior to starting capmatinib; palliative radiotherapy for bone lesions =< 2 weeks prior to starting capmatinib is allowed\r\n* Receipt of any anticancer or investigational agent within 4 weeks or =< 5 half-lives of the agent (whichever is longer) prior to the first dose of capmatinib; if previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before the first dose of capmatinib
CERITINIB EXCLUSION CRITERIA: Prior treatment with the following antineoplastic therapies within the following time frame:\r\n* Any prior treatment with ceritinib\r\n* Radiotherapy to lung fields =< 4 weeks prior to starting ceritinib; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy =< 2 weeks prior to starting ceritinib; palliative radiotherapy for bone lesions =< 2 weeks prior to starting ceritinib is allowed\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within 4 weeks prior to the first dose of study drug (within 6 weeks for nitrosoureas, mitomycin C or liposomal doxorubicin)
REGORAFENIB EXCLUSION CRITERIA: Prior treatment with the following anti-neoplastic therapies within the following time frame:\r\n* Any prior treatment with regorafenib\r\n* Radiotherapy within 2 weeks prior to enrollment\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within 4 weeks prior to the first dose of study drug (within 6 weeks for nitrosoureas, mitomycin C or liposomal doxorubicin)
ENTRECTINIB EXCLUSION CRITERIA: Prior treatment with the following anti-neoplastic therapies within the following time frame:\r\n* Any prior treatment with entrectinib\r\n* Any prior treatment with TRK, ROS1, or ALK inhibitors\r\n* Radiotherapy within 2 weeks prior to enrollment\r\n* Whole brain radiotherapy within 2 weeks prior to enrollment, or stereotactic radiation to the brain within 1 week prior to enrollment\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within 2 weeks prior to the first dose of study drug
Subjects must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes: \r\n* Chemotherapy, biological therapy, immunotherapy, or an investigational therapy at least 2 weeks prior to starting DS3032b\r\n* Corticosteroids at least 2 weeks prior to starting DS3032b, except for a dose equivalent to dexamethasone of >= 4 mg/day\r\n* Nitrosoureas, nitrogen mustards, mitomycin C, or monoclonal antibodies at least 6 weeks prior to starting DS3032b\r\n* Autologous stem cell transplantation at least 12 weeks prior to starting DS3032b\r\n* Allogeneic stem cell transplantation at least 24 weeks prior to starting DS3032b, and these subjects must also NOT have moderate to severe active acute or chronic graft versus host disease (GVHD)\r\n* Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment
Subjects who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with DS3032b
Patient received chemotherapy within 2 weeks prior to initiation of treatment with Toca 511 (6 weeks for nitrosoureas).
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
4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
Systemic anti-neoplastic therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study treatment;
Retinoids: 4 weeks
Interferons: 4 weeks
Low dose methotrexate: 4 weeks
Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study).
Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study
2 weeks or more since end of previous systemic or radiation treatment (4 weeks or more for bevacizumab plus interferon-alfa)
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
Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs
Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs
Prior radiotherapy to a dose of >= 50 Gy
Patient who has received thoracic radiotherapy to lung fields =< 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =< 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment is allowed
Prior radiotherapy is allowed
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before randomization; Note: no washout required for single dose Gamma Knife radiation
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
For Part II (Arm C): Patients can have either locally advanced or metastatic pancreas adenocarcinoma; up to two prior treatment regimens are permissible (excluding a prior PARP inhibitor) for either localized or metastatic pancreas adenocarcinoma; prior combined chemotherapy and radiotherapy is permissible provided the patient has measurable disease outside the radiation port; prior therapy must have been completed at least 3 weeks prior to starting study therapy
Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)
At least 2 weeks must have elapsed since the administration of previous therapy; six weeks must have elapsed since administration of nitrosoureas or mitomycin C; seven days must have elapsed since the administration of filgrastim (G-CSF) and/or sargramostim (GM-CSF)
Patients should not have received prior systemic therapy for metastatic RCC; prior radiotherapy must have been completed at least 2 weeks prior to the administration of study drug; patients must be 2 weeks from prior major surgery and 1 week from pre-treatment biopsy; prior systemic adjuvant therapy (excluding with PD1 or CTLA4 pathway blockers) is allowed if treatment completed > 12 months previously
Having received immunotherapy or chemotherapy within 2 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study treatment; the patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients who have received chemotherapy, radiotherapy, any other investigational agents within 4 weeks (6 weeks for nitrosoureas or mitomycin) prior to study enrollment
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have received chemotherapy in the previous 3 weeks (6 weeks for nitrosoureas or mitomycin); or who received radiotherapy or any other investigational agents within 3 weeks prior to study enrollment
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients who have received chemotherapy, radiotherapy, any other investigational agents within 3 weeks (6 weeks for nitrosoureas or mitomycin) prior to study enrollment
Anti-cancer therapy, such as chemotherapy, immunotherapy, targeted and hormonal/endocrine therapy, or investigational agents within two weeks for oral drugs, four weeks for intravenous drugs, and six weeks for nitrosoureas, mitomycin C, or bevacizumab prior to administration of the first dose of study drug
Monoclonal antibodies therapy within 2 weeks before study entry
Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
Corticosteroid use within 2 weeks of study treatment
Estimated survival of at least 8 weeks
AT THE TIME OF INFUSION: Subjects should have been off other investigational antineoplastic therapy for two weeks prior to entry in this study; temozolomide will be allowed up to 48 hours pre-infusion; dexamethasone up to a total dose of 2 mg per day will be allowed if medically indicated
Washout of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, and 2 weeks for palliative radiotherapy; 3 months from high-dose chemotherapy and stem cell rescue; 3 weeks from major surgery. Participants must have recovered from the acute toxic effects of all prior anticancer therapy before enrollment into the study.
Patients must not have received myelosuppressive therapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Greater than or equal to 2 weeks must have elapsed for local palliative radiotherapy (re-irradiation for progressive disease or upfront radiation therapy [RT] at initial diagnosis) and enrollment on study for stratum II; at least 24 weeks must have elapsed if patient received craniospinal radiotherapy due to any other prior malignancies
Prior treatment with vorinostat is allowed but at least 3 weeks must have elapsed from the last dose and effects of prior therapy have resolved
Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, surgery, or radiotherapy prior to entering this study:\r\n* Myelosuppressive chemotherapy: patient has not received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: at least 2 weeks must have elapsed since any irradiation; at least 6 weeks must have elapsed since craniospinal radiation therapy (RT) or substantial bone marrow irradiation
Acute infection requiring systemic anti-infectives, antivirals, or antifungals within two weeks prior to first dose
Chemotherapy: \r\n* Must not have received myelosuppressive chemotherapy within 3 weeks of the study entry (6 weeks if prior nitrosourea); prior treatment with either dasatinib or temsirolimus but not both is allowed; at least 3 weeks must have elapsed from the last dose
Radiotherapy (XRT): at least 4 weeks for focal XRT or 8 weeks for craniospinal XRT must have elapsed prior to study entry
Any radiotherapy within 2 weeks of registration
Prior treatment with bevacizumab within 12 weeks of study entry
Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy or investigational treatment within 3 weeks preceding first dose of study treatment, or chemotherapy without delayed toxicity within 2 weeks preceding first dose of study treatment
Radiotherapy within 4 weeks prior to enrollment, except as follows:\r\n* Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to enrollment, and\r\n* Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor-investigator prior to enrolling
May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or nitrosureas within the last 6 weeks prior to study treatment.
Able to initiate study treatment no later than 6 weeks from last dose of any antineoplastic component of prior therapy regimen
Myelosuppressive chemotherapy: must not have received within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Receipt of the following treatment prior to first dose of BGB-3111: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.
Bilirubin =< 3 x UNL, values =< 2 weeks
Completion of definitive therapy 4-12 weeks prior to enrollment; there are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least 4 weeks prior to enrollment
Completion of definitive therapy for oligometastatic disease greater than 12 weeks prior to enrollment
Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Patient who has received thoracic radiotherapy to lung fields =< 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =< 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment is allowed
Any significant systemic infection within 4 weeks prior to dosing
Patients receiving bevacizumab within 12 weeks prior to protocol treatment
Must be at least 4 weeks post-operative
No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within four weeks before beginning treatment with SB-485232 (six weeks for nitrosoureas and mitomycin C); subjects must have recovered at least to grade 2 from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study
Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness; subjects must complete therapy prior to enrollment; topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment
Chemotherapy or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; hydroxyurea may be continued until 72 hours prior to first dose and at least 24 hours before the baseline bone marrow aspiration is performed
Patients who have had radiotherapy =< 4 weeks prior to starting study drug, or =< 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture)
Previous chemotherapy/immunotherapy within 3 weeks before study entry
Wash-out requirements (standard or investigational):\r\n* At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen\r\n* At least 23 days since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient’s most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment
Any number of prior therapies is permitted; from the start of study treatment, the following time periods must have elapsed: 6 weeks from nitrosourea-containing chemotherapy, 4 weeks from non-nitrosourea-containing cytotoxic chemotherapy (except 23 days from last daily dose of temozolomide taken in a 5 of 28 day regimen), and 2 weeks from last dose of a targeted agent (except 4 weeks for bevacizumab); there is no time period requirement for prior radiation therapy
Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
Must not have received myelosuppressive chemotherapy and/or biologics within 3 weeks of entry onto this study (4 weeks if prior nitrosourea)
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
Radiation within 4 weeks of study enrollment; radiotherapy not permitted while on study; exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions
Chemotherapy, biologics, immunotherapy, vaccine, cytokine therapy within 4 weeks prior to enrollment
Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies; including investigational biologic agents) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment
Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
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
Treatment with corticosteroids within 4 weeks prior to enrollment
Patients must have failed external beam radiotherapy >= 5,000 cGy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy; all radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment; prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment
Patients who have had chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas), surgical resection within 4 weeks prior to entering the study, or have received experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol); however, this does not preclude re-treatment with M032 at a later date
Patients must be ?4 weeks since major surgery, radiotherapy, chemotherapy (6 weeks if they were treated with nitrosureas) or biotherapy/targeted therapies.
Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation
Required wash out periods for prior therapy (for cohort B):\r\n* Topical therapy: 2 weeks \r\n* Chemotherapy: 4 weeks\r\n* Radiotherapy: 4 weeks\r\n* Other investigational therapy: 4 weeks\r\n* Rituximab: 12 weeks
Chemotherapy within 3 weeks of the first scheduled study treatment
Require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 4 weeks, or have used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion; the exception being patients on chronic physiologic dose of steroid (Turnstile II)
Have received radiotherapy, chemotherapy, biological therapy or investigational treatment less than four weeks (six weeks for nitrosourea or mitomycin C) prior to first dose of study medication or have not recovered from all acute toxicities from prior treatments.
Minimum interval since last investigational agent and/or prior cytotoxic drug therapy (patient must have also recovered from the toxic effects of any prior therapy):\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 4 weeks of first dose
Patients on alemtuzumab within 6 weeks prior to consenting
Bilirubin =< 1.5 x UNL obtained =< 2 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
Subjects who have had chemotherapy within 4 weeks prior to entering the study
Relapsed/refractory MCL: Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, major surgery within 4 weeks or vaccination with live attenuated vaccines within 4 weeks of the first dose of study drug
Hormonal therapy within 2 weeks before the first dose of study treatment
Patients must have completed any radiotherapy four weeks prior to study entry, 0-2 weeks for local palliative radiotherapy (XRT) (small port)
Patients must have had at least one prior chemotherapeutic regimen; steroids alone and local radiation do not count as regimens; radiotherapy must have been completed at least 4 weeks prior to entry into the study; Rituxan alone does not count as a regimen; however, Bexxar or Zevalin (ibritumomab tiuxetan) do and patients must have completed radioimmunotherapy (RIT) > 12 months prior to enrollment
Patients must have recovered from the toxic effects of prior therapy and be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy; any questions related to the definition of non-cytotoxic agents should be directed to the principal investigators; for those who have received radiation, 4 weeks must have elapsed before beginning vaccination
History of phototherapy within 2 weeks prior to study initiation
Requires no steroids within 4 weeks and have not used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion; the exception being patients on chronic physiologic dose of steroid (Turnstile II)
Completed all prior therapies (immunosuppressive medications, antineoplastic therapy, vaccination, immunotherapy, chemotherapy, radiotherapy, major surgery, etc) >4 weeks prior to the first study dose of medication (alemtuzumab ? 6 months).
Use of any MPN-associated myelofibrosis-directed therapy within 2 weeks prior to study day 1
Radioimmunotherapy within 12 weeks
COHORT 3: ATOPIC DERMATITIS PATIENTS: Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling
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 should have been off other investigational therapy for 4 weeks prior to entry in this study
Patients who have had chemotherapy or radiotherapy within two weeks, 4 weeks for nitrosoureas, mitomycin C, pegylated-doxorubicin and one half-life for bevacizumab, hormone therapy within one week, trastuzumab within 2 weeks or lapatinib within one week of study day 1
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 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 who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks (wks), whichever is shorter, from the last day of treatment; 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
The patient must have undergone prior external beam radiotherapy to a dose of 54-60 Gy to the brain stem; at least 4 weeks but no more than 14 weeks must have elapsed from the completion of radiotherapy
Specific KS therapy, including cytotoxic chemotherapy but not including HAART, within the past 4 weeks (6 weeks if the therapy was bevacizumab)
Use of other anticancer treatments or agents within the past 4 weeks (6 weeks if the therapy was a monoclonal antibody)
Patients must be at least 4 weeks from radiation therapy; additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from procarbazine, 2 weeks from vincristine and 4 weeks from last bevacizumab administration; patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents; all toxicities from prior therapies should be resolved to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 (except for toxicities such as alopecia, or vitiligo)
History of tocilizumab therapy within prior 6 weeks
Radiotherapy within the 2 weeks prior to initiation of treatment
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and any prior immunotherapy approach, 4 weeks is indicated as washout period
Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass
At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
Have experienced >2 seizures within 4 weeks prior to study entry.
Evidence of recovery from any prior chemotherapy; no myelosuppressive anticancer chemotherapy or biological therapy within 3 weeks (6 weeks if a nitrosourea or mitomycin C agent) prior to registration
No prior radiotherapy to the upper abdomen
At least 4 weeks for focal radiation therapy (RT) or >= 6 weeks for craniospinal RT must have elapsed prior to study entry
Prior therapy: at least 4 weeks should have elapsed since any biologic therapy, or immunotherapy; three weeks should have elapsed since last dose of chemotherapy or radiotherapy
Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for nitrosoureas or mitomycin C). Subjects with HCC who have been on a stable dose of sorafenib for at least 4 weeks will be candidates for enrollment in Expansion Cohort
Prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
More than 4 weeks since prior systemic corticosteroids
Prior Therapy: at least 2 weeks should have elapsed since any biologic therapy; three weeks should have elapsed since last dose of chemotherapy
INCLUSION CRITERIA FOR CCT: at least 2 weeks should have elapsed since any biologic therapy; three weeks should have elapsed since last dose of chemotherapy
Chemotherapy within 3 weeks of Cycle 1 Day 1
Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
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
Received any antibody targeting T-cell check point or co-stimulation pathways within 4 weeks, received any other monoclonal antibody within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor) within 2 weeks prior to study treatment.
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to study treatment.
Any systemic anticancer therapy within 3 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, or anticancer immunotherapies, a washout period of 6 weeks is required. For patients in Cohort 2, this does not apply to the most recently received hormone therapy.
Chemotherapy, targeted therapy, biologic or hormonal agents within 3 weeks prior to entering the study
Intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or
Prior chemotherapy within 3 weeks of study registration
Able to begin study therapy within 3 weeks (+/- 1 week) of final IV/IP chemotherapy
Thoracic radiotherapy to lung fields ? 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities
?4 weeks for monoclonal antibodies (?8 weeks for alemtuzumab),
?3 weeks for phototherapy
Inclusion Criteria:\n\n        For Arm A, B, and C: Histologically confirmed World Health Organization Grade IV\n        glioblastoma. WHO Grade IV gliomas will be allowed on protocol.\n\n        For Arm D and E: WHO Grade IV glioma as per above and tumor must harbor a histone H3 K27M\n        mutation as evidenced by testing any tumor sample with a immunohistochemistry or DNA\n        sequencing test.\n\n        Unequivocal evidence of progressive disease on contrast-enhanced brain computerized\n        tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Assessment in\n        Neuro-Oncology Criteria (RANO), or have documented recurrent glioblastoma on diagnostic\n        biopsy.\n\n        Previous first line therapy with at least radiotherapy and temozolomide.\n\n        For Arm A: Any number of recurrences are allowable. For Arm B: First recurrence (only)\n        glioblastoma who had a complete tumor resection at first diagnosis. For Arm C: Patients\n        must have clinical and/or radiographic evidence of first recurrence of glioblastoma (only)\n        and be eligible for salvage surgical resection as deemed by the site Investigator.\n\n        Must be 12 weeks from radiotherapy. If patients are within 12 weeks of radiotherapy, then\n        the progressive lesion must be outside of the high-dose radiation target volume or have\n        unequivocal evidence of progressive tumor on a biopsy specimen.\n\n        From the projected start of scheduled study treatment, the following time periods must have\n        elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy\n        (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies,\n        or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n\n        All adverse events Grade > 1 related to prior therapies (chemotherapy, radiotherapy, and/or\n        surgery) must be resolved, except for alopecia.\n\n        Male or Female age ?18 years.\n\n        Karnofsky Performance Status (KPS) ? 60% (see Appendix A).\n\n        Adequate organ and marrow function as defined below, all screening labs should be performed\n        within 14 days of treatment initiation:\n\n          -  leukocytes ? 3,000/mcL\n\n          -  absolute neutrophil count ? 1,500/mcL\n\n          -  platelets ? 100,000/mcL\n\n          -  hemoglobin > 8.0 mg/dL\n\n          -  total bilirubin < 2.0 x upper limit of normal\n\n          -  AST (SGOT)/ALT (SGPT) ?2.5 × upper limit of normal creatinine OR creatinine clearance\n             ?60 mL/min/1.73 m2 for patients with creatinine levels above normal.\n\n        CT or MRI within 14 days prior to start of study drug.\n\n        Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. For\n        Arm B: Corticosteroid dose must be stable or decreasing for at least 2 weeks prior to study\n        entry.\n\n        The effects of ONC201 on the developing human fetus are unknown. For this reason, women of\n        childbearing potential and men must agree to use adequate contraception (hormonal or\n        barrier method of birth control; abstinence) prior to study entry and for the duration of\n        study participation. Should a woman become pregnant or suspect she is pregnant while she or\n        her partner is participating in this study, she should inform her treating physician\n        immediately. Male subjects should agree to use adequate method of contraception starting\n        with the first dose of study therapy through 120 days after the last dose of therapy.\n\n        Archival tissue for evaluation of correlative objectives (if available). Archival tissue is\n        required for Arms B and C.\n\n        Ability to understand and the willingness to sign a written informed consent document.\n\n        Exclusion Criteria:\n\n        History of allergic reactions attributed to compounds of similar chemical or biologic\n        composition to ONC201 or its excipients.\n\n        Current or planned participation in a study of an investigational agent or using an\n        investigational device.\n\n        Uncontrolled intercurrent illness including, but not limited to, ongoing or active\n        infection or psychiatric illness/social situations that would limit compliance with study\n        requirements.\n\n        Active infection requiring systemic therapy.\n\n        Prior stereotactic radiotherapy, convection enhanced delivery (CED) or brachytherapy must\n        have had a biopsy to confirm radiographic progression is consistent with progressive tumor\n        and not treatment-related necrosis. If the recurrent lesion is outside of any prior\n        high-dose radiation target volume or distant from the prior CED or brachytherapy site,\n        subjects will be considered eligible\n\n        Pregnant women because ONC201 is novel agent with unknown potential for teratogenic or\n        abortifacient effects. Because there is an unknown but potential risk for adverse events in\n        nursing infants secondary to treatment of the mother with ONC201, breastfeeding should be\n        discontinued if the mother is treated with ONC201.\n\n        Known HIV-positive test on combination antiretroviral therapy.\n\n        Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmias or\n        bradycardia. Receiving therapeutic agents known to prolong QT interval will be excluded.\n        History of CHF, or MI or stroke in the last 3 months will be excluded.\n\n        Active illicit drug use or diagnosis of alcoholism.\n\n        Prior bevacizumab for treatment of glioblastoma. The rationale for restricting enrollment\n        to patients who have not had prior bevacizumab therapy is that data regarding the efficacy\n        of any therapy after progression on bevacizumab therapy are lacking.\n\n        Tumors with isocitrate dehydrogenase 1 (IDH1) or IDH2 mutations as determined by\n        immunohistochemistry for the IDH1 R132H variant or by direct sequencing. IDH1/2-mutant\n        gliomas have a markedly longer overall survival rate compared to those with IDH1/2-wildtype\n        glioma (Parsons et al., 2008; Yan et al., 2009), indicating IDH1/2-mutant gliomas have a\n        distinct natural history.\n\n        Known additional malignancy that is progressing or requires active treatment within 3 years\n        of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell\n        carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative\n        therapy.\n\n        Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2\n        weeks of baseline disease assessments; or not fully recovered from any side effects of\n        previous procedures.\n\n        Concomitant use of CYP3A4/5 inhibitors during the treatment phase of the study and within\n        72 hours prior to starting study drug administration.\n\n        Concomitant use of potent CYP3A4/5 inducers, which include enzyme inducing antiepileptic\n        drugs (EIAEDs) (see Appendix B), during the treatment phase of the study and within 2 weeks\n        prior to starting treatment.\n\n        Planned concurrent use Optune™. Prior use of the device is allowable.\n\n        For Arm D: Evidence of leptomeningeal spread of disease.
Have had DVT or venous thromboembolism within 6 weeks of study entry
Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
4 weeks from cytotoxic agents
6 weeks from nitrosoureas
12 weeks from radiotherapy
Has received chemotherapy (except hydroxyurea), biological therapy, radiotherapy or investigational therapy within 4 weeks before baseline (C1D1).
Prior radiotherapy
Radiotherapy ? 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
At least 2 weeks beyond corticosteroids.
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug; all side effects from prior therapy must recover to grade 1 or less prior to starting on trial
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
Surgical treatment or chemotherapy within three weeks of scheduled macrobead implantation or within four weeks of bevacizumab (or similar drugs), or radiation therapy within four weeks of scheduled macrobead implantation
Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
Mammogram within 6 weeks of diagnosis
Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry
Recovered from acute toxicities of other treatments (? Grade 2). All other MDS treatments discontinued at least 4 weeks prior to treatment except epoetin alpha (Procrit) 2 weeks.
Medical history of RBC transfusion dependent anemia ?4 units of RBCs during the 16 weeks prior to admin of study drug & ?2 units of RBCs over prior 8 weeks (day -56 to day 1 prior to treatment; baseline period) for documented Hgb of ? 9g/dL (during baseline). Didn't have a 56 day RBC transfusion-free period during 16 weeks prior to administration of study drug.
Received hematopoietic growth factors within specified limits prior to treatment (2 weeks for epoetin alpha (Procrit) & 4 weeks for darbepoetin alpha (Aranesp)).
Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
Patients who have had chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or systemic mitomycin C) before the initiation of study treatment
Patients who have signs or symptoms of infection within 2 weeks before initiation of study treatment
Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C), anticancer antibodies within 4 weeks, radio or toxin immunoconjugates within 2 weeks, radiation therapy within 3 weeks or major surgery within 2 weeks prior to entering the study\r\n* Palliative (limited-field) radiation therapy is permitted if the patient has additional measurable lesions to assess response of therapy
Has received radiotherapy within the 28 days prior to first dose or within 12 weeks for patients with glioblastoma, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control.
Use of systemic anti-cancer therapy ? 4 weeks, or six weeks if the systemic therapy contains a nitrosourea or mitomycin C.
Enrollment and randomization within 12 weeks of initial cholecystectomy
Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
Ongoing or previous anti-cancer treatment within 4 weeks of study treatment start (or 6 weeks for mitomycin C, nitrosoureas and monoclonal antibodies); with exceptions.
Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Any radiotherapy within 3 weeks except palliative stereotactic body radiation therapy (SBRT) within 2 weeks
any systemic therapy against GvHD < 2 weeks prior to study Day 1
Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study Day 1
Treatment with a therapeutic antibody targeting CD38 < 12 weeks prior to study Day 1
Radiotherapy or prior systemic chemotherapy within 2 weeks
Prior radiotherapy (RT) to current field of CNS disease ? 4 weeks
Nitrosourea cytotoxic drug ? 6 weeks
Anti-CD20 therapy within 4 weeks of enrollment;
Patients must have completed radiation therapy or major surgery >= 3 weeks, or biologic therapy or chemotherapy >= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 3 weeks prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy; palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1.
Signs or symptoms of infection as determined by the treating team within 2 weeks prior to cycle 1, day 1.
Last dose of chemotherapy must be at least 3 weeks before first dose of study treatment; there is no required washout for endocrine therapy
Subjects must be >= 4 weeks beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents (>= 8 weeks from previous bevacizumab treatment) at the time of first dose of study drug(s)
No steroids for at least 2 weeks prior to enrollment, and patient must not be expected to require steroids during the study period
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 4 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Signs or symptoms of infection =< 2 weeks prior to registration
(Prior to treatment) Note: evaluate at least 1 week before T cell infusion. a. Adequate venous access – consider peripherally inserted central catheter (PICC) or central line. b. ECOG/Zubrod performance status of ‘0-1. c. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT scan]). d. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, radiotherapy or major surgery. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. e. Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible. f. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 3 months after study drug is stopped. g. Willing and able to give informed consent.
Signs or symptoms of infection within 2 weeks prior to week 1, day 1
Bilirubin ? 1.5 x UNL ? 2 weeks
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
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, major surgery within 4 weeks or vaccination with live attenuated vaccines within 4 weeks of the first dose of study drug.
Cancer immunotherapy within four weeks prior to start of daratumumab treatment (exception blinatumomab within two weeks prior)
Patient has completed radiotherapy within 2 weeks prior to treatment initiation.
A minimum of two weeks of VMS diary recording prior to SGB
Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
Radiotherapy within 4 weeks of protocol therapy
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Last chemotherapy at least 3 weeks from initiation of study treatment
Part 1 patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy or mitomycin C\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent, except bevacizumab/ vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 6 weeks from bevacizumab/VEGFR inhibitors
Patients who have had systemic therapy or radiotherapy within 3 weeks prior to the first dose of study therapy
Patients must have:\r\n* Had their last fraction of local irradiation to primary tumor >= 12 weeks prior to registration\r\n* Had their last fraction of craniospinal irradiation or total body irradiation >= 12 weeks prior to registration
Antibodies or immunotherapy within 6 weeks before the first dose of study treatment.
Requires or may require treatment with high-dose systemic corticosteroids within 2 weeks of the start of intravenous pembrolizumab infusions and within 2 weeks following the first infusion of pembrolizumab
Radiotherapy (except for palliative reasons) the previous two weeks before.
The absolute neutrophil count (ANC) must be > 1000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
The platelet count must be > 75,000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
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 anti-cancer therapy: must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Radiation therapy (RT): >= 2 weeks for local palliative radiation therapy (RT) (small port); >= 6 weeks must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation\r\n* Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies
The subject must have first vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant temozolomide or radiotherapy
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Patients who have had anti-cancer therapy within 2 weeks prior to entering the study
Contraindication to antiangiogenic agents, including:\r\n* Serious non-healing wound, non-healing ulcer, or bone fracture\r\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment; other surgical procedures within 2 weeks prior to initiating study treatment\r\n* Pulmonary hemorrhage/bleeding event >= grade 2 within 12 weeks prior to initiating study treatment\r\n* Any other hemorrhage/bleeding event >= grade 3 within 12 weeks prior to initiating study treatment
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: must not have received chemotherapy within 2 weeks of enrollment and within 2 week of starting protocol therapy\r\n* Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy for both enrollment on study and for commencement of protocol therapy\r\n* Immunotherapy: patients may not have received immunotherapy within 3 weeks of enrollment and within 6 weeks of commencing protocol therapy
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
TREATMENT: Any prior therapy, radiotherapy, or major surgery must have been completed >= 3 weeks (> 6 weeks for nitrosoureas or mitomycin C) or 5 half-lives of the agent (whichever is shorter) prior to enrollment on protocol, and the participant must have recovered to eligibility levels from prior toxicity; radiofrequency ablation (RFA) of localized lesions should have been performed >= 2 weeks prior to treatment
Any of the following therapies prior to pre-registration:\r\n* Chemotherapy =< 4 weeks\r\n* Immunotherapy =< 4 weeks\r\n* Biologic therapy =< 4 weeks; Note exception: prior viral and/or gene therapy are exclusion criteria\r\n* Radiotherapy =< 4 weeks
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
Patients must have completed chemotherapy, biological or radiotherapy >= 3 weeks prior to entering the study
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Major surgery < 4 weeks or radiation therapy < 2 weeks of study entry; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Subjects must have received trastuzumab in the metastatic setting and experienced disease progression on this drug; any number of prior therapies is permitted; prior therapy with other HER2 targeted agents (trastuzumab emtansine [TDM-1], pertuzumab, lapatinib) is allowed; the last dose of cytotoxic chemotherapy must have occurred >= 3 weeks prior to study registration; the last radiation therapy must have occurred >= 3 weeks prior to study registration
Any non-investigational anticancer therapy within prior 2 weeks
Patients with hemoptysis in excess of 2.5 mL within 6 weeks prior to the first dose of study medication
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 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:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion\r\n* Bowel toxicity is not expected from the target field due to increased risk of perforation
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; treatment with hydroxyurea is permitted during cycle 1 to maintain white blood cell (WBC) < 40,000/uL
Chemotherapy or dose of other potentially myelosuppressive treatment within 3 weeks prior to Screening (6 weeks for nitrosoureas or mitomycin C)
Palliative radiotherapy (? 10 fractions) within 2 weeks prior to Screening
Recent therapeutic intervention including a) prior nitrosoureas or mitomycin C; prior radio- or toxin-immunoconjugates within 6 weeks; b) therapeutic anticancer antibodies (including rituximab, ofatumumab and obinituzumab) within 4 weeks; and c) all other chemotherapy or radiation therapy within 2 weeks prior to initiation of study drug
Off all other treatments for MDS for at least 2 weeks prior to Screening.
Any anti-cancer therapy or investigational agents =< 4 weeks prior to registration
At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
4 weeks from prior cytotoxic therapy
6 weeks from nitrosoureas
3 weeks from procarbazine
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
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
The subject has received systemic chemotherapy (including investigational agents) within 4 weeks, or biological agents (antibodies, immune modulators, cytokines, or vaccines) within 6 weeks, or hormonal anticancer therapy within 2 weeks before the first dose of study treatment (within 4 weeks in the case of fulvestrant) (vaccines, such as flu shot or, pneumovax are not exclusions)
Patients must not have received chemotherapy within 4 weeks, pegfilgrastim (PEG-G-CSF) (Neulasta) within 4 weeks or filgrastim (G-CSF) (Neupogen) within 2 weeks prior to enrollment
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 must have recovered to at least eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01), or therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitors prior to entering the study; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI) discretion, and should have recovered to eligibility levels from any toxicities
Prior cranial radiotherapy
Diethylstilbestrol, estrogens, saw palmetto, or other preparations that are known to have possible endocrine effects on prostate cancer that have been started within the past 8 weeks, as they may affect PSA levels or response; these are allowed if the patient has been on a stable dose for at least 8 weeks prior to cycle 1 day 1 (C1D1)
-  Subjects who have received any prior chemotherapy, radiotherapy, biologic/targeted\n             anti-cancer therapy or surgery within 4 weeks (6 weeks for monoclonal antibodies,\n             radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before\n             the first study drug administration and have not recovered (to AEs <  Grade 2) from\n             the toxic effects from any prior therapy
Prior therapy:\r\n* Patients with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within 1 year of completion of adjuvant chemotherapy\r\n* Prior therapy for high grade serous platinum-sensitive ovarian cancer patients must have included 2 prior platinum-based chemotherapy regimens\r\n* Participants must be at least 4 weeks since prior radiation therapy, 3 weeks since prior chemotherapy, and 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C\r\n* No small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter\r\n* For any hormonal therapy, participants must have stopped them at least 1 week prior to initiating therapy\r\n* Amount of prior radiotherapy: participants may not have had > 25% of their bone marrow radiated
Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Prior “systemic” radiopharmaceuticals (strontium, samarium, radium 223 dichloride) must be completed >= 8 weeks prior to enrollment
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Patients who have received oral or IV chemotherapy or targeted anticancer therapy =< 2 weeks (4 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment; steroids used for anti-cancer properties must be tapered to 10 mg or less of prednisone (or equivalent) for at least 2 weeks prior to initiating therapy
Palliative radiotherapy for bone metastases < 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Patients who have received prior treatment with anti?CTLA-4 may be enrolled, provided the following requirements are met:\r\n* Minimum of 12 weeks from the first dose of anti?CTLA-4 and > 6 weeks from the last dose\r\n* No history of severe immune-related adverse effects from anti?CTLA-4 (CTCAE grade 3 and 4)
Patients must have received standard treatment appropriate for their tumor type\r\n* Myelosuppressive chemotherapy: patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue without TBI: no evidence of active graft vs. host disease and >= 2 months must have elapsed since transplant
Radiotherapy within 4 weeks prior to entering the study
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks prior to the first day of study defined treatment
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1 or radio-immunotherapy =< 4 weeks prior to cycle 1 day 1
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
Patients may have had prior radiotherapy for metastatic disease as long as it was > 4 weeks prior to registration and the patient has recovered from adverse events associated with the radiotherapy
PHASE II: Patients may have had prior radiotherapy for metastatic disease as long as it was > 4 weeks prior to randomization and the patient has recovered from adverse events associated with the radiotherapy
Prior full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to first study drug administration
Patients must be at least 3 weeks from prior thoracotomy (if performed)
Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosoureas/mitomycin)
Prior therapy:\r\n* The patient’s malignancy must have relapsed after or failed to respond to frontline curative therapy and/or there must not be any curative treatment options available at the time of study entry\r\n* There is no limit to the number of prior treatment regimens; however, patients must have fully recovered from the acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment; any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less\r\n* Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen\r\n* Monoclonal antibodies: at least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: 3 weeks must have elapsed since external beam radiation therapy (XRT)
Patients must be >= 3 weeks from last chemotherapy or radiation (6 weeks for nitrosoureas or mitomycin)
Patient has not recovered from any toxicity of prior therapies; an interval of \r\n* At least 6 weeks must have elapsed since taking a nitrosourea-containing chemotherapy regimen\r\n* At least 4 weeks since completing a non-nitrosourea-containing cytotoxic chemotherapy regimen (except temozolomide: only an interval of 23 days is required from the last does administered when patient has been recently treated with the standard temozolomide regimen of daily for 5 days, repeated every 28 days)\r\n* At least 2 weeks from taking the last dose of targeted agent\r\n* At least 4 weeks from the last dose of bevacizumab
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
Patients who have had chemotherapy, radiation therapy, or other investigational agents within 3 weeks prior to entering study, 6 weeks for nitrosoureas or mitomycin
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; hydroxyurea may be administered for count control both pre-treatment and during cycle 1 only
Prior systemic therapies allowed, except for those treatments directed toward, or with activity against, c-Met or vascular endothelial growth factor/receptor (VEGF/R), and the chemotherapy agents temozolomide and dacarbazine; prior treatment must have been no earlier than 3 weeks prior to starting treatment with cabozantinib with exceptions noted below and the following: at least 4 weeks since prior hepatic infusion or at least 2 weeks since radiation therapy
No cytotoxic chemotherapy including investigational cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within the last 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
At least 2 weeks since prior radiotherapy or stereotactic radiosurgery, and 4 weeks since prior major surgery at time of study enrollment
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
Patients must be at least 4 weeks from any prior systemic therapy (6 weeks for nitrosoureas or mitomycin C), surgery or radiation
Recent prior therapy:\r\n* Systemic chemotherapy =< 2 weeks (6 weeks for nitrosoureas) or radiation therapy =< 3 weeks prior to apheresis; exceptions: \r\n** There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such; \r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; \r\n** Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria; \r\n** Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; \r\n** For radiation therapy: radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
Patient must have recovered from toxicity of prior chemotherapy, molecularly targeted agents and/or radiotherapy; patient may not have received chemotherapy in the prior 4 weeks (6 weeks for nitrosoureas or mitomycin C); patients may have not received a molecularly targeted agent within the past 4 weeks or 5 half lives (which ever is less); patients may not have received radiotherapy in the prior 3 weeks
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Any exogenous hormone therapy must be completed 4 weeks prior to registration
No targeted therapy within 2 weeks of first vaccine administration
No immunomodulatory therapy within 2 weeks of first vaccine administration
During Screening period, no steroid therapy within 4 weeks of first vaccine administration
Prior investigational anti-cancer therapy within 4 weeks prior to day 1
Inclusion Criteria:\n\n          1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or\n             gliosarcoma;\n\n          2. Measurable disease by RANO criteria;\n\n          3. Disease progression or recurrence following standard of care treatment with\n             temozolomide and radiation;\n\n          4. An interval of at least 4 weeks between prior surgical resection and study\n             enrollment;\n\n          5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from\n             prior chemotherapy, and enrollment in this protocol;\n\n          6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;\n\n          7. Karnofsky performance status > 60%\n\n        Exclusion Criteria:\n\n          1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab,\n             aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib,\n             etc);\n\n          2. Prior stereotactic radiotherapy;\n\n          3. Active infection;\n\n          4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;\n\n          5. Subjects who suffered from an acute cardiac event within the last 12 months;\n\n          6. Subjects with active vascular disease, either myocardial or peripheral;\n\n          7. Subjects with proliferative and/or vascular retinopathy;\n\n          8. Subjects with known active second malignancy;
Inclusion Criteria:\n\n          1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or\n             gliosarcoma;\n\n          2. Measurable disease by RANO criteria;\n\n          3. Disease progression or recurrence following standard of care treatment with\n             temozolomide and radiation;\n\n          4. An interval of at least 4 weeks between prior surgical resection and study\n             enrollment;\n\n          5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from\n             prior chemotherapy, and enrollment in this protocol;\n\n          6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;\n\n          7. Karnofsky performance status > 60%\n\n        Exclusion Criteria:\n\n          1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab,\n             aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib,\n             etc);\n\n          2. Prior stereotactic radiotherapy;\n\n          3. Active infection;\n\n          4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;\n\n          5. Subjects who suffered from an acute cardiac event within the last 12 months;\n\n          6. Subjects with active vascular disease, either myocardial or peripheral;\n\n          7. Subjects with proliferative and/or vascular retinopathy;\n\n          8. Subjects with known active second malignancy;
Previous radiosurgery to any intracranial site within the prior 6 weeks
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: Must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies\r\n* External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as “measurable” for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry\r\n* Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry\r\n* Study specific limitations on prior therapy:\r\n** Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor\r\n** Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry
Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized\r\n* For the fourth cohort, ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of BMS-936558; ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of BMS-936558\r\n* All drug related toxicities must have resolved to grade 1 or less, and patients must be off steroids for at least 3 weeks\r\n* Patients in the fourth cohort who required infliximab or other immune suppressants including mycophenolic acid will be excluded\r\n* For the fifth cohort, ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of BMS-936558; all drug related toxicities must have resolved to grade 1 or less, and patients must be off steroids for at least 2 weeks and any other immune suppressant such as mycophenoloc acid or infliximab for at least 3 weeks\r\n* Patients in the fifth cohort who experienced grade 3-4,neurologic or ophthalmologic side effects or any other grade 4 side effect other than liver, pancreatic, gastrointestinal (GI), endocrine, pulmonary or skin related will be excluded
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
Electrocardiogram (EKG) within 8 weeks of registration
Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
Patients must be at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
Intravesical therapy within 8 weeks prior to beginning study treatment with the exception of:
previous intravesical BCG therapy, which can be given at least 5 weeks before the diagnostic biopsy required for entry into the study
Patients must be enrolled within 6 weeks of primary surgery or within 6 weeks after diagnosis of recurrent disease
Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)
Immunotherapy (e.g., tumor vaccine) At least 6 weeks since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)
Previous stereotactic or highly conformal radiotherapy within 3 weeks before the start of dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion(s)
Treatment with approved anti-cancer therapy (with the exception of abiraterone) within 3 weeks of study drug. Abiraterone must not be administered within 2 weeks prior to initiation of study treatment
Other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression)
Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy
Subject must have no evidence of active acute or chronic GVHD (Grade 0) for 4 weeks prior to the first dose of lenalidomide.
Subject has isolated Central Nervous System (CNS) involvement or extramedullary relapse. (Subjects with combined CNS/marrow relapse may be Subject has had prior treatment with cytotoxic chemotherapy within 2 weeks of the first dose of lenalidomide with the exception of hydroxyurea (allowed prior to the first dose of lenalidomide and through Day 14 of Cycle 1) and intrathecal (IT) cytarabine will be administered within 2 weeks prior to administration of lenalidomide.
Subjects who received palliative radiotherapy ?2 weeks of study drug initiation.
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or prior radiation therapy within 4 weeks prior to study Day 1.
Radiotherapy within 2 weeks prior to study day 1.
Peripheral edema requiring medical intervention within 2 weeks prior to study day 1.
At least 4 weeks since any previous treatment for cancer
Investigational therapy within 4 weeks prior to CMB305 dosing
Participation in another clinical trial within 4 weeks
Patients who have received chemotherapy within 3 weeks prior to the initiation of study treatment, or endocrine therapy within 2 weeks prior to the initiation of study treatment; if patients are already on trastuzumab, this medication may be continued
Signs or symptoms of infection within 2 weeks prior to first dosing.
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Have received radiation therapy within 4 weeks (?4 weeks) prior to randomization or has not recovered from toxic effects of the treatment that was given >4 weeks prior to randomization.
Investigational therapy within 3 weeks prior to CMB305 dosing
Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment (hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for prostate cancer and palliative radiotherapy greater than (>) 2 weeks prior to Cycle 1, Day 1 are allowed)
Severe infections within 4 weeks or signs or symptoms of infection within 2 weeks prior to Cycle 1
At least 2 weeks from end of targeted therapy
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
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
Any other chemotherapy, immunotherapy or anticancer agents within 2 weeks of the first dose of study treatment.
Patients must have received neoadjuvant chemotherapy of at least 16 weeks. This period must include 6 weeks of a taxane -containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 16 weeks is also eligible).
Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) at date of randomization.
10 weeks or more have passed since completion of radiotherapy at day of randomization and 16 weeks interval since the date of final surgery have passed.
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)
Radiotherapy within 3 weeks prior to the first dose of lenvatinib.
Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
Hospitalization within 2 weeks prior to screening
Any therapeutic antibody within 4 weeks of first dose of study drugs.
Investigational therapy within 3 weeks prior to LV305 dosing.
Prior radiotherapy is allowed
Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.
Wash out periods prior to Day 1 of Cycle 1: At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy
Chemotherapy: nitrosoureas At least 6 weeks
Has hemoptysis within 6 weeks prior to randomization.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
First day of dosing with tesevatinib is less than 2 weeks from the last treatment of cytotoxic chemotherapy, biological therapy, or immunotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. Surgical procedures must have been performed at least 2 weeks prior to the start of study treatment. Subjects must have recovered from the reversible effects of prior lung cancer treatments, including surgery and radiation therapy (excluding alopecia)
Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
Treatment with chemotherapy (other than high-dose chemotherapy as described above) or differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2 antibody treatment) within 3 weeks prior to initiation of study drug or, if treatment included nitrosoureas, within 6 weeks prior to initiation of study drug
Treatment with thoracic or mediastinal radiotherapy within 3 weeks prior to initiation of study drug
Investigational therapy within 4 weeks prior to G100 dosing
At least 2 weeks must have elapsed from the use of any other endocrine therapy
None of the following therapies are allowed prior to registration:\r\n* Chemotherapy =< 2 weeks\r\n* Immunotherapy =< 2 weeks\r\n* Biologic therapy =< 2 weeks\r\n* Hormonal therapy =< 2 weeks\r\n* Monoclonal antibodies =< 2 weeks\r\n* Radiation therapy =< 2 weeks\r\n* Anti-Her-2 or other “targeted” (e.g. mammalian target of rapamycin [mTOR]) therapy =< 2 weeks\r\n** NOTE : Any toxicities derived from these therapies must be =< grade 2 prior to starting study therapy
Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
Prior treatment (chemotherapy [chemo], radiation, hormone, and immune therapies) must be completed > 4 weeks prior to randomization (> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
SUB-PROTOCOL AIM A: Any of the following treatments:\r\n* Chemotherapy within 4 weeks before treatment with nab-rapamycin\r\n* Hormonal therapy within 4 weeks before treatment with nab-rapamycin (with the exception of leuprolide, degarelix, or goserelin)\r\n* Immunotherapy within 4 weeks before treatment with nab-rapamycin\r\n* Radiotherapy within 4 weeks before treatment with nab-rapamycin \r\n* Treatment with nitrosoureas, mitomycin, or extensive radiotherapy within 6 weeks before treatment with nab-rapamycin\r\n* Immunosuppressive agents within 3 weeks before treatment with nab-rapamycin (except corticosteroids used as antiemetics)\r\n* Use of prior mTOR pathway inhibitor therapy
Subject who has had cytotoxic chemotherapy within 3 weeks prior to leukapheresis; immune therapy or biological therapy within 4 weeks prior to leukapheresis; corticosteroids or any other immunosuppressive therapy within 2 weeks prior to leukapheresis; tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) and any other anti-cancer treatment within 1 week prior to leukapheresis.
An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
Prior stereotactic radiotherapy;
Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
Prior treatment will be permitted including surgery (>= 4 weeks), cytotoxic chemotherapy (maximum of 2 prior regimens); radiation, interferon, targeted growth factors (>= 4 weeks); and prior treatment with octreotide, will be allowed
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.
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
Chemotherapy administered within 4 weeks (except 6 weeks for nitrosoureas, 12 weeks for an implanted nitrosoureas wafer, and 1 week from metronomic chemotherapy, like daily temozolomide and etoposide) prior to Day 1 of study treatment, unless the subject has recovered from all expected toxicities from the chemotherapy.
Subjects must have received their last chemotherapy, non-anti-VEGF biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C, and 8 weeks if the last regimen was an anti-VEGF therapy
Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product (IP) administration.
Prior radiotherapy must be completed at least 4 weeks before patient begins study therapy.
No prior systemic therapy for CLL or SLL including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy), radiation therapy, within 4 weeks of enrollment; no prior carmustine (BCNU) or mitomycin C within 6 weeks of enrollment; no radioimmunotherapy within a year of enrollment; no corticosteroids administered within 2 weeks prior to study entry, except for maintenance therapy (=< prednisone 20 mg daily or equivalent) for a non-malignant disease
Receiving chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed at least 3 weeks prior to study entry, unless underlying disease is progressing on therapy
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Any other investigational agent or chemotherapy, radiotherapy, or immunotherapy administered within 4 weeks prior to Screening.
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to start of study treatment. Biologic, novel therapy (including investigational agents in this class) or corticosteroids within 2 weeks prior to patient registration. Patient has side effects of the previous therapy > grade 1 or previous baseline.
EXCLUSION FOR TREATMENT: Recent prior therapy: systemic chemotherapy less than 2 weeks prior to infusion or apheresis (6 weeks for clofarabine or nitrosoureas for apheresis) or radiation therapy less than or equal to 3 weeks prior to apheresis; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Use of investigational agents within 2 weeks or any anticancer therapy within 2 weeks before study entry; the patient must have recovered from all acute toxicities from any previous therapy
Treatment with cytotoxic or biologic agents within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin or nitrosoureas); at least 4 weeks must have elapsed from any prior surgery, radiation, hormonal or other drug therapy for their cancer
Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
Red blood cell (RBC) transfusion dependent, 1) Received at least 4 units of RBCs over any 8 consecutive weeks during the 16 weeks prior to randomization, 2) Pretransfusion Hb must have been less than or equal to (<=)9.0 gram per deciliter (g/dL)
Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
Prohibited treatments and/or therapies\r\n* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); however, use of corticosteroids is allowed for the treatment of immune related adverse events (irAEs), or adrenal insufficiency\r\n* Any non-oncology vaccine therapy used for prevention of infectious diseases within 4 weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior treatment with a CD137 agonist, ipilimumab or other CTLA4 inhibitor\r\n* Prior investigational agents within 2 weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within 2 weeks prior to first dose of ipilimumab/nivolumab
Within 3 weeks prior to the first dose of CDX-0158 of any biologic treatment or IV chemotherapy.
Inactivated vaccines should precede the initiation of any study regimen and/or standard adjuvant therapy by at least 2 weeks, but preferably 4 weeks or longer
For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Was treated for at least 24 weeks with MK-3475 before discontinuing therapy
Prior immunotherapy will be permitted; however, any prior immunotherapy must be discontinued at least 2 weeks before peptide vaccine administration; non-immunologic therapy may be continued
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
Any chemotherapy within 3 weeks of the first dose of AZD1775, except hormonal therapy in the refractory cohort.
Radiotherapy
Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study
Have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
Patients must be screened for HBV. Patients who are either HBsAg positive or HBV-DNA positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.
Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry in core
Patient has received chemotherapy, targeted anticancer therapy, pelvic and/or para-aortic radiotherapy or has had major surgery =< 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy
Prior palliative radiotherapy to metastases
Patients that have been treated with any of the following within 4 weeks of starting trial treatment: chemotherapy, immunotherapy, biological therapies, molecular targeted, hormone therapy (except LHRH agonists and LHRH antagonists), radiotherapy (except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within 2 weeks prior to study treatment).
Prior treatment with bevacizumab within twelve weeks before the first infusion.
Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration
Platelet transfusion independent for at least 4 weeks prior to enrollment
Systemic anticancer therapy within 3 weeks of study entry, except for nitrosoureas or mitomycin C (6 weeks).
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas or mitomycin within 6 weeks before the first dose of study treatment
No chemotherapy, radiation, biologics or immunotherapy within 2 weeks prior to registration (6 weeks if last received carmustine [BCNU] or mitomycin C)
Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
Patients may have had prior adjuvant treatment for colorectal cancer; the prior treatment regimen must not have included bevacizumab but may have included oxaliplatin and the last dose of chemotherapy must have been > 6 months prior to study entry; patients with prior radiotherapy are acceptable; it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated
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
Other experimental drugs =< 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
Bicalutamide (Casodex) and nilutamide discontinued < 6 weeks prior to registration
Participant completed all prior radiotherapy with curative intent ? 3 weeks prior to randomization
Previous radiotherapy within 2 weeks of starting study therapy.
Any approved anti-cancer therapy within 3 weeks prior to enrollment with the following exceptions: \r\n* Palliative radiotherapy for bone metastases must be completed > 7 days prior to baseline imaging and > 21 days prior to cycle 1 day 1 of treatment\r\n* Hormone replacement therapy or oral contraceptives are permitted \r\n* Administration of intravesical bacillus Calmette-Guerin (BCG) > 4 weeks before cycle 1, day 1 is allowed
Any approved anti-cancer therapy within 3 weeks prior to enrollment o Administration of intravesical bacillus Calmette-Guerin (BCG) > 4 weeks before cycle 1, day 1 is allowed
The patient must not have required a paracentesis within the preceding 4 weeks nor be projected to require a paracentesis within the next 8 weeks.
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and washout period is 6 weeks; prior immunotherapy - washout is 4 weeks
Exposure to any IP during the last 4 weeks prior to enrollment.
Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within 6 weeks prior to starting treatment
Any drug used for GVHD within 4 weeks prior to enrollment
a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide; c) Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic or immunotherapy agents that can present with major delayed toxicity (eg, anti-CTLA-4), 4 weeks is indicated as washout period
Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass
Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
Prior radiotherapy within 2 weeks of study treatment
Patients must be >= 2 weeks (minimum) to 4 weeks (preferred) from prior myelosuppressive chemotherapy (primarily lenalidomide) to facilitate mobilization
There should also be a minimum of 4 weeks from any prior radiotherapy except for palliative bone directed therapy
At least 4 weeks from last chemotherapy or bevacizumab (Avastin®) therapy (6 weeks for nitrosourea or mitomycin C), or for chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity, at least 2 weeks from last dose.
Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at least 2 weeks must have elapsed from the time of treatment, and the patient must have subsequent post-radiotherapy histologic documentation of recurrence in the irradiated field, unless the recurrence is a new lesion outside the irradiated field.
Platelets ?100,000/?L (?150,000/?L, if within 12 weeks of prior nitrosourea treatment).
At least 4 weeks must have elapsed since the last chemotherapy, targeted therapy, immunotherapy, radiotherapy, liver-directed therapy, or major surgery. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. If started before T-cell administration, ipilimumab infusions must be least 21 days apart.
Concurrent radiotherapy to any site or radiotherapy within 2 weeks 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 who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
No systemic therapy for RRP for four weeks prior to treatment
Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment (not including palliative radiotherapy at focal sites); prior use of an investigational monoclonal antibody therapy within 3 months, or prior use of nitrosoureas or mitomycin C within 6 weeks; patients must have recovered from acute toxicity due to radiotherapy
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study are not eligible
Previous chemotherapy and/or investigational agents are allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained bis-chloroethyl nitrosourea [BCNU] or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry
Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs
Radiation therapy within 2 weeks of starting the study treatment; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Allowed prior therapies include:\r\n* Surgery (major surgery at least more than four weeks prior to baseline assessment)\r\n* Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy as long as there is progressive measurable disease outside the area of locoregional therapy or there is progression in the previously treated areas\r\n* Any number of previous lines of systemic therapy; last treatment before enrollment must have occurred more than 4 weeks for chemotherapy, 6 weeks for antibodies or more than 5 half-lives of prior tyrosine kinase inhibitors (TKIs) or small molecules
Prior antitumor therapy within 2 weeks of enrollment (with the exception of somatostatin analogs)
At the time of enrollment, patients must be ? 4 weeks since all of the following treatments (and recovered from the toxicity of prior treatment to <= Grade 1, exclusive of alopecia): major surgery; radiotherapy; chemotherapy (note: must be ? 6 weeks since therapy if treated with a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab); immunotherapy; Biotherapy/targeted therapies.
Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
Patients may have had prior chemotherapy or immunotherapy or radiation therapy; all prior therapies must be stopped 4 weeks prior to first dose of study treatment, with the exception of patients who have received ipilimumab, which must be stopped 6 weeks prior to first dose of study treatment; patients are prohibited from receiving live vaccines within 30 days prior to first dose of study treatment
World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1
Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration.
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
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
Prior treatment in any other interventional clinical trial within 4 weeks prior to Day 1 of the study.
Steroid dose increased in the most recent two weeks
Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment: a) cytotoxic or targeted chemotherapy: greater than or equal to the duration of the cycle of the most recent treatment regimen (a minimum of 3 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C); b) biologic therapy (e.g., antibodies): greater than or equal to 4 weeks
Presence of hepatic encephalopathy within 4 weeks of 1st dose
Any chemotherapy must have been completed 4 weeks prior to enrollment
Any radiotherapy must have been completed 2 weeks prior to enrollment
Patients who have received palliative radiotherapy within 4 weeks of study entry.
Chemotherapy < 2 weeks prior to the first planned dose of study treatment
Radiotherapy < 3 weeks prior to the first planned dose of study treatment
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
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
No limit is placed on the number of prior therapies; prior treatment with irinotecan or eribulin is allowed, although patients must not have received co-administration of eribulin and irinotecan and must not have had disease progression while receiving either eribulin or irinotecan; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Must not have received within three weeks of start date of this protocol chemotherapy; six weeks is required after administration of nitrosourea agents\r\n* At least 7 days since the completion of therapy with a growth factor or at least 14 days for a long-acting growth factor (e.g. pegfilgrastim)\r\n* At least 7 days or 3 half-lives since the completion of therapy with a biologic agent, whichever is longer; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are expected to occur; the duration of this interval must be discussed with the principal investigator (PI) of the study\r\n* At least 6 weeks since the completion of any type of immunotherapy (e.g. tumor vaccines)\r\n* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: >= 2 weeks for local palliative radiotherapy (XRT) (small port); >= 6 months must have elapsed if prior total body irradiation (TBI), craniospinal XRT; >= 3 months must have elapsed if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if therapeutic doses of metaiodobenzylguanidine (MIBG) or other substantial bone marrow (BM) irradiation was given\r\n* Allogeneic and autologous hematopoietic stem cell transplant (HSCT) will be allowed, if there is no evidence of active graft vs. host disease and >= 2 months must have elapsed since infusion; patients must not be on systemic immunosuppression
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
Patients must have >= 4 weeks since prior chemotherapy or radiation (>= 6 weeks for nitrosoureas or mitomycin C)
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
Prior nitrosourea or mitomycin C =< 6 weeks prior to registration
Before starting study treatment, all patients must have recovered from toxic effects of prior therapies; at least 2 weeks must have elapsed since any prior signaling pathway modulators, (e.g., epidermal growth factor receptor [EGFR], fibroblast growth factor receptor [FGFR], or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., carmustine [BCNU], lomustine [CCNU]); in general, at least 4 weeks must have elapsed from any other anticancer therapy; prior anticancer therapies not encompassed above will be permitted at the discretion of the investigator
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must recover to a grade 1 before starting the trial
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Discontinuation of all prior chemotherapy, immunotherapy, or biological therapy at least 3 weeks prior to the first dose of investigational product is required.
At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy
No experimental intravesical therapy within 6 weeks of study entry
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; treatment with mitomycin C or radio-immunotherapy must be completed within 6 weeks prior to cycle 1 day 1
Patients who have received chemotherapy or radiation therapy to > 30% of marrow bearing bone within < 2 weeks or experimental agent/therapy within 4 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 2 weeks before first dose of study drug
Participants who have had radiotherapy within 4 weeks prior to study entry
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Cholangitis that required treatment or intervention within 4 weeks of study enrollment
Chemotherapy (approved or investigational) within 3 weeks prior to the first day of treatment or antibody therapy within 6 weeks prior to the first day of treatment
Patients must be >= 4 weeks beyond treatment with any chemotherapy or radiotherapy, and must have recovered to =< grade 2 toxicity for any treatment-limiting toxicity of prior therapy; (exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field); also, patients who have received non-chemotherapeutic biologic agents will need to wait at least five half-lives or four weeks, whichever is shorter, from the last day of treatment; exception: no washout of cetuximab or regorafenib is required for patients who have received prior cetuximab or regorafenib and have recovered from any treatment-related toxicities to grade =< 1
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
At least 8 weeks must have elapsed from the use of strontium-89, radium-223, samarium-153, or immunotherapy (e.g., Provenge) prior to beginning protocol therapy
AT THE TIME OF INFUSION: Off investigational therapy for 4 weeks prior to study entry
Patients who have received oral or IV chemotherapy, targeted anticancer therapy or radiation therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment
At least 4 weeks (28 days) prior to registration: Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)
Prior systemic radiotherapy and hemibody external radiotherapy
Patients must be off radiation therapy or chemotherapy 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting induction chemotherapy
Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
Participants may have had up to two previous cytotoxic therapeutic regimens provided these were discontinued >= 4 weeks before starting the trial
Strontium-89, samarium-153, or radium-223 therapy within 4 weeks of cycle 1, day 1
Radiotherapy, chemotherapy or immunotherapy within 4 weeks, or palliative radiation to bone metastases within 14 days of administration of cycle 1, day 1
Prior systemic radiotherapy and hemibody external radiotherapy
Myelosuppressive chemotherapy: Must not have received within 3 weeks (6 weeks if prior nitrosourea)
Radiotherapy =< 3 weeks prior to registration, except if to a non-target lesion only
Systemic chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy intended to treat underlying malignancy, within 3 weeks before the first dose or 6 weeks for antibody therapy
Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks before first dose.
Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
Patient was treated with trastuzumab or other antibody based therapy within three weeks of starting study treatment or with chemotherapy or hormonal cancer therapy within two weeks of starting study treatment.
at least 8 weeks without tumor progression after any whole brain radiotherapy
Last dose of chemotherapy or experimental therapy more than 4 weeks (6 weeks in the case of nitrosourea) prior to enrollment date; 2 weeks if the last therapy was received as part of a “phase 0” or “exploratory investigational new drug (IND)” trial; last surgery more than 4 weeks prior to enrollment; core biopsies or fine need aspiration (FNA) will not require any waiting period
Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a 2 week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications
Myelosuppressive chemotherapy:\r\n* Subjects must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks if nitrosourea
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
Patients who have received wide field radiotherapy ? 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy.
Granulocytes >= 1500/mm^3 within 4 weeks of enrollment
Patients must have completed any chemotherapy, radiation therapy, biologic therapy, or major surgery >= 4 weeks prior to enrollment (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study, at the discretion of the principal investigator; patients must have recovered to eligibility levels from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous (IV) bisphosphonate treatment prior to study entry may continue this treatment
Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy ? 3 weeks prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Vaccination within 4 weeks prior to the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
Fludarabine within 4 weeks prior to leukapheresis
Prior anti-cancer therapy within 4 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
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
No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:\r\n* Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens); Note: treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed; treatment with flutamide within 4 weeks prior to enrollment is not allowed; treatment with all other gonadotropin-releasing hormone (GnRH) analogues or antagonists is allowed\r\n* Chemotherapy\r\n* Biologic therapy\r\n* Investigational therapy\r\n* Immunotherapy
Chemotherapy (approved or investigational) within 3 weeks prior to signing consent
Antibody therapy within 6 weeks prior to signing consent
Radium-223, strontium-89, or samarium-153 therapy within 4 weeks of enrollment
Radiotherapy, chemotherapy or immunotherapy within 4 weeks, or single fraction of palliative radiotherapy within 14 days of administration of enrollment
PART B: Prior radiotherapy to proposed target lesions is not permitted unless completed more than 4 weeks prior to treatment within the study and that there has been documented progression at these sites; radiotherapy to non-target lesions is permitted within 2 weeks of study entry provided all acute effects of the radiotherapy have resolved to =< grade 1
More than 2 seizures over the last 4 weeks prior to study entry
Patients must have completed WBRT > 12 weeks prior to enrollment to limit cases of pseudoprogression; however if new lesions are noted < 12 weeks but > 4 weeks prior to enrollment, those patients are eligible
Patients must have discontinued active immunotherapy (interleukin [IL]-2, interferon, cytotoxic T-lymphocyte antigen 4 [CTLA-4], etc.) or chemotherapy at least 4 weeks prior to entering the study and oral targeted therapy at least 2 weeks prior to entering the study and have recovered from adverse events due to those agents; patients must not receive any other investigational anticancer therapy during the period on study or the four weeks prior to entry, with the exception of vaccines
Anti-tumor therapy (i.e. chemotherapeutics or investigational agents or immunotherapy) within 4 weeks prior to enrollment
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks, hormonal therapy within 1 week prior to day 1 cycle 1
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
Patients who have received radiotherapy =< 2 weeks prior to starting treatment
Patients who have had standard of care chemotherapy, large field radiotherapy, or major surgery must wait 2 weeks prior to entering the study; for recent experimental therapies a 28 day period of time must elapse before treatment
At the time of registration, patient must be at least 2 weeks from prior vincristine, 3 weeks from prior procarbazine, and 4 weeks from other prior cytotoxic chemotherapy
Anti-neoplastic treatment less than 4 weeks prior to enrollment, with the exception of hydroxyurea
Treatment with corticosteroids within 2 weeks
Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks)
Patients must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy
Rapidly progressing cancer likely to require palliative systemic intervention within 8 weeks after study entry
Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued >= 4 weeks prior to randomization
Prior radiation therapy must be completed > 4 weeks prior to enrollment and the patient must have recovered from all toxicity. Prior radiopharmaceuticals (strontium, samarium) must be completed ? 8 weeks prior to enrollment.
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must recover to a grade 1 before starting the trial
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 2 weeks (or =< 3 weeks for a monoclonal antibody) prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Patients who have received systemic anti-cancer therapy such as chemotherapy, immunotherapy and/or biologic therapy =< 4 weeks prior to study entry; concurrent anti-cancer therapy (chemotherapy, immunotherapy, biologic therapy) other than the ones specified in the protocol is not permitted during study participation; patients must have discontinued the above cancer therapies for 4 weeks prior to the first dose of study medication, as well as recovered from toxicity (to =< than grade 1, except for alopecia) induced by previous treatments; any investigational drugs should be discontinued 4 weeks prior to the first dose of study medication
Patients who have received androgen ablative therapy for less than 8 weeks immediately prior to initiation of study drug are eligible provided they had only PSA evidence of progression (as defined above) with no visible metastases by CT-scan and bone scan (within 6 weeks) prior to starting androgen ablation
Any radiotherapy or immunotherapy within the last 3 weeks (limited palliative radiation is allowed >= 2 weeks); chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C); chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks
Any radiotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed >= 2 weeks); chemotherapy regimens with delayed toxicity within the last 4 weeks; chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI608.
Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities)
Patients must be ? 4 weeks since major surgery, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) or biotherapy/target therapies and ? 2 weeks since radiotherapy.
Sorafenib treatment within 2 weeks of randomization.
Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
Experimental medications within the last 4 weeks prior to day 1
Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
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
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
Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents
Patients who have had external beam radiotherapy, cytotoxic chemotherapy, or oral multikinase inhibitors within 4 weeks prior to study enrollment
Patients who have been treated with radioactive iodine within 24 weeks prior to study enrollment (radioactive iodine within 24 weeks will be allowed if negative post-treatment scan or progressive disease defined by RECIST 1.1)
Treatment with any known therapeutic or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
The following amounts of time must have elapsed prior to entry on study:\r\n* 2 weeks from local radiation therapy (XRT)\r\n* 8 weeks from prior craniospinal or if > 50% of the pelvis has been irradiated\r\n* 6 weeks must have elapsed if other bone marrow radiation has occurred
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)
If taking systemic therapy for cGvHD at the time of enrollment, must be on a stable or tapering schedule in the preceding 4 weeks (extracorporeal photopheresis has to be stopped at least by 4 weeks before enrollment)
The patient has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or nitrosoureas or mitomycin within 6 weeks before the first dose of study treatment
Cohort 3: Patients with recurrent WHO grade 2 glioma may have received prior external beam radiotherapy and/or chemotherapy; patients with stable WHO grade 2 glioma must have had prior chemotherapy (at least one cycle of temozolomide or procarbazine, lomustine, and vincristine [PCV]-based chemotherapy); with regard to the prior therapy in Cohort 3, patients may have had treatment for no more than 2 prior relapses; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or observation of stable disease; the intent therefore is that patients may have had 3 prior therapies (initial therapy and treatment for 2 relapses); if the patient had a surgical resection for relapsed disease, and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse\r\n* In Cohort 3 with recurrence, tumor recurrence is defined by the increase of maximum tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images; increase of tumor size can be based on comparison with previous scans performed up to prior 3 years to allow assessment of slow-growth of the tumor\r\n* In Cohort 3, patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 4 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the Principal Investigator; with regard to previous RT, there must be at least 6 months from the completion of RT (or radiosurgery)
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
Patients must have documented radiologic or clinical progressive disease following at least one prior anti-VEGF regimen administered either as a single agent or in combination with other agents for at least 8 weeks; the prior anti-VEGF treatment regimen must have included bevacizumab, pazopanib, sorafenib or sunitinib administered not more than 12 weeks before study entry; Note: enrollment not more than 8 weeks after the last dose of anti-VEGF therapy is encouraged; nevertheless, intercurrent therapy with an mTOR inhibitor (everolimus or temsirolimus) will be allowed if progression on that treatment is observed within 12 weeks of the prior anti-VEGF therapy
No chemotherapy or immunotherapy for a minimum of three weeks prior to study enrollment
Exposure to chemotherapy, radiotherapy, biologics or investigational agents within 3 weeks prior enrollment in the study
Last dose of cytotoxic chemotherapy must have been at least 4 weeks (6 weeks for nitrosoureas) prior to catheter placement; patients are eligible if they received bevacizumab or other anti-vascular endothelial growth factor (VEGF) therapies, although the most recent dose must be at least 6 weeks prior to catheter placement
Myelosuppressive chemotherapy: interval >= 6 weeks and >= 4 weeks from last dose of nitrosourea and other chemotherapy drugs before study enrollment, respectively; however, interval must be >= 1 week from last dose of oral etoposide and other drugs administered at low doses (metronomic regimen) before study enrollment
Interval >= 4 weeks and =< 8 weeks from the completion of radiochemotherapy
Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
Recent therapeutic interventions within 3 (chemotherapy/radiotherapy) to 10 weeks (immunotherapy)
A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past 4 weeks
Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation
Treatment with another chemotherapy or hormonal therapy within the past 2 weeks
No radiotherapy within 2 weeks: exception: patients may receive palliative low dose radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the treating physician; palliative radiotherapy could be given before aerosol treatment is started if necessary
The participant 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 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
Radiotherapy or systemic therapy within 2 weeks of Cycle 1 Day 1 (C1D1)
Prior peripheral ASCT within 12 weeks of C1D1
Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
Patients on Octreotide LAR at a fixed dose of 20 mg or 30 mg at 3-4 weeks intervals for at least 12 weeks prior to randomization in the study.
Treatment with >30 mg Octreotide LAR at 3-4 weeks intervals within 12 weeks prior to randomization in the study.
prior immunotherapy, or prior investigational agents should be washed out 4 weeks before apheresis and must be completed 4 weeks prior to pre-infusion lymphodepletive chemotherapy.
monoclonal antibody therapy must be completed at least 6 weeks prior to pre-infusion lymphodepletive chemotherapy
All previous cytotoxic chemotherapy, monoclonal antibody therapy, immune therapy should be washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion lymphodepletive chemotherapy.
Systemic corticosteroid or other immunosuppressive therapy should be washed out 2 weeks before apheresis and must be completed at least 2 weeks prior to pre-infusion lymphodepletive chemotherapy
Patients must have recovered (to Common Toxicity Criteria [CTC] version [v.]4.0 =< grade 1 unless indicated below) from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, with the exception of alopecia, weight changes and grade I or II lymphopenia\r\n* Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea or mitomycin-C)\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (RT): patients must have had their last fraction of craniospinal RT >= 6 months prior to study entry and their last fraction of focal RT >= 4 weeks prior to study entry; if the lesion used for on-study criteria is in the radiation field, there must be evidence of tumor progression after radiation therapy was completed\r\n* Study specific limitations on prior therapy:\r\n** Patients who have received thalidomide are eligible if all acute thalidomide-related toxicity has resolved\r\n** Patients must not have received lenalidomide previously
The use of the 5-alpha-reductase inhibitor dutasteride and systemic steroids must be discontinued within 4 weeks of degarelix injection for Cohort 1, 2, and 4, and within 4 weeks of surgery for Cohort 3
Prior sunitinib and everolimus will be permitted; a wash-out period of 2 weeks is required prior to first dose on this study
Prior full field radiotherapy =< 4 weeks or limited field radiotherapy =< 2 weeks prior to enrollment; patients must have recovered from all therapy-related toxicities; the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease
Prior and concurrent therapy:\r\n* Chemotherapy: At least four weeks since prior cytotoxic chemotherapy or 6 weeks since nitrosoureas or mitomycin\r\n* Molecular targeted agents including monoclonal antibodies and tyrosine kinase inhibitors: At least two weeks since last therapy\r\n* Endocrine therapy: Subject may be remain on luteinizing hormone-releasing hormone (LHRH) antagonist therapy for prostate cancer if tumor progression has been confirmed\r\n* Radiotherapy: At least 3 weeks since most recent radiotherapy\r\n* Palliative radiotherapy to localized painful lesions is acceptable when the subject is on study: At least one week after completion of radiation therapy (RT) and recovery from associated toxicities before restarting ARQ 761; irradiated lesions will not be evaluable for response\r\n* Other investigational therapy: At least four weeks since any other investigational therapy\r\n* Concurrent therapy: No other concurrent anticancer or investigational therapy permitted except as noted above
Subjects who have had cytotoxic chemotherapy or treatment with monoclonal antibodies within 4 weeks (6 weeks for nitrosoureas or mitomycin C), radiotherapy within 3 weeks, or other molecular targeted therapies (including tyrosine kinase inhibitors within 2 weeks prior to entering the study)
More than two seizures over the last 4 weeks prior to study entry
Systemic chemotherapy within 2 weeks prior to study entry (signing consent form)
Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
The first dose of study treatment must be at least three weeks since prior chemotherapy, including sunitinib or everolimus
Patients who have received either immunotherapy within =< 8 weeks; chemotherapy within =< 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Prior radiotherapy must have been completed at least 2 weeks prior to study entry For Arm M:
Nitrosurea: ? 6 weeks
Biologic therapy: ? 4 weeks
Previous chemotherapy, immunotherapy, and hormone therapy must be completed at least 4 weeks prior to the administration of MLN2480 and radiation must be completed at least 3 weeks prior to the administration of MLN2480; all associated toxicity must be resolved to ? Grade 1
Prior investigational agents for malignant or non-malignant disease within 4 weeks prior to Day 1
INCLUSION CRITERIA:\n\n        Phase 1b\n\n          -  Histologically confirmed diagnosis of a hematologic malignancy, excluding patients\n             with acute leukemia or MDS.\n\n          -  Relapsed after standard therapy for their malignancy and considered to be an\n             appropriate candidate for a Phase 1 clinical study by their treating physician.\n\n        Phase 2\n\n          -  Multiple myeloma with measurable disease\n\n          -  Waldenström macroglobulinemia with symptomatic relapse\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n\n        Ethical/Other\n\n          -  Patients must sign a written informed consent form in accordance with federal, local,\n             and institutional guidelines.\n\n          -  Female patients of childbearing potential must have a negative serum or urine\n             pregnancy test and agree to use effective contraception. Male patients must use an\n             effective barrier method of contraception.\n\n        EXCLUSION CRITERIA:\n\n          -  Chemotherapy with approved or investigational anticancer therapeutics, including\n             steroid therapy intended to treat underlying malignancy, within 3 weeks prior to first\n             dose or 6 weeks for antibody therapy.\n\n          -  Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8\n             weeks prior to first dose. Localized radiation therapy within 1 week prior to first\n             dose.\n\n          -  Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6\n             weeks is required).\n\n          -  Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks;\n             allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should\n             not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in\n             Filipovich 2005).\n\n          -  Evidence of central nervous system (CNS) lymphoma.\n\n          -  Prior treatment with carfilzomib unless in the phase 2.\n\n          -  Major surgery within 3 weeks prior to first dose.\n\n          -  Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or\n             myocardial infarction within 6 months.\n\n          -  Acute active infection requiring systemic antibiotics, antivirals, or antifungals.\n\n          -  Known or suspected human immunodeficiency virus (HIV) infection or patients who are\n             HIV seropositive.\n\n          -  Active hepatitis A, B, or C infection.\n\n          -  Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the\n             first dose.\n\n          -  Patients with pleural effusions requiring routine thoracentesis or ascites requiring\n             routine paracentesis.\n\n          -  History of previous clinically significant GI bleed in the last 6 months prior to\n             first dose.\n\n          -  Female patients who are pregnant or lactating.
Patients must have recovered from the toxic effects of prior therapy including but not limited to: \r\n* An interval of >= 4 weeks (28 days) from prior cytotoxic therapy except 6 weeks from nitrosoureas\r\n* An interval of >= 1 week (7 days) from any non-cytotoxic agents\r\n* An interval of >= 3 months from the completion of radiation therapy
Prior cranial radiotherapy
Recovered from side effects that might interfere with the protocol therapy and:\r\n* >= 4 weeks must have elapsed from last radiation treatment to time of study entry\r\n* >= 4 weeks must have elapsed from the last chemotherapy administration to time of study entry\r\n* >= 8 weeks from the last immunotherapeutic agent administered to time of study entry
Interval >= 4 weeks between open brain biopsy and initiation of protocol-based therapy
Patients who have received chemotherapy within </= 2 weeks by time of cycle 1 day 1 of therapy on trial ; or radiation therapy to > 30% of marrow-bearing bone within 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies.
Time since the last dose of prior therapy to treat underlying malignancy:\r\n* Cytotoxic chemotherapy or endocrine therapy: >= the duration of the most recent cycle of the previous regimen (with a minimum of 3 weeks for all, except 6 weeks for nitrosourea, mitomycin-C)\r\n*Biologic therapy (e.g., antibodies): >= 4 weeks\r\n* >= 5 X half-life of a small molecule therapeutic\r\n* >= 4 weeks interval between whole brain radiation therapy and initiation of protocol-based therapy for ARM C or D patient with stable brain metastases\r\n* >= 2 weeks interval between stereotactic radiosurgery (SRS) or gamma knife (or equivalent) and initiation of protocol-based therapy for ARM C or D patient with stable brain metastases\r\n* Patients enrolled in ARM C may remain on trastuzumab without a washout period\r\n* Patients enrolled in ARM D may remain on lapatinib without a washout period
Received wide field radiotherapy =< 4 weeks, or SRS or gamma knife for brain metastasis =< 2 weeks or limited field radiation for palliation =< 2 weeks prior to starting either BYL719 or BKM120 or have not recovered from side effects of such therapy
Radiotherapy within 4 weeks prior to first dose of FOLFIRI
Patients must have recovered to at least eligibility levels following any display of adverse events and/or toxicity due to prior chemotherapy or biologic therapy; they must not have had hormonal therapy, chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C, or 7-hydroxystaurosporin [UCN-01]); patients must be >= 2 weeks since any prior administration of study drug in a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion; patients must be >= 4 weeks since any prior radiation or major surgery; however, patients receiving bisphosphonates or therapeutic anticoagulation are eligible for this trial
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 prior therapy for lymphoma within the previous 2 weeks for standard treatments and within 4 weeks for experimental therapies unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion criteria
Treatment with radiotherapy within the past 4 weeks or radiopharmaceutical therapy (strontium, samarium) within the past 8 weeks
For Parts A, B, and D: have discontinued sorafenib for at least 2 weeks
Date of randomization must be within 32 weeks of initiation of optimal systemic therapy
Patients must have adequate organ function to undergo local therapy 4 weeks +/ - 2 weeks prior to randomization per investigator discretion and institutional guidelines
A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or radiotherapy or surgery and the start date of study therapy
At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
TREATED PRIMARY - PRIOR RADIOTHERAPY:
Use of hematopoietic growth factors within the 2 weeks prior to initiation of therapy
Have not received anti-cancer therapy for at least 2 weeks prior to study entry, with the exception of low dose ara-C (LDAC) given as subcutaneous injections (no less than 15 days prior), hydroxyurea or anagrelide (no less than 24 hours prior), TKI (no less than 5 days prior), and interferon (no less than 2 weeks prior)
Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
Patients who have had chemotherapy within 3 weeks or radiotherapy or targeted therapy 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Prior anti-tumor therapy within 2 weeks
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol
Interval of at least 12 weeks from prior radiotherapy unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new enhancement on MRI outside of the radiation treatment (RT) field
Receiving therapy for chronic GVHD for more than 16 weeks.
Patients must be off all \statin\ drugs for ?2 weeks prior to initiation of therapy.
Surgery involving general anesthesia, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to entering the study. Palliative radiotherapy is allowable. Collection of lumenal tissue for vaccine manufacture must be avoided.
Systemic cytotoxic therapy within 3 weeks of treatment
Autologous SCT within 12 weeks prior to study entry (Arms A and D only)
Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least six weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the PI’s discretion, and should have recovered to eligibility levels from any toxicities
Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI’s) discretion, and should have recovered to eligibility levels from any toxicities
KS therapy other than HAART within 3 weeks
Hemoptysis within 4 weeks
Previous bevacizumab within 6 weeks prior to enrollment
Cytotoxic chemotherapy =< 3 weeks, or biologic or novel targeted therapies =< 2 weeks, or corticosteroids =< 2 weeks, prior to registration; patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.
Patients must have recovered from the toxic effects of prior therapy to < grade 2 non hematological or grade 2 or lesser hematological toxicity per CTC ver 4 (except deep vein thrombosis): 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not count). Patients who receive anticancer agents for non-therapeutic purposes unrelated to this study
Last dose of prior chemotherapy received less than 4 weeks prior to randomization
No prior treatment except for local radiation or a short course of steroids for control of symptoms; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
ASCT within 4 weeks (i.e., ASCT is allowed if it occurred before enrollment in Study NEOD001-201 or after completion of Study NEOD001-201 if it was at least 4 weeks before Month 1-Day 1 of this study)
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Discontinuation of all cytotoxic chemotherapy and anti-CD20 antibody therapy for ? 4 weeks, alemtuzumab for ? 8 weeks, targeted therapy for ? 2 weeks, and investigational therapy for ? 3 weeks before enrollment (Phase 1b) or randomization (Phase 2). For individuals with relapsed CLL most recently treated with B-cell receptor (BCR) pathway inhibitors who, in the opinion of the investigator, will not tolerate waiting 3 weeks, a washout period of > 5 half-lives is allowed. If on a systemic corticosteroid, the dose must be stable for the previous 4 weeks.
Prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
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
Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
Prior radiotherapy to the pelvis
No more than 3 prior lines of chemotherapy; prior therapy with doxorubicin is permitted but no more than lifetime cumulative dose of 150 mg/m^2; at least 3 weeks since prior chemotherapy or radiotherapy, at least 6 weeks if the last regimen included bis-chloroethylnitrosourea (BCNU) or mitomycin C
Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib and 2 weeks after the last dose of erlotinib
Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration. Chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity or palliative radiation to a limited area within the last two weeks.
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
At least 6 weeks must have elapsed since administration of nitrosureas.
Patients must be >= 4 weeks from cytotoxic chemotherapy, except >= 6 weeks for mitomycin C or nitrosoureas, and >= 8 weeks from prior 7-hydroxystaurosporine (UCN01); >= 4 weeks from monoclonal antibody therapy (cetuximab, bevacizumab); >= 4 weeks from prior experimental therapy; >= 2 weeks from radiation or hormonal therapy; >= 2 weeks from sorafenib, sunitinib or temsirolimus treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LhRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study
Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been completed at least 2 weeks prior to enrollment; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of enrollment are strongly encouraged to receive palliative radiotherapy prior to enrollment
Conventional cytotoxic chemotherapy: ?4 weeks (? 6 weeks for nitrosoureas and mitomycin-C)
Biologic therapy (e.g., antibodies): ?4 weeks
Minimum of 12 weeks from the first dose of antiCTLA-4 and 6 weeks from the last dose
Patients who have had anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment; hydroxyurea is an exception; administration of hydrea to control high WBC is permitted
Radiotherapy within 2 weeks
Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the first dose of study drug.
Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication
Washout periods for prior therapy are as follows\r\n* Bevacizumab – last dose must be >= 6 weeks prior to day 1 of study treatment\r\n* Targeted therapy – last dose must be >= 5 half-lives prior to initiation of day 1 of study treatment\r\n* Other chemotherapy, immunotherapy, or radiotherapy – last dose must be =< 3 weeks prior to day 1 of study treatment
Palliative radiation therapy within 2 weeks of Day 1, or within 4 weeks of Day 1 if a radionuclide was utilized.
Subjects who have received systemic antitumor therapy within 4 weeks or radiotherapy to target lesions within 3 weeks before the first dose of study drug, which is longer
Significant co-morbidities within 4 weeks prior to enrollment
Monoclonal based therapies within 4 weeks and all other immunotherapy within 2 weeks prior to first dose of study treatment.
Systemic radiation therapy within 4 weeks, focal radiotherapy within 2 weeks and radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dose of study treatment.
If patients have been treated with anti-VEGF agents, such as bevacizumab, last dose must be >= 4 weeks
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Ability to participate in the clinical study for a minimum of at least 2 cycles (6 weeks).
All prior chemotherapy completed at least three weeks before study treatment
Palliative radiotherapy is allowed up to 2 weeks before the first RO6927005 infusion; palliative 8 Gy radiotherapy is allowed during therapy.
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must recover to a grade 1 before starting the trial
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have had chemotherapy, biologic therapy or radiotherapy within 3 weeks prior to entering the study
Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C, and 1 week for hormone therapy) prior to starting study drug or who have not recovered from side effects of such therapy
Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
Must be at least 4 weeks since treatment with standard or investigational chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, and 8 weeks since any monoclonal antibodies or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment
Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy
Radiotherapy within 4 weeks before enrollment.
Radiotherapy within 4 weeks before enrollment.
Prior local therapy within 2 weeks (for both phases I and II) or prior systemic therapy within 4 weeks of starting protocol treatment
Patients must have completed any previous surgery or radiotherapy >= 4 weeks prior to enrollment
Prior external beam radiation therapy completed < 3 weeks or single fraction of palliative radiotherapy within 14 days prior to first dose of study drug.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ? 2 weeks prior to Cycle 1 Day 1, except ibrutinib which may be continued until one day prior to initiation of selinexor; radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Patients must have recovered to Grade ? 1 from clinically significant adverse effects.
Patients who receive other chemotherapy; patients must have been off previous therapy for >= 2 weeks and must have recovered from clinically significant toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing) with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine (including prophylactic intrathecal medication), thioguanine, and tyrosine kinase inhibitors are permitted within 2 weeks of randomization as maintenance or to reduce the peripheral blood blast counts; during ibrutinib therapy, only steroids and hydroxyurea are permitted to reduce peripheral blood blast counts; patients who have had chemotherapy or radiotherapy within 2 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 2 weeks earlier
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
All studies required for evaluation will be performed within 8 weeks of Photofrin administration
Receiving any cancer therapy within 2 weeks of first dose (including surgery, and/or tumor embolization) Note: the following are allowed: Corticosteroids to control systemic or local symptoms, up to a dose of 10 mg prednisone or equivalent daily and stable for at least 7 days prior to enrollment. Subjects with prostate cancer may remain on GnRH agonists. Other hormonal therapies (e.g., bicalutamide, abiraterone and enzlutimide) for prostate cancer must be stopped 4 weeks prior to enrolment. Note: the following are NOT allowed: Chemotherapy regimens with delayed toxicity within the last 3 weeks. Nitrogen mustards, Melphalan, Monoclonal antibody or Nitrosourea within the last 6 weeks.
Any major surgery, radiotherapy or immunotherapy within the 4 weeks prior to first dose of study drug, or palliative radiotherapy to a single symptomatic lesion within the 2 weeks prior to first dose of study drugs.
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
4 weeks from prior cytotoxic therapy
6 weeks from nitrosoureas
3 weeks from procarbazine
Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks if nitrosourea
Prior local therapy within 2 weeks of starting the study treatment
The last dose of previous therapy targeting RET kinase must be given at least 4 weeks prior to the first dose of ponatinib
Previous treatment with cytotoxic chemotherapy, immunotherapy, or radiotherapy are permitted, if the last dose was given at least 4 weeks prior to the first dose of ponatinib
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
Prior focal radiotherapy
Have completed treatment greater than 4 weeks prior to enrollment.
Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame
Completed prior chemotherapy a minimum of 4 weeks previously (6 weeks for BCNU and/or mitomycin C), 4 weeks for prior immune therapy, 6 weeks for antibodies to checkpoints CTLA4, PD1, PDL1, etc, and 2 weeks for targeted agents (i.e. inhibitors of MEK, BRAF, Akt, PI3K, mTORC1/2) or localized radiation therapy; all treatment related toxicity must have resolved to grade 2 or less or to a baseline level as well
Patients who received radiotherapy within 4 weeks of entry
Signs or symptoms of infection within 2 weeks prior to the first dose of study treatment
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
Bevacizumab within 4 weeks.
Other chemotherapy (e.g., mitomycin-C, nitrosourea) or immunotherapy (e.g., antibody, cytokine) within 4 weeks
Current use of systemic corticosteroids greater than (>) 20 milligrams (mg) prednisone per day (or equivalent); or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Prior radiotherapy with curative intent
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)
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
Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs
Treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks.
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
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
No chemotherapy within 4 weeks prior to study treatment administration; nitrosoureas and mitomycin C are not allowed within 6 weeks prior to initiation of study treatment
Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
Patients who have received either immunotherapy within =< 8 weeks; chemotherapy within =< 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Patients should not have received any chemotherapy or investigational agents for at least 4 weeks before entering the study (6 weeks for nitrosoureas or mitomycin C)
No more than 12 weeks must have elapsed from hysterectomy.
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior prior or within 6 weeks prior to Cycle 1/Visit Day 1 for nitrosoureas or mitomycin C;
At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.
A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past 4 weeks
Concurrent or previous anti-cancer chemotherapy, immunotherapy or investigational agents < 3 weeks, or palliative radiation < 2 weeks prior to the first day of study treatment. Patients who receive gamma knife radiosurgery for brain metastases or whole brain radiation are eligible if gamma knife radiosurgery was performed > 2 weeks before treatment is started or whole brain radiation was performed > 4 weeks before treatment is started, and are clinically stable.
< 6 weeks for mitomycin-C or nitrosoureas
Prior radiotherapy within 2 weeks prior to first dose of study drug
Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing).
Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
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: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation\r\n* Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
Palliative radiotherapy within 2 weeks prior to first dose of study-drug treatment in Cycle 1
Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
Received chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Received chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last two weeks.
Receipt of cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C) of scheduled dosing day 1.
Recent therapy with any active anticancer agent within 4 weeks of the 1st dose of the study drugs
Prior therapy with nitrosoureas or mitomycin within 6 weeks prior to the first dose of TKM-080301.
Less than three weeks since the last radiotherapy dose
Patients must not have received myelosuppressive therapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Washout from prior hormonal therapy of at least 2 weeks prior to C1D1
At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
Participants who have received radiotherapy less than 2 weeks prior to first dose of study medication
Has recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: At least 3 weeks since completion (6 weeks for nitrosourea)\r\n* Biologic (anti-neoplastic agent): At least 14 days since completion of therapy with a biologic agent\r\n* Radiation (XRT): >= 1 week must have elapsed from prior palliative XRT to non-target lesions
Prior treatment with bevacizumab within twelve weeks before the first infusion.
Oral treatment with antimicrobial therapy starting less than two weeks prior to first dose.
Off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least 4 weeks prior to study enrollment and recovered from all toxicities; if patient is already on ruxolitinib for a minimum of 16 weeks prior to study enrollment, patient can proceed to mobilization and collection
Subject has had chemotherapy within 4 weeks prior to the first study dose.
Discontinuation of all other therapies (including other investigational drugs, radiotherapy, or chemotherapy) for the treatment of cancer ?4 weeks (?6 weeks if nitrosoureas, ?12 weeks if radiotherapy) before initiation of study treatment
Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment.
Subject has had radiotherapy or surgery within the 4 weeks prior to treatment with ASP4132.
Completed 24 weeks of treatment in Protocol 8400-401
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1; any clinical trial therapy (including investigational anti-cancer study) =< 3 weeks prior to cycle 1 day 1
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Patients who have had chemotherapy (or so-called ‘targeted’ systemic therapy), large field radiotherapy, or major surgery must wait 4 weeks after completing treatment prior to entering the study
Prior chemotherapy completed at least 3 weeks prior to study enrollment
More than 4 weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen; note: patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria
Patients who have received chemotherapy, biological agents or investigational therapy within 4 weeks prior to entering the study
Patients who have had palliative radiotherapy within 3 weeks prior to entering the study
Has received treatment with focal radiotherapy within 2 weeks, or radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks of receiving cyclophosphamide on Day -3
Administration of any other vaccine ? 4 weeks of receiving cyclophosphamide on Day -3
Radiotherapy < or = 4 weeks or limited field radiation for palliation < or = 2 weeks prior to starting with the investigational product.
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Received palliative/focal radiotherapy within 2 weeks of first dose of study treatment.
Subjects must have the following minimum wash-out and adverse event (AE) recovery period from previous treatments without treatment between documentation of relapse/progression and enrollment of specifically:\r\n* >= 2 weeks for local radiation therapy\r\n* >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 8 weeks\r\n* >= 15 weeks for anti-cluster of differentiation (CD)137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= 2 weeks from resolution (i.e., =< grade 1 or at baseline) from AEs due to procedures performed or therapeutic agents administered\r\n* >= 2 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox, and therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteroids are allowed, topical corticosteroids are allowed)\r\n* >= 2 weeks for phototherapy\r\n* >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
Prior radiation therapy completed < 3 weeks or single fraction of palliative radiotherapy < 14 days prior to first dose of KPT-330 (selinexor)
Patient has received chemotherapy or anticancer therapy ? 4 weeks prior to starting study drug
Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.
Patient has received chemotherapy or anticancer therapy ? 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.
Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy; typically, this is 3–4 weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C, for which 6 weeks is needed for recovery
Able to initiate study treatment at least 2 weeks but no more than 4 weeks after completion of salvage therapy
Local-regional therapy within 4 weeks before Day 1
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: must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Bisphosphonates: at least 4 weeks since the completion of therapy with a bisphosphonate\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiation therapy (RT): >= 2 weeks (wks) for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
No chemotherapy or investigational agent for at least 3 weeks prior to the start of SL-701, with at least 6 weeks of elapsed time from last dose of nitrosoureas.
Following treatment-free period prior to enrollment to the study: i)Surgery: 4 weeks for major surgery (e.g., laparotomy and thoracotomy); 2 weeks for less extensive surgery (e.g., colostomy) ii)Radiation: 4 weeks (2 weeks for palliative irradiation to bone metastases [except for pelvic irradiation], and brain metastasis) iii) Chemotherapy (including systemic treatment with anticancer therapy and retinoid therapy): 3 weeks (6 weeks for nitrosourea antineoplastic agent and mitomycin C) iv) Antibody-based therapy: 4 weeks v) Small molecule targeted agents: If myelosuppression is not expected, 2 weeks or 5 half-lives, whichever is longer; otherwise, 3 weeks vi) Hormonal treatment: 3 weeks. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment. vii) Pleurodesis: 2 weeks
Patients treated with local radiotherapy with or without a brief (2 weeks or less) exposure to steroids are eligible; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
All patients must be off previous chemo- and/or radiotherapy for at least three (3) weeks prior to entrance into the study and have recovered from any toxic effects induced by such treatment(s); no nitrosourea type drug or ipilumimab treatments are permitted within the last six (6) weeks prior to enrollment. No major surgery within 14 days of enrollment. Patients may continue to receive anti-estrogen/steroid therapy that has been initiated at least eight weeks prior to enrollment in the study.
Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
Patient has discontinued all corticosteroids for that indication for at least 2 weeks;
Interferon therapy < 4 weeks prior to study day 1.
Peripheral edema ? grade 2 within 2 weeks prior to study day 1.
within 3 weeks prior to the first dose of KTN3379, or
Has the subject received cytotoxic chemotherapy within the past 3 weeks (6 weeks for nitrosoureas) of the planned date of vector injection?
Extensive prior radiotherapy.
completed all treatment and follow-up through at least 12 weeks
Stopped tobacco use for 4 weeks prior to day 1 and during the study
Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy
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
Adequate recovery from prior systemic or local melanoma therapy; no systemic anticancer therapy in the 4 weeks and no ipilimumab in the 6 weeks from planned vemurafenib administration; no radiation therapy in 2 weeks prior to date plan to initiate vemurafenib treatment and no surgery in 3 weeks prior to date of planned vemurafenib administration
Treatment with radiotherapy, chemotherapy or investigational therapy within 1 month (or 5 half lifes for cytotoxics) prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.
Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
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
Receipt of any biological therapy within 6 weeks of the first dose of GSK3052230
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
Anti-cancer therapy (including conventional cytotoxic chemotherapy and/or biological therapy) and radiotherapy must be completed and any associated toxicities resolved to </= Grade 1 levels or baseline levels and at least 2 weeks must have elapsed before enrollment. Treatment with monoclonal antibodies must be completed at least 14 days before entry. Must have completed immunosuppressive medications or vaccinations before enrollment.
Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies).
Asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomization, AND
No enzyme inducing anticonvulsants for >= 4 weeks prior to randomization
Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
Discontinued prior systemic treatment or any investigational drug for at least 2 weeks (14 days) or for at least 3 weeks for IV anti-cancer drugs, prior to the study randomization
No prior systemic therapy or radiation therapy active against myeloma lasting more than four weeks duration; any prior therapy must be completed a minimum of 21 days before starting study drugs; enrollment of subjects who require radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
Prior therapy requirements: \r\n* At least >= 1 prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy\r\n* At least 4 weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy\r\n* At least 2 weeks from completion of prior radiation therapy\r\n* At least 4 weeks from last dose of prior investigational therapy\r\n* Not receiving any current anti-cancer therapy\r\n* At least 4 weeks from last dose of interferon or IL-2 therapy\r\n* At least 8 weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and anti-programmed cell death 1 (PD1)\r\n* At least 4 weeks from last dose of prior other biologic agents
Received radiation therapy, surgery, or chemotherapy within 2 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
Prior treatment with a Smoothened inhibitor Systemic anticancer treatment within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies).
Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months before first dose of study treatment.
Chemotherapy, targeted therapies, radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug, whichever is longer and up to a maximum of 4 weeks (in the case of nitrosoureas and mitomycin C within 6 weeks) before the first administration of study drug. Localized radiation therapy and ongoing luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab, are permitted
Chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug
Patients who have had radiotherapy =< 4 weeks prior to starting study drug, or =< 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
Patients who have received either immunotherapy within =< 8 weeks; chemotherapy within =< 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of Day 1 visit, or radionuclide therapy within 8 weeks of Day 1
Completion of radiation therapy >= 12 weeks prior to registration and prior chemotherapy >= 4 weeks prior to registration (>= 6 weeks from nitrosourea-containing regimens)
Prior treatment with one to three lines of systemic chemotherapy for locally advanced or metastatic disease and two weeks from any previous anticancer therapy including biologics and recovered from expected toxicity; at least 4 weeks from major surgery and recovered; at least 3 weeks from radiation affecting more than 25% of bone marrow and recovered; and 2 weeks from other palliative radiation and recovered. No more than 450 mg/m2 cumulative dose of doxorubicin is allowed.
Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
Immunotherapy for cancer within 4 weeks of initial study treatment
Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
Have had a loco-regional procedure for the treatment of hepatocellular carcinoma (such as a percutaneous, trans-arterial, or radio-ablative procedure) less than 4 weeks prior to beginning protocol therapy. Protocol therapy may begin a minimum of 4 weeks after such a procedure provided the following criteria are met:
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
Prior local radiotherapy is allowed if it is completed at least 4 weeks prior to the first dose of study drug and the subject has evaluable lesions not previously irradiated
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* At least 4 weeks out from their last dose of radiation therapy\r\n* At least 4 weeks post-operative (op) from any major surgical procedure\r\n* At least 3 weeks out from their last dose of chemotherapy and/or biologic/targeted therapy
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., Tarceva, hydroxychloroquine, bevacizumab, etc.)
Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or mitomycin C) prior to administration of the first dose of study treatment.
Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients who have had prior monoclonal antibody therapy must have completed that therapy at least 3 half-lives of the antibody or 6 weeks ago; patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center principal investigator (PI) after consultation with a cardiologist and if screening echocardiogram is normal
Receipt of other anticancer therapy within 2 - 6 weeks, depending on the treatment
Antithymocyte globulin or similar anti-T cell antibody therapy ? 4 weeks prior to Cycle 1 Day 1
Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?3 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1;
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
Receipt of any investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0639 or in the case of monoclonal antibodies, 6 weeks prior to the first dose of MEDI0639
Patients who have had large field radiotherapy must wait 2 weeks prior to entering the study
At least 6 weeks must have elapsed since prior systemic mitomycin C
At least 8 weeks must have elapsed since any dose of Strontium-89
At least 4 weeks must have elapsed since prior Sm-153 lexidronam (Quadramet™)
At least 4 weeks must have elapsed since prior radiotherapy
At least 4 weeks from last chemotherapy or bevacizumab (Avastin) therapy (6 weeks for nitrosourea or mitomycin C), or for chemotherapy regimes given continuously or on a weekly basis with limited potential for delayed toxicity, at least 2 weeks from last dose.
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose of ARQ 092 (within 2 weeks for orally administered drugs)
Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
An interval of at least 6 weeks between prior surgical resection, 4 weeks from the end of prior radiotherapy
An interval of at least 3 months from the completion of most recent radiation therapy; at least 4 weeks from a non-nitrosourea chemotherapy regimen and at least 6 weeks from a nitrosourea containing regimen
Prior thoracic radiotherapy
Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
?2 weeks for cytotoxic therapy (except hydroxyurea, which is permitted at doses of ?5g/day during the first 2 weeks of Cycle 1) prior to C1D1.
Inclusion Criteria:\n\n          -  Must have evidence of c-MET dysregulation from either local data or the results of\n             molecular pre-screening evaluations.\n\n          -  Confirmed diagnosis of a solid tumor.\n\n          -  Measureable lesion.\n\n          -  Refractory to currently available treatment or no therapies available.\n\n          -  18 years or older.\n\n          -  ECOG performance status of 0, 1, or 2.\n\n          -  Obtained written informed consent.\n\n        Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:\n\n          -  Written documentation of EGFRwt NSCLC.\n\n          -  Written documentation of c-MET positivity.\n\n          -  Patients should not have received more than three prior lines of antineoplastic\n             therapy for NSCLC.\n\n          -  Presence of at least one measurable lesion as determined by modified RECIST version\n             1.1\n\n        Exclusion Criteria:\n\n        HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET\n        inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically\n        unstable or requiring increasing doses of steroids to control their CNS disease.\n\n        Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with\n        significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension,\n        peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute\n        coronary syndrome) within 6 months of starting study treatment or heart attack within 12\n        months of starting study treatment.\n\n        Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or\n        current anti-angiogenic therapy for patients with GBM. Radiation therapy within ? 4 weeks\n        (< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within ?\n        2 weeks (< 12 weeks GBM) prior to the start of study treatment. Any persistent side effect\n        of prior radiotherapy must be resolved to ? Grade 1 prior to the first dose of study drug.\n\n        Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:\n\n          -  Patients who have received more than three prior lines of antineoplastic therapies\n\n          -  Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or\n             radiotherapy, except alopecia\n\n          -  Patients have received anti-cancer therapies within the following time frames prior to\n             the first dose of study treatment:\n\n               -  Conventional cytotoxic chemotherapy: ?4 weeks (?6 weeks for nitrosoureas and\n                  mitomycin-C)\n\n               -  Biologic therapy (e.g., antibodies): ?4 weeks\n\n               -  Non-cytotoxic small molecule therapeutics: ?5 half-lives or ?2 weeks (whichever\n                  is longer)\n\n               -  Other investigational agents: ?4 weeks\n\n               -  Radiation therapy (palliative setting is allowed.): ?4 weeks\n\n               -  Major surgery: ?2 weeks\n\n        Other protocol-defined inclusion/exclusion criteria may apply.
Radiotherapy or systemic therapy within 2 weeks of baseline
Patients who have had chemotherapy (other than sorafenib treatment), large field radiotherapy, or major surgery must wait 4 weeks prior to entering the study
Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy (except alopecia)
Patients who have received radiotherapy within =< 4 weeks prior to registration
Treatment with anti CD 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.
Prior use of monoclonal antibody (other than anti CD20) within 3 months prior to randomization. Chemotherapy or other systemic lymphoma therapy within 4 weeks of study entry.
Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
4-12 weeks since completion of combined modality therapy
Last dose of chemotherapy or experimental therapy more than 4 weeks (6 weeks in the case of nitrosourea) prior to enrollment date; unless the last therapy consisted of an oral agent whose average half life is known to be less than 48 hours in which case only 2 weeks need to have elapsed; regardless of the therapy, any toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy must have been resolved
Last radiotherapy treatment 4 weeks prior to starting treatment with this protocol – with the exception of palliative radiotherapy – and there must be sites of measurable disease that did not receive radiation
Cytotoxic chemotherapy: ? the duration of the cycle of the most recent treatment regimen (a minimum of 2 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C).
Biologic therapy (e.g., antibodies): ? 4 weeks.
Has completed any prior radiotherapy ? 4 weeks prior to randomization
Has completed any prior hormonal therapy ? 2 weeks prior to randomization
Patients must have fully recovered from the effects of any prior surgery, chemotherapy or radiation therapy; a minimum time period of 3 weeks should elapse between the completion of radiation therapy for recurrent/metastatic disease and enrollment in the study; a minimum of 4 weeks should elapse between the completion of chemotherapy or any experimental therapy and enrollment in the study; a minimum of 4 weeks should elapse between prior major surgery (such as open biopsy or significant traumatic injury) and enrollment in the study; a minimum of 2 weeks should elapse between prior minor surgical procedures (such as chemotherapy infusion port placement or core visceral organ biopsy) and enrollment in the study
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study; a minimum of 6 weeks treatment break is required in case of nitrosoureas or mitomycin C
Less than (<) 4 weeks since the last anti-tumor therapy prior to Day 1 of study treatment
Patients who have received either immunotherapy within =< 8 weeks; chemotherapy within =< 3 weeks; or radiation therapy to > 30% of marrow-bearing bone within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)
Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks. Limited radiotherapy within the last 2 weeks.
Any prior chemotherapy therapy is allowed in this protocol; no more than 2 prior cytotoxic chemotherapy regimens are allowed for eligibility; non-myelotoxic therapies such as sunitinib and sorafenib or everolimus are not considered \cytotoxic chemotherapies\; patients must be >= 4 weeks from prior radiation or cytotoxic chemotherapy, except >= 6 weeks for mitomycin C and nitrosoureas; >= 2 weeks from hormonal therapy; >= 4 weeks from prior experimental therapy; >= 4 weeks from monoclonal antibody therapy (cetuximab, bevacizumab), >= 2 weeks from sorafenib, sunitinib or temsirolimus and >= 8 weeks from prior 7-hydroxystaurosporine (UCN01) treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LHRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, low dose cytarabine and intrathecal chemotherapy
Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count), 4 weeks for experimental biologic agents (epidermal growth factor receptor [EGFR] inhibitors, etc) and 7 weeks from Gliadel implantation
Patients must have recovered from the toxic effects of prior therapy:\r\n - 4 weeks from any investigational agent\r\n - 4 weeks from prior cytotoxic therapy (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 3 weeks from vincristine)\r\n - 3 weeks for non-cytotoxic or biologic agents e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, tarceva, etc; note a 3-week washout is required for prior treatment with bevacizumab
Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible
Chemotherapy: Must not have received myelosuppressive chemotherapy within 3 weeks prior to study entry (6 weeks if prior nitrosourea)
Immunotherapy, radiotherapy, or chemotherapy ? 2 weeks prior to enrollment. (? 6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and ? 6 weeks from prior antibody therapy).
Antiviral treatment for influenza in 2 weeks prior to randomization
No prior radiotherapy
Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
All previous treatment (including surgery, radiotherapy and systemic anti-neoplastic therapy) must have been completed at least three weeks prior to study entry and any acute toxicities must have resolved
Prior biologic or immunologic therapy =< 4 weeks prior to study entry
Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
Patients who received anti-cancer therapy prior to the first dose of WNT974 within the following time frames:\r\n* Biological therapy with a prolonged half-life (e.g., monoclonal antibodies) within 4 weeks\r\n* Cytotoxic agents associated with delayed hematologic recovery (e.g., nitrosourea or mitomycin-C) within 6 weeks\r\n* Other systemic anti-cancer agents within 3 weeks\r\n* Radiotherapy within 2 weeks
Palliative radiation treatment (e.g., pain control, bony lesions at risk of fracture) completed =< 2 weeks of starting study treatment; patient will be eligible if palliative radiotherapy is completed > 2 weeks from the start of study treatment and has recovered from radiotherapy toxicities
Patient who has received thoracic radiotherapy to lung fields =< 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities; for all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =< 2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities; palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment is allowed
Systemic anticancer treatments (including chemotherapy and biologics) less than 3 weeks prior to T cell therapy; locally directed therapy (e.g. radiation) 2 weeks prior to cell infusion
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks, or palliative radiation < 2 weeks prior to the first day of study treatment, or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia); patients who receive gamma knife radiosurgery for brain metastases are eligible if procedure was performed > 2 weeks before treatment is started, is clinically stable and has been on stable low dose corticosteroid treatment (e.g., dexamethasone 2 mg/day, prednisolone 12 mg/day for at least 14 days before start of study treatment are eligible); ongoing hormonal therapies (luteinizing hormone-releasing hormone [LHRH] antagonists, megestrol) are allowed
Prior cranial radiotherapy
Have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to initiating administration of the study drugs
No methadone within 4 weeks prior to registration
No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration
Prior treatment with thoracic radiotherapy completed > 4 weeks and =< 9 months prior to enrollment
Received external beam radiotherapy within 4 weeks prior to registration
Prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
Due to receive at least 6 weeks (for aim 1 and 2) or 12 weeks (for aim 3) of CTX at enrollment
COHORT A SPECIFIC INCLUSION: At least 12 weeks elapsed since prior radiotherapy
Before starting study treatment, patients must have recovered from toxic effects of prior therapies (except for residual alopecia or grade 2 peripheral neuropathy) and at least 3 weeks must have elapsed since any prior signaling pathway modulators, (e.g., EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., carmustine [BCNU], lomustine [CCNU]); in general, at least 4 weeks must have elapsed from any other anticancer therapy (e.g. bevacizumab)
Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or anti-tumor vaccine).
Radiotherapy less than 3 weeks before the first dose of study treatment. If prior radiotherapy occurred <4 to 6 weeks before study start, as radiated lesions cannot be reliably assessed by fluorodeoxyglucose-positron emission tomography (FDG-PET), nonradiated target lesions are required for eligibility, and prior radiotherapy information must be submitted to the IRC.
Subjects must have the following minimum wash-out from previous treatments and without treatment between documentation of relapse/progression and enrollment:\r\n* >= 2 weeks for local radiation therapy\r\n* >= 8 weeks for low dose (12 Gy or less) total skin electron beam therapy (TSEBT)\r\n* >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 16 weeks\r\n* >= 15 weeks for anti-CD137 or anti-CTLA-4 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= 2 weeks from resolution (i.e., < grade 1 or at baseline) from adverse event (AE)s due to procedures performed or therapeutic agents administered\r\n* >= 2 weeks for retinoids, interferons, vorinostat, romidepsin and denileukin diftitox\r\n* >= 4 weeks for doses of systemic corticosteroidsgreater than 10 mg/day of prednisone or equivalent; patients who are on physiologic doses of corticosteroids (prednisone equivalent 10 mg/day or less) may participate, however, they must be on a stable dose for at least 4 weeks before enrollment; patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least 4 weeks before enrollment; inhaled corticosteroids are acceptable; local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications\r\n* >= 2 weeks for phototherapy\r\n* >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
Patients who have had chemotherapy or targeted small molecule therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study
Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents).
INCLUSION CRITERIA:\n\n          1. Subjects must be ? 18 years old and have a life expectancy ? 12 weeks\n\n          2. Histologically proven, primary (de novo) GB that has recurred or progressed (first or\n             second recurrence, including this recurrence)\n\n          3. Confirmation that archived tissue is available from first diagnosis of GB for\n             biomarker analysis\n\n          4. Recurrent tumor must be supratentorial, contrast-enhancing GB no smaller than 1 cm x 1\n             cm (largest perpendicular dimensions) and no larger than 4 cm maximum in a single\n             direction based on MRI taken within 14 days prior to catheter placement\n\n          5. Karnofsky Performance Score (KPS) ? 70\n\n          6. Subjects must be able and willing to undergo multiple brain MRI examinations\n\n          7. Subjects must be able and willing to comply with all study procedures\n\n          8. Any related toxicities following discontinuation of prior GB therapies must have\n             resolved to CTCAE Grade 1 or lower prior to inclusion in this study\n\n        EXCLUSION CRITERIA:\n\n          1. Prior treatment with cytotoxic chemotherapy\n\n               1. Temozolomide (standard induction and / or maintenance dosing) within the past 4\n                  weeks prior to planned infusion\n\n               2. \Metronomic\ Temozolomide (low-dose, continuous administration) within the past 7\n                  days prior to planned infusion\n\n               3. Nitrosoureas within the past 6 weeks prior to planned infusion\n\n               4. Treatment with any other cytotoxic agent within the past 4 weeks prior to planned\n                  infusion\n\n          2. Prior investigational treatment within the past 4 weeks or prior immunotherapy or\n             antibody therapy within the past 4 weeks prior to planned infusion\n\n          3. Prior treatment with bevacizumab (Avastin) or other vascular-endothelial growth factor\n             (VEGF) inhibitors or VEGF-receptor signaling inhibitors within the past 4 weeks prior\n             to planned infusion\n\n          4. Prior therapy that included interstitial brachytherapy or Gliadel® Wafers (carmustine\n             implants) within the past 12 weeks prior to planned infusion\n\n          5. Prior surgery (including stereotactic radiosurgery and biopsy procedures) within the\n             past 4 weeks prior to planned infusion\n\n          6. Ongoing Optune© therapy within 5 days of planned infusion\n\n          7. Secondary GB (i.e., GB that progressed from low-grade diffuse astrocytoma or AA)\n\n          8. Known mutation in either the isocitrate dehydrogenase 1 (IDH1) or the IDH2 gene.\n\n          9. Tumor in the brainstem (not including fluid-attenuated inversion recovery [FLAIR]\n             changes), an infratentorial tumor, diagnosis of gliomatosis cerebri (highly\n             infiltrative T2 hyperintense tumor with ill-defined margins encompassing at least\n             three lobes of the brain.\n\n         10. Tumor with a mass effect (e.g. 1-2 cm midline shift)\n\n         11. Subjects with tumors for which the preponderance of tissue is not of the type in which\n             convection would be possible (e.g. preponderance of cystic component)\n\n         12. Tumor with geometric features that make them difficult to adequately cover the tumor\n             volume with infusate by using CED catheters\n\n         13. Clinical symptoms that are thought by the Investigator to be caused by uncontrolled\n             increased intracranial pressure, hemorrhage, or edema of the brain\n\n         14. Any condition that precludes the administration of anesthesia\n\n         15. Known to be human immunodeficiency virus positive\n\n         16. Concurrent or a history of any significant medical illnesses that in the\n             Investigator's opinion cannot be adequately controlled with appropriate therapy or\n             would compromise the subject's ability to tolerate the study drug therapy and/or put\n             the subject at additional risk or interfere with the interpretation of the results of\n             this trial\n\n         17. Known history of allergy to gadolinium contrast agents\n\n         18. Presence of another type of malignancy requiring treatment within < 3 years prior to\n             the screening visit, except for adequately treated carcinoma in-situ of the cervix,\n             prostate cancer not actively treated, and basal or squamous cell carcinoma of the skin
Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.
Use of plaquenil must be discontinued two weeks prior to first study treatment
Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
Subject has participated in another clinical study for systemic therapy within 6 weeks of baseline.
Chronic nausea over the past 4 weeks
Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
Prior surgery or radiotherapy (RT) within 2 weeks of study entry
Prior surgery or radiotherapy (RT) within 2 weeks of study entry
Phase II: Patients with MBC who\r\n* Have been diagnosed with leptomeningeal disease in the past eight weeks\r\n* Have diagnosed with progressive brain metastases after initial radiation therapy in the past eight weeks\r\n* Have been diagnosed brain metastases and began whole brain radiation therapy in the past eight weeks\r\n* Have an unplanned hospital admission and be discharged within the past eight weeks\r\n* Have been diagnosed with triple negative breast cancer and started second-line therapy within the past eight weeks\r\n* Have received at least three different therapy regimens within a twelve month period and began the third-line therapy regimen within the past eight weeks\r\n* Have HER2+ disease and started third-line therapy in the past eight weeks; or\r\n* Have estrogen receptor positive (ER+) disease and started third line chemotherapy in the past eight weeks\r\n* Have begun a treatment clinical trial in the past eight weeks
The presence of fatigue for at least 2 weeks
No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry)
Acupuncture treatment in the preceding 4 weeks prior to day 1
Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks
On AI therapy for at least 4 weeks
Patients who have had chemotherapy within three (3) weeks or radiation within four (4) weeks; patients may not receive additional chemotherapeutic agents while on this study
Use of probiotics =< 2 weeks prior to registration
Within the first 3 weeks of initiation of a new type of therapy
No untreated urinary retention within 6 weeks prior to registration
Signs or symptoms of significant infection within 2 weeks prior to Day 1
Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of durvalumab and IPH2201
Treatment with chemotherapy or biologic therapy within 3 weeks, except for hydroxyurea, which must be discontinued prior to treatment on 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:\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
Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
Patients who have been on opioid therapy for the last 4 weeks or more
Initiation of extracorporeal pheresis (ECP) therapy within 4 weeks prior to enrollment
Low-dose IL-2 therapy in the 4 weeks prior
Describe fatigue as being present every day for most of day for a minimum of 2 weeks
Describe fatigue as being present every day for most of the day for a minimum of 2 weeks
Histologically proven stage 0-III invasive carcinoma of the breast\r\n* Patient’s must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study
Initiation of hormone therapy < 4 weeks prior to enrollment in the study
Patients who do not have at least 10 weeks before receiving local control
Initiation of extracorporeal pheresis (ECP) therapy within 4 weeks prior to enrollment
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 muscle relaxant medications such as cyclobenzaprine within four weeks of enrollment and during course of the study, unless the regimen of muscle relaxants is stable for 4 weeks prior to enrollment and does not change for the duration of the study
Use of probiotics =< 2 weeks prior to registration
This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment.
Screening visit 2 must occur within 8 weeks prior to administration of the first dose of Polyphenon E
Regular use of NSAIDs =< 6 weeks prior to randomization, defined as a frequency of 7 consecutive days (1 week) for > 3 weeks (Exception: low dose aspirin [81 mg] for those subjects who are chronic users of aspirin prior to the beginning of the study)
At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy or mitomycin C\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent except bevacizumab/vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 6 weeks from bevacizumab/VEGFR inhibitors
Nitrosoureas: 6 weeks
Other cytotoxic agents: 4 weeks
Anti-angiogenic agents including bevacizumab: 4 weeks
Radiotherapy within 4 weeks or less prior to starting first veledimex dose
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
All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy must be washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion lymphodepletive chemotherapy.
Systemic corticosteroid or other immunosuppressive therapy should be washed out 2 weeks before apheresis and must be completed at least 2 weeks prior to pre-infusion lymphodepletive chemotherapy.
Anti-cancer Agents: Patients who are currently receiving other anticancer agents are not eligible. Patients must have fully recovered from the effects of prior chemotherapy, generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas).
Completed definitive local therapy and have scans, 10?12 weeks after completion of definitive local therapy confirming either Complete Response (CR), Partial Response (PR), or Stable Disease (SD). If salvage neck dissection or salvage laryngectomy is not performed, patients must initiate study treatment within 4 weeks of the screening scans and within 16 weeks after completion of the definitive local therapy. If salvage neck dissection or salvage laryngectomy is performed, patients must initiate study treatment within 4 weeks of screening scans and within 20 weeks after completion of definitive local therapy.
Other cytotoxic agents: 3 weeks
Nitrosoureas: 6 weeks
Cranio-spinal radiation ? 12 weeks NOTE: Subjects in Arm 2 (ie, with DIPG) must be ? 2 weeks and ? 10 weeks after standard focal radiotherapy (dose of 5400 to 5960 cGy and maximum dexamethasone of 1 mg/m2/day)
Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks prior to study day 1 as well as systemic radiation therapy within 28 days prior to study day 1 or focal radiotherapy within 14 days prior to study day 1.
Participants must not have pneumonia or acute bronchitis for at least 2 weeks prior to enrollment
Patient must not have undergone therapy with any VEGF monoclonal antibodies in the last twelve weeks; patient must not be receiving any small molecule anti-VEGF drug within previous 4 weeks
Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
Systemic radioisotope therapy within 24 weeks prior to study enrollment
Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody
Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest)
Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest)
Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES
Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
Patient must not have had myelosuppressive chemotherapy =< 3 weeks prior to entry onto this study (or 6 weeks if prior nitrosourea)
Any major radiotherapy, tumor-directed systemic or immunotherapy within the last 4 weeks for any indication
Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non- central nervous system (CNS) disease with medical monitor approval.
Participants who have had chemotherapy, radiotherapy, biological therapy, immunotherapy or other anticancer agents within 14 days (six weeks for nitrosoureas or mitomycin C) prior to entering the study
Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (? 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration.
Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within 4 weeks prior to the first dose of study treatment
Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.
Subjects may not have received prior radiotherapy to the index lesion within 4 weeks
Subjects agree to be contacted 4-6 weeks after each study visit
Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior
Required imaging studies obtained within four weeks prior to registration
Participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study
In patients who will receive bortezomib for imaging purposes only:\r\n* Total bilirubin < 1.5 x upper limit of normal obtained within 2 weeks prior to registration\r\n* Platelet count >= 70,000/mm^3 obtained within 2 weeks prior to registration\r\n* No pre-existing peripheral neuropathy greater than grade 1
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for bevacizumab) of liver resection
Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL >= 3 weeks before initiation of study treatment
Need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging
Willing to be seen at baseline, 6 weeks, 12 weeks, and 16 weeks for the study time points
Prior chemotherapy within 2 weeks; prior immunotherapy or biologic therapy within 4 weeks; prior radiation therapy within 3 weeks
Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents; <=8 weeks for cell-based therapy or anti-tumor vaccine), or not recovered from the reversible effects of prior anticancer therapy.
Wash-out periods: at least three weeks since the last anticancer therapy, including radiation therapy (RT) in more than 35% of the bone marrow; at least three weeks since the last biological/investigational therapy [excluding monoclonal antibodies (MAbs)]; at least four weeks since the last MAb-containing therapy; and at least six weeks since nitrosoureas and mitomycin C (systemic). In the case of hormonesensitive breast cancer progressing while on hormone therapy, the latter must be either stopped up to one week before or continued without changes during the trial.
The patient has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug.
No chemotherapy within 2 weeks of first dose of SGI-110 (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the exception of hydroxyurea which will be allowed during course 1 of treatment.
Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agent; <=8 weeks for cell-based therapy or anti-tumor vaccine).
Radiotherapy less than 3 weeks before the first dose of study treatment.
Last dose of anti-CD20 antibody therapy must have been >4 weeks before the first dose of XmAb13676
At least 4 weeks since any previous treatment for cancer
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
Leukapheresis ? 2 weeks prior to starting CC-90009.
Systemic anticancer treatment including investigational agents or radiotherapy <2 weeks before the first dose of study treatment (<4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or antitumor vaccine) or have not recovered from acute toxic effects from prior chemotherapy and radiotherapy.
Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment
Complete initial work up earlier than 12 weeks prior to subject registration
Radiotherapy to the bone marrow within 6 weeks prior to enrollment OR within3 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 60% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received.
Glioma patients must have completed chemoradiotherapy at least 12 weeks prior to screening and their baseline scan
Patients who have received prior systemic anticancer therapy ? 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)