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+Patients must have normal organ and marrow function independent of transfusion for at least 7 days prior to screening and independent of growth factor support for at least 14 days prior to screening
+Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment\r\n* Myelosuppressive chemotherapy: patients must have completely recovered from all acute toxic effects of chemotherapy, immunotherapy or radiotherapy prior to study enrollment; at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of hydroxyurea\r\n** Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of protocol therapy\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor; 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* 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:\r\n** At least 30 days after 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:\r\n** >= 2 weeks must have elapsed since local palliative external radiation therapy (XRT) (small port)\r\n** >= 6 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\r\n** >= 4 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 >= 3 months must have elapsed since transplant
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity (e.g. doxorubicin), biologic therapy, or immunotherapy within 21 days prior to enrollment and/or daily or weekly chemotherapy (e.g. sunitinib, sorafenib and pazopanib) without the potential for delayed toxicity within 14 days prior to enrollment
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): At least 7 days after the last dose of agent\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* External beam radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after total body irradiation (TBI), craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation.\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Stem cell infusion (with or without TBI):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 100 days after infusion, no evidence of graft versus host disease (GVHD) and no requirement for immunosuppression\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Patients must not have received prior exposure to nivolumab; for patients enrolled in parts C, D and E, patients must not have received prior nivolumab or ipilimumab
+Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration\r\n* Transmural myocardial infarction within the last 6 months prior to study entry\r\n* Unstable ventricular arrhythmia within the last 6 months prior to study entry\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\r\n* Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry\r\n* Bleeding within 28 days prior to study entry due to any cause, requiring transfusion\r\n* Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted\r\n* Known bleeding or clotting disorder\r\n* Uncontrolled psychotic disorder
+Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
+Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
+Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
+Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
+X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid \r\n* Hematopoietic growth factors: >= 14 days must have elapsed since the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed since the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed after infusion, and no evidence of graft-versus-host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed after completion\r\n* Cellular therapy: >= 42 days must have elapsed since the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X ray (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days must have elapsed since systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY2606368
+Protocol treatment is to begin within 2 calendar days of patient randomization.
+Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of study medication (napabucasin or FOLFIRI) within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of study medication. Standard dose of bevacizumab (5 mg/kg) may be administered prior to FOLFIRI infusion, per Investigator decision, for as long as permanent decision to include or exclude bevacizumab is made prior to patient randomization. Radiotherapy, immunotherapy (including immunotherapy administered for non-malignant diseaseneoplastic treatment purposes), or investigational agents within four weeks of first planned dose of study medication, with the exception of a single dose of radiation up to 8 Gy (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
+The subject received any investigational treatment within the past 30 days or prior immunotherapy or antibody therapy within the past 45 days.
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable
+Patients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to randomization
+Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomization
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* External beam radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to selinexor
+At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
+At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair
+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; the duration of this interval must be discussed with the study chair
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; at least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea); the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-metaiodobenzylguanidine [MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to pevonedistat; patients with prior exposure to irinotecan or temozolomide are eligible
+Subjects who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
+Serum creatinine level =< IULN within 28 days prior to registration
+Within 28 days prior to registration: ANC >= 1,000/mcL
+Within 28 days prior to registration: Serum creatinine =< 2.0 x IULN
+ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between registration and randomization needs to be observed, as long as:\r\n* Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date\r\n* Randomization occurs no more than 24 weeks from surgery date
+STEP I: Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 28 days after stopping lenalidomide; male subjects must also agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from lenalidomide; male subjects must be willing to use condoms for 90 days after discontinuation of carfilzomib
+Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registration
+Absolute neutrophil count (ANC) of >= 1,500/mL within 21 days prior to registration; patients must not have had a blood transfusion within 28 days prior to registration
+Platelet count >= 100,000/ mL within 21 days prior to registration; patients must not have had a blood transfusion within 28 days prior to registration
+Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values
+Patients must have lactate dehydrogenase (LDH) obtained within 28 days prior to registration in order to obtain baseline stratification information
+Patients must have dermatology exam obtained within 28 days prior to registration to obtain baseline measurement; exam to be performed by treating physician or designated dermatologist
+No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment
+No treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registration
+Serum creatinine =< 2.0 x IULN within 28 days prior to registration
+None of the following conditions:\r\n* Grade 3 or greater infection, or infection requiring intravenous systemic treatment within 28 days prior to registration; patients should be off antibiotics at the time of registration.\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days prior to registration\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days prior to registration\r\n* History of surgery as follows:\r\n** Major surgery (as an example, surgery requiring anesthesia and a > 24 hour hospital stay) within 3 months prior to registration, with wound healing at least 28 days prior to registration\r\n** Minor surgery within 28 days prior to registration with complete wound healing at least 10 days prior to registration\r\n** Minor procedures within 7 days prior to registration such as thoracentesis, paracentesis, or 18 g or smaller needle biopsy of tumor\r\n** Patients with clinically relevant ongoing complications from prior surgery are not eligible
+No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration
+Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing (packed red blood cells and platelet transfusions are acceptable)
+Use of finasteride within 30 days prior to registration
+Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
+Within less than or equal to 14 days prior to registration: Glycosylated hemoglobin (HbA1c) < 7.0%
+For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registration
+Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert’s syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
+Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration
+Signs or symptoms of infection within 14 days prior to randomization
+Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with 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
+Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy
+Prior therapy\r\n* Patients =< 30 days from the last dose of cytarabine used for treatment of TMD
+No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria
+Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy.
+Patients must have lactate dehydrogenase (LDH) performed within 28 days prior to registration
+Bilirubin =< 1.5 times normal 14 days prior to study entry
+Blood cell count (CBC)/differential obtained within 60 days prior to registration on study
+Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration; (CIS disease is not expected to have been completely excised)
+All patients with T1 urothelial carcinoma must undergo re-transurethral resection of bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT; tissue from the re-resection must be submitted; the TURBT that identified the recurrent T1 disease may have taken place more than 60 days prior to registration
+Patients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registration
+Bone scan as clinically indicated within 90 days prior to registration
+Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
+Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
+Prestudy history and physical must be obtained within 90 days prior to registration; patients must have a complete blood count (CBC) and basic metabolic panel including creatinine, potassium, chloride, blood urea nitrogen (BUN), carbon dioxide (CO2) and glucose within 28 days prior to registration
+Patient must be registered to step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy
+No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible
+Patients must have total bilirubin =< 2.0 x IULN within 14 days prior to registration
+Patients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registration
+Total bilirubin =< 2.0 x IULN within 14 days prior to registration
+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
+Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131iodine [I]-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to olaparib, veliparib, niraparib, rucaparib, talazoparib or other poly adenosine diphosphate ribose polymerase inhibitors (PARPi)
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to JNJ-42756493 (erdafitinib) or another FGFR inhibitor such as (but not limited to) AZD4547, BGJ398, BAY1163877, LY2874455
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total-body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to a BRAF inhibitor (e.g. vemurafenib, dabrafenib or encorafenib)
+No previous chemotherapy within 16 days prior to enrollment except for bleomycin which cannot have been given within 5 days prior to enrollment
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >=14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\t\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor leukocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation; Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to other NTRK inhibitors including but not limited to LOXO-101 (larotrectinib), entrectinib (RXDX-101), DS6051, PLX7486
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to LY3023414\r\n* Patients must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor)
+CYP3A isoenzymes within 7 days of randomization.
+Thrombolytic use within 10 days prior to first day of study therapy
+Patients with whole blood transfusion in the last 120 days prior to entry to the study
+Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
+Within 21 days of treatment initiation:\r\nPlatelets >= 100,000/mcL
+Within 21 days of treatment initiation:\r\nHemoglobin >= 9 g/dL or >= 5.6 mmol/L
+Patients must have a peripheral blast count < 25,000/uL within 2 days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown)
+Patients must have bilirubin =< 2 x IULN within 7 days prior to registration (unless the bilirubin is primarily unconjugated)
+Participants must have a CD4 count performed within 30 days of enrollment
+Patients who have had a transfusion within 7 days of screening are NOT eligible for participation
+At the time of registration: patients must have recovered from the toxic effects of prior therapy: >= 28 days from any investigational agent, >= 28 days from prior cytotoxic therapy, >= 14 days from vincristine, >= 42 days from nitrosoureas, >= 21 days from procarbazine administration, and >= 7 days 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
+Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* They have recovered from the effects of surgery\r\n* A minimum of 28 days have elapsed from the day of surgery to the day of registration step 2; for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration step 2\r\n* Residual disease following resection of recurrent ependymoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to consent; if the \within 96-hour after surgery\ scan is more than 14 days before consent, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and consent, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days
+Patients must be enrolled before treatment begins; the date protocol therapy is to start must be no later than 42 days from the time of recurrence and within 7 days from enrollment
+A MRI of the spine is required within 10 days prior to or at least 10 days after surgery
+Serum HCGbeta and AFP levels must be assessed within 7 days prior to registration
+Patient must have lumbar CSF for cytology, protein, AFP and HCGbeta within 7 days prior to registration
+Subjects must be =< 90 days from diagnosis of PCNSL in the brain or spine; time from pathologic diagnosis to initiation of treatment should be specified; subjects with history of only ocular lymphoma are eligible if < 90 days since documented brain parenchymal disease (by imaging or by biopsy)
+4. Receipt of G-CSF, GM-CSF or erythropoietin within 28 days prior to study entry or receiving TAB001;
+PRIOR TO STUDY ENROLLMENT
+Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea
+* Platelets >= 100 x 10^9 cells/ L (unsupported, defined as no platelet transfusion within 7 days)
+Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose.
+Are not using steroids for at least 7 days prior to trial treatment
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
+Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757 Exceptions: Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade .1 Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
+Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection in the 30 days before screening.
+No craniotomy within 21 days of registration
+Any prior intra-lesional MCC therapy within 180 days from day 1 of study treatment
+ESA use of less than 28 days and no ESA within the 12 weeks prior to randomization
+Dexamethasone: 7 days
+Thalidomide: 7 days
+Lenalidomide: 7 days
+Pamolidomide: 7 days
+Bortezomib: 7 days
+Carfilzomib: 7 days
+G-CSF: 14 days
+GM-CSF or Neulasta®: 21 days
+Erythropoietin or erythrocyte stimulating agents: 30 days
+Eltrombopag, romiplostim or platelet stimulating agents: 30 days
+Carmustine (BCNU): 42 days/6 weeks
+Treatment within 30 days prior to enrollment/randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
+Registration must be completed =< 28 days of pre-registration
+Palliative radiotherapy within 14 days before initiation of study treatment
+At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair
+At least 7 days must have passed after the last treatment with a biologic agent; for agents that have known adverse events occurring beyond 7 days from administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
+Within 14 days of treatment initiation:\r\nPlatelets >= 100,000/mcL
+Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
+Hematopoietic growth factors: patients must be at least 7 days since the completion of therapy with a growth factor prior to registration
+Biologic (anti-neoplastic agent): patients must be at least 7 days since the completion of therapy prior to registration
+Patients must demonstrate adequate organ function as defined below; all screening labs to be obtained =< 14 days prior to registration; (Note: screening labs will be repeated again on cycle 1 day 1 [C1D1] if they were performed outside of the =< 4 day window)
+COHORT 2: AST (SGOT) and ALT (SGPT) =< 3 X ULN within 14 days of treatment initiation
+Potassium >= 3.5 mmol/L (within institutional normal range, or correctable with supplements), within 14 days of registration
+Glycated hemoglobin (HbA1c) < 6.4%, within 14 days of registration
+Resolution or stabilization of clinically significant adverse events from prior therapy (completed at least 14 days prior to first dose of talimogene laherparepvec [TVEC])
+Average transfusion requirement of ? 2 units per 28 days of packed RBCs confirmed for a minimum of 112 days immediately preceding Cycle 1 Day 1.
+No consecutive 56 days that was RBC transfusion-free during the 112 days immediately preceding Cycle 1 Day 1.
+Prior cytotoxic chemotherapy within 21 days from the initiation of HCT conditioning. Note, certain low intensity treatments not intended to induce remission but rather stabilize disease are acceptable up to 7 days prior to initiation of HCT conditioning
+Radiotherapy within 14 days before randomization; seven days may be considered if to single area
+Patients with bone marrow metastatic disease who do not meet the above criteria will be eligible to enroll in the study with the following count criteria; these patients will not be evaluable for hematologic toxicity or hematologic dose limiting toxicity (DLT)\r\n* ANC > 750/uL within 7 days prior to first dose of abemaciclib\r\n* Platelet count > 50,000/uL (may receive platelet transfusions) within 7 days prior to first dose of abemaciclib\r\n* Hemoglobin >= 7.5 g/dL (may receive red blood cells [RBC] transfusions) within 7 days prior to first dose of abemaciclib
+Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration; for biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration
+Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
+Whole blood transfusion in the last 120 days prior to entry to the study
+Have initiated treatment with bisphosphonates less than 30 days prior to study registration; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to study registration
+Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor; for agents that have known histologic verification of malignancy at original diagnosis or relapse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
+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; the duration of this interval must be discussed with the study chair
+Radiotherapy within 14 days before enrollment
+Any major surgery, chemotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed >= 2 weeks); concurrent hydroxyurea is allowed if less than or equal to 2 grams daily and on stable dose for >= 14 days prior to study entry
+Patient has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 28 days or limited field radiation for palliation =< 14 days prior to starting trial medications or has not recovered from side effects of such therapy
+Patients who have had radiotherapy within 14 days before registration are not eligible; NOTE: if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Protocol treatment plan must include beginning therapy within 5 consecutive days after registration
+Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
+The following laboratory values obtained =< 21 days prior to registration; complete blood count (CBC), sodium, potassium, aspartate aminotransferase (AST), bilirubin and creatinine are to be obtained pre-study; Note: treatment initiation and dosing modification should be performed at the individual investigators discretion and be consistent with the product label and their medical practice
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to study day 1, or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to study day 1
+Radiotherapy within 28 days prior to baseline.
+Clinical MRIs performed at baseline must be completed within 28 days before the first dose of cabozantinib
+No prior lapatinib within 7 days prior to initiation of protocol treatment
+Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin), but must have been discontinued at least 30 days prior to the study enrollment; vaginal preparations (e.g., Vagifem or Estring) are allowed
+Patients may not have had any prior systemic therapy =< 21 days prior to registration for treatment of ovarian cancer
+Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
+PIK3CA MUTANT COHORT (closed 03/17/2016): In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
+PIK3CA WILD TYPE COHORT (closed 03/17/2016): In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
+Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor; at least 14 days from the last administration of PEG-ylated GCSF (Neulasta)
+At least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these patients must be discussed with the Study Chair or Co-Chair on a case-by-case basis including any patient on a drug with a half-life of > 48 hours
+Platelets (PLT) >= 100,000 obtained =< 14 days prior to registration
+Serum phosphorus >= lower limit of normal (LLN) within 7 days before the first dose of cabozantinib
+Calcium >= LLN within 7 days before the first dose of cabozantinib
+Magnesium >= LLN within 7 days before the first dose of cabozantinib
+Potassium >= LLN within 7 days before the first dose of cabozantinib
+Hematologic: Platelets ?100 x 10(9)/L; ANC ?1.5 x 10(9)/L (without platelet transfusion or growth factors within the 7 days prior to the screening laboratory assessment)
+Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C)
+Within 10 (except as noted) days of planned treatment initiation: Lactate dehydrogenase (LDH) =< 1.5 x institutional ULN (may be within 28 days)
+Previous radiotherapy within 7 days of Cycle 1 Day 1.
+Absolute neutrophil count >= 1.5 x 10^9/L within 28 days of treatment initiation and must be independent of hematopoietic growth factor support
+Platelets >= 100 x 10^9/L within 28 days of treatment initiation and must be independent of hematopoietic growth factor support
+A serum TSH and AM cortisol must be obtained within 28 days prior to randomization to obtain a baseline value.
+Obtained within 14 days prior to C1D1: Neutrophils >= 1500/uL
+Obtained within 14 days prior to C1D1: HBV viral load negative
+Obtained within 14 days prior to C1D1: HCV NA analysis negative
+Acceptable hematologic status (growth factors cannot be used within the previous 7 days), as specified below:
+Completion of ASCT within 100 days prior to Day 1 of Cycle1.
+Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days before the first dose of the IMP. Hormonal therapy may be administered up to 7 days prior to the first dose of the IMP.
+Clinically significant surgical intervention within 21 days of the first dose of the IMP or with ongoing post-operative complications if more than 21 days.
+Radiotherapy administered less than 21 days prior to the first dose of the IMP, or localized palliative radiotherapy administered less than 7 days prior to the first dose of the IMP, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 4.03.
+Platelet transfusions are acceptable prior to treatment to achieve the above numbers, however growth factors are not allowed within 14 days of registration
+Subjects who are able and willing to give written informed consent\n\n          -  Documented primary or secondary AML, as defined by the WHO criteria (2008), by\n             histopathology refractory to previous induction chemotherapy and/or relapsed after\n             achieving remission with a prior chemotherapy and who are not candidates for other\n             available therapy likely to confer clinical benefit.\n\n          -  For Phase 2a only: in addition to inclusion criteria 2 above, patients must have a\n             FLT3 mutation of any type\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\n          -  In the absence of rapidly progressing disease, the interval from prior treatment to\n             time of FF-10101-01 administration should be at least 14 days for cytotoxic agents\n             other than hydroxyurea, at least 5 half-lives for non-cytotoxic agents, and 14 days\n             for monoclonal antibody therapies. Hydroxyurea may be continued for a maximum of 14\n             days from the start of FF-10101-01 dosing, through Cycle 1 Day 14, with a maximal dose\n             of 5 grams/day\n\n          -  Persistent chronic clinically significant toxicities from prior chemotherapy or\n             surgery must be ?Grade 2\n\n          -  If subject has had a hematopoietic stem cell transplant, subject must be ?60 days\n             post-transplant with no clinically significant GVHD requiring systemic therapy\n\n          -  Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ?3 times the\n             upper limit of normal and total bilirubin of ?1.5x the upper limit of normal. If total\n             bilirubin is equal to or exceeds 1.5x the upper limit of normal, the subject can still\n             be included if direct bilirubin is ?1.5x the upper limit of normal\n\n          -  Calculated creatinine clearance of ?60 mL/min\n\n          -  Female subjects of childbearing potential and sexually mature male subjects must agree\n             to use a medically accepted method of contraception other than an oral contraceptive\n             for the duration of the study.\n\n        Exclusion Criteria:\n\n          -  Subjects diagnosed with acute promyelocytic leukemia\n\n          -  Subjects with Bcr-Abl positive leukemia (chronic myelogenous leukemia in blast crisis)\n\n          -  Subjects with clinically active CNS leukemia\n\n          -  Subjects with major surgery within 28 days prior to the first administration of\n             FF-10101-01\n\n          -  Subjects with radiation therapy within 28 days prior to the first administration of\n             FF-10101-01\n\n          -  Subjects with active malignant disease requiring therapy other than AML or\n             myelodysplastic syndrome with transformation into AML\n\n          -  Subjects with an active uncontrolled infection\n\n          -  Subjects with a medical condition, serious intercurrent illness, or other circumstance\n             that, in the Investigator's judgment, could jeopardize the subject's safety as a study\n             subject, or that could interfere with the study objectives\n\n          -  Subjects known to have human immunodeficiency virus infection, or who have active\n             hepatitis B or C infection as determined by serological testing\n\n          -  Subjects with congestive heart failure, New York Heart Association (NYHA) Class 3 or\n             4, or subjects with a past history of congestive heart failure NYHA Class 3 or 4 and\n             in whom echocardiogram or multiple gate acquisition (MUGA) scan performed within 3\n             months prior to screening or at screening showed a LVEF <40%\n\n          -  Female subjects who are pregnant or breast feeding\n\n          -  Subjects on 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or\n             other drugs known to have muscle toxicity\n\n          -  Subjects taking strong inhibitors of CYP3A4 will be excluded from the study unless\n             therapeutic substitution is possible\n\n          -  Subjects taking strong inducers of CYP3A4 will be excluded from the study unless\n             therapeutic substitution is possible\n\n          -  Use of systemic immunosuppressive agents within 14 days prior to first dose of\n             FF-10101\n\n          -  Subjects taking drugs known to cause Torsades de Pointes will be excluded from the\n             study unless therapeutic substitution is possible\n\n          -  Subjects known to have long QT syndrome\n\n          -  Subjects with mean QTcF values following 3 ECGs conducted 5 minutes apart of >470 msec
+Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to the NK cell infusion (excluding preparative regimen pre-meds)
+Male patients must agree to use a condom during treatment and for 90 days after dosing and must agree not to donate sperm for 90 days after dosing
+Serum potassium >= 3.5 mmol/L performed within 30 days prior to the date of registration (if < 3.5, can be repleted and reassess for eligibility as long as stable off potassium supplementation for > 48 hours [hrs])
+Baseline tumor measurements must be documented from tests within 28 days of study entry; other non-laboratory tests must be performed within 28 days of study entry
+Obtained within 14 days prior to registration: Potassium > 3.5 mmol/L (within institutional normal range)
+Absolute neutrophil count >= 1,500/microliters, completed within 14 days prior to the date of registration
+Platelets >= 100,000/microliters, completed within 14 days prior to the date of registration
+Creatinine =< 1.5 X institutional ULN, completed within 14 days prior to the date of registration OR
+Recent (within 30 days before enrollment) or concurrent yellow fever vaccination
+Radiation oncology consultation within 28 days to confirm that disease can be encompassed in the radiotherapy field and that normal tissue constraints can be met
+Fever within 3 days prior to study enrollment.
+Patients must have discontinued all biologic therapy at least 21 days before participation
+are not using steroids for at least 7 days prior to study registration. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
+At least 7 days must have elapsed since the completion of therapy with a growth factor that supports platelet or white cell number or function. At least 14 days must have elapsed after receiving peg-filgrastim.
+At least 7 days must have elapsed since the completion of therapy with a biologic agent. For biologic agents that have known adverse events occurring beyond 7 days after administration, the period prior to enrollment must be extended beyond the time during which adverse events are known to occur.
+At least 21 days must have elapsed since the completion of the last dose of VEGF-Trap, and at least 7 days since a VEGF blocking tyrosine kinase inhibitor. Subjects must have recovered from any VEGF blocking drug-related toxicity (e.g., proteinuria).
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular Therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation Therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\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 (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n* Patients must not have received prior exposure to ramucirumab
+Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine
+Treatment must be scheduled to commence within 14 working days after registration and may not begin prior to registration.
+Absolute neutrophil count >= 1000/ mm^3 (unsupported) and documented within 14 days prior to registration and within 14 days prior to the start of treatment
+Platelets >= 100,000/ mm^3 (unsupported) and documented within 14 days prior to registration and within 14 days prior to the start of treatment
+Albumin >= 2 g/dL and documented within 14 days prior to registration and within 14 days prior to the start of treatment
+Lab values must also be verified, meeting eligibility criteria, within 14 days prior to starting treatment. If treatment is planned > 14 days after lab values were obtained for registration, labs must be repeated
+Biologic agent: patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n* For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration
+Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration; for bevacizumab, patients must have received last dose >= 32 days prior to study registration
+Documented within 14 days of registration: Sodium: >= 130 and =< 145 mmol/L
+Documented within 14 days of registration: Potassium: 3.4- 4.8 mmol/L
+Documented within 14 days of registration: Calcium: >= 7 mg/dL
+Documented within 14 days of registration: Magnesium: >= 0.7 mmol/L
+Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.
+Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization.
+Treatment with an experimental therapy within the last 28 days
+Randomization within 28 days of diagnosis of last progression
+Obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug: Platelets (PLT) >= 75,000/uL; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
+Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
+Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study.
+Have poorly controlled hypertension defined as blood pressure >160/90 on at least 2 repeated determinations on separate days within 2 weeks (14 days) prior to initiation of screening
+Patients with history of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) within 28 days prior to registration
+Cytotoxic therapy within 21 days prior to cycle 1 day (D) 1
+?28 days for prior monoclonal antibody used for anticancer therapy with the exception of denosumab.
+Inclusion Criteria:\n\n        Subjects must meet all of the following applicable inclusion criteria to participate in\n        this study:\n\n          -  Male or female ? 18 years of age at time of consent. NOTE: Both pre- and\n             post-menopausal women are eligible. Pre-menopausal status is defined as either:\n\n               -  Last menstrual period within the last 12 months.\n\n               -  In case of therapy-induced amenorrhea, plasma estradiol and /or FSH is in the\n                  premenopausal range per local normal range.\n\n          -  Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to\n             curative therapy. NOTE: Although not required as a protocol procedure, a patient with\n             a new metastatic lesion should be considered for biopsy whenever possible to reassess\n             ER/PR/HER2 status if clinically indicated. If a biopsy is prospectively done as part\n             of standard of care, the study would like to store samples for correlative research.\n\n          -  Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR\n             positive (ER >1%, PR >1%), HER2 negative breast cancer. NOTE: Subject has\n             HER2-negative breast cancer (based on most recently analyzed biopsy) is defined as a\n             negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a\n             negative in situ hybridization (e.g. FISH, CISH, SISH, DISH, etc.) test is required by\n             local laboratory testing.\n\n          -  Metastatic disease evaluable on imaging studies. Subjects may have measurable disease\n             as per RECIST 1.1 or bone-only disease. NOTE: Bone-only subjects are eligible if their\n             disease can be documented/ evaluated by bone scans, CT or MRI. Their disease will be\n             assessed using MDA criteria. NOTE: Previously irradiated lesions are eligible as a\n             target lesion only if there is documented progression of the lesion after irradiation.\n\n          -  No prior systemic anti-cancer therapy for advanced HR+ disease. NOTE: Subjects\n             receiving adjuvant treatment with aromatase inhibitors at time of recurrence are\n             allowed to participate. There is no AI washout period required.\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n\n          -  Provided written informed consent and Health Insurance Portability and Accountability\n             Act of 1996 (HIPAA) authorization for release of personal health information, approved\n             by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). NOTE: HIPAA\n             authorization may be included in the informed consent or obtained separately.\n\n          -  Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A\n             negative serum or urine pregnancy test is required within 72 hours of study\n             registration from women of childbearing potential. If the urine test cannot be\n             confirmed as negative, a serum pregnancy test will be required.\n\n          -  Women of childbearing potential (WOCP) must be willing to use two effective methods of\n             birth control such as use of a double barrier method (condoms, sponge, diaphragm, or\n             vaginal ring with spermicidal jellies or cream), or total abstinence for the course of\n             the study until 120 days after the last dose of study drug. The use of hormonal\n             contraceptives is discouraged. NOTE: Women are considered to be of childbearing\n             potential unless they are postmenopausal for at least 12 consecutive months or\n             surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or\n             hysterectomy).\n\n          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory\n             tests, and other study procedures.\n\n          -  Male subjects capable of fathering a child must agree to use adequate contraception or\n             total abstinence for the course of the study until 120 days after the last dose of the\n             study drug.\n\n        NOTE: Male subjects will be considered as capable of fathering a child unless they have\n        azoospermia (whether due to having had a vasectomy or due to an underlying medical\n        condition).\n\n          -  Co-enrollment in an imaging biomarker study or other non-therapeutic study is allowed.\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the criteria below may not participate in the study:\n\n          -  Prior treatment with any CDK 4/6 inhibitor.\n\n          -  Confirmed diagnosis of HER2 positive disease.\n\n          -  Known uncontrolled or symptomatic CNS metastases. Subjects with known brain metastasis\n             will only be eligible after their tumors have been treated with definitive resection\n             and /or radiotherapy and they are neurologically stable for at least 1 month off\n             steroids.\n\n          -  Advanced, symptomatic, visceral spread with a life expectancy less than 4 months.\n\n          -  Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.\n\n          -  Prior history of blood clots, pulmonary embolism or deep vein thrombosis.\n\n          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly\n             alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled\n             nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n\n          -  Concurrent malignancy or malignancy within 3 years of randomization, with the\n             exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma,\n             non-melanomatous skin cancer or curatively resected cervical cancer.\n\n          -  Any other concurrent severe and/or uncontrolled medical condition that would, in the\n             investigator's judgment, contraindicate subject participation in the clinical study.\n\n          -  Currently receiving any of the following substances and cannot be discontinued 7 days\n             prior to study registration:\n\n               -  Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit\n                  hybrids, pomelos, star-fruit, and Seville oranges.\n\n               -  Medications that have a narrow therapeutic window and are predominantly\n                  metabolized through CYP3A4/5.\n\n               -  Known strong inducers or inhibitors of CYP2D6.\n\n          -  Major surgery within 14 days prior to study registration or has not recovered from\n             major side effects of surgery.\n\n          -  Known history of human immunodeficiency virus [(HIV) HIV 1/2 antibodies].\n\n          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n             [qualitative] is detected) (testing not mandatory)\n\n          -  Any clinically significant infection defined as any acute viral, bacterial, or fungal\n             infection that requires specific treatment. NOTE: Anti-infective treatment must be\n             completed ? 7 days prior to study registration.\n\n          -  Known allergy to palbociclib or any of its excipients\n\n          -  Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study\n             registration. NOTE: if fracture is at a metastatic site, is chronic, and no surgical\n             treatment is planned, the subject can be enrolled.\n\n          -  Any condition that, in the opinion of the investigator, might jeopardize the safety of\n             the subject or interfere with protocol compliance.\n\n          -  Any mental or medical condition that prevents the subject from giving informed consent\n             or participating in the trial.\n\n          -  Treatment with any therapeutic investigational agent within 28 days prior to\n             registration for protocol therapy. The subject must have recovered from the acute\n             toxic effects of the regimen.
+Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy, Note:\r\n* Post-chemotherapy restaging imaging must be completed no earlier than 56 days prior to Step 1 registration\r\n• For patients with limited-stage small cell lung cancer who receive thoracic radiotherapy concomitant with chemotherapy, patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy\r\n• For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted; if consolidative thoracic radiotherapy is performed prior to study registration, then patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor.
+Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with 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. The duration of this interval must be discussed with the Study Chair.
+Major hemorrhagic event within 28 days
+Radiotherapy within 14 days before enrollment; if the involved field is limited to a single site, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Radiotherapy or chemotherapy within the 14 days prior to the first dose of BGB324 being administered (other than hydroxyurea)
+Without transfusion and growth factors within 7 days
+In addition to the pathologic diagnosis, at least ONE of the following cytopenias must be present:\r\n* Hemoglobin < 11 g/dL within 14 days of registration; this includes patients with transfusion dependency\r\n** NOTE: transfusion dependency at screening is defined for this protocol as 1-8 disease-related units red blood cells (RBC) transfused in the previous 8 weeks; patients receiving more than 8 disease-related units of RBCs within 8 weeks of registration are excluded\r\n* Platelet count must be ? 20,000/mm^3 and < 100,000/mm^3 within 14 days of registration\r\n* Absolute neutrophil count (ANC) < 1000/mm^3 within 14 days of registration
+Prior chemotherapy, other investigational agents, or radiation must be discontinued for at least 28 days prior to the first administration of COTI-2. Hormone treatments must be discontinued for at least 28 days prior to the first administration of COTI-2.
+Patients must be at least 28 days past their last course of lymphoma or CLL treatment, at least 84 days past their last course of rituximab treatment. Patients with pre-existing severe or life threatening side effects/conditions from prior therapy or due to other diseases may not be enrolled
+obinutuzumab (terminal half-life in NHL = 36.8 days); required washout = 184 days (26 weeks)
+ofatumumab (terminal half-life in CLL = 17.6 days); required washout = 88 days (13 weeks)
+ibritumomab tiuxetan (biologic half-life in NHL = 1.9 days [based upon measurement of radioactivity from administered [111In]-ibritumomab tiuxetan]; required washout = 10 days (1.5 weeks)
+Patients must not have received any vaccines for 28 days prior to administration of their first dose of MT-3724 and should not receive any vaccine during the study or within 28 days after their last dose of MT-3724.
+Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment
+Histological confirmation of follicular lymphoma grades I, II diagnosed within 12 months (365 days) prior to registration; NOTE: the day of biopsy should be used as day 1 of diagnosis for this calculation
+Radiotherapy within 14 days before randomization.
+Male patients must agree to use a condom during treatment and for 90 days after dosing and must agree not to donate sperm for 90 days after dosing
+Radiotherapy within 14 days before enrollment; radiotherapy is excluded during induction and consolidation 1 while receiving MLN 9708
+Active infection requiring IV anti-infective usage within the last 7 days prior to study treatment.
+Any major surgeries within 28 days.
+The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin
+Patients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals during the days of reolysin treatment and for two days after
+Inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife system
+Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ?28 days or limited field radiation for palliation ?7 days prior to starting study drug or has not recovered from side effects of such therapy.
+Evidence of hemoptysis within the last 7 days.
+COHORT B ONLY: Obtained =< 14 days prior to registration: N-terminal pro b-type natriuretic peptide (NT-ProBNP) < 7500 ng/dL
+Radiotherapy =< 14 days prior to registration; NOTE: if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Radiotherapy =< 14 days prior to enrollment; patients must have recovered from all radiotherapy-related toxicities
+Subjects should not have packed red blood cells (PRBC) or platelet transfusion within 14 days of the screening
+COHORT B, GROUP 7: GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be < 1.5 x institutional ULN (IULN); stability is defined as the second measurement being no more than one point higher than the first
+Patients may not have fever (38.5*C) within 7 days of enrollment
+Must have QTc < 460 msec for patients receiving drugs that have a risk of inducing Torsades de Pointes within 7 days prior to registration for protocol therapy
+Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Platelets >= 75,000 / uL.
+Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Albumin > 2.5 mg/dL.
+TREATMENT WITH SJCAR19: Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion
+Patients who have had a whole blood transfusion within 120 days prior to enrollment. (Packed red blood cells and platelet transfusions are acceptable)
+Patients must have discontinued enzalutamide at least 28 days prior to enrollment.
+Patients with microscopic hematuria (defined as > 100 red blood cells [RBCs] on urinalysis) or worsening urinary symptoms within 7 days prior to the initiation of study treatment.
+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
+At least 42 days must have elapsed since chimeric antigen receptor (CAR)-T cell therapy
+Radiotherapy ? 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of study drugs
+Use of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide ? 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped ? 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis\r\n* Daratumumab or any other anti-CD38 monoclonal antibody therapy within 30 days of leukapheresis
+Patients with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to enrollment, except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the patient is otherwise suitable for enrollment
+Platelets < 75,000 cell/mm^3 (75 x 10^9/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours prior to study drug administration
+Willing to be smoke-free for 7 days
+Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ? 14 days prior to C1D1);
+In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.
+Patients on dialysis within 7 days of enrollment.
+Obtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULN
+Obtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULN
+Recovery from the toxic effects of prior therapy, with a minimum time of: \r\n* >= 28 days elapsed from the administration of any investigational agent\r\n* >= 28 days elapsed from the administration of any prior cytotoxic agents, except\r\n* >= 14 days from vincristine, >= 21 days from procarbazine, and >= 42 days from nitrosureas\r\n• >= 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid) \r\nInvestigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly.
+Anticancer treatment within designated period before enrollment including\r\n* Minor surgical procedure (such as biliary stenting) within 14 days\r\n* Major surgical procedure or radiation treatment within 28 days\r\n* Chemotherapy or experimental drug treatment with published half-life known to be 72 hours within 14 days\r\n* Experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days\r\n* Radiotherapy for measurable lesions delivered in a normal organ-sparing technique within 21 days (except for palliative radiotherapy)
+Obtained within 28 days prior to registration: Platelets >= 100 x 10^9/L
+Treated with at least one line of chemotherapy in the palliative setting or with neoadjuvant or adjuvant chemotherapy within the prior six months; the allowable window between treatments is 21 days for chemotherapy or a tyrosine kinase inhibitor (TKI) or 5 half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agent
+Prior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of ? 5% in peripheral blood by flow cytometry)
+Cardiac function (12 lead- electrocardiogram [ECG] versus [vs] non-12 lead ECG), performed within 14 days prior to day 1 of protocol therapy
+3-14 days from prior TKI depending on half-life.
+If a patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 100 days after completing treatment with CORT125281 or enzalutamide. A condom is required during and for 100 days after completing treatment with enzalutamide if a patient is engaged in sexual activity with a pregnant woman. Patients must also agree to avoid sperm donation during the study and for at least 100 days after the final treatment administration.
+Prior radiotherapy =< 14 days
+STRATUM B: ANC >= to 1000/mm^3 without growth factor support within 7 days of the test
+STRATUM C: ANC >= 1,000/mm^3 without growth factor support within 7 days of the test
+Has received wide field radiotherapy (including therapeutic radioisotopes such as radium 223) ? 28 days or limited field radiation for palliation ? 14 days prior to starting study drug or has not recovered from side effects of such therapy.
+Patients with active infection or with a fever > 38.5 degrees (^0) Celsius (C) within three days prior to the first treatment
+Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
+COHORT 3: ENDOMETRIAL CANCER: Patients with bone metastases who have initiated denosumab or bisphosphonate therapy within 28 days prior to cycle 1 day 1
+Obtained within 14 days prior to randomization/registration: neutrophils >= 1500/uL
+Whole blood transfusions in the last 120 days prior to entry to the study
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Solid tumor patients: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Lymphoma patients: a waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e. corticosteroid, vincristine, thioguanine[6MP], and/or methotrexate)\r\n** >=14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy; additionally, patients must have fully recovered from all acute toxic effects of prior therapy; Note: cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Hematopoietic growth factors: >= 14 days must have elapsed from the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without traumatic brain injury [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed from infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed from infusion\r\n* Cellular therapy: >= 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* External beam radiation (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days must have elapsed from the last dose of systemically administered radiopharmaceutical therapy\r\n* Histone deacetylase (HDAC) inhibitors: Patients must not have received prior therapy with entinostat; patients who have received therapy with other HDAC inhibitors are eligible
+Hematologic function, as follows (no red blood cell or platelet transfusions are allowed within 14 days of the first dose of enfortumab vedotin):
+Must have undergone a nephrectomy and/or metastasectomy ?28 days prior to signing informed consent and ?12 weeks prior to randomization.
+Corticosteroid therapy for 7 days prior to enrollment
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone morrow (BM) radiation\r\n** Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to palbociclib, ribociclib, abemaciclib or any other CDK4/6 inhibitors
+Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.
+Biopsy-proven HSIL (anal intraepithelial neoplasia 2 [AIN2] with a positive p16 stain, AIN 2-3, or AIN3) of the anal canal at either the squamocolumnar junction or distal anus, documented within 60 days prior to enrollment, but not less than 7 days prior to randomization
+Cluster of differentiation (CD)4 count >= 200 within 120 days prior to enrollment or plasma HIV-1 RNA < 200 copies/mL within 120 days prior to randomization
+Platelets >= 100,000/L (unsupported), within 14 days of registration and within 7 days of the start of treatment
+Serum calcium and magnesium above the institutional lower limit of normal, within 14 days of registration and within 7 days of the start of treatment
+Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab
+Obtained within 28 days prior to the first dose of cabozantinib: serum phosphorus >= 2.5 mg/dl.
+Obtained within 28 days prior to the first dose of cabozantinib: calcium >= 8 mg/dL.
+Obtained within 28 days prior to the first dose of cabozantinib: magnesium >= 1.2 mg/dL.
+Obtained within 28 days prior to the first dose of cabozantinib: potassium >= 3.0 meq/L.
+To be performed within 14 days prior to day 1 of protocol therapy: Absolute neutrophil count (ANC) >= 1,500/mm^3\r\n* NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care
+No increase in steroid dose within the past 7 days
+At least 30 days from any major surgeries including brain biopsy and have complete resolution of its effects
+Chemotherapy or radiotherapy within 14 days prior to starting study treatment; in case of monoclonal antibodies/biologics, within 28 days prior to starting study treatment
+Creatine phosphokinase (CPK) ? ULN obtained ? 14 days prior to randomization
+Prothrombin time (PT) within normal limits (WNL)+/- 15 % unless on active anticoagulation obtained ? 14 days prior to randomization
+First detectable AdV DNA plasma viremia since the qualifying transplant occurred within 21 days prior to Day 1.
+NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1
+NIH Stage 2 or higher acute GVHD of the liver (i.e., bilirubin > 3 mg/dL [SI: > 51 ?mol/L]) within 7 days prior to Day 1
+Use of vasopressors within 7 days prior to Day 1
+Requirement for mechanical ventilation within 7 days prior to Day 1, or sustained oxygen delivery for > 24 hours within 7 days prior to Day 1, or any oxygen requirement within 48 hours prior to Day 1
+Use of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplant (allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide =< 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped >= 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis
+Subjects (men and women) must agree to not donate sperm (males) or eggs (females) during and up to 120 days after the last dose of study treatment
+Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Cytotoxic chemotherapy: At least 7 days must have elapsed since the completion of cytotoxic therapy (other than standard ALL maintenance therapy) with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy\r\n* Nitrosoureas: At least 42 days must have elapsed since administration of nitrosoureas\r\n* Hematopoietic growth factors: At least 14 days after the last dose of long acting hematopoietic growth factor (e.g. Neulasta) or 7 days for short acting growth factor (e.g. Neupogen)\r\n* Radiation: At least 84 days must have elapsed since administration of craniospinal, hemipelvic or other radiation therapy to more than 25% of the bone marrow containing spaces; at least 42 days must have elapsed if other substantial marrow radiation has been given\r\n* Nelarabine prior therapy: Patients who have previously been treated with nelarabine are eligible, however if they have previously received a regimen of nelarabine, cyclophosphamide and etoposide, they are not eligible\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; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: At least 42 days after the completion of any type of immunotherapy (e.g. tumor vaccines or chimeric antigen receptor T cell (CART) therapy\r\n* Monoclonal antibodies: Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of a monoclonal antibody\r\n* Stem cell infusion: No evidence of active graft versus (vs.) host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n* Study specific limitations on prior therapy: Patient may not have previously received therapy with an mTOR inhibitor\r\n* Prior intrathecal therapy: Patients may be enrolled on study regardless of the timing of prior intrathecal therapy; however, they MAY NOT BEGIN TREATMENT ON THIS PROTOCOL UNTIL A MINIMUM OF 7 DAYS HAS ELAPSED SINCE PRIOR INTRATHECAL THERAPY
+At least 30 days from any major surgeries including brain biopsy and have complete resolution of its effects
+Has a diagnosis of immunodeficiency and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (subjects may receive steroids before or after SRS to prevent or manage cerebral edema; inhalational steroids are permitted)
+Absolute lymphocyte count >= 500/mm^3 obtained =< 14 days prior to registration
+> 14 days since any prior therapy for AML excluding hydroxyurea
+Patients must have discontinued all biologic therapy at least 14 days prior to registration
+Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;
+Significant clinical change in health in the past 30 days
+Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride
+Use of dutasteride within 90 days prior to therapy; PSA should not be obtained prior to 90 days after stopping dutasteride
+Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to screening)
+Has had relapse prior to primary neutrophil engraftment or =< 21 days post HCT
+Has been on immunosuppressant therapy within 7 days prior to the first dose of pembrolizumab
+Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Receiving any anticancer therapy for biliary tract cancer =< 21 days prior to registration
+Patients treated metastatic lesions to the brain may be enrolled after completing stereotactic radiosurgery (may enroll 14 days after treatment) or whole brain radiation (may enroll 14 days after treatment) and being weaned off corticosteroids (may enroll 14 days after weaning)
+Within 10 days prior to on-study date: Absolute lymphocyte count ? 500/mm^3
+Expected survival of > 90 days
+Neutrophils >= 1500/uL within 14 days of registration
+Acute VOC ending 7 days prior to first dosing
+Patients must be off sorafenib for at least four days prior to TACE treatment
+White blood cells (WBCs) >= 2000/microL within 14 days of study registration.
+Neutrophils >= 1500/microL within 14 days of study registration.
+Platelets >= 100 x 10^3/microL within 14 days of study registration.
+Medically supervised (ie, performed in a clinic) pregnancy testing, including those who commit to true abstinence. Two pregnancy tests must be conducted prior to starting pomalidomide. The first pregnancy test must be performed 10 to 14 days prior to the start of pomalidomide and the second pregnancy test must be performed within 24 hours prior to starting pomalidomide. Females of childbearing potential with regular or no menstrual cycles must also agree to have pregnancy tests weekly for the first 28 days study participation, every 28 days while on study, at study treatment discontinuation, and at Day 28 following pomalidomide discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while on study, at study treatment discontinuation visit, and at Days 14 and 28 following pomalidomide discontinuation.
+Immunomodulatory therapy: ? 28 days prior to screening.
+Obtained within 21 days prior to randomization/registration: Neutrophils >= 1500/uL.
+Must not have received a long-acting growth factor (eg, Neulasta) within 14 days or a short-acting growth factor within 7 days.
+Must not have received radiotherapy (XRT) within 14 days prior to study drug administration (small field) or 42 days for craniospinal XRT, or if ?50% radiation of pelvis.
+Subject is unlikely to survive 30 days.
+Herbal preparations are not allowed throughout the study, and should be discontinued 14 days prior to initiation of study treatment
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to study enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to study enrollment
+Evidence of an infection within 7 days of planned injection.
+Subjects must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to screening).
+Platelets >= 80,000 x 10^9/L unsupported by transfusions (within 14 days of study registration)
+Within 7 days before the first dose of study treatment: Serum phosphorus, calcium, magnesium and potassium >= lower limit of normal (LLN)
+Therapy with biologic agents (non-myelosuppressive) must have been completed >= 7 days prior to study entry; 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
+Radiotherapy =< 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Prior experimental therapy within 30 days of enrollment
+Platelets ? 100,000/?L without transfusion support within 28 days prior to study treatment
+Prior chest radiotherapy ? 3 months, wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent), or limited field radiation for palliation ? 14 days prior to study treatment - Such patients must have recovered adequately from any side effects of such therapy.
+Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
+Potassium >= 3.5 mmol/L (within institutional normal range) within 14 days of cycle 1 day 1
+Achieved at least a partial response (PR) and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR
+Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: \spot\ radiation for areas of pain is permitted), and major surgery within 14 days before randomization.
+Whole blood transfusion in the last 120 days prior to entry to the study
+Patients must not have had chemotherapy =< 28 days or radiotherapy =< 7 days prior to study treatment
+Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
+Any signs or symptoms of bowel obstruction within 28 days prior to study entry
+Neutrophils (Neuts) >= 1500/uL, within 30 days before study registration
+Cytotoxic chemotherapy last dose must have been received at least 28 days prior to enrollment, their last dose of biological therapy, 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 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment
+Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment
+Neutrophils >= 1500/uL within 14 days prior to first dose
+Patients may be transfused with packed red blood cells (PRBCs) up to 7 days prior to when enrollment labs are drawn to achieve Hgb >= 9.0 mg/dL
+Hepatic impairment, defined as AST (SGOT), or ALT (SGPT) > 2 x institutional ULN, within 21 days of initiation of protocol therapy or
+Prior chemotherapy or radiotherapy within 14 days prior to first dose of therapy provided subject has received no growth factor support of any kind within 28 days prior to first dose of therapy, otherwise prior chemotherapy within 28 days prior to first dose of therapy
+Participated within the last 30 days in a clinical trial.
+Fewer than 28 days before Cycle 1 Day 1 since any prior chemotherapy (less than 42 days in the case of mitomycin or a nitrosourea)
+Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
+Aspartate transaminase (AST) =< 2.5 x ULN obtained =< 7 days prior to registration
+Obtained within 14 days of randomization: Neutrophils >= 1500/uL
+Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment
+Systemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
+Systemic antineoplastic therapy in the past 14 days (excluding hydroxyurea)
+Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
+Absolute lymphocyte count >= 500/mm^3 obtained =< 14 days prior to registration
+Hematocrit (Hct) >= 28% within 30 days of enrollment to study
+Blood glucose <1.5 ULN within 30 days of enrollment to study
+History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 28 days of study enrollment
+No prior use of ketoconazole for greater than 7 days
+Performed within 14 days (+ 3 working days) prior to registration: Platelet count of > 100,000/mm^3 (may be reached by transfusion).
+Performed within 14 days (+ 3 working days) prior to registration: Creatinine < 1.5 mg/dL
+Be at least 14 days from the last administration of bevacizumab
+Patients must not have had prior cancer therapy (including biologic, cytotoxic, and experimental therapies, nitrosoureas, and Gliadel wafers or other surgically implantable antitumor treatment) within 21 days of registration; if questions arise, please ask the principal investigator (PI)\r\n* NOTE: Patients must not have Novocure within 24 hours of registration
+Total bilirubin =< 1.5 x ULN, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)
+Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1)
+Allo-HSCT within 90 days of leukapheresis
+Sufficient recovery from first or second ASCT within 60-120 days of transplant (Cohort C)
+Off antibiotic/antifungal therapy for >/=14 days (Cohort C)
+Hematopoietic growth factors: at least 7 days since the completion of therapy with a growth factor that supports platelet, red or white cell number or function
+Biologic (anti-neoplastic agent): at least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these patients must be discussed with the Study Chair on a case-by-case basis
+Radiotherapy for RCC within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms
+Within 14 days of registration: Potassium >= 3.5 mmol/L (within institutional normal range)
+Blood transfusion within 30 days of consent
+Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.
+Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to study registration; this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
+Any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment excluding steroids; attempts should be made to have patient on lowest possible dose of steroids; these medical entities can be exacerbated by PD-1 blockade
+FOR AML ONLY: Obtained =< 14 days prior to registration: No ANC restriction
+FOR AML ONLY: Obtained =< 14 days prior to registration: PLT >= 10,000/uL (transfusion to get platelets >= 10,000 is allowed)
+FOR TCL ONLY: Obtained =< 14 days prior to registration: ANC >= 1,000/uL
+FOR TCL ONLY: Obtained =< 14 days prior to registration: PLT >= 100,000/uL
+Recent infection requiring intravenous anti-infective treatment that was completed =< 14 days before enrollment
+Radiotherapy =< 14 days prior to registration; NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 28 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. PARP inhibitors, =< 7 days or 5 half-lives whichever is shorter)\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
+Within 14 days prior to planned start of treatment: Platelets >= 100,000/mm^3\r\n* Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
+Has completed prior therapies according to the criteria below:\r\n* Cytotoxic chemotherapy - at least 21 days since last dose prior to first dose of ribociclib\r\n* Small molecule inhibitors - at least 14 days since last dose prior to first dose of ribociclib\r\n* Monoclonal antibodies - at least 3 half-lives since last dose prior to first dose of ribociclib; exception: denosumab for bony metastases is allowable\r\n* Immunotherapy (e.g. tumor vaccines) - at least 42 days since last dose prior to first dose of ribociclib\r\n* Radiation - at least 14 days since last dose prior to first dose of ribociclib
+Consent to undergo mandatory prostatic core biopsies at the time of fiducial marker placement and 21 days (+/- 7 days) after with or without SD-101 therapy, depending on study arm
+Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.
+Within 14 days before first dose of avelumab: therapeutic or palliative radiation therapy; (subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab)
+Platelets >= 20,000/mcL or recovery to the baseline count (in the absence of transfusion), within 14 days prior to treatment
+Radiotherapy within 14 days before randomization; seven days may be considered if to single area
+Uncontrolled HTN 14 days prior to enrollment
+Platelets >= 50,000/mcL in the absence of transfusion support within 7 days of determining eligibility within 16 days of treatment initiation
+At the time of registration, subject must be removed from prior therapy as follows:\r\n* >= 28 days from any investigational agent,\r\n* >= 4 weeks (28 days) from prior cytotoxic therapy,\r\n* >= 2 weeks (14 days) from vincristine,\r\n* >= 6 weeks (42 days) from nitrosoureas,\r\n* >= 3 weeks (21 days) from procarbazine administration,\r\n* >= 1 week (7 days) for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
+Patients having undergone recent resection of recurrent or progressive tumor will be eligible given all of the following conditions apply:\r\n* At least 2 weeks (14 days) have elapsed from the date of surgery and the patients have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent malignant glioma is not mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, a magnetic resonance imaging (MRI) should be done no later than 96 hours in the immediate post-operative period or at least within 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; the patient must have been on a stable steroid dose for at least 5 days prior to the baseline MRI; steroids may be initiated as clinically indicated once baseline imaging has been completed with a goal of titrating steroids as soon as clinically warranted
+Subjects with active infection or with a fever > 38.50 degrees Celsius (C) within t3 days prior to the first scheduled treatment
+Receipt of any anti-cancer therapy within 14 days of starting BP1001, with the exception of hydroxyurea or anagrelide, or TKI (within 2 days)
+Recent prior chemotherapy:\r\n* Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions:\r\n** Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy\r\n** Prior chemotherapy directed at a “myeloproliferative neoplasm” like hydroxyurea is not exclusionary\r\n* Previously treated patients (group 2)\r\n** Alkylators (e.g. melphalan, cyclophosphamide) =< 28 days prior to registration\r\n** Anthracyclines =< 28 days prior to registration\r\n** High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< 28 days prior to registration
+Radiotherapy =< 14 days prior to registration
+Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to registration)
+Must have previously untreated lymphoma; a short (< 2 week) course of steroids for symptom palliation is permitted; prior involved field radiotherapy for symptom palliation is permitted as long as there is measurable disease outside the radiation port; if radiotherapy has been given, there should be at least 7 days between last treatment and beginning of protocol therapy
+Radiotherapy within 14 days before enrollment; if the involved field is small (single nodal area), 7 days will be considered a sufficient interval between treatment and beginning of protocol therapy
+Prior Therapy\r\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n** Cytotoxic chemotherapy (including investigational agents) or biologic agents (eg. cytokines or antibodies): At least 3 weeks after the last dose\r\n** Nitrosoureas/mitomycin C: At least 6 weeks from the last dose\r\n** Radiotherapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; e.g. stem cell Infusion without TBI: no evidence of active graft versus (vs.) host disease and at least 56 days must have elapsed after transplant or stem cell infusion
+Wide field radiotherapy within 28 days of cycle 1/day 1 or active side effects of such therapy
+=< 28 days post pre-registration
+Any of the following therapies prior to registration:\r\n* Chemotherapy =< 21 days\r\n* Immunotherapy =< 21 days\r\n* Biologic therapy =< 21 days\r\n* Hormonal therapy =< 14 days\r\n* Monoclonal antibodies =< 14 days\r\n* Radiation therapy =< 14 days\r\n* Minor surgical or interventional procedure =< 7 days\r\n• Major surgical procedure =< 21 days
+Administration of myeloid growth factors or platelet transfusion =< 14 days prior to registration
+Receipt of corticosteroids =< 7 days prior to registration, unless patient has been taking a continuous dose of no more than 15 mg/day of prednisone for at least 30 days prior to registration
+At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
+Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study
+Less than 21 days between registration and the last receipt of chemotherapy, biotherapy, immunotherapy, radiotherapy (excluding palliative radiotherapy), or major surgery; prior receipt of immunomodulatory therapy (eg: nivolumab) is permitted, as long as there has been a 21 day washout period following the most recent treatment
+The ability to interrupt non-steroidal anti-inflammatory drugs NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
+Platelet count >= 50 x 10^9/L (without use of growth factors [ie., interleukin 11 (oprelvekin)]) (within 14 days prior to registration)
+Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) =< 5 times ULN (within 14 days prior to registration)
+Potassium, sodium, magnesium, and calcium (corrected for serum albumin) =< grade 1 or within the institutional ranges of normal; if clinically appropriate, electrolytes may be corrected and values reassessed prior to enrollment (within 14 days prior to registration)
+Presence of radiologically documented disease; all radiology studies must be performed within 28 days prior to registration
+In accordance with National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) policy, protocol treatment is to begin within 2 working days of patient registration
+Prior radiotherapy completed <28 days before study enrollment.
+Patients who have had an active infection requiring systemic therapy =< 7 days prior to day -14 are not eligible UNLESS they are symptom-free and have a negative culture at the time of dosing on day -14
+Received an allogeneic HCT within the last 100 days; enrollment within 30-100 days after transplant, and after adequate recovery of counts
+Absolute neutrophils >= 1500/mm^3, within 14 day prior to registration
+No prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
+Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.
+No prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
+Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued 14 days prior to starting OTS167.
+Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1days), or a single dose of cytarabine (for proliferative disease)
+No abnormalities on pre-entry electrocardiogram, obtained within 28 days prior to being registered on study
+Blood transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility
+Platelets >= 100,000/mcL (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
+Prior cranial radiotherapy within 90 days of months of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
+Patients must have platelets (plt) >= 50,000/uL; platelet transfusion and packed red blood cell transfusion can also be given prior to the start of treatment and during treatment to achieve a target plt >= 50,000/uL provided that patients have not received growth factors for at least 14 days prior to entering trial
+Patients previously treated with ibrutinib > 14 days are ineligible; if patient has been treated with ibrutinib for < 14 days, it must be discontinued 1 week (7 days) weeks prior to study initiation
+Whole blood transfusions in the last 120 days
+Consultation with a medical oncologist at enrolling site =< 56 days prior to registration, with determination that treatment with neoadjuvant chemoradiotherapy with weekly carboplatin and paclitaxel is considered acceptable
+Use of thiazolidinedione (TZD) within 28 days prior to enrollment
+Bilirubin =< 2 times institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 10 days prior to study day 0)
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Use of amiodarone within 90 days prior to first dose
+Has had any major surgery, extensive radiotherapy, or anti-cancer therapy (e.g., chemotherapy with delayed toxicity, biologic therapy, or immunotherapy) within 21 days prior to enrolment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrolment. Prolonged immobilization must have resolved prior to enrolment.
+Treatment with biologic therapy within 21 days of registration.
+Obtained =< 14 days prior to registration: Platelet (PLT) >= 100,000
+The ability to interrupt nonsteroidal antiinflammatory drug (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
+PRIOR TO LYMPHODEPLETION: Imaging results from within 30 days prior to enrollment into the main study (used as baseline measure for documentation of progression) before the lymphodepletion; with prior sponsor approval, these results may be obtained at a time point greater than 30 days from lymphodepletion if obtained per the patient’s standard of care and if no other chemotherapy/lymphoma treatment received between most recent scans and start of
+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
+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
+Be able to start the drug therapy between 42 to 100 days following allogeneic SCT;\r\n* No more than 1 prior allogeneic SCT\r\n* Post-transplant bone marrow consistent with complete remission with no evidence of minimal residual disease by flow-cytometry or cytogenetics or molecular testing\r\n* Adequate engraftment within 14 days prior to starting study drug: absolute neutrophil count (ANC) >= 1.0 x 10^9/L without daily use of myeloid growth factor; and, platelet >= 50 x 10^9/L without platelet transfusion within 1 week
+Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to study registration
+Patients must have the following minimum intervals from prior treatments:\r\n* Surgery – 4 weeks\r\n* Nitrosoureas – 6 weeks\r\n* Cytotoxic chemotherapy – standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose; for drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval\r\n* Investigational therapy or non cytotoxic therapy – 2 weeks
+Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =<14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =<14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
+PHASE I: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study; patients having undergone recent surgery are eligible as long as they are at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering from any operative or perioperative complications; no measurable disease post resection will be required
+Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment
+Systemic corticosteroid steroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
+Use of amiodarone within 90 days prior to first dose
+Must have started ADT for metastatic disease within 134 days (for Arm A and B) or within 30 days (for Arm C)
+Prior frontline therapy for B-CLL must have been discontinued >= 56 days but =< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
+Patients who have been off of FOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days prior to treatment on study
+Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy
+Ability to interrupt chronic non-steroidal anti-inflammatory drugs (NSAIDs) beginning 2 days before (5 days before for long-acting NSAIDs) and continuing for 2 days following administration of each pemetrexed dose
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Patients who are currently receiving any other experimental agent, must have stopped other experimental agents at least 21 days prior to 1st study dose
+Completion of prior systemic therapy at least 14 days prior to enrollment
+Neutrophils >= 1500/uL obtained within 14 days prior to randomization/registration
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+The subject must have recovered from the acute toxic effects of all prior therapy with the exception of alopecia. The following time must have elapsed from the last dose of the following medications to study enrollment:\r\n* Myelosuppressive chemotherapy: 14 days\r\n* Hematopoietic growth factors: 7 days (14 days for Neulasta)\r\n* Biologic agent: 7 days\r\n* Monoclonal antibody: 3 half-lives \r\n* Immunotherapy (ie tumor vaccines): 42 days\r\n* Palliative small port radiation therapy (XRT): 14 days\r\n* Substantial bone marrow XRT: 6 weeks\r\n* Stem cell transplant or infusion without total body irradiation (TBI): 12 weeks\r\n* Total body irradiation (TBI): 24 weeks
+Subjects with a history of tumor progression within 30 days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than 30 days after their most recent prior dose of anthracycline will be eligible.
+Expected survival is greater than 100 days
+Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration.
+Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
+Biologic agents- At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoids
+Hematopoietic growth factors- At least 7 days must have elapsed since the last dose of G-CSF or GM-CSF. At least 14 days must have elapsed since last dose of pegfilgrastim (Neulasta®).
+Plts ? 75,000 - cannot be transfused (must be ? 7 days from last plt transfusion)
+Participation to a study involving a medical or therapeutic intervention in the last 30 days
+Patients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\r\n** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, iodine I 131 metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have received prior exposure to selumetinib (AZD6244 hydrogen sulfate)
+Serum triglyceride level =< 300 mg/dL within 7 days prior to enrollment
+Serum total cholesterol level =< 300 mg/dL within 7 days prior to enrollment
+Prior treatment with immune-modulating agents within 28 days before REGN2810
+Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;
+Immunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)
+Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ?50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
+High dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat)
+Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)
+Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet all of the following criteria:\r\n* Myelosuppressive chemotherapy: 14 days must have elapsed since the completion of myelosuppressive therapy; individuals may have received any of the following medications within 14 days without a “wash-out” period:\r\n** Standard maintenance therapy (vincristine, mercaptopurine [6MP], corticosteroids, low dose methotrexate)\r\n** Hydroxyurea\r\n** Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine\r\n* Radiation therapy (XRT):\r\n** Total body irradiation (TBI) or craniospinal radiation therapy: must have been completed more than 90 days from study entry\r\n** Palliative XRT: XRT for chloromas does not require a washout period\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; the duration of this interval must be discussed with the study chair\r\n* Immunotherapy: at least 6 weeks after the completion of any type of immunotherapy, e.g. tumor vaccines and chimeric antigen receptor T-cells\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 28 days prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrollment
+At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody; seven days must have elapsed since the last dose of retinoids
+Inotuzumab within 30 days and must have ALT, AST and bilirubin < ULN.
+A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 days
+CAR-T infusion or other cellular therapy within 30 days
+Within 14 days prior to study entry: Platelets (Plt) >= 100 x 10^3/L
+Expected to undergo HCT within 120 days of enrollment
+Needing valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+ARM C COHORT 4: Patients who have had decompression of the biliary tree within the last 14 days, must have a stable bilirubin level as confirmed by two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be =< 2 X IULN; stability is defined as the second measurement being no more than one point higher than the first
+PHASE I STUDY ELIGIBILITY CRITERIA:\r\nHemoglobin (Hgb) >= 10 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing OR Hgb 9-9.9 g/dL and the value is constant across 2 readings within 2 weeks, in the absence of packed red blood cell transfusion 28 days prior to dosing
+Patients must have an expected survival of > 60 days and must be free of major infection
+Complete blood count (CBC) with differential and a comprehensive metabolic panel (CMP) including liver function tests (LFTs) obtained within 14 days prior to registration
+Subject must have at least 2 of the following risk factors\r\n* Pretreatment edema/tumor ratio (>= 35:1) as contoured on a baseline MRI obtained at most 60 days prior to registration; patients are allowed to have whole brain radiotherapy (WBRT) or corticosteroid use between the time of pretreatment MRI and SRS (as long as the corticosteroids can be safely tapered at least 5 days prior to the treatment planning MRI and WBRT is at least 4 days prior to registration)\r\n* Greater than 40 pack year history of smoking cigarettes\r\n* Whole brain radiotherapy at least 4 days and no more than 1 year prior to registration\r\n* Recursive partitioning analysis (RPA) class III
+Patients treated on any other therapeutic clinical protocols within 10 days prior to registration or during participation in the study
+Use of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.
+Platelets >= 100,000/?L without transfusion support within the past 28 days
+Patients who have received wide field radiotherapy =< 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
+Acute infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to initiation of study
+Time to initiation of maintenance therapy: patients may start maintenance therapy as early as 60 days post-transplant and up to 210 days post-transplant; as long as they meet the following criteria:
+Radiotherapy within 14 days before enrollment
+Radiotherapy within 28 days before enrollment; if the involved field is small, 14 days will be considered a sufficient interval between treatment and administration of the therapy
+At least 14 days must have passed after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor
+Splenectomy ? 90 days prior to the first dose of PRTX-100
+Treatment with IVIG ? 14 days prior to the first dose of PRTX-100
+Treatment with an anti-Rh D antigen agent (e.g. WinPho) ? 14 days prior to the first dose of PRTX-100
+No sooner than 45 days but no later than 90 days after allogeneic HSCT.
+Adequate engraftment within 7 days prior to starting study therapy: ANC ? 1.0 x 109/L without daily use of myeloid growth factor; and platelet ? 25 x 109/L without platelet transfusion within 1 week
+Prior therapy:\r\n* Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n** Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\r\n** Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines \r\n** Antibodies: > 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade < 1 \r\n** External beam radiation therapy (XRT): at least 14 days after local palliative XRT (small port); 6 weeks must have elapsed since treatment with therapeutic doses of iodine 131-metaiodobenzylguanidine (I131-MIBG); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT, or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n** Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant and 42 days for autologous stem cell infusion after I131-MIBG therapy\r\n** Subjects must not have received any prior therapy with simvastatin
+Radiotherapy within 14 days before randomization; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+Platelets >= 100 K/cumm (must be within 7 days of MLA)
+Electrocardiogram (EKG) with QTcB (Bazett’s formula) > 480 ms done within 14 days of enrollment
+At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
+At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor.
+At least 7 days after the last dose of a biologic agent.
+At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior TBI, craniospinal XRT or if ? 50% radiation of pelvis; At least 42 days must have elapsed if other substantial bone marrow radiation.
+A complete blood count and differential must be obtained within 21 days prior to radiation fraction 1
+Biologic (anti-neoplastic agent): at least 7 days must have elapsed since the completion of therapy with other biologic agents; for other biologic 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; the duration of this interval must be discussed with the study chair
+Demonstrate adequate organ function, screening labs that include hematology and chemistry labs should be performed within 14 days of registration on the study
+If the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (such as ketoconazole), these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspended
+Patients on antiplatelet/anticoagulant medication that cannot safely be discontinued 5-7 days prior to the procedure
+White blood cell count > 50,000 per micro liter (/µL); hydroxyurea may be used to control the level of circulating leukemic blast cell counts prior to study entry and, if needed, concomitantly while on TAK-659 treatment during the first 28 days of the study. Hydroxyurea can be used up to a maximum dose of 5 gram per (g/) day.
+Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist =< 28 days prior to registration
+Confirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision =< 28 days prior to registration
+Within 4 days prior to the first dose of cabozantinib: Serum phosphorus, calcium, potassium >= lower limit of normal (LLN)
+Within 4 days prior to the first dose of cabozantinib: Serum magnesium >= 1.2 mg/dL
+Protocol treatment is to begin within 2 working days of patient randomization
+Received wide field radiotherapy =< 28 days or limited field radiation for palliation =< 14 days prior to registration or who have not recovered from side effects of such therapy
+Patients are eligible for enrollment if they have not had prior investigational or approved cytotoxic chemotherapy within 28 days prior to the first dose (week 1, day 1); 42 days in the case of alkylating agents; 28 days or 5 half-lives (whichever is less; but not less than 14 days) in case of investigational or approved molecularly targeted agent; 14 days in the case of radiotherapy; any number of prior therapies is allowable
+Platelets >= 100,000/uL (without transfusion or growth factor support), performed within 28 days prior to registration
+Interested in quitting smoking in the next 30 days
+Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
+Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days of registration; however, erythrocyte growth factor is allowed as per published American Society of Clinical Oncology (ASCO) guidelines
+Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
+Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
+Have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
+Patients must be at least 28 days post systemic steroids prior to enrollment
+Within 30 days of first vaccination: Lymphocyte count >= 800/mm^3
+Within 30 days of first vaccination: Blood glucose < 1.5 ULN
+Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor.
+Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with 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. The duration of this interval must be discussed with the Study Chair.
+The time from the end last induction, re-induction, or consolidation regimen should be greater than or equal to 14 days from planned start of study treatment; Note: Chemotherapy given within 14 days of planned study enrollment for the purpose of controlling counts is permitted
+Any major surgery, extensive radiotherapy (> 15 days of treatment), chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to first dose of study treatment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to first dose of study treatment
+Patients must not have taken nonsteroidal anti-inflammatory drugs (NSAID) in the past 14 days before treatment on this protocol
+Use of finasteride within 30 days prior to registration
+Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
+At the time of treatment on protocol patients must have recovered from the toxic effects of prior therapy: > 10 days from any noncytotoxic investigational agent, > 28 days from prior cytotoxic therapy or Avastin, > 14 days from vincristine, > 42 days from nitrosoureas, > 21 days from procarbazine administration, and > 7 days 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
+Within 14 days prior to registration: Blood urea nitrogen (BUN) and creatinine (Cr) < 2 x ULN
+LVEF < 50% and >= 40% documented in echocardiogram done within the last 30 days
+Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
+Radiotherapy to any site for any reason within 28 days prior to study entry
+At least 7 days should have elapsed since the completion of therapy with a biologic agent
+Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
+Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
+Receipt of posaconazole or voriconazole as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately before randomization.
+Patients must not have had a known interruption of TKI therapy of greater than 21 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
+Melanoma specific systemic therapy within 30 days of enrollment
+Pregnancy testing will be performed within 14 days prior to treatment (Turnstile II)
+Expected survival if untreated of > 90 days
+Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment; patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study
+Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before treatment; patients who have been on trastuzumab for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on trastuzumab for the duration of the study
+Discontinuation of anti-coagulants and anti-platelet drugs at least 7 days prior to start of study drug; aspirin 81 mg is permitted as long as platelet count is > 50 and there is no evidence of active bleeding or coagulopathy (INR > 1.5, fibrinogen > 150)
+Patients must be between 100 to 180 days after ASCT
+Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days
+Erythropoietin or related hormones must not have been administered within the past 28 days
+Adequate cardiac function as demonstrated by electrocardiogram (EKG) and/or echocardiographic evidence (may be performed within 30 days prior to treatment)
+Patient must have received last dose of known myelosuppressive chemotherapy > 21 days prior to enrollment; > 42 days if nitrosurea
+Biologic agent - must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent > 7 days prior to study enrollment\r\n* 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
+Patients must have had their last fraction of: \r\n* Craniospinal irradiation (> 24 Gy) > 3 months prior to enrollment\r\n* Focal irradiation > 42 days prior to enrollment\r\n* Local palliative irradiation (small port) > 14 days
+Received systemic anticancer therapy (including cytotoxic chemotherapy, investigational agent, antineoplastic monoclonal antibodies, or immunotherapy) ?14 days prior to first dose of AP32788 (except for reversible EGFR TKIs [ie, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of AP32788).
+Inclusion Criteria:\n\n          1. Patients must have a histologically confirmed diagnosis of malignant PEComa that is\n             either metastatic or locally advanced and for which surgery is not a recommended\n             option.\n\n          2. Patients must have available tumor block along with the corresponding pathology report\n             (or approximately 30 unstained slides, with a minimum of 16 slides), and/or fresh\n             biopsy to allow retrospective centralized confirmation of malignant PEComa and for\n             mTOR pathway analysis and biomarker analysis.\n\n          3. Patients must have one or more measurable target lesions by CT scan or MRI. Measurable\n             disease by RECIST v1.1.\n\n          4. Patients must not have been previously treated with an mTOR inhibitor.\n\n          5. Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or\n             other therapeutic agents (except mTOR inhibitors) is allowed, if completed after 5\n             half-lives or ?28 days prior to enrollment, whichever is shorter.\n\n          6. Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG)\n             performance status 0 or 1.\n\n          7. Patients must have the following blood chemistry levels at screening (obtained\n\n             ?14 days prior to enrollment (local laboratory):\n\n               1. total bilirubin ?1.5 x upper limit of normal (ULN) mg/dl\n\n               2. AST ?2.5 x ULN (?5 x ULN if attributable to liver metastases)\n\n               3. serum creatinine ?1.5 x ULN\n\n          8. Adequate biological parameters as demonstrated by the following blood counts at\n             screening (obtained ?14 days prior to enrollment, local laboratory):\n\n               1. Absolute neutrophil count (ANC) ?1.5 × 109/L;\n\n               2. Platelet count ?100,000/mm3 (100 × 109/L);\n\n               3. Hemoglobin ?9 g/dL.\n\n          9. Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL.\n\n         10. Male or non-pregnant and non-breast feeding female:\n\n               -  Females of child-bearing potential must agree to use effective contraception\n                  without interruption from 28 days prior to starting IP and while on study\n                  medication and have a negative serum pregnancy test (? -hCG) result at screening\n                  and agree to ongoing pregnancy testing during the course of the study, and after\n                  the end of study treatment.\n\n               -  Male patients must practice abstinence or agree to use a condom during sexual\n                  contact with a pregnant female or a female of childbearing potential while\n                  participating in the study, even if he has undergone a successful vasectomy.\n\n         11. Life expectancy of >3 months, as determined by the investigator.\n\n         12. Ability to understand and sign informed consent.\n\n         13. Willingness and ability to comply with scheduled visits, laboratory tests, and other\n             study procedures.\n\n        Exclusion Criteria:\n\n        A patient will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Patients with lymphangioleiomyomatosis (LAM) are excluded.\n\n          2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A\n             patient with controlled and asymptomatic CNS metastases may participate in this study.\n             As such, the patient must have completed any prior treatment for CNS metastases ?28\n             days (including radiotherapy and/or surgery) prior to start of treatment in this study\n             and should not be receiving chronic corticosteroid therapy for the CNS metastases.\n\n          3. Active gastrointestinal bleeding, if transfusion dependent.\n\n          4. Pre-existing thyroid abnormality is allowed provided thyroid function can be\n             controlled with medication.\n\n          5. Uncontrolled serious medical or psychiatric illness. Patients with a \currently\n             active\ second malignancy other than non-melanoma skin cancers, carcinoma in situ of\n             the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ? 6 and\n             postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are\n             ineligible. Patients are not considered to have a \currently active\ malignancy if\n             they have completed therapy and are free of disease for ?1 year).\n\n          6. Liver-directed therapy within 2 months of enrollment. Prior treatment with\n             radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial\n             embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if\n             these therapies did not affect the areas of measurable disease being used for this\n             protocol.\n\n          7. Recent infection requiring systemic anti-infective treatment that was completed\n\n             ?14 days prior to enrollment (with the exception of uncomplicated urinary tract\n             infection or upper respiratory tract infection).\n\n          8. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.\n\n          9. Unstable coronary artery disease or myocardial infarction during preceding 6 months.\n\n         10. Receiving any concomitant antitumor therapy.\n\n         11. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary\n             hypertension.\n\n         12. The use of certain medications and illicit drugs within 5 half-lives or 28 days,\n             whichever is shorter prior to the first dose of study drug and for the duration of the\n             study will not be allowed.\n\n         13. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving\n             the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with\n             narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride,\n             dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to\n             receiving the first dose of ABI-009.
+Obtained =< 28 days prior to randomization: \r\nPlatelet count >= 100,000/mm^3
+Obtained =< 28 days prior to randomization:\r\nHemoglobin > 9.0 g/dL
+Adequate hematologic function independent of growth factor support for at least 7 days prior to screening and randomization, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which cannot be administered within 14 days of screening
+Unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 14 days (fruits and juices for at least 7 days) prior to day 1 of FOLFIRI + bevacizumab initiation
+Patient must begin therapy within 7 calendar days of registration
+A MRI of the spine is required within 10 days prior to or at least 10 days after surgery
+Serum HCGB and AFP levels must be assessed within 7 days prior to registration
+Patient must have lumbar CSF for cytology, protein, AFP and HCGB within 7 days prior to registration
+Inclusion Criteria (Parts B & C):\n\n          -  18 years or older\n\n          -  Histologically confirmed unresectable Stage III or Stage IV malignant melanoma, or\n             other solid tumor malignancies\n\n          -  Failed to respond to or relapsed following standard treatment, declined or was not\n             eligible for standard treatment.\n\n          -  Expected survival of at least 12 weeks.\n\n          -  Eastern Cooperative Oncology Group performance status score of 0 or 1 is required.\n\n          -  Evidence of adequate organ function by standard laboratory tests.\n\n        Exclusion Criteria (Parts B & C):\n\n          -  Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS\n             metastases within 35 days prior to dosing.\n\n          -  Ocular melanoma which has not metastasized or presence of a non-solid tumor.\n\n          -  A history of any major surgery within 4 weeks prior to dosing.\n\n          -  Any history of antitumor therapy completed within 28 days prior to dosing.\n\n          -  Subjects with active autoimmune disease or history of known or suspected autoimmune\n             disease, with the exception of subjects with isolated vitiligo, resolved childhood\n             asthma/atopy, psoriasis not requiring systemic treatment and controlled thyroid\n             disorders.\n\n          -  Clinically significant heart disease, defined as NYHA Class III or IV.\n\n          -  Any significant systemic infection requiring IV antibiotics.\n\n          -  Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface\n             antigen (HBsAg), or hepatitis C antibodies (HCAb) unless HCV RNA undetected/negative.\n\n          -  Treatment with any other anti-human GITR monoclonal antibody (mAb) or immunomodulatory\n             therapy 42 days prior to dosing (30 days for Interleukin-2 & Interferon-?, 7 days for\n             Topical Imiquimod).\n\n          -  Adverse events from prior anti-cancer therapy that have not resolved to grade ?1\n             except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy.\n\n          -  Use of any investigational drugs within 30 days prior to dosing.\n\n          -  Any condition that requires or is likely to require treatment with pharmacologic doses\n             of systemic corticosteroids. Subjects are permitted to receive physiologic replacement\n             of corticosteroid therapy (? 10 mg prednisone daily).
+Pre-treatment tests must be performed within 30 days prior to enrollment
+Anticipated need for systemic steroid therapy within 28 days after vaccine administration
+Prior Therapy: therapy with monoclonal antibodies and/or chemotherapy must be stopped at least 14 days prior to anti-CD19 CAR-transduced T cell infusion, and recovery of treatment-associated toxicity to =< grade 2 is required prior to infusion of cells; for patients that have received prior DCI, the last dose must be at least 28 days prior to anti- CD19 CAR-transduced T cell administration; note that patients can be enrolled on this study at any time after or during therapy, but at least 14 days must elapse from the time of prior monoclonal antibody administration or chemotherapy until anti-CD19 CAR-transduced T cells are infused, and at least 28 days must elapse from the time of withdraw of immunosuppression, or DCI, or other immunomodulatory therapies such as lenalidomide until anti-CD19 CAR-transduced T cells are infused; systemic immunosuppression must be stopped at least 28 days prior to protocol entry; there is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such
+Prostate volume: =< 100 cc\r\n* Determined using: volume = ?/6 x length x height x width\r\n* Measurement from CT or ultrasound =< 90 days prior to registration
+Radiotherapy within 21 days prior to initiation of study treatment
+Myelosuppressive chemotherapy: must not have received within 28 days of entry onto this study (42 days if prior nitrosourea drug) accompanied by hematopoietic recovery or 14 days of stopping non-myelosuppressive therapy as long as hematopoietic requirements are met
+Biologic (anti-neoplastic agent): must not have received within 7 days of entry onto this study (21 days if prior vascular endothelial growth factor (VEGF)-trap and at least 3 half-lives after last dose of a monoclonal antibody); for biologic 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
+Subjects whose physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to being administered HSV1716 to 28 days following administration should not be in the study
+WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
+Pregnancy testing will be performed within 7 days prior to treatment (Turnstile II)
+Require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 30 days, or have used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion; Exception: patients on physiologic dose of steroid (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
+Subjects must have had prior treatment with temozolomide; at least 28 days must have elapsed since completion of temozolomide or other chemotherapy
+Unexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
+Platelet ?100 x 10^9/L, without transfusion within 7 days preceding the lab assessment
+Hematopoietic growth factors: ?14 days after the last dose of a long-acting growth factor (eg, Neulasta) or 7 days for a short-acting growth factor. For agents that have known adverse events (AEs) occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur.
+Stem cell infusions (with or without total body irradiation [TBI]): ?84 days
+Radiotherapy =< 14 days prior to registration; Note: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Patient is at least 21 days removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021.
+INCLUSION CRITERIA\n\n          1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.\n\n          2. Patient has SCD, including HbSS, HbSC, HbS?0-thalassemia, or HbS?+-thalassemia,\n             documented in their medical history.\n\n          3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable\n             regimen.\n\n          4. Per medical history and/or patient recall, patient has had at least 1 and no more than\n             10 sickle cell-related pain crises in the 12 months before the Screening Visit and\n             none occurring in the 4 weeks before the Randomization Visit.\n\n          5. Patient completes daily eDiary entries for at least 10 days during the last 14 days of\n             the Run in Period as assessed at the Randomization Visit.\n\n          6. Women of childbearing potential must have a negative pregnancy test prior to\n             randomization and must agree to use protocol-specified contraception from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n          7. Male patients must be surgically sterile by vasectomy (conducted ?60 days before the\n             Screening Visit or confirmed via sperm analysis) or must agree to use\n             protocol-specified contraception and agree to refrain from sperm donation from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n        EXCLUSION CRITERIA\n\n          1. Patient requires a program of prescheduled, regularly administered chronic blood\n             transfusion therapy.\n\n          2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before\n             the Randomization Visit.\n\n          3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before\n             the Randomization Visit.\n\n          4. Patient is taking aspirin ?325 mg daily, P2Y12 inhibitors, any anticoagulant\n             medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors\n             of PDE5, moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for\n             the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors\n             in any form.\n\n          5. Patient has major concurrent illness or medical condition that in the opinion of the\n             Investigator would preclude participation in a clinical study.\n\n        NOTE: Other inclusion and exclusion criteria apply, per protocol
+Inclusion Criteria:\n\n        - Patients must be ? 1 and ?25 years of age.\n\n        Diagnosis:\n\n        - Patients with AML must have ? 5% blasts (by morphology) in the bone marrow\n\n          -  Patients may have CNS or other sites of extramedullary disease. No cranial irradiation\n             is allowed during the protocol therapy.\n\n          -  Patients with secondary AML are eligible\n\n          -  Patients with Down syndrome and DNA fragility syndromes (such as Fanconi anemia, Bloom\n             syndrome) are excluded.\n\n        Performance Level:\n\n        - Karnofsky >50% for patients >16 years of age and Lansky > 50% for patients ? 16 years of\n        age (See Appendix II for Performance Scales)\n\n        Prior therapy\n\n        - Patients must have fully recovered from the acute toxic effects of all prior\n        chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n          1. Phase 1\n\n             - Any patient with AML in 1st or greater relapse, OR\n\n             - Patients with AML failed to go into remission after first or greater relapse, OR\n\n             - Patients with AML failed to go into remission from original diagnosis after two or\n             more induction attempts.\n\n          2. Cytoreduction with hydroxyurea - Hydroxyurea can be initiated and continued for up to\n             24 hours prior to the start of decitabine/vorinostat. It is recommended to use\n             hydroxyurea in patients with significant leukocytosis (WBC >50,000/L) to control blast\n             count before initiation of systemic protocol therapy.\n\n          3. Patients who relapsed while they are receiving cytotoxic therapy\n\n             - At least 14 days must have elapsed since the completion of the cytotoxic\n             therapy,except Intrathecal chemotherapy.\n\n             Hematopoietic stem cell transplant (HSCT):\n\n             - Patients who have experienced their relapse after a HSCT are eligible, provided they\n             have no evidence of acute or chronic Graft-versus-Host Disease (GVHD).\n\n             Hematopoietic growth factors:\n\n             - It must have been at least 7 days since the completion of therapy with GCSF or other\n             growth factors at the time of enrollment. It must have been at least 14 days since the\n             completion of therapy with pegfilgrastim (Neulasta ®)\n\n             Biologic (anti-neoplastic agent):\n\n             -At least 7 days after the last dose of a biologic agent. For agents that have known\n             adverse events occurring beyond 7 days after administration, this period must be\n             extended beyond the time during which adverse events are known to occur. The duration\n             of this interval must be discussed with the study chair.\n\n             Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after\n             the last dose of monoclonal antibody (i.e. Gemtuzumab = 36 days)\n\n             Immunotherapy: At least 42 days after the completion of any time of immunotherapy,\n             e.g. tumor vaccines or CAR T-cell therapy.\n\n             XRT: Cranio or craniospinal XRT is prohibited during protocol therapy. No washout\n             period is necessary for radiation given to non-CNS chloromas; >90 days must have\n             elapsed if prior TBI, cranio or craniospinal XRT.\n\n             Prior Demethylating and/or HDAC Inhibitor Therapy: Patients who have received prior\n             DNMTi (e.g. decitabine) and/or HDACi (e.g. vorinostat) therapy are eligible to\n             participate in this Phase 1 study. At least 7 days must have passed from prior DNMTi\n             or HDACi as a washout period.\n\n             Renal and hepatic function: Patients must have adequate renal and hepatic functions as\n             indicated by the following laboratory values:\n\n             A. Adequate renal function defined as: Patient must have a calculated creatinine\n             clearance or radioisotope GFR ? 70ml/min/1.73m2 OR a normal serum creatinine based on\n             age/gender.\n\n             B. Adequate Liver Function Defined as: Direct bilirubin < 1.5 x upper limit of normal\n             (ULN) for age or normal, AND alanine transaminase (ALT) < 5 x ULN for age. The hepatic\n             requirements are waived for patients with known or suspected liver involvement by\n             leukemia. This must be reviewed by and approved by the study chair or vice chair.\n\n             Adequate Cardiac Function Defined as: Shortening fraction of ? 27% by echocardiogram,\n             OR ejection fraction of ? 50% by radionuclide angiogram (MUGA).\n\n             Reproductive Function A. Female patients of childbearing potential must have a\n             negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n\n             B. Female patients with infants must agree not to breastfeed their infants while on\n             this study.\n\n             C. Male and female patients of child-bearing potential must agree to use an effective\n             method of contraception approved by the investigator during the study and for a\n             minimum of 6 months after study treatment.\n\n             Exclusion Criteria:\n\n             -No NG or G-Tube administration of Vorinostat is allowed. Capsule must be swallowed\n             whole or given as oral suspension.\n\n             -They are currently receiving other investigational drugs.\n\n             -There is a plan to administer non-protocol chemotherapy, radiation therapy, or\n             immunotherapy during the study period.\n\n             -They have significant concurrent disease, illness, psychiatric disorder or social\n             issue that would compromise patient safety or compliance, interfere with consent,\n             study participation, follow up, or interpretation of study results.\n\n             -They have a known allergy to any of the drugs used in the study.\n\n             -Patients with Down syndrome are excluded.\n\n               -  Patients with DNA fragility syndromes are excluded (e.g. Fanconi Anemia, Bloom\n                  Syndrome)\n\n               -  They are receiving valproic acid (VPA) therapy.\n\n               -  Patients with Acute Promyelocytic Leukemia (APL, APML) are excluded\n\n               -  Patients with documented active and uncontrolled infection at the time of study\n                  entry are not eligible
+Protocol treatment is to begin within 5 working days of patient enrolment.
+Subject is receiving anticoagulation; washout period of 7 days
+Radiotherapy within 14 days before enrollment (if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.)
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 30 days of enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days of enrollment
+Hospitalization within 30 days of enrollment for cancer related events
+Patients not expected to be available for follow-up for at least 114 days after transplant
+Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within the past 28 days
+Receiving treatment with any medication known to produce QT prolongation within 7 days of study entry
+Treated with hydroxyurea within 30 days;
+Patients who test positive for infectious hepatitis types A, B, or C within 14 days of registration are NOT eligible for participation
+Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
+Prior cancer therapy with pemetrexed/cisplatin must have been completed at least 30 days prior to the first cycle of milataxel; prior radiotherapy (less than 25% of the bone marrow) must have been completed at least 30 days prior to study enrollment.
+Prior cancer therapies not completed within 30 days prior to the first cycle of milataxel; radiotherapy completed less than 30 days prior to study enrollment; patients not recovered from radiation-related toxicities; patients receiving any concurrent anti-cancer therapy, including trastuzumab, bevacizumab or an investigational agent while on-study; patients with greater than 2 prior radiotherapy treatments.
+Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
+Hematocrit >= 30 performed within 60 days of enrollment
+Subjects with short-term CVCs indwelling less than 5 days;
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).
+Is willing to abstain from grapefruit and Seville oranges (or juice) from 7 days before the first dose until study completion
+Bilirubin ? 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
+Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy
+Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
+Systemic radiation therapy or major surgery < 28 days prior to study Day 1 as well as focal radiotherapy < 14 days prior to study Day 1.
+The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
+Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
+All cytokines or hematopoietic growth factors must be discontinued a minimum of 7 days prior to the start of vorinostat on this protocol
+ANC >= 750/uL (no hematopoietic growth factors within 7 days of the start date for vorinostat on this protocol)
+Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days
+Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) \r\n* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\r\n* Cellular therapy: ? 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): ? 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: ? 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ? 1\r\n* Palliative radiation therapy (XRT): At least 28 days after local palliative XRT (small port); 6 weeks must have elapsed since treatment with therapeutic doses of 131I-MIBG; at least 42 days must have elapsed if other substantial BM radiation\r\n* Stem cell infusion without traumatic brain injury (TBI): No evidence of active graft versus (vs.) host disease and at least 84 days must have elapsed after transplant and 42 days for autologous stem cell infusion after 131I-metaiodobenzylguanidine (131I-MIBG) therapy\r\n* Prior taxane and nucleoside analogue usage: Patients who have previously received a taxane, including nab-paclitaxel, or a nucleoside analogue, including gemcitabine, are eligible as long as they have not received gemcitabine in combination with nab-paclitaxel\r\n* Medical cannabis and cannabidiol (CBD oil): ? 72 hours must have elapsed since the last administration of these products\r\n* Investigational agents not otherwise specified: ? 30 days must have elapsed since the last dose of any agents not specified above; for agents with an uncertain washout period or for any questions or uncertainty the study principle investigator (PI) should be notified
+Radiotherapy ? 14 days prior to registration; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Lymphocytes ? 500 / mcL within 7 days of treatment initiation
+Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart ? 14 days of registration and continue for at least 28 days
+Potassium >= lower limit of normal (LLN) range for the institution =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
+Magnesium >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
+Sodium >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
+Phosphorus >= LLN =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
+All screening labs should be performed within 14 days (+3 working days) of treatment initiation: platelets >= 100,000 /mcL;
+Brain metastases considered unstable as: a. without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR b. associated with symptoms and/or findings; OR c. requiring corticosteroids or anticonvulsants in the prior 60 days.
+Treatment with antibiotics within 2 weeks (14 days) of dosing
+Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Absolute neutrophil count (ANC) >= 1,000/mm^3\r\n* NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
+Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Platelets >= 75,000/mm^3\r\n* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
+Active infection =< 5 days prior to registration or fever > 38 degrees Celsius (C) on day of registration
+Clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
+Obtained within 28 days prior to registration: Platelets > 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
+Acute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 14 days prior to first dose of rucaparib
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to randomization and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to randomization
+Uncontrolled infection not responding to appropriate antimicrobial treatment after 7 days; study chair is the final arbiter
+AICD firing within the last 30 days
+Radiotherapy to any site for any reason within 28 days prior to treatment
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\r\n** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent\r\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Stem cell Infusions (with or without total body irradiation [TBI]):\r\n** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)\r\n** Autologous stem cell infusion including boost infusion: >= 42 days\r\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\r\n* Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; Note: Radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy\r\n* Patients must not have had prior exposure to tazemetostat or other inhibitor(s) of EZH2
+No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration
+Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Targeted therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrow
+Male subjects who are not employing an effective method of birth control from starting dose of durvalumab (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab; refrain from sperm donation while taking durvalumab and for at least 90 days after the last dose of durvalumab
+Platelets >= 100 x 10^9 cells/L (unsupported, defined as no platelet transfusion within 7 days)
+To be performed within 28 days prior to day 1 of protocol therapy: Normal eye examination
+If the subject has enzalutamide discontinuation for >7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in dosing of 28 days is required
+If the subject has enzalutamide discontinuation for <=7 days prior to dosing start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in dosing of 14 days is required
+Recent prior therapy, defined as: Any investigational or approved non-biologic anti-cancer drug (see exception below) within 14 days prior to the first dose of GSK525762 and abiraterone/enzalutamide. Exception: For allowed androgen deprivation therapy (hormonal, abiraterone, enzalutamide. Concomitant prednisone (or equivalent) allowed in combination with abiraterone dosing, any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK525762 and abiraterone/enzalutamide, any anti-cancer biologic agents within five half-lives prior to the first dose of GSK525762 and abiraterone/enzalutamide, if the subject received radiotherapy <90 days prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response. Exception: Any radiotherapy within 14 days prior to the first dose of GSK525762 and abiraterone/enzalutamide must be limited to a single fraction of radiotherapy for the purpose of palliation (confined to one field) is permitted, any major surgery within 28 days prior to the first dose of GSK525762 and abiraterone/enzalutamide
+Consumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the first dose of study treatment and during the study.
+Consumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the first dose of study treatment and during the study.
+Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within 14 days except for alkylating agents (e.g., melphalan) within 28 days.
+No prior therapy is allowed except for the following:\r\n* Short courses of corticosteroid (defined as =< 7 days of corticosteroids within the 4-weeks preceding registration) are allowed\r\n** Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible; previous courses of inhaled corticosteroids of any duration are allowed\r\n* A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration; if patient has received intrathecal (IT) cytarabine prior to informed consent for protocol treatment, day 1 IT cytarabine should not be administered\r\n* Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration
+Treatment with systemic corticosteroid or immune-modulators =< 30 days prior to randomization
+Radiotherapy within 14 days prior to first IMP administration.
+Within 14 days prior to registration: Total serum calcium (corrected for serum albumin as needed) or ionized calcium within institution’s normal range
+Within 14 days prior to registration: Magnesium within institution’s normal range
+The patient must have failed at least one prior therapy - surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy - prior to study registration; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks prior if nitrosourea\r\n* Biologic agent: Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study registration\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended to beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n** For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration\r\n* Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration\r\n* For bevacizumab, patients must have received last dose >= 32 days prior to study registration\r\n* Bone marrow transplant: Patient must be:\r\n** >= 6 months since allogeneic bone marrow transplant prior to registration\r\n** >= 3 months since autologous bone marrow/stem cell prior to registration
+Anti-measles virus immunity as demonstrated by IgG anti-measles antibody per institutional guidelines (within 21 days prior to study registration)
+Within 28 days of study registration: Platelets >= 100,000 cells/mm^3 (independent of blood transfusion and/or growth factors within 3 months prior to registration)
+Within 28 days of study registration: Potassium >= 3.5 mmol/L
+Fiberoptic exam with laryngopharyngoscopy within 28 days prior to registration
+Any approved AML-related therapy within 14 days prior to enrollment
+Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy
+The subject has received radiation therapy:\r\n* To bone metastasis within 14 days before the first dose of study treatment \r\n* To any other site(s) within 28 days before the first dose of study treatment
+Serum potassium, magnesium, and calcium levels within 28 days before randomization must be within normal limits (WNL) for the lab within 28 days before randomization
+Patients must have adequate organ and bone marrow function =< 14 days prior to registration, as defined below (Note: blood transfusion or growth factors is not permitted within 14 days of registration):
+Subjects under the age of 18 must have had prior therapy according to the best available therapy as determined by their primary brain tumor specialist (to include oncology, neurosurgery and/or radiation oncology) including systemic and/or cranial or spinal radiation or chemotherapy; subjects over the age of 18 may be enrolled as part of first-line treatment; those subjects who enroll as first-line treatment will not be restricted from traditional treatments in the future; at least 14 days must have elapsed since completion of cranial radiotherapy and 28 days since completion of chemotherapy; at least 28 days must have elapsed since completion of total spine radiotherapy
+Subjects with no previous radiotherapy treatment must have a consultation with a radiation oncologist or providers must have a discussion in the context of Neuro-Oncology Tumor Board within 60 days prior to start of IA/BBBD chemotherapy to determine the need for radiotherapy prior to or after IA/BBBD
+Prior immunotherapy
+Patients must have fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study\r\n* Myelosuppressive chemotherapy:\r\n** No waiting period will be required for patients receiving standard \maintenance-like\ chemotherapy including oral mercaptopurine, weekly low-dose oral methotrexate, and intermittent vincristine; otherwise, at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exceptions of hydroxyurea or corticosteroids used for cytoreduction\r\n** Intrathecal cytotoxic therapy: No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone; intrathecal chemotherapy given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* 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 completion of therapy with a biologic agent (including tyrosine kinase inhibitors); 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* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab; patients must have been off blinatumomab infusion for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria \r\n* >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or 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* At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion; patient must have had no more than one previous HSCT and currently have no evidence of active graft versus (vs.) host disease (GVHD)\r\n* At least 30 days must have elapsed from the last chimeric antigen receptor (CAR)-T cell infusion
+Patients must have fully recovered (to grade 1) from the acute toxic effects of all prior anti-cancer therapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\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; the duration of this interval must be discussed with the study chair\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* External beam radiation therapy (XRT): at least 7 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI) or if >= 50% radiation of pelvis; >= 14 days from whole brain radiation, craniospinal radiation, or targeted radiation to central nervous system (CNS) tumors; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Hematopoietic stem cell transplantation (HSCT): >= 56 days from stem cell transplant with no evidence of active graft versus (vs) host disease; must be off immunosuppressive therapy for at least 4 weeks and have no active graft-versus-host disease (GVHD) at the time of entry onto this trial\r\n* Surgery: >= 14 days from surgery\r\n* Others: >= 7 days from last dose of short active hematopoietic growth factors, i.e. filgrastim, >= 14 days for long-acting, i.e. pegfilgrastim\r\n* Steroids: patients with CNS tumors who are managed with steroids are eligible if they have no worsening neurologic deficits and are on a stable or decreasing dose of corticosteroids for greater than or equal to 7 days prior to registration; patients with leukemia receiving corticosteroids or hydroxyurea are eligible provided that the corticosteroids are not being used to manage GVHD and there has been no increase in corticosteroid of hydroxyurea dose for 7 days prior to starting PLX3397
+Concomitant medication restrictions\r\n* Growth factor(s): growth factors that support platelet or white cell number or function must not have been administered within 7 days prior to enrollment (14 days if Neulasta)\r\n* Corticosteroids: patients requiring corticosteroids should not be on a chronic dose; patients should be off steroid for at least 14 days prior to immunotherapy (IT) and they should not receive steroids during protocol treatment\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible
+ARM A: Any corticosteroid use =< 28 days prior to registration
+ARM A: Any radioembolization or transarterial chemoembolization (TACE) =< 84 days prior to registration
+ARM B: obtained =< 14 days prior to registration: \r\n* AST/ALT =< 2.5 x ULN
+ARM B: obtained =< 14 days prior to registration: \r\n* INR =< 1.5 x ULN
+ARM B: obtained =< 14 days prior to registration: \r\n* aPTT =< 1.5 x ULN
+ARM B: Any corticosteroid use =< 28 days prior to registration
+ARM B: Any radioembolization or TACE =< 84 days prior to registration
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
+Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: absolute neutrophil count (ANC) ? 1000 cells/ul (growth factor cannot be used within the previous 5 days)
+Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within the prior 21 days except for alkylating agents (e.g. melphalan) within the prior 28 days
+Obtained within 30 days prior to registration: Platelet > 100 k
+Patients who have had radiotherapy within 14 days prior to entering the study
+Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent such as steroids, retinoids; Note: for agents that have known adverse events occurring beyond 7 days after administration (i.e. monoclonal antibodies), this period must be extended beyond the time during which acute adverse events are known to occur
+Prior treatment with any other agent that may affect M-protein =< 30 days prior to registration
+ADDITIONAL CRITERIA FOR COHORTS 1A AND 1B PARTICIPANTS ONLY: No corticosteroid dosing within 5 days of study therapy initiation
+-  Patients must have a histologically confirmed diagnosis of invasive breast carcinoma\n             with positive estrogen and/or progesterone receptor status, and negative human\n             epidermal growth factor receptor (HER-2), for whom endocrine therapy is planned.\n\n          -  The HER-2 test result is negative (and should be reported as such), if a single test\n             (or all tests)performed in a tumor specimen show:\n\n               -  Immunohistochemistries (IHC) 1+ negative or IHC 0 negative or\n\n               -  in situ hybridization (ISH) negative using a single probe ISH or dual probe ISH.\n\n          -  Estrogen receptor (ER) and progesterone receptor (PgR) positivity must be assessed\n             according to American Society of Clinial Oncology (ASCO)/College of American\n             Physicians (CAP) guidelines as either ER or PR ? 1% positive nuclear staining. If HER2\n             IHC is 2+, an evaluation for gene amplification must be performed and the gene must\n             not be amplified. Gene amplification evaluation is not required if evaluation by IHC\n             is 0 or 1+ by institutional standards.\n\n          -  Patients must be post-menopausal women with a confirmed diagnosis of metastatic breast\n             cancer (M1). Pathologic confirmation of histology is preferable. In the case of bone\n             metastases only, biopsy-proven metastatic disease of solitary site, or multiple sites\n             of involvement are required. Post-menopausal is defined by one of the following\n             criteria as per National Comprehensive Cancer Network (NCCN) guidelines Version 3.\n             2013:\n\n               -  Prior bilateral oophorectomy and/or hysterectomy\n\n               -  Patients ? 60 years of age\n\n               -  Patients < 60 years of age and amenorrheic for ? 12 months in the absence of\n                  chemotherapy, tamoxifen, toremifene, or ovarian suppression and\n                  follicle-stimulating hormone (FSH) and estradiol in the post-menopausal range\n\n               -  Patients < 60 years of age taking tamoxifen or toremifene must have FSH and\n                  plasma estradiol levels within post-menopausal ranges\n\n          -  Patients must have measurable or evaluable disease. Patients must have a chest and\n             abdominal computerized tomography (CT) and bone scan within 28 days prior to\n             registration. All scans needed for assessment of measurable disease must be performed\n             within 28 days prior to registration. Evaluable disease must be assessed within 28\n             days prior to registration\n\n          -  Patients with a history of prior chemotherapy or hormone therapy or immunotherapy for\n             recurrent or metastatic disease are NOT eligible. Prior adjuvant or neoadjuvant\n             chemotherapy if completed more than 12 months prior to registration is acceptable. Any\n             number of prior hormonal therapy regimens for the adjuvant setting but not for\n             metastatic or recurrent disease is allowed; prior adjuvant or neoadjuvant treatment\n             with an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane) is allowed, if\n             completed more than 12 months prior to randomization.\n\n          -  Patients who have taken luteinizing hormone-releasing hormone (LHRH) analogue as\n             adjuvant therapy are eligible provided they have a) discontinued such therapy at least\n             12 months prior to registration AND b) have not resumed their menstrual periods.\n\n          -  Patients must not have had prior exposure to fulvestrant or mTOR inhibitors (e.g.,\n             rapamycin, everolimus, temsirolimus, deforolimus). Concurrent bisphosphonate therapy\n             is allowed. Patients must not have prior treatment with any investigational drug\n             within 28 days prior to registration and must not be planning to receive any other\n             investigational drug for the duration of the study.\n\n          -  Patients must have an International Normalized Ratio (INR) ? 1.6 within 28 days prior\n             to registration.\n\n          -  Patients must have adequate bone marrow function, as defined by Absolute Neutrophil\n             Count (ANC) of ? 1,500/mL, hemoglobin ? 9 g/dL and a peripheral platelet count ?\n             100,000/ mL, all within 28 days prior to registration.\n\n          -  Patients must have adequate hepatic function obtained within 28 days prior to\n             registration and documented by all of the following:\n\n               -  Bilirubin ? 1.5 mg/dL (or ? 3.0 mg/dL if due to Gilbert's Syndrome)\n\n               -  alanine aminotransferase (ALT) (SGPT) and aspartate aminotransferase (AST) (SGOT)\n                  ? 2.5 x Institutional Upper Limit of Normal (IULN), or ? 5 x IULN if hepatic\n                  metastases are present.\n\n          -  Patients must have adequate renal function with serum creatinine level ? IULN within\n             28 days prior to registration.\n\n          -  Patients must have a fasting cholesterol ? 300 mg/dL and triglycerides ? 2.5 x IULN\n             obtained within 28 days prior to registration. Patients may be on lipid lowering\n             agents to reach these values.\n\n          -  Patients must have a complete history and physical examination within 28 days prior to\n             registration.\n\n          -  Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC],\n             clotting factor deficiency) or long-term anti-coagulant therapy (other than\n             antiplatelet therapy) are NOT eligible.\n\n          -  Patients with presence of life-threatening metastatic visceral disease, defined as\n             extensive hepatic involvement, or any degree of brain or leptomeningeal involvement\n             (past or present), or symptomatic pulmonary lymphangitic spread are not eligible.\n             Patients with discrete pulmonary parenchymal metastases are eligible, provided their\n             respiratory function is not significantly compromised as a result of disease in the\n             opinion of the investigator.\n\n          -  Patients must have a performance status of 0 - 2 by Zubrod criteria.\n\n          -  Patients must not have any Grade III/IV cardiac disease as defined by the New York\n             Heart Association Criteria (i.e., patients with cardiac disease resulting in marked\n             limitation of physical activity or resulting in inability to carry on any physical\n             activity without discomfort), unstable angina pectoris, myocardial infarction within 6\n             months, or serious uncontrolled cardiac arrhythmia.\n\n          -  Patients must not have uncontrolled diabetes (defined as an Hg A1C >7% within 28 days\n             prior to registration).\n\n          -  Patients must not have an organ allograft or other history of immune compromise.\n             Patients must not be receiving chronic, systemic treatment with corticosteroids or\n             other immunosuppressive agent. Topical or inhaled corticosteroids are allowed.\n\n          -  Patients known to be HIV positive may be enrolled if baseline CD4 count is > 500\n             cells/mm3 AND not taking anti-retroviral therapy. Patients with known chronic or\n             active hepatitis are not eligible. Patients must not have any known uncontrolled\n             underlying pulmonary disease.\n\n          -  Patients must be able to take oral medications. Patient may not have any impairment of\n             gastrointestinal function or gastrointestinal disease that may significantly alter the\n             absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting,\n             diarrhea, malabsorption syndrome or small bowel resection).\n\n          -  Patients must not have received immunization with an attenuated live vaccine (e.g.\n             intranasal influenza, MMR, oral polio, varicella, zoster, yellow fever and BCG\n             vaccines) within seven days prior to registration nor have plans to receive such\n             vaccination while on protocol treatment.\n\n          -  Patients must not have taken within 14 days prior to registration, be taking, nor plan\n             to take while on protocol treatment, strong CYP3A4 inhibitors, and/or CYP3A4 inducers.\n\n          -  No other prior malignancy is allowed except for adequately treated basal cell or\n             squamous cell skin cancer, in situ cervical cancer or other cancer for which the\n             patient has been disease-free for 5 years.
+At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen
+No prior therapy is allowed except for the following:\r\n* Corticosteroids: short courses of corticosteroid (defined as =< 7 days of corticosteroids within the 4 weeks preceding registration) are allowed prior to registration; note: if patient has received pre-treatment with corticosteroids, they should not receive steroid prophase\r\n** Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4 weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible\r\n* IT cytarabine: a single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration; if patient has received IT cytarabine prior to registration, day 1 IT cytarabine should not be administered\r\n* Emergent radiation therapy: emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration
+Participants who have received more than 7 days of corticosteroids in the preceding 4 weeks or more than 28 days of corticosteroids in the preceding 6 months are not eligible
+All cytokines or hematopoietic growth factors must be discontinued a minimum of 7 days prior to protocol therapy
+Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study registration
+Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment
+Radiotherapy =< 14 days prior to registration\r\n* NOTE: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of study drugs
+Chronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapy
+Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis < 7 days prior to the start of treatment on protocol (day -7)
+Patients who have been off of FOLFIRINOX more than 70 days prior to treatment on study
+Aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
+Patients must have an eye exam performed within 28 days prior to sub-study registration; patients with uncontrolled glaucoma or intra-ocular pressure >= 21 mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to registration
+Patients must have albumin, urinalysis, and Troponin I obtained within 7 days prior to sub-study registration
+Patients must have corrected calcium and phosphate < upper limit or normal (ULN) obtained within 7 days prior to sub-study registration
+Patients must have albumin, urinalysis, and Troponin I obtained within 7 days prior to substudy registration
+Patients must have corrected calcium and phosphate < ULN obtained within 7 days prior to sub-study registration
+Patients must have MUGA/echocardiogram performed within 28 days prior to sub-study registration
+Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
+Patients must have a sodium (Na), potassium (K), chlorine (Cl), calcium (Ca), magnesium (Mg), and glycosylated hemoglobin measurement (HbA1c) performed within 7 days prior to sub-study registration
+Patients must have a Na, K, Cl, Ca, Mg, and HbA1c performed within 7 days prior to sub-study registration
+Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); 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
+Cytogenetics, fluorescence in situ hybridization (FISH) or mutational analysis confirming adverse risk features must have been done within 90 days prior to enrollment
+Within 14 days of subject registration: Serum creatinine =< 1.5 X IULN
+Within 14 days of subject registration: Potassium, calcium (corrected for serum albumin) and magnesium within IULN
+Systemic chemotherapy washout period >= 7 days; for investigational dugs and monoclonal antibodies washout period >= 5 x drug half-life; there are no limitations on number of prior treatment regimens
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\r\n* Biologic (anti-neoplastic agent): at least 14 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\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 (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal and/or entire spinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion
+Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair
+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; the duration of this interval must be discussed with the study chair
+Patients receiving chronically dosed corticosteroids within 7 days prior to enrollment are not eligible for this trial
+Serum direct bilirubin (DB) =< 1.5 times ULN within 14 days prior to admission
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy:\r\n** Solid tumors (Part A and Part B): at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Acute lymphoblastic leukemias (ALL) (Part C):\r\n*** Patients with leukemia who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study\r\n*** Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy, with the exception of hydroxyurea\r\n*** Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of BMN 673\r\n*** Note: patients with leukemia are permitted to receive intrathecal chemotherapy, including methotrexate or cytarabine; intrathecal therapy should be restricted to days 15 and 22 of each 28 day cycle \r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\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 (XRT): at least 14 days after local palliative XRT (small port); at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; patients with prior total body irradiation (TBI), craniospinal XRT and/or >= 50% radiation of the pelvis are not eligible\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion
+At least 60 days must have passed since the first cell infusion and the subject must not have experienced a dose limiting toxicity (DLT) in this time
+Neurologic symptoms or imaging findings that necessitate the use of steroids on the day of enrollment or in the prior 7 days
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+Absolute neutrophil count (ANC) >= 1.0 x 10^9/L without use of pegfilgrastim in the preceding 21 days and without non-pegylated filgrastim (G-CSF) or sargramostim (GM-CSF) within 7 days prior to study entry
+Platelets >= 70 x 10^9/L without platelet transfusion 7 days prior to study entry
+At least 7 days must have passed since the last treatment with lenalidomide, pomalidomide, thalidomide, proteasome inhibitors, or low dose cyclophosphamide (up to 50 mg daily), at least 21 days must have passed since the last treatment with daratumumab, elotuzumab, investigational therapy and most conventional chemotherapy including cyclophosphamide, bendamustine, doxorubicin, cisplatin, and etoposide; and at least 35 days since the last treatment with melphalan
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Patients must be enrolled on study within 31 days of definitive surgical resection at which time tissue is acquired to determine a diagnosis; patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than five (5) calendar days after the date of study enrollment; patients who are started on protocol therapy on a Phase II study prior to study enrollment will be considered ineligible
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 14 days prior to enrollment and/or daily or weekly chemotherapy with the potential for delayed toxicity within 14 days prior to enrollment
+Prior recent systemic or investigational therapy within 21 days of initiation of study treatment; an exception is that EGFR inhibitor may be continued up until 3 days of initiation of study treatment
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 28 days prior to randomization and/or daily or weekly chemotherapy or other approved anti-myeloma therapy without the potential for delayed toxicity within 14 days prior to registration
+Patients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for review
+Patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
+Patients must have baseline skeletal survey to document lytic lesions, osteopenia or compression fracture within 28 days prior to registration
+At least 14 days and no more than 28 days must have elapsed between the last day of treatment on Arm 1 and registration to Arm 3
+Patients must have serum protein electrophoresis (SPEP) and kappa and lambda light chain testing performed within 14 days prior to registration in order to establish baseline measurements
+Relapse must have occurred >= 60 days after transplant
+Prior DLI is allowed, however not within the 30 days before the 1st dose of ALT-803
+> 10% lymphoplasmacytic cells (measured within 28 days prior to registration OR
+Prior irradiation is allowed if > 28 days prior to registration have elapsed since\n             the date of last treatment.
+Patients asking or who have had prior treatment with a drug like vorinostat (i.e., valproic acid) within the last 30 days
+Patients must have an expected survival of > 60 days and must be free of major infection
+Urinalysis within 14 days demonstrating no evidence of a urinary tract infection
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* Myelosuppressive chemotherapy:  \r\n** Solid tumors: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** ALCL:\r\n*** Patients with ALCL who relapse while receiving standard maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study\r\n*** Patients who relapse while they are not receiving standard maintenance therapy, must have fully recovered from all acute toxic effects of prior therapy; at least 14 days must have elapsed after the completion of cytotoxic therapy\r\n* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\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; the duration of this interval must be discussed with the study chair\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 (XRT):  \r\n** Solid tumors: at least 14 days after local palliative XRT (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n** ALCL: at least 14 days after local palliative XRT (small port); at least 84 days must have elapsed if prior TBI, craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial BM radiation\r\n* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant and >= 42 days for autologous stem cell infusion after iodine (I)131-MIBG therapy\r\n* Patients must not have received prior therapy with crizotinib\r\n* Prior anthracycline dose: patients with a total lifetime cumulative anthracycline dose of > 650 mg/m^2 at the time of enrollment are not eligible for Part B of the study
+Patients with an active infection or with a fever >= 101.3 degrees Fahrenheit (F) within 3 days of the first scheduled day of protocol treatment
+Any of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Radiation to > 25% of bone marrow
+Pretreatment lab values must be performed within 14 days of patient registration unless otherwise specified; other baseline studies must be performed within 30 days of registration
+The following pre-study tests should be obtained within 14 days prior to registration in accordance with good medical practice; results of these tests do not determine eligibility and minor deviations are acceptable if they do not impact patient safety in the judgment of the treating physician:
+Serum electrolytes including sodium, potassium, blood urea nitrogen (BUN), creatinine, glucose, magnesium, phosphate, and calcium within 10 days prior to registration
+At least 7 days since the completion of therapy with a growth factor
+At least 7 days since the completion of therapy with 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; the duration of this interval must be discussed with the study chair
+Patients must have an expected survival of > 60 days and must be free of major infection
+Expected survival if untreated less than 60 days
+cytotoxic agents (e.g. Mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted between 14 to 60 days prior to beginning study treatment
+Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ? 50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
+Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)
+Hematopoietic cell transplantation (At least 60 days from infusion of hematopoietic cells prior to first dose of tazemetostat)
+Radiotherapy within 7 days of study treatment
+Radiotherapy within 14 days of study treatment
+Subject has had prior treatment with biologic antineoplastic agents less than 7 days before the first dose of lenalidomide. For agents that have known Adverse Events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.
+Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ? 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed).
+A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy
+The following tests must be performed within 42 days prior to registration either for diagnosis/staging or to obtain baseline values:\r\n* White blood cells (WBC)\r\n* Hemoglobin\r\n* Lactate dehydrogenase (LDH)\r\n* Hepatitis B-surface antigen (Ag) and anti-core antibody (Ab)
+Evidence of myeloid engraftment (eg, absolute neutrophil count ? 0.5 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
+Radiotherapy within 14 days of randomization
+Discontinuation of all drugs used to treat underlying MF disease at least 7 days prior to baseline visit
+Patients receiving sirolimus (for any indication including GVHD prophylaxis) within 14 days of screening for enrollment.
+Active or recent (within 7 days) episode of transplant associated microangiopathy.
+Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment
+Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to registration
+Platelet count ? 30,000 cells/?L without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
+Have undergone major surgery within 28 days (?28 days) prior to randomization or subcutaneous venous access device placement within 7 days (?7 days) prior to randomization.
+Requiring corticosteroids or anticonvulsants in the prior 60 days
+Radiotherapy within the last 28 days prior to the first RO6958688 infusion with the exception of limited-field palliative radiotherapy.
+The last dose of trastuzumab must have been given >2 weeks and ?1 year (365 days) from enrollment
+Performed within 14 days of patient registration: Serum creatinine =< 1.5 x IULN
+Performed within 14 days of patient registration: Serum potassium > 3.8 mmol/L (can be achieved with replacement)
+Receipt of intravenous antibiotics for infection within 7 days prior to enrollment
+Minimum of 14 days elapsed since the end of any prior therapy
+Must be relapsed or refractory after 1 or 2 prior therapies. For this protocol, relapsed is defined as progressive disease (PD) documented more than 60 days after last dose; refractory is defined as documented absence of hematologic response or hematologic progression on or within 60 days after last dose of prior therapy.
+Inclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study (with the\n        enrollment date defined as the date in which the subject is assigned a cohort in Integrated\n        Response Technology [IRT]) and receive their first dose of luspatercept:\n\n          1. Subject is ?18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Subject has Myeloproliferative neoplasm (MPN)-associated myelofibrosis (PMF, post-\n             Post-polycythemia vera myelofibrosis (PV MF), and/or Post-essential thrombocythemia\n             myelofibrosis (post-ET MF)) as confirmed from the most recent local bone marrow biopsy\n             report according to the World Health Organization 2016 criteria.\n\n          3. Subject has anemia defined as:\n\n               1. Cohorts 1 and 3A\n\n                    -  Obtain ? 3 Hemoglobin (Hgb) levels of ? 9.5 g/dL recorded on ? 3 different\n                       days, including the day of dosing, in the 84-day period immediately up to\n                       the C1D1 date. There must be ? 14 days in between each Hgb measurement. No\n                       subjects with an interval ? 42 days between hemoglobin measurements will be\n                       enrolled.\n\n                    -  There must not be any Red blood cell (RBC) transfusions within the 84-day\n                       period immediately up to the C1D1 date.\n\n               2. Cohorts 2 and 3B\n\n                    -  Average RBC-transfusion frequency: 2 to 4 RBC units/28 days over at least\n                       the 84 days immediately up to the C1D1 date. There must be no interval > 42\n                       days without ? 1 RBC-transfusion.\n\n                    -  Subjects must have a Hgb value of < 13 g/dL on C1D1 prior to luspatercept\n                       administration.\n\n                    -  Only RBC transfusions given when the Hgb ? 9.5 g/dL are scored in\n                       determining eligibility.\n\n                    -  RBC transfusions given because of bleeding, infection, or chemotherapy\n                       induced anemia are not scored in determining eligibility.\n\n          4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ? 2.\n\n          5. Subject is not anticipated during the 6 months from the C1D1 date to receive a\n             hematopoietic cell transplant.\n\n          6. A female of childbearing potential (FCBP) for this study is defined as a female who:\n             1) has achieved menarche at some point, 2) has not undergone a hysterectomy or\n             bilateral therapy does not rule out childbearing potential) for at least 24\n             consecutive months (ie, has had menses at any time in the preceding 24 consecutive\n             months). FCBP participating in the study must:\n\n               1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting\n                  study therapy. She must agree to ongoing pregnancy testing during the course of\n                  the study, and after end of study treatment. This applies even if the subject\n                  practices true abstinence* from heterosexual contact.\n\n               2. Either commit to true abstinence* from heterosexual contact (which must be\n                  reviewed on a monthly basis and source documented) or agree to use, and be able\n                  to comply with, effective contraception** without interruption, 28 days prior to\n                  starting investigational product, during the study therapy (including dose\n                  interruptions), and for 12 weeks (approximately 5 times the mean terminal\n                  halflife of luspatercept based on multiple-dose pharmacokinetics [PK] data) after\n                  discontinuation of study therapy.\n\n          7. Male subjects must:\n\n             a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to\n             use a condom during sexual contact with a pregnant female or a female of childbearing\n             potential while participating in the study, during dose interruptions and for at least\n             12 weeks (approximately 5 times the mean terminal half-life of luspatercept based on\n             multiple-dose PK data) following investigational product discontinuation, even if he\n             has undergone a successful vasectomy\n\n          8. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          9. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment (with the\n        enrollment date defined as the date in which the subject is assigned a cohort in Integrated\n        Response Technology (IRT)):\n\n          1. Subject use of hydroxyurea or other drugs with potential effects on hematopoiesis or\n             ongoing adverse events from previous treatment ? 112 days immediately up to the\n             enrollment date.\n\n             a. Systemic corticosteroids are permitted for nonhematological conditions providing\n             the subject is receiving a stable or decreasing dose for ? 84 days immediately up to\n             enrollment and is receiving a constant dose equivalent to ? 10 mg prednisone for the\n             28 days immediately up to enrollment.\n\n          2. Cohort 1 and 2 only: subjects treated with Janus kinase 2 gene (JAK2) inhibitors ? 112\n             days immediately up to the enrollment date or if anticipated/substantial likelihood\n             for subject to receive ruxolitinib within the first 168 days on the study.\n\n          3. Cohort 3 only: subjects not receiving a stable dose of ruxolitinib as part of their\n             standard-of-care therapy for 112 days immediately up to the enrollment date.\n\n          4. Subject use of ESAs or androgenic steroids ? 112 days immediately up to the enrollment\n             date.\n\n          5. Initiation of iron chelation therapy (ICT) or change with ICT dose within ? 112 days\n             up to the enrollment date.\n\n          6. Subject with anemia from iron deficiency, B12 and folate deficiencies, hemolytic\n             anemia, infection, or bleeding.\n\n          7. Pregnant or breastfeeding females.\n\n          8. Subject with blood myeloblasts ? 5%.\n\n          9. Subject with major surgery within 8 weeks up to the enrollment date. Subject must have\n             completely recovered from any previous surgery immediately up to the enrollment date.\n\n         10. Subject with prior history of malignancies, other than disease under study, unless the\n             subject has been free of the disease for ? 5 years. However, subject with the\n             following history/concurrent conditions is allowed:\n\n               -  Basal or squamous cell carcinoma of the skin\n\n               -  Carcinoma in situ of the cervix\n\n               -  Carcinoma in situ of the breast\n\n               -  Incidental histologic finding of prostate cancer (T1a or T1b using the tumor,\n                  nodes, metastasis [TNM] clinical staging system)\n\n         11. Subject with prior therapy of luspatercept or sotatercept.\n\n         12. Subject participation in any other clinical protocol or investigational trial that\n             involves administration of experimental therapy and/or therapeutic devices within 30\n             days immediately up to the enrollment date.\n\n         13. Subject with prior hematopoietic cell transplant.\n\n         14. Subject with any of the following laboratory abnormalities:\n\n               -  Neutrophils < 1 x 109/L\n\n               -  White blood count (WBC) > 100 x 109/L\n\n               -  Platelets\n\n                    -  Cohorts 1 and 2: < 25 x 109/L\n\n                    -  Cohort 3A and 3B: < 50 x 109/L\n\n                    -  All Cohorts: > 1000 x 109/L\n\n               -  Estimated glomerular filtration rate < 45 mL/min/1.73 m2 (via the 4-variable\n                  modification of diet in renal disease [Modification of diet in renal disease\n                  (MDRD)] formula)\n\n               -  Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3.0 x upper\n                  limit of normal (ULN)\n\n               -  Direct bilirubin ? 2 x ULN\n\n                  o higher levels are acceptable if these can be attributed to active red blood\n                  cell precursor destruction within the bone marrow (ie, ineffective\n                  erythropoiesis)\n\n               -  Uncontrolled hyperthyroidism or hypothyroidism\n\n         15. Subject with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6\n             months immediately up to the enrollment date.\n\n         16. Subject with diastolic blood pressure ? 90 mmHg or systolic blood pressure ? 140 mmHg\n             measured during the Screening Period despite appropriate treatment.\n\n         17. Subject with inadequately controlled heart disease and/or have a known left\n             ventricular ejection fraction <35%.\n\n         18. Subject with history of severe allergic or anaphylactic reactions or hypersensitivity\n             to recombinant proteins or excipients in the investigational product (see luspatercept\n             Investigator's Brochure (IB)).\n\n         19. Subject with uncontrolled systemic fungal, bacterial, or viral infection (defined as\n             ongoing signs/symptoms related to the infection without improvement despite\n             appropriate antibiotics, antiviral therapy, and/or other treatment).\n\n         20. Subject with human immunodeficiency virus (HIV), evidence of active infectious\n             Hepatitis B (HepB), and/or evidence of active Hepatitis C (HepC).\n\n         21. Subject with any significant medical condition, laboratory abnormality, psychiatric\n             illness, or is considered vulnerable by local regulations (eg, imprisoned or\n             institutionalized) that would prevent the subject from participating in the study.\n\n         22. Subject with any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study.\n\n         23. Subject with any condition or concomitant medication that confounds the ability to\n             interpret data from the study.\n\n         24. Subject on anticoagulant therapy not under appropriate control or subject not on a\n             stable dose of anticoagulant therapy for ? 8 weeks up to the enrollment date.\n\n         25. Subject on anagrelide within 28 days immediately up to the enrollment date.\n\n         26. Subject with a major bleeding event (defined as symptomatic bleeding in a critical\n             area or organ and/or bleeding causing a decrease in hemoglobin of ? 2g/dL or leading\n             to transfusion of ? 2 units of packed red cells) in the last 6 months prior to\n             enrollment.
+Prior AML or ALL therapy (non-experimental) within 28 days of first dose of ONO-7475 (except those permitted in the protocol)
+Prior radiotherapy within 21 days of screening. Localized radiation therapy to a single site within the last 7 days is acceptable. Concurrent radiotherapy is not permitted.
+Patients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to cycle 1 day 1 or those patients who have not recovered adequately from side effects of such therapy
+Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
+No active or recent hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration
+Subjects with a history of bleeding related to cancer under study requiring a medical intervention (eg, embolization procedure, RBC transfusion, or hospitalization) within 30 days of study enrollment (Treatment Groups B and C only).
+? 28 days elapsed from the administration of any prior cytotoxic agents, except ? 14 days from vincristine, ? 21 days from procarbazine, and ? 42 days from nitrosureas
+? 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid)
+A minimum of 28 days must have elapsed from the day of surgery to first dose of the study drug. For core or needle biopsy, a minimum of 7 days must have elapsed prior to study entry
+Subject has received prior therapy for cancer or major surgery within 28 days, or 42 days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1, or 14 days for tamoxifen;
+Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab.
+Completed palliative radiotherapy within 7 days of the first dose of study medication.
+Serum creatinine =< IULN within 14 days prior to registration
+CA19-9 must be performed within 14 days prior to registration
+Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
+Agreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
+Requiring corticosteroids or anticonvulsants in the prior 60 days
+Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
+Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
+At least 14 days for stereotactic radiosurgery
+Autologous hematopoietic cell infusion after high dose therapy At least 60 days
+Hematopoietic growth factor At least 14 days
+Is unwilling to adhere to contraception criteria from time of enrollment in study to at least 30 days after last dose of IP.
+Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
+Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration
+Patients must have CA19-9 obtained within 14 days prior to registration; if CA19-9 is normal a carcinoembryonic antigen (CEA) must be tested within 14 days prior to registration
+Patients must have blood urea nitrogen (BUN), alkaline phosphatase, sodium, potassium, calcium, glucose, chloride, and bicarbonate levels obtained within 14 days prior to registration
+Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP. c. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP. d. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab. A female subject of childbearing potential (FCBP) is a female who:
+Potassium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
+Total calcium (corrected for serum calcium) =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
+Magnesium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
+Sodium =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
+Phosphorus =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
+Treatment with erlotinib must be discontinued at least 3 days prior to first dose of tesevatinib and treatment with afatinib or other tyrosine kinase inhibitor must be discontinued at least 3 days prior to first dose of tesevatinib
+Completed treatment with systemic corticosteroid or immune-modulators < 30 days prior to registration;
+Patients who have had grade 2 or higher diarrhea, despite optimal antidiarrheal supportive care, within 7 days prior to registration are not eligible
+Digital rectal exam within 90 days of registration on study
+Hemoptysis >1 teaspoon in 24 hours within the last 28 days.
+Patients must be off all non-transfusion therapy for MDS for 28 days prior to initiation of study treatment, including all types of growth factors; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
+Total bilirubin =< 2.0 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction
+Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose
+Inclusion Criteria:\n\n        In order to be eligible for participation in this trial, the patient must:\n\n          1. Have histologically or cytologically confirmed small cell lung cancer. Confirmation\n             will be done at each participating site.\n\n          2. Have relapsed or progressed after only one prior chemotherapy regimen, which must have\n             been an etoposide-platinum doublet. Eligible patients will be defined as follows:\n\n             \Sensitive\ Disease: Patients who had one previous line of chemotherapy and relapsed\n             after > 60 days of completion of treatment.\n\n             \Refractory\ Disease: Patients with no response to first-line chemotherapy or\n             progression >60 days after completing treatment.\n\n          3. Be ? 18 years of age on day of signing informed consent.\n\n          4. Have a life expectancy of at least 3 months.\n\n          5. Have a performance status of ? 1 on the ECOG Performance Scale.\n\n          6. Have measurable disease based on RECIST 1.1.\n\n          7. Have a tumor tissue specimen available from either a core or excisional biopsy. The\n             tumor specimen should be of adequate size and tumor cellularity to perform whole exome\n             sequencing and immunohistochemistry. In subjects for whom newly obtained samples\n             cannot be obtained (e.g. tumor inaccessible or safety concern), archived tissue may be\n             submitted, if it otherwise satisfies all specimen criteria. Archival samples must have\n             been obtained within 42 days prior to signing consent (please refer to section 12.1 of\n             protocol).\n\n          8. Demonstrate adequate organ function as defined in Table 1.\n\n             Table 1. Adequate Organ Function Laboratory Values System Laboratory Value\n             Hematological Absolute neutrophil count (ANC) ?1,500 /mcL Platelets ?100,000 / mcL\n             Hemoglobin ?8 g/dL (without transfusion) Renal Serum creatinine\n\n             OR\n\n             Glomerular Filtration Rate (GFR) ?1.5 X upper limit of normal (ULN)\n\n             OR\n\n             GFR ?60 mL/min* for patient with creatinine levels > 1.5 X institutional ULN Hepatic\n             Serum total bilirubin ? 1.5 X ULN\n\n             OR\n\n             Direct bilirubin ? ULN for patients with total bilirubin levels > 1.5 ULN AST (SGOT)\n             and ALT (SGPT) ? 2.5 X ULN\n\n             OR\n\n             ? 5 X ULN for patients with liver metastases Albumin ? 2.5 mg/dL\n\n             *GFR should be calculated per institutional standards.\n\n          9. Female patients of childbearing potential should have a negative urine or serum\n             pregnancy within 72 hours of starting treatment. If the urine test is positive or\n             cannot be confirmed as negative, a serum pregnancy test will be required.\n\n         10. Female patients of childbearing potential must be willing to an adequate method of\n             contraception as outlined in Section 14.4.1 - Contraception for the course of the\n             study through 120 days after the last dose of study medication (see Section 13.4.1).\n             Patients of childbearing potential are those who have not been surgically sterilized\n             or have not been free from menses for > 1 year.\n\n             Note: Abstinence is acceptable if this is the usual lifestyle and preferred\n             contraception for the subject.\n\n         11. Male patients must agree to use an adequate method of contraception as outlined in\n             Section 14.4.1 - Contraception - starting with the first dose of study therapy through\n             120 days after the last dose of study therapy. Note: Abstinence is acceptable if this\n             is the usual lifestyle and preferred contraception for the subject.\n\n        Exclusion Criteria:\n\n          -  The patient must be excluded from participating in the trial if the patient:\n\n               1. Is currently participating in or has participated in a study of an\n                  investigational agent or using an investigational device within 14 days of the\n                  first dose of treatment.\n\n               2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or\n                  any other form of immunosuppressive therapy within 7 days prior to the first dose\n                  of trial treatment.\n\n               3. Has had a prior monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or\n                  who has not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to\n                  agents administered more than 14 days earlier.\n\n               4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy\n                  within 2 weeks prior to study Day 1 or who has not recovered (i.e., ? Grade 1 or\n                  at baseline) from adverse events due to a previously administered agent.\n\n                  Note: Patients with ? Grade 2 neuropathy or ? Grade 2 alopecia are an exception\n                  to this criterion and may qualify for the study.\n\n               5. Has undergone major surgery, he/she must have recovered adequately from the\n                  toxicity and/or complications from the intervention prior to starting therapy.\n\n               6. Has a known additional malignancy that is progressing or requires active\n                  treatment.\n\n               7. Has known active central nervous system (CNS) metastases. Patients with\n                  previously treated brain metastases may participate provided they are stable\n                  (without evidence of progression by imaging for at least four weeks prior to the\n                  first dose of trial treatment and any neurologic symptoms have returned to\n                  baseline), have no evidence of new or enlarging brain metastases, and are not\n                  using steroids for at least 7 days prior to trial treatment.\n\n               8. Has known carcinomatous meningitis.\n\n               9. Has an active autoimmune disease requiring systemic treatment in the past 2 years\n                  or a documented history of clinically severe autoimmune disease, or a syndrome\n                  that requires systemic steroids or immunosuppressive agents. Patients with\n                  vitiligo or resolved childhood asthma/atopy would be an exception to this rule.\n                  Patients that require intermittent use of bronchodilators or local steroid\n                  injections would not be excluded from the study. Patients with hypothyroidism\n                  stable on hormone replacement or Sjorgen's syndrome will not be excluded from the\n                  study.\n\n              10. Has evidence of interstitial lung disease, or history of (non-infectious)\n                  pneumonitis that required steroids, or current pneumonitis.\n\n              11. Has an active infection requiring systemic therapy.\n\n              12. Has a history or current evidence of any condition, therapy, or laboratory\n                  abnormality that might confound the results of the trial, interfere with the\n                  patient's participation for the full duration of the trial, or is not in the best\n                  interest of the patient to participate, in the opinion of the treating\n                  investigator.\n\n              13. Has known psychiatric or substance abuse disorders that would interfere with\n                  cooperation with the requirements of the trial.\n\n              14. Is pregnant or breastfeeding, or expecting to conceive or father children within\n                  the projected duration of the trial, starting with the pre-screening or screening\n                  visit through 120 days after the last dose of trial treatment.\n\n              15. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CD137, or\n                  anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including\n                  ipilimumab or any other antibody or drug specifically targeting T-cell\n                  co-stimulation or checkpoint pathways).\n\n              16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n\n              17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n                  [qualitative] is detected).\n\n              18. Has received a live vaccine within 30 days prior to the planned first dose of\n                  study therapy.\n\n                  Note: Seasonal influenza vaccines for injection are generally inactivated flu\n                  vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®)\n                  are live attenuated vaccines, and are not allowed.\n\n              19. Has a known history of active TB (Bacillus Tuberculosis).\n\n              20. Hypersensitivity to pembrolizumab or any of its excipients.
+Radiotherapy, at least 14 days from last local site radiotherapy
+Hematopoietic growth factor; at least 14 days from last dose
+ANC ?1000/mm3 (?1.0 × 109/L) without growth factor support for 14 days
+Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1
+Cryoablation should be performed within 14 days of screening visit
+Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608 and BBI503. Patients may begin BBI608 and BBI503 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse effects have resolved or have been deemed irreversible
+Patients who have, within 14 days prior to Day 1 dosing:
+Laboratory results within 7 days prior to MRZ administration (transfusions and/or growth factor support may not be used to meet this criteria):
+Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 14 days of the first dose of BBI608, except for BBI608 for which a washout period is not required.
+Patients planning to take a vacation for 7 or more consecutive days during the course of the study.
+Patients must have at least one metastatic lesion that can be followed on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with 99mTc labelled diphosphonates
+Contraception is recommended for 28 days prior to starting therapy, while participating in this study, during dose interruptions, and for at least 3 days after discontinuation of ibrutinib, 28 days after discontinuation of lenalidomide, and 12 months after discontinuation of rituximab
+Patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbopoeitin which require at least 14 days prior to screening and randomization
+Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert’s disease
+Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
+Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
+Patients must have newly diagnosed active multiple myeloma (MM); except where otherwise indicated below that assessment is required within 14 days, all tests for establishing baseline disease status must be completed within 28 days prior to registration for patients with no prior therapy, or within 28 days prior to initiation of first Induction course for patients with prior therapy
+Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
+Lymphocyte count >= 0.5 x 10^9/L, obtained within 14 days prior to initiation of study treatment
+Patients with ECHO EF >= 45% within 28 days prior to registration
+Radiotherapy within 28 days of randomization
+At least 21 days since the last dose of bevacizumab, other antibody, or interferon.
+have had unprotected sexual intercourse within 30 days before study entry,
+Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608. Patients may begin BBI608 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse events (AEs) have resolved or have been deemed irreversible
+Platelet or packed red blood cell transfusion within 14 days of pre-treatment evaluation
+Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.
+Tamoxifen therapy less than 14 days before first dose of study treatment
+Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
+Prior cell therapy for relapse within the past 90 days
+Patients must be registered within 35 days of completion of chemoradiation
+Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 7 days prior to registration
+Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment
+Platelets >= 75 x 10^9/L (no platelet transfusion within past 14 days)
+Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
+Evaluation by a medical oncologist within 45 days prior to study registration
+Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.
+Prior EGFR inhibitor within 6 days; received prior treatment with any other agent with antitumor activity chemotherapy, radiotherapy, or immunotherapy within 14 days; any investigational therapy within 28 days or 5 half-lives, whichever is shorter; blood transfusion or hemopoietic factor within 14 days; major surgery within 14 days; any strong CYP3A4 inhibitors within 7 days
+Evidence of nonhealing wounds, ulcers, or bone fractures within 28 days prior to study entry.
+Investigation or cytotoxic therapy within 28 days or nitrosoureas within 42 days of the first treatment with G-202
+Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax
+Presence of uncontrolled seizures =< 5 days prior first drug dose, defined as status epilepticus or multiple seizures not responding to appropriate therapy
+Insufficient time for recovery from prior therapy:\r\n* Less than 28 days from WBRT or SRS;\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine, irinotecan or topotecan administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. \r\n* When radiation necrosis is suspected, standard of care (SOC) confirmatory imaging, such as MRI perfusion, magnetic resonance (MR) spectroscopy and or positron emission tomography (PET) will be performed, and patients with findings consistent with radiation necrosis will be excluded
+Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
+No experimental medications within 30 days of study entry
+Radiotherapy within 28 days prior to first dose.
+Patients must have an expected survival of > 60 days and must be free of major infection
+Use of erectile dysfunction drugs (e.g., Cialis, Viagra) within 14 days prior to treatment or during study
+At least 14 days must have elapsed since completion of myelosuppressive therapy
+At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid
+Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days of entry on this study; seven days must have elapsed since administration of a short acting myeloid growth factor
+Gastric or esophageal varices that require interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.
+Measurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma; baseline scans used for measurement should be obtained within 30 days of registration, and baseline bone marrow biopsy and/or aspiration should be obtained with 90 days of registration
+Use of biologic response modifiers within 60 days of first dosing
+Bone marrow cellularity of >= 50% of age defined normal values by core biopsy; cellularity must be evaluated within 90 days of the dosimetry infusion and at least 21 days after receiving any cytoreductive/myelosuppressive chemotherapy
+Patients must not be participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration
+Pregnancy tests must occur within 10-14 days and again within 24 hours prior to initiation of cycle 1 of lenalidomide; females of childbearing potential (FCBP) with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on lenalidomide therapy (including breaks in therapy); at discontinuation of lenalidomide and at day 28 post the last dose of lenalidomide; females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on lenalidomide therapy (including breaks in therapy), at discontinuation of lenalidomide and at day 14 and day 28 post the last dose of lenalidomide
+Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment
+Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment
+Patients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.
+Use of finasteride within 30 days prior to registration
+Use of dutasteride within 90 days prior to registration
+Willingness to maintain a low iodine diet for 12 days (starting 7 days prior to virus injection continuing until after the I131 radioiodine therapy on Day 5)
+Radiotherapy within 14 days prior to day 1 of protocol therapy
+Patient needing valproic acid during the study or within 5 days prior to first dose
+Need for transfusion within 14 days prior to the first dose of trial treatment
+Hydroxyurea for ? 14 days
+Preemptive treatment with retinoic acid prior to exclusion of APL ? 7 days
+Have an expected survival of > 60 days
+Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration
+The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
+Platelets (PLT) >= 50,000/uL; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment, obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug
+Current or recent (=< 90 days prior to randomization) endoluminal stent in the stomach, bowel, colon or rectum
+Colonoscopy, sigmoidoscopy, or proctoscopy =< 7 days prior to randomization
+Platelets > 100 k without transfusion support in the past 28 days
+Open wounds or unhealed fractures within 28 days of starting study treatment
+Platelets >= 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Inclusion Criteria: (All Subjects)\n\n          -  Male or female adult subjects ?18 years of age\n\n          -  Diagnosis of histologically or cytologically confirmed for:\n\n               -  For Schedule 1 and 2: advanced solid tumor malignancy that is refractory to\n                  standard therapy and/or for whom no further standard therapy is available\n\n               -  For Schedule 3: advanced/metastatic tumors for which mFOLFOX6 is appropriate, or\n                  advanced/metastatic tumors that may be sensitive to each component of mFOLFOX6 or\n                  sensitive to topoisomerase 1 inhibitors including pancreatic, colorectal,\n                  esophageal, gastric, bladder or ovarian cancer, triple-negative breast cancer,\n                  small cell lung cancer (SCLC), cholangiocarcinoma, among others\n\n          -  For Schedules 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status of\n             0 to 2, For Schedule 3: ECOG Performance Status of 0 or 1\n\n          -  Life expectancy >12 weeks in the opinion of the Investigator\n\n          -  Subjects with acceptable pre-study* hematology and biochemistry labs ?3 days prior to\n             Week 1 Day 1 (W1D1) defined as:\n\n               -  absolute neutrophil count (ANC) ?1.500 cells / µL (1.5 x 10°/L, without growth\n                  factor support\n\n               -  platelet count ?100,000 cells/µL (100 x 10° cells/L), without growth factor\n                  support\n\n               -  hemoglobin ?9 g/dL (90/g/L)\n\n               -  serum total bilirubin ?1.5 upper limit of normal (ULN), unless Gilbert's disease\n\n               -  alanine transaminase (ALT) or aspartate transaminase (AST) ?2.5 x ULN, (5 x ULN\n                  for subjects with liver metastases)\n\n               -  calculated or measured creatinine clearance ?40 mL/min\n\n                    -  NOTE: If screening hematology and biochemistry labs are performed ?3 days\n                       prior to W1D1, additional pre-study labs do not need to be repeated to\n                       confirm eligibility. However, if screening hematology and biochemistry labs\n                       are performed greater than 3 days prior to W1D1, additional pre-study labs\n                       will need to be performed to confirm continued eligibility to ensure labs\n                       remain acceptable per protocol\n\n          -  Females of childbearing potential must agree to use two effective methods of\n             contraception (or abstain completely from heterosexual intercourse) from the time of\n             informed consent and for 30 days following last dose of study drug\n\n               -  NOTE: Females of childbearing potential are defined as women physically capable\n                  of becoming pregnant unless the female subject cannot have children due to\n                  surgery or other medical reasons (effective tubal ligation, ovaries or the uterus\n                  removed, or are post-menopausal). Fertile males of childbearing potential are\n                  defined as men who are sexually capable to impregnate the female partner even if\n                  surgically sterilized (i.e., vasectomy).\n\n                    -  highly effective methods of contraception include intra-uterine device (IUD)\n                       and hormonal contraception (oral, injectable, patches or implant)\n\n                    -  effective methods of contraception include barrier methods (latex condom,\n                       diaphragm with spermicide, cervical cap, sponge)\n\n                    -  when possible, subjects should be strongly encouraged to include at least\n                       one highly effective method of contraception\n\n          -  Male subjects must agree to use appropriate method of barrier contraception (latex\n             condom with a spermicidal agent) or abstain completely from heterosexual intercourse\n             fro the time of informed consent and for 120 days following last dose of study drug\n             unless female partner absolutely cannot have children because of surgery or for other\n             medical reasons\n\n          -  Negative urine pregnancy test\n\n          -  Ability to understand and willingness to sign a written informed consent form\n\n          -  Able to comply with study visit schedule and assessments\n\n        Exclusion Criteria: (All Subjects)\n\n          -  Subject has received:\n\n               -  chemotherapy or small molecular targeted therapy <2 weeks prior to W1D1\n\n               -  approved antibody therapy <5 half-lives from W1D1 (or 4 weeks since last therapy,\n                  whichever is the shortest)\n\n               -  local palliative radiation <14 days from W1D1\n\n               -  invasive surgery requiring general anesthesia <30 days from W1D1\n\n               -  chemotherapy with nitrosoureas or mitomycin C <45 days from W1D1\n\n          -  Uncontrolled grade 2 or greater toxicity except alopecia related to any prior\n             treatment (i.e., chemotherapy, targeted therapy, radiation or surgery) within 7 days\n             prior to W1D1 unless approved by the Medical Monitor\n\n          -  Prolongation of QT/QTc interval (QTc interval >470) using the Fredericia method of QTc\n             analysis\n\n          -  Women who are pregnant or nursing\n\n          -  Any known human immunodeficiency virus (HIV) infection or acquired immune deficiency\n             syndrome (AIDS) or any concurrent infection requiring IV antibiotics\n\n          -  Any known clinically significant or concurrent acute liver disease, including viral\n             hepatitis\n\n          -  Primary brain malignant tumors\n\n          -  Subjects with uncontrolled symptomatic central nervous system (CNS) involvement\n\n          -  Subjects requiring steroids at stable dose (>4 mg/day dexamethasone or equivalent) for\n             at least 2 weeks\n\n          -  Uncontrolled hypertension >150/100 mmHg\n\n          -  Concurrent participation in any other investigational therapeutic study, unless\n             non-interventional study and approved by Sponsor\n\n          -  History of stroke, deep venous thrombosis (DVT), transient ischemic attack (TIA),\n             unstable angina, or myocardial infarction within 3 months prior to W1D1\n\n          -  Uncontrolled concurrent disease or illness including but not limited to:\n\n               -  symptomatic congestive heart failure (NYHA Class III or IV) per the NYHA\n                  Classification, unstable angina pectoris, clinically significant cardiac\n                  arrhythmia\n\n               -  unstable or untreated cardiac conditions or ejection fraction of <50% as\n                  determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)\n\n               -  diabetes mellitus (i.e., fasting blood glucose >220 despite acceptable chronic\n                  diabetes therapy)\n\n               -  psychiatric illness that would limit compliance with study requirements, as\n                  determined by the Investigator\n\n          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory\n             abnormality that may increase the risk associated with study participation or study\n             drug administration or that may interfere with the interpretation of study results\n             and, in the judgment of the Investigator, would make the subject inappropriate for the\n             study.\n\n          -  Known hypersensitivity to any component of CRLX101 or excipient or documented medical\n             condition that would prohibit adequate pre-medication with antihistamine.\n\n          -  Presence of ?Grade 1 cystitis\n\n        Exclusion Criteria for Subjects Enrolled in Schedule 2 Only\n\n          -  Minor surgical procedure, excluding placement of a vascular access device, within 24\n             hours prior to W1D1.\n\n          -  Cardiovascular disease defined as congestive heart failure (NYHA Class II, III, or IV)\n             per the NYHA Classification, angina pectoris requiring nitrate therapy, or myocardial\n             infarction within the last 6 months prior to therapy\n\n          -  Uncontrolled hypertension (defined as the presence of systolic blood pressure ?150\n             mmHg or diastolic blood pressure ?100 mmHg on two separate occasions. Blood pressure\n             must be controlled to a systolic blood pressure <150 mmHg and/or to diastolic blood\n             pressure <100 mmHg prior to study treatment), or any prior history of hypertensive\n             crisis or hypertensive encephalopathy\n\n          -  Peripheral vascular disease >Grade 1\n\n          -  Known congenital long QT syndrome, history of torsades de pointes or ventricular\n             tachycardia.\n\n          -  Known history of pulmonary hypertension or non-infectious interstitial pneumonitis.\n\n          -  History or evidence of thrombotic or hemorrhagic disorders: including cerebrovascular\n             accident (CVA) / stroke or transient ischemic attack (TIA), intracerebral hemorrhage\n             or sub- arachnoid hemorrhage ? 6 months prior to W1D1\n\n          -  Chronic daily aspirin >325 mg/day or clopidogrel (>75 mg/day)\n\n          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\n             within 6 months prior to randomization\n\n          -  Any of the following serious, non-healing conditions:wound, ulcer, or bone fracture\n\n          -  Proteinuria at screening as demonstrated by either: urine dipstick ?2+ (subjects\n             discovered to have a ?2+ proteinuria on dipstick urinalysis at baseline should undergo\n             24-hour urine collection and must demonstrate <1g of protein in 24 hours to be\n             eligible): 24-hour urine collection demonstrates >1g of protein in 24 hours\n\n          -  Immunocompromised subjects, including known seropositivity for human immunodeficiency\n             virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as\n             detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to\n             hepatitis C virus [anti HCV] with confirmatory testing). [Note: testing is not\n             mandatory to be eligible for the study. However, if a subject is at risk for having\n             undiagnosed hepatitis C virus (HCV) (due to history of injection drug use or due to\n             geographic location for example), testing at screening should be considered]\n\n          -  Chronic treatment with corticosteroids (prednisone >12.5 mg/day or dexamethasone >2\n             mg/day excluding inhaled steroids\n\n        Exclusion Criteria for Subjects Enrolled in Schedule 3 Only\n\n          -  Known hypersensitivity to 5FU, oxaliplatin or other platinum agent, or to their\n             excipients\n\n          -  Known dihydropyridine dehydrogenase (DPD) enzyme deficiency (testing not required)\n\n          -  Baseline peripheral neuropathy grade ? 2\n\n          -  Progressive disease within ? 6 months of completing an oxaliplatin containing adjuvant\n             therapy\n\n          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed\n             consent
+Obtained =< 7 days prior to registration:\r\nCreatinine =< 2 x ULN
+Hemoptysis >1 teaspoon in 24 hours within the last 28 days.
+Subjects who have been on hormonal therapy up to 30 days prior to enrollment and receiving degarelix are allowed to be on the study
+Platelets >= 100 x 10^9/L obtained within 14 days prior to registration
+Aspartate transaminase (AST) =< 3 times ULN for age obtained =< 7 days prior to registration
+Administration of live vaccines =< 14 days prior to registration; note: patients may not receive any viral immunizations during the study and for 28 days after the last dose of Reolysin
+All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment
+Radiation therapy within 7 days of enrollment; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 7 days have elapsed since the last date of therapy
+The subject has received radiation therapy:\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
+Bacterial peritonitis within 30 days
+Patients must have received their last dose of known myelosuppressive anticancer therapy greater than 28 days prior to study enrollment or > 42 days if nitrosourea
+Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment\r\n* 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 and discussed with the PI
+Patients on alternative supplements should strongly be encouraged to discontinue them prior to enrollment; if they opt to continue, they may enroll on study as long as they have been receiving the supplement for at least 30 days, there is NO evidence of hepatic, renal or other organ dysfunction, administration is approved by the PI, and administration is documented in the study diary
+Patients should have no significant worsening in clinical status for a minimum of 2 days prior to enrollment
+Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days and recovery from nadir)
+Immunotherapy within the 21 days prior to randomization
+Focal therapy within the 7 days prior to randomization
+Extended field therapy within the 21 days prior to randomization
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to study registration, and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to registration
+Treatment with surgery or chemotherapy within 21 days prior to study entry or radiation within 14 days of study entry.
+Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
+The subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug, with the exception of bevacizumab which can be 14 days or maintain the subject's current bevacizumab dosing schedule\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Prior treatment with TH-302
+Platelets >= 100 x 10^9/L and no platelet transfusion within the past 14 days prior to study registration
+Willingness to abstain from all omega-3 fish oil supplements for 30 days prior to baseline evaluation and during the study intervention
+Enrollment within 28 days of the date of radiographic diagnosis
+Platelets >= 100,000 cells/mm^3 based on CBC/differential obtained within 21 days prior to study registration
+Blood urea nitrogen (BUN) =< 30 mg/dl within 21 days prior to study registration
+Any investigation agents must be discontinued at least 30 days prior to study treatment initiation
+Anticipated blood donation within the next 90 days
+Enrollment in other studies for any disease in the past 30 days
+Have used any systemic steroids within 14 days of study treatment
+Inclusion Criteria\n\n        a. History of morphologically confirmed AML w/ classification other than WHO Acute\n        Promyelocytic Leukemia (FAB M3), based on bone marrow examination.\n\n        i. not a candidate for allogeneic HSCT or no intention to move to HSCT at time of\n        enrollment.\n\n        ii. Patient's AML could be in morphologic CR or no further cytotoxic chemotherapy is\n        currently being considered.\n\n        iii. Completed consolidation chemotherapy, if available and/or appropriate for patient.\n\n        iv. Can have history of allogeneic HSCT transplant, but must be off immunosuppression for\n        at least 2 wks. before enrollment and w/o GVHD and/or toxicities from HSCT.\n\n        b. Diagnosed in past 5 years w/ smoldering MM at high risk of progressing to symptomatic\n        MM.\n\n        i. Diagnosis defined as: Bone marrow infiltration with plasma cells (PCs) ?10% and presence\n        of a monoclonal component, Ig G ?3 g/dl or IgA ?2 g/dl or Bence-Jones proteinuria >1 g/dl\n        and absence of lytic lesions on skeletal survey, absence of hypercalcemia (corrected\n        calcium <11 mg/dl), absence of renal failure (creatinine ?1.5 x ULN), and absence of anemia\n        (hemoglobin >10 g/dl or not 2 g/dl below LLN).\n\n        ii. Must meet one of following:\n\n          -  ?10% PCs in bone marrow and IgG ?3 g/dl or IgA ?2 g/dl,\n\n          -  ?10% PCs in bone marrow and serum FLC ratio (involved : uninvolved) >100 in blood, or\n\n          -  IgG ?3 g/dl or IgA ?2 g/dl and FLC ratio (involved: uninvolved) >100 in blood. c. MM\n             post-treatment disease that is clinically stable and does not require treatment at\n             least 4 weeks prior to enrollment.\n\n             i. At least one line of treatment and achieved at least PR by IMWG ii. Stable disease\n             or better per IMWG based on 2 subsequent assessments at least one month apart d.\n             history of morphologically confirmed MDS i. previously received at least one treatment\n             for MDS, including but not limited to chemotherapy or hypomethylating agent(s).\n             Subjects may be previously untreated if they refuse treatment with or are not\n             appropriate candidates for chemotherapy or hypomethylating agent(s) in the\n             investigator's opinion.\n\n        ii. intermediate, high, or very high risk MDS by IPSS-r iii. No curative intent option of\n        allogeneic HSCT or refused consideration for allogeneic HSCT iv. Could have history of\n        allogeneic HSCT transplant and relapsed, but must be off immunosuppression for at least 2\n        weeks before enrollment and without GVHD and/or toxicities from HSCT.\n\n        2. Low, moderate, to high levels of OFA expression by IHC analysis of tumor specimens.\n\n        3. HLA-A*02 haplotype.\n\n        4. ECOG performance status 0 to 2.\n\n        5. 18 years or older.\n\n        6. life expectancy ?3 months.\n\n        7. Has following laboratory parameters w/in 28 days:\n\n          -  ANC ?500/mm3\n\n          -  ALC >500/mm3\n\n          -  PLT ?25,000/mm3 and may be transfused\n\n          -  Hgb >8 g/dL (may have been transfused)\n\n          -  Serum creatinine ?1.5 x ULN\n\n          -  Total bilirubin ?2.0 mg/dL, unless elevated bilirubin due to Gilbert's syndrome\n\n          -  ALT and AST less than 5×ULN\n\n             8. If female of child-bearing potential, negative serum pregnancy test result w/in 28\n             of D1 and agree to abstain from heterosexual intercourse or use acceptable method of\n             birth control (hormonal or barrier method) from Screening through 30 days after last\n             dose\n\n             9. If male having sexual contact with a female of child-bearing potential, agrees to\n             use a latex condom dor agrees to ensure partner uses an acceptable method of birth\n             control (hormonal or barrier method)from Screening through 30 days after last dose\n\n             10. Able to provide written informed consent\n\n        Exclusion Criteria\n\n          1. Received chemotherapy, biological therapy, or radiation therapy less than one month\n             before D1\n\n          2. No prior history of active CNS involvement\n\n          3. Grade 2 or higher peripheral neuropathy w/in 28 days\n\n          4. Acute promyelocytic leukemia (FAB M3)\n\n          5. Other active systemic malignancy treated w/ cytotoxic chemotherapy in previous 12 mos.\n\n          6. Monoclonal gammopathy of undetermined significance\n\n          7. For smoldering MM, baseline bone lesions or plasmacytomas\n\n          8. For smoldering MM, lytic lesions on skeletal surveys and hypercalcemia (i.e., ?11\n             mg/dL)\n\n          9. Known HIV or hepatitis virus infection\n\n         10. Active infection requiring antibiotics\n\n         11. History of prior or active autoimmune disease such as Lupus or rheumatoid arthritis\n\n         12. Significant kidney or liver disease, uncontrolled severe cardiovascular or pulmonary\n             disease, other uncontrolled medical condition that would compromise subject's ability\n             to tolerate study treatment\n\n         13. Received any investigational treatment w/in 30 days\n\n         14. Receiving systemic glucocorticosteroid >10 mg daily. Concurrent use after registration\n             on study should be restricted to equivalent of prednisone 10 mg per day. Prior or\n             concurrent topical or localized glucocorticosteroid therapy to treat non-malignant\n             comorbid disorders is permitted. Subject requiring routine use of steroid inhalers are\n             not eligible.\n\n         15. Major surgery w/in 4 wks.\n\n         16. G-CSF w/in 30 days
+Treatment with chemotherapy, monoclonal antibodies or biological agents (e.g. ibrutinib, lenalidomide) within 28 days prior to entering the study
+Any of the following prior therapies:\r\n* Chemotherapy =< 21 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 21 days prior to registration\r\n* Radiation to > 25% of bone marrow prior to registration\r\n* Hormonal therapy =< 14 days prior to registration
+Plans to begin bisphosphonates or denosumab after registration or began therapy regiment =< 30 days from registration\r\n* NOTE: patients on a stable dose of bisphosphonates or denosumab > 30 days prior to registration are acceptable
+Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment
+Patients who have had prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 28 days of starting study treatment (not including palliative radiotherapy at focal sites), or corticosteroids that are prohibited per protocol within 14 days of starting study treatment
+Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.
+Patients must have normal organ and marrow function, independent of transfusion or growth factor support within 14 days before enrollment; patients should not receive growth factors or transfusions for at least 7 days prior to the first dose of study drug, with the exception of pegylated GCSF (pegfilgrastim) and darbepoetin, which require at least 14 days prior to screening and enrollment
+Anti-cancer therapy (including immunotherapy) =< 4 weeks prior to registration/randomization; exception: adjuvant Leukine =< 14 days prior to registration/randomization
+Fine needle aspirations or core biopsies =< 7 days prior to registration/ randomization
+Active or recent history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration/randomization
+Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< 14 days prior to registration\r\n* Immunotherapy =< 14 days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n* Radiation therapy =< 14 days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life’s whichever is shorter)\r\n* Patients must be off other biologic therapies including hematopoietic growth factors >= 7 days prior to registration\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 14 days prior to registration
+Most recent chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days of the first dose of study treatment. Most recent targeted therapy <14 days of the first dose of study treatment.
+Wide field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ?28 days or limited field radiation for palliation ?7 days prior to starting study drug or has not recovered from side effects of such therapy
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+Patients will be registered on study based on the local exam under anesthesia (EUA) done for diagnostic purposes prior to study entry; the EUA done at study entry should be done within 14 days prior to study entry
+Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 days prior to randomization
+Subjects must be off any steroids 7 days prior to the initiation of treatment
+Subjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatment
+Hematopoietic growth factors: at least 7 days since the completion of therapy with a growth factor that supports platelet, red or white cell number or function
+Biologic (anti-neoplastic agent): at least 14 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur; these subjects must be discussed with the study chair on a case-by-case basis
+Patients with hemoptysis within 28 days prior to entering the study
+Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registration
+Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of the first dose of BBI608.
+No treatment with cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
+No treatment with a steroid intended to treat myeloma within 14 days prior to cycle 1 day 1
+No increase in steroid dose within the past 7 days
+Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor, 14 days for long-acting (e.g. polyethylene glycol [PEG]-filgrastim)
+Participants must have had their last dose of cytotoxic chemotherapy at least 28 days 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 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment
+Receipt of intravenous (IV) antibiotics for infection within 7 days prior to enrollment into the study
+Non-leukocyte depleted whole blood transfusion within 120 days of the date of the pharmacogenetic sample collection.
+At least 7 days since the completion of therapy with a hematopoietic growth agent (filgrastim, sargramostim, and erythropoietin) and 14 days for long-acting formulations
+Active infection =< 5 days prior to registration or fever > 38 degrees Celsius (C) on day of registration
+Platelets >= 100 x 10^9/L (tested within 14 days prior to registration)\r\n* Subjects may not have had a transfusion within 7 days of screening assessment
+Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
+Emergency treatment for hyperleukocytosis with hydroxyurea for ? 10 days;
+Preemptive treatment with retinoic acid prior to exclusion of APL ? 7 days;
+Whole breast radiotherapy is required for participants who underwent breast-conserving therapy, including lumpectomy or partial mastectomy. Participants must have completed radiotherapy at least 14 days prior (but no more than 84 days prior) to study registration.
+Prior radiotherapy less than 14 days prior to enrollment, except for WHO Grade 1 4 glioma (radiotherapy is not permitted within 3 months prior to enrollment) and ATC (radiotherapy is not permitted within 7 days prior to enrollment). Treatment-related AEs must have resolved prior to enrollment.
+Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable.
+Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
+Venetoclax within 4 days prior to leukapheresis
+Idelalisib within 2 days prior to leukapheresis
+Treatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)
+Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil counts): ?7 days after the last dose of agent
+Hematopoietic growth factors: ?14 days after the last dose of a long-acting growth factor or 7 days for short-acting growth factor. 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
+Radiotherapy (XRT)/External Beam Irradiation including Protons: ?14 days after local XRT; ?150 days after total body irradiation, craniospinal XRT or if radiation to ?50% of the pelvis; ?42 days if other substantial bone marrow radiation.
+Central line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment.
+Fine needle aspirate within 7 days prior to enrollment.
+Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollment
+Patients must have normal organ and marrow function, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoeitin which require at least 14 days prior to screening and randomization
+Prior use of growth factors =< 14 days prior to registration
+No prior use of ketoconazole for greater than 7 days
+Immunotherapy within 28 days prior to signing consent
+At the time of registration; patients must have recovered from the toxic effects of prior therapy:\r\n* >= 28 days from any investigational agent\r\n* >= 28 days from prior cytotoxic therapy\r\n* >= 14 days from vincristine\r\n* >= 42 days from nitrosoureas\r\n* >= 21 days from procarbazine administration\r\n* > 21 days from bevacizumab administration and\r\n* >= 7 days 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 Academic principal investigator (PI)
+Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > 28 days from surgery\r\n* Residual disease following resection of recurrent GBM or GS is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days
+Patients must be at least 28 days post immunosuppressants prior to enrollment
+Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed for up to 28 days after the start of AG-221 for the control of peripheral leukemic blasts in subjects with white blood cell [WBC] counts >30,000/?L as well as prior to enrollment).
+Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= 28 days prior to registration\r\n* Mitomycin C/nitrosoureas >= 42 days prior to registration\r\n* Immunotherapy >= 28 days prior to registration\r\n* Biologic therapy >= 28 days prior to registration\r\n* Radiation therapy >= 28 days prior to registration\r\n* Radiation to < 25% of bone marrow
+Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration
+Patients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to study entry
+Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs; (immune checkpoint inhibitors that are antibody-based will only require 28 days before enrollment)
+Prior randomization into this clinical study.
+Treatment with an immunotherapy within 30 days
+Subjects may not have had a transfusion within 7 days of screening assessment
+Obtained =< 7 days prior to registration: Magnesium within normal limits (WNL)
+Obtained =< 7 days prior to registration: Potassium WNL
+Obtained =< 7 days prior to registration: Phosphorus WNL
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\r\n* At least 14 days after the last dose of myelosuppressive chemotherapy (28 days if prior nitrosourea); Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy\r\n* At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\r\n* 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; the duration of this interval must be discussed with the study chair\r\n* At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* At least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Patients with prior autologous or allogeneic stem cell transplant (SCT) are excluded from this study\r\n* At least 28 days must have elapsed since the most recent dose of bleomycin, to allow adequate time to detect evidence of bleomycin-related pulmonary toxicity
+Patients who have participated in other interventional (treatment-related) clinical trials within 30 days of enrollment are excluded
+Tolerability of prior treatment with sorafenib defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal.
+Patients who have had chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C), radiotherapy within 14 days, biological therapy within 14 days, hormonal therapy within 7 days, and investigational therapy within 21 days prior to enrollment
+Patients with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to enrollment
+Use of anticoagulants that cannot be discontinued both 5 days before and 5 days after EUS
+Any of the following prior therapies:\r\n* Chemotherapy =< 28 days prior to registration\r\n* Mitomycin C/nitrosoureas =< 42 days prior to registration\r\n* Immunotherapy =< 28 days prior to registration\r\n* Biologic therapy =< 28 days prior to registration\r\n* Radiation therapy =< 28 days prior to registration\r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) =< 28 days prior to registration\r\n* Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy
+History of thrombosis or thromboembolic event within last 30 days prior to study entry
+Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of 28 days prior to registration from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:\r\n* 14 days from administration of vincristine\r\n* 42 days from administration of nitrosoureas\r\n* 21 days from administration of procarbazine
+Time to initiation of maintenance therapy; patients may start maintenance therapy as early as 60 days post-transplant and up to 180 days post-transplant; as long as they meet the following criteria:
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+Patients must be 28 days from the end of the last induction course or at least 14 days from completion of previous methyltransferase inhibitor therapy (azacitidine or decitabine) at the time of registration
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first PANOBINOSTAT treatment
+Platelet count < 75,000/uL at the screening visit (note: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the screening visit)
+Used any systemic steroids within 28 days of study treatment
+Are currently enrolled or discontinued less than 14 days from another clinical trial
+Patients less than 30 days post HSCT
+Insufficient time for recovery from prior therapy:\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
+No current or recent (within 28 days of enrollment) full dose anticoagulants or thrombolytic agents
+Complete initial work-up within 8 days prior to treatment that allows definite staging
+Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total
+Obtained within 14 days prior to registration: Potassium >= 3.5 mmol/L
+Radiotherapy within 14 days before randomization.
+Lactating females are not eligible unless they have agreed not to breastfeed their infants while receiving protocol therapy and for 28 days after the last dose of lenalidomide
+For pemetrexed arms: the ability to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
+Adequate coagulation parameters (within 21 days prior to registration)
+Radiotherapy to any site for any reason =< 14 days prior to randomization
+Complete initial work-up within 8 days prior to treatment that allows definite staging.
+Prior systemic therapy within 28 days of study enrollment
+At least 2 weeks must have elapsed since the completion of therapy with a monoclonal antibody; seven days must have elapsed since the last dose of retinoids
+Hematopoietic Status (within 30 days prior to randomization):
+Hepatic Status (within 30 days prior to randomization):
+Within 14 days prior to registration: Blood urea nitrogen (BUN) =< 1.5 x upper limit of normal range
+Treatment with proton pump inhibitor (PPI); patients on PPI therapy prior to enrollment must stop using the PPI for at least 4 days prior to the first dose of MLN8237
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Prior cetuximab, panitumumab, or other monoclonal antibody therapy allowed if given 28 days prior to the 1st infusion of armed T cells
+Recent prior chemotherapy:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide) =< 7 days prior to registration
+Transplant < 60 days prior to study enrollment
+All standard tumor-staging procedures necessary to define baseline extracranial disease status completed =< 42 days prior to pre-registration
+Cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
+Protocol treatment must begin within 5 consecutive days after registration
+Any experimental therapy ? 28 days prior to randomization
+E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+All necessary baseline studies for determining eligibility must be obtained within 42 days of registration unless otherwise stated
+The above tests must be obtained within 14 days of study treatment
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Patient must have undergone ASCT between 60 and 90 days prior to study registration
+For CML chronic phase (CP) and accelerated phase (AP) patients, received hydroxyurea or anagrelide within 24 hours prior to receiving the first dose of ponatinib; interferon, cytarabine, or immunotherapy within 14 days prior to first dose of ponatinib; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
+Enrollment within 14 days of the completion of End of Treatment Visit of the original study
+Patients must be within 30 days of completing induction therapy.
+Has had radiotherapy within 14 days of randomization. Participants who received radiotherapy >14 days prior to randomization must have completely recovered from any radiotherapy-related AEs/toxicities
+One course of hypomethylating agent therapy (i.e.; up to 7 doses of azacitidine or 3-5 days of decitabine) within 30 days prior to enrollment (Day 1)
+Use of experimental drugs ? 30 days prior to screening
+Prior treatment with extended-field radiotherapy within 28 days prior to enrollment or prior treatment with extended-field radiotherapy for evaluating tumor lesions within 14 days prior to enrollment.
+Treatment must begin within 90 days of the last dose of immunochemotherapy
+Inclusion Eligibility Criteria\n\n        Age Patients must be ? 1 and ? 21 years of age at the time of enrollment.\n\n        Diagnosis Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) with ? 5%\n        blasts in the bone marrow (M2 or M3), with or without extramedullary disease (excluding\n        active Central Nervous System 3 involvement).\n\n        Subjects with first relapse must have an M3 marrow to be eligible.\n\n        Performance Level Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for\n        patients ? 16 years of age.\n\n        Prior Therapy\n\n          1. Patients must have recovered from the acute toxic effects (? Grade 2 or baseline) of\n             all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study,\n             unless otherwise specified. Subjects with disease related cytopenias will be eligible.\n\n          2. Patients must have relapsed disease after attaining at least a first remission. They\n             may be in first to third relapse.\n\n          3. Patients with Philadelphia chromosome t(9;22) positive disease must have received at\n             least two prior tyrosine kinase inhibitors.\n\n          4. Patients who have experienced their relapse after a Hematopoietic stem cell\n             transplantation (HSCT) are eligible, provided they have no evidence of\n             graft-versus-host disease (GVHD) and are at least 100 days post-transplant at the time\n             of enrollment.\n\n          5. Prior anthracycline lifetime cumulative exposure: Patients must have less than 320\n             mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline\n             chemotherapy.\n\n          6. Hematopoietic growth factors: It must have been at least seven days since the\n             completion of therapy with granulocyte colony-stimulating factor (GCSF) or other\n             growth factors at the time of enrollment. It must have been at least 14 days since the\n             completion of therapy with pegfilgrastim (Neulasta®).\n\n          7. Biologic anti-neoplastic agents: At least seven days after the last dose of a biologic\n             agent. For agents that have known adverse events occurring beyond seven days after\n             administration, this period must be extended beyond the time during which adverse\n             events are known to occur. The duration of this interval must be discussed with the\n             study chair or vice chair.\n\n          8. Monoclonal antibodies: At least three half-lives (or 30 days—whichever is longer) of\n             the antibody must have elapsed after the last dose of monoclonal antibody. (e.g.,\n             Rituximab = 66 days, Epratuzumab = 69 days)\n\n          9. Immunotherapy: At least 30 days after the completion of any type of immunotherapy,\n             e.g. tumor vaccines, chimeric antigen receptor T-cells.\n\n         10. Recent prior chemotherapy: At least 14 days after standard vincristine and the\n             completion of any type of chemotherapy induction regimen. At least 3 weeks after\n             radiation therapy. At least 30 days after the completion of any investigational\n             neoplastic agent is also required. An investigational agent is defined as any drug\n             that is not approved and licensed for sale by the FDA for institutions in the United\n             States, by Health Canada for institutions in Canada and by The Therapeutic Goods\n             Administration for institutions in Australia.\n\n        Exceptions:\n\n          1. There is no time restriction in regard to prior intrathecal chemotherapy provided\n             there is complete recovery from any acute toxic effects of such; it is allowable to\n             enroll a patient that has received IT Cytarabine (ARA-C), IT Methotrexate (MTX) or\n             triple IT therapy within 14 days of enrollment as part of their evaluation to diagnose\n             disease relapse. The IT therapy given within 14 days of initiation of protocol\n             specified chemotherapy, will substitute for the day 1 IT.\n\n          2. Subjects with rapidly progressive disease may receive hydroxyurea until they begin\n             study therapy;\n\n          3. Patients who relapse while on maintenance-type ALL therapy or are receiving\n             maintenance therapy for disease stabilization will not require a wash-out period\n             before entry into this study. However, there must be at least 14 days after any dose\n             of standard vincristine.\n\n        Renal and Hepatic Function\n\n          1. Renal function: Patient's serum creatinine must be ? 1.5 x institutional upper limit\n             of normal (ULN) according to age. If the serum creatinine is greater than 1.5 times\n             normal, the patient must have a calculated creatinine clearance or radioisotope\n             glomerular filtration rate (GFR) ? 70milliliter/min/1.73m2. Alternatively, a 24-hour\n             creatinine clearance may also be used.\n\n          2. Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\n             must be < 3 x institutional upper limit of norm ULN. Total bilirubin must be ? 1.5 x\n             ULN (except in the case of subjects with documented Gilbert's disease ? 5 × ULN).\n\n        Cardiac Function Patients must have a shortening fraction ? 27% or an ejection fraction ?\n        55% by echocardiogram, cardiac MRI or multigated acquisition scan (MUGA).\n\n        Reproductive Function\n\n          1. Female patients must not be pregnant and those of childbearing potential must have a\n             negative urine or serum pregnancy test confirmed within one week prior to enrollment.\n\n          2. Female patients with infants must agree not to breastfeed their infants while on this\n             study.\n\n          3. Male and female patients of childbearing potential must agree to use an effective\n             method of contraception during the study.\n\n        Exclusion Eligibility Criteria\n\n        Patients will be excluded if they have active Central Nervous System (CNS) 3 status.\n\n        Patients will be excluded if they have isolated testicular disease.\n\n        Patients with biphenotypic leukemia will be excluded.\n\n        Patients will be excluded if they have refractory disease or fourth relapse and beyond,\n        defined as any of the following:\n\n          1. Patients with four or more prior induction attempts,\n\n          2. Refractory disease after first or greater relapse and a re-induction attempt,\n\n          3. Failing to go into remission from original diagnosis after two previous induction\n             attempts.\n\n        Patients will be excluded if they have previously received Marqibo®.\n\n        Patients will be excluded if they have a known allergy to any of the drugs used in the\n        study, with the exception that patients with an allergy to PEG-asparaginase who can receive\n        Erwinia are eligible.\n\n        Patients will be excluded if they have active, uncontrolled systemic fungal, bacterial,\n        viral or other infection despite appropriate antibiotics or other treatment.\n\n        Patients who require azole antifungal agents will be excluded. Azoles must be discontinued\n        at least one week prior to the start of Marqibo®.\n\n        Patients will be excluded if there is a plan to administer non-protocol chemotherapy,\n        radiation therapy, another investigational agent or immunotherapy during the study period.\n\n        Patients with pre-existing, persistent grade 2 or greater sensory or motor neuropathy from\n        any cause will be excluded.\n\n        Patients will be excluded if they have Down syndrome, significant concurrent disease,\n        illness, psychiatric disorder or social issue that would compromise patient safety or\n        adherence with the protocol treatment or procedures or interfere with consent, study\n        participation, follow up, or interpretation of study results.\n\n        Patients positive for human immunodeficiency virus (HIV) will be excluded due to the\n        increased risk of complications such as severe infection and unknown interaction of\n        Marqibo® with antiretroviral drugs.\n\n        Active hepatitis B or C infection as defined by seropositive for hepatitis B (hepatitis B\n        surface antigen (HBsAg)) or hepatitis C and elevated liver transaminases (defined as above\n        the ULN per the institution normal ranges).
+Neutrophils >= 1.0 x 10^9/L (growth factor support is not allowed), within 14 days prior to registration
+Radiotherapy within the last 21 days;
+Patients with hemoptysis within 28 days prior to entering the study
+Patients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for patients who received metronomic chemotherapy or non-cytotoxic agents, e.g., bevacizumab, interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
+Neutrophil count >= 1.5 x 10^9/l anytime within the last seven days before enrollment; patients can be on myeloid or erythroid growth factors, for example filgrastim
+Platelets (PLT) >= 75,000/uL obtained =< 14 days prior to registration with no platelet transfusion requirement for 7 days prior to enrollment
+Use of hydroxyurea within 7 days prior to screening labs
+Growth factors within 14 days prior to screening labs
+Patient may be enrolled 40 to 100 days after transplant
+Prior treatment with dose dense regimens of temozolomide is not allowed (e.g, 7 days on/7 days off, 21 day/28 day and daily low dose continuous dosing). However, prior treatment with standard day 1-5 dosing in the adjuvant setting and low dose daily dosing as part of chemoradiation therapy are allowed
+Less than 28 days since last treatment used to treat the disease
+14 days must have elapsed since the completion of myelosuppressive therapy; individuals may have received any of the following medications within 14 days without a “wash-out” period:\r\n* Hydroxyurea\r\n* Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine
+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; the duration of this interval must be discussed with the principal investigator
+Immunomodulatory agents within 7 days
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to randomization; daily or weekly chemotherapy (with the exception of hydroxyurea) without the potential for delayed toxicity within 14 days prior to randomization unless there is evidence of rapidly progressive disease
+Inclusion Criteria:\n\n        Subjects must satisfy the following criteria to be enrolled in the study:\n\n          1. Subject has an eligible disease:\n\n               -  Primary Acute myeloid leukemia (AML) induction failure: no Complete Remission\n                  (CR) after 2 or more induction attempts or\n\n               -  Relapsed AML: not in CR after 1 or more cycles of standard re-induction\n                  chemotherapy\n\n                    -  For relapsed subjects > 60 years of age, the 1 cycle of standard\n                       re-induction chemotherapy is not required if either of the following\n                       criteria is met:\n\n                    -  relapse within 6 months of last chemotherapy\n\n                    -  blast count <30% within 10 days of starting this protocol therapy or\n\n               -  Secondary AML (MDS transformation or treatment related):\n\n             or\n\n             • AML relapsed > 2 months after transplant Subjects with prior central nervous system\n             (CNS) involvement are eligible provided that it has been treated and Cerebrospinal\n             fluid (CSF) is clear for at least 2 weeks prior to Visit 1.\n\n          2. Subject is ? 18 and ? 70 years of age at the time of signing the informed consent form\n             (ICF).\n\n          3. Subject must understand and voluntarily sign an ICF prior to any study-related\n             assessments/procedures being conducted.\n\n          4. Subject is willing and able to adhere to the study schedule and other protocol\n             requirements.\n\n          5. Karnofsky Performance Status > 50%.\n\n          6. Ability to be off prednisone and other immunosuppressive drugs for at least 3 days\n             prior to the PNK-007 cell infusion.\n\n          7. Female of childbearing potential (FCBP) must:\n\n             a. Have two negative pregnancy tests as verified by the Investigator prior to starting\n             study therapy. She must agree to ongoing pregnancy testing during the course of the\n             study, and after the end of study treatment. This applies even if the subject\n             practices true abstinence from heterosexual contact.\n\n          8. Either commit to true abstinence from heterosexual contact or agree to use, and be\n             able to comply with, effective contraception without interruption, 28 days prior to\n             starting PNK-007, during the study therapy (including dose interruptions), and for 28\n             days after discontinuation of study therapy. Male subjects must: a. Practice true\n             abstinence or agree to use a condom during sexual contact with a pregnant female or a\n             female of childbearing potential while participating in the study, during dose\n             interruptions and for at least 28 days following PNK-007 discontinuation, even if he\n             has undergone a successful vasectomy.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subject has any significant medical condition, laboratory abnormality, or known\n             psychiatric illness that would prevent the subject from participating in the study.\n\n          2. Subject has any condition including the presence of laboratory abnormalities which\n             places the subject at unacceptable risk if he or she were to participate in the study.\n\n          3. A subject has any condition that confounds the ability to interpret data from the\n             study.\n\n          4. Subject has a body weight exceeding 120kg.\n\n          5. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or\n             alkaline phosphatase ? 2.5 x the upper limit of normal (ULN) at screening.\n\n          6. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening\n             calculated using the Modification of Diet in Renal Disease Study equation or history\n             of an abnormal eGFR < 60 and a decline of > 15 mL/min/1.73 m2 below normal in the past\n             year.\n\n          7. Subject has a bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease)\n             at screening.\n\n          8. Subject has had prior treatment with biologic antineoplastic agents no less than 7\n             days before PNK-007 infusion and at least 5 half lives. For agents that have known\n             Adverse Events (AEs) occurring beyond 7 days after administration (ie, monoclonal\n             antibodies), this period must be extended beyond the time during which acute AEs are\n             known to occur. An exception to this criteria is hydroxyurea which can be given\n             throughout the Screening/Baseline Period up to the time of the pre-conditioning\n             treatment.\n\n          9. Subject has bi-phenotypic acute leukemia.\n\n         10. Subject has had a transplant < 60 days prior to Visit 1 (Screening/Baseline visit).\n\n         11. Subject has had treatment for graft-versus-host disease < 30 days prior to Visit 1\n             (Screening/Baseline visit).\n\n         12. Subject is pregnant or breastfeeding.\n\n         13. Subject has new or progressive pulmonary infiltrates or pleural effusion large enough\n             to be detected by chest x-ray or Computed tomography (CT) scan.\n\n         14. Subject has active autoimmune disease other than controlled connective tissue disorder\n             or those who are not on active therapy.\n\n         15. Subject is HIV positive.\n\n         16. Subject has a history of malignancy except primary, secondary, or relapsed Acute\n             myeloid leukemia (AML), or excised and cured non-melanoma skin cancer, or cervical\n             carcinoma in situ that was surgically ablated more than 5 years prior to PNK-007\n             infusion.\n\n         17. Subject has a history of severe asthma and is presently on chronic medications or has\n             a history of other symptomatic pulmonary disease.\n\n         18. Untreated chronic infection or treatment of any infection with systemic antibiotics\n             within 2 weeks prior to dosing with PNK-007.\n\n         19. Subject has any other organ dysfunction (CTCAE Version 4.03 Grade 3) that will\n             interfere with the administration of the therapy according to this protocol.\n\n         20. Subject has a resting left ventricular ejection fraction (LVEF) of < 35% obtained by\n             echocardiography or multigated acquisition scan (MUGA).
+Ongoing infection with, or treatment or prophylaxis for, CMV within the past 28 days.
+Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
+Radiotherapy within 14 days prior to first dose of study treatment
+Prior radiotherapy =< 14 days, or if subjects have not recovered from radiotherapy
+Recent infection requiring a course of systemic anti-infectives that was completed =< 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection [UTI])
+The donor has donated plasma within 7 days before screening or has donated blood within 56 days before screening.
+All subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Other anti-cancer therapy up to 14 days prior to enrollment, with the exception of hydroxyurea, which can be given up to 4 days prior to enrollment.
+Change in chemotherapy agent is planned 7 days before or after enrollment (change in dose(s) permitted),
+Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing
+steroids are currently not required and more than 14 days since last steroid treatment
+Hematopoietic grow factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).
+Biologic (anti-neoplastic) therapy: It must be at least 7 days after last does of 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. The duration of this interval must be discussed with the study chair
+Patients will be excluded if they have had any positive fungal culture in the last 30 days prior to enrollment.
+Patients must suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinib
+Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
+Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment
+Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days
+For Post-allo Part B: Treatment must begin at least 60 days, but no more than 100 days post-transplant.
+42 days for nitrosureas, mitomycin C, and liposomal anthracycline
+LVEF < 40% as determined by echocardiogram performed at screening or within 90 days prior to C1D1
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
+Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ? 28 days prior to Day 1 of Cycle 1.
+AbGn-168H (neihulizumab) therapy can begin not more than 14 days after diagnosis of aGvHD
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708 (ixazomib citrate)
+For those patients who had a biliary stent inserted, 2 stable bilirubin readings within 48 to 72 hours of each other taken at least 5 days and not more than 14 days post-stenting must be obtained. In addition, there should be no complications (eg, infection) present and bilirubin levels should have stabilized (2 readings with total bilirubin within 20% of each other) before administering first treatment.
+Patients with active infection or with a fever > 38.5 degrees Celsius (C) within three days prior to the first scheduled treatment
+Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).
+Radiotherapy within 14 days prior to Baseline.
+Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
+At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since \limited palliative radiotherapy\, defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 GY.
+Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
+Radiotherapy or chemotherapy ending within 14 days of study enrollment
+Anti-neoplastic treatment less than 14 days prior to enrollment, with the exceptions of hydroxyurea or, in the case of a patient with primary refractory AML, prior induction chemotherapy
+14 days from last dose of bevacizumab
+Subject has received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, whether conventional or investigational, major surgery within 21 days, or radiotherapy within 21 days of treatment in this study, or at any time during the study.
+Platelets: >= 100,000/mm^3 (transfusion independent defined as not receiving platelet transfusions within 7 days prior to registration)
+Subjects whose primary physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to the injection to 28 days following the injection are excluded from this study
+Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of MLN9708
+Inclusion Criteria:\n\n        Registration: Patients having both diffuse and follicular architectural elements will be\n        considered eligible if the histology is predominantly follicular (? 50% of the\n        cross-sectional area), and there is no evidence of transformation to a large cell\n        histology.\n\n          -  Biopsy-proven diagnosis of Grade 1 or 2 follicular non-Hodgkin's lymphoma with no\n             evidence of transformation to large cell histology.\n\n          -  Meet criteria for Low Tumor Burden:\n\n               -  No nodal or extra nodal mass ? 7 centimeter (cm)\n\n               -  <3 nodal masses >3 cm in diameter\n\n               -  No systemic symptoms or B symptoms\n\n               -  No splenomegaly >16 cm by CT scan\n\n               -  No risk of compression of a vital organ.\n\n               -  No leukemic phase with >5000/mm³ circulating lymphocytes.\n\n          -  No cytopenias defined as:\n\n               -  Platelets <100,000/mm³\n\n               -  Hemoglobin (Hgb) <10 g/dL\n\n               -  Absolute Neutrophil Count (ANC) <1500/mm³\n\n          -  Must have Stage III or Stage IV disease.\n\n          -  Baseline measurements/evaluations obtained within 6 weeks of registration. Patient\n             must have at least one objective measurable disease parameter.\n\n          -  Age ? 18 years.\n\n          -  Eastern Oncology Cooperative Group Performance Status 0-1.\n\n          -  Must not have received investigational agents within 30 days of registration.\n\n          -  Signed Institutional Review Board (IRB)-approved informed consent.\n\n          -  Willing to provide blood samples for research purposes.\n\n          -  Women must not be pregnant or breastfeeding.\n\n          -  Women of childbearing potential and sexually active males must use an accepted and\n             effective method of contraception.\n\n          -  No prior chemotherapy, radiotherapy or immunotherapy for lymphoma.\n\n          -  No prior treatment with cytotoxic drugs or rituximab for a previous cancer or another\n             condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody.\n\n          -  No prior use of any monoclonal antibody within 3 months of randomization.\n\n          -  No history of severe allergic/anaphylactic reactions to humanized/murine monoclonal\n             antibodies or known sensitivity/allergy to murine products.\n\n          -  No history of prior malignancy except for adequately treated basal cell or squamous\n             cell skin cancer, in situ cervical cancer, or other cancer for which the patient has\n             been disease-free for at least 2 years and did not require treatment with cytotoxic\n             drugs or rituximab.\n\n          -  No major surgery within 4 weeks prior to randomization, other than for diagnosis.\n\n          -  Must be Human Immunodeficiency Virus (HIV) negative.\n\n          -  Have adequate organ function without growth factor and/or transfusion support within ?\n             2 weeks prior to registration:\n\n               -  ANC ? 1500/mm³\n\n               -  Hgb ? 10 g/dL\n\n               -  Platelets ? 100,000/mm³\n\n               -  Serum Creatinine ? 2x Upper Limit Normal (ULN)\n\n               -  Total Bilirubin ? 2x ULN\n\n               -  AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ? 5x ULN\n\n               -  PTT (Partial Thromboplastin Time) or aPTT (activated Partial Thromboplastin Time)\n                  >1.5x the ULN in the absence of a lupus anticoagulant\n\n               -  INR (International Normalized Ratio) >1.5x the ULN in the absence of therapeutic\n                  anticoagulation\n\n          -  No active, uncontrolled infections (afebrile for ? 48 hours off antibiotics).\n\n          -  Must not receive immunization with attenuated live vaccines within 28 days prior to\n             registration or during the study period.\n\n          -  Must be tested for hepatitis B surface antigen (HBsAg) and total hepatitis B core\n             antibody (anti-HBc) within 2 weeks of registration. Patients who are chronic carriers\n             of HBsAg and anti-HBc are excluded.\n\n          -  Must be tested for hepatitis C antibody within 2 week of registration. If this test is\n             positive, patients are excluded unless a hepatitis C virus ribonucleic acid (HCV RNA)\n             is negative.\n\n          -  No evidence of significant, uncontrolled concomitant diseases that could affect\n             compliance with the protocol or interpretation of results, including significant\n             cardiovascular disease (i.e., severe arrhythmia, myocardial infarction within the\n             previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease.
+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
+Biologic (anti-neoplastic agent) or metronomic non-myelosuppressive chemotherapy: at least 7 days must have elapsed since the 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
+A minimum of 5 days must have elapsed since the administration of hematopoietic growth factors with short half life (filgrastim, erythropoietin), while for longer – acting hematopoietic growth factors, the minimum time elapsed is 20 days
+In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
+Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
+Patient has received other investigational drugs or chemotherapy within 21 days or approved anti-myeloma therapy within 14 days.
+Inclusion Criteria:\n\n        3.1.1 Histologically-proven, invasive primary squamous, basaloid, or cloacogenic carcinoma\n        of the anal canal; 3.1.2 AJCC 2009 TN Stage: T1N1-N3, T2(< 4cm)N1-N3, T2(> 4cm)N0,T3N0-3,\n        T4N0-3;based upon the following minimum diagnostic workup: 3.1.2.1 History/physical\n        examination within 14 days prior to registration; 3.1.2.2 Within 42 days prior to\n        registration, the patient must have an anal examination by any of the following:\n        colonoscopy, sigmoidoscopy, or rigid proctoscopy, with documentation of primary anal lesion\n        size, distance from anal verge.\n\n        3.1.3 Groin examination within 42 days prior to registration with documentation of any\n        groin adenopathy and lymphadenopathy (location: right vs. left; medial vs. lateral; mobile\n        vs. fixed; and size); 3.1.4 X-ray (PA and lateral), CT scan, or PET/CT scan of the chest\n        within 42 days prior to registration; 3.1.5 CT scan, MRI, or PET/CT of the abdomen and\n        pelvis within 42 days prior to registration; 3.1.6 Zubrod Performance Status 0-1; 3.1.7 Age\n        ? 18; 3.1.8 Laboratory data obtained ? 14 days prior to registration on study, with\n        adequate bone marrow, hepatic and renal function defined as follows:\n\n          -  Absolute neutrophil count (ANC) ? 1,500 cells/mm3;\n\n          -  Platelets ? 100,000 cells/mm3;\n\n          -  Hemoglobin ? 8.0 g/dl (Note: The use of transfusion or other intervention to achieve\n             Hgb ? 8.0 g/dl is acceptable.);\n\n          -  Serum creatinine ? 1.5 mg/dl;\n\n          -  Bilirubin < 1.4mg/dl;\n\n          -  ALT/AST < 3 x ULN;\n\n          -  Negative serum pregnancy test for women of child-bearing potential; 3.1.9 Women of\n             childbearing potential and male participants must agree to use a 2 forms of medically\n             effective means of birth control (such as a condom and spermicide) throughout their\n             participation in the treatment phase of the study and for 90 days post last dose of\n             study drug.\n\n        3.1.10 Patients must sign a study-specific informed consent prior to study entry.\n\n        3.1.11 Patients with a history of clinically significant pulmonary disease must have PFTs\n        demonstrating a DLCO ? 40%. This testing is considered standard of care prior to mitomycin,\n        5-FU and radiation.\n\n        3.1.12 Patients with a history of clinically significant cardiac disease must have a LVEF ?\n        30% by ECHO. (MUGA scan may also be used to determine LVEF) This testing is considered\n        standard of care prior to mitomycin, 5-FU and radiation.\n\n        3.1.13 Patients must be able to swallow pills.\n\n        Exclusion Criteria:\n\n        3.2.1 Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free\n        for a minimum of 2 years; 3.2.2 Prior systemic chemotherapy for anal cancer; 3.2.3 Prior\n        allergic reaction to the study drugs involved in this protocol. 3.2.4 Prior radiotherapy to\n        the pelvis that would result in overlap of radiation therapy fields; 3.2.5 Severe, active\n        co-morbidity, defined as follows: 3.2.5.1 Patients with uncontrolled intercurrent illness\n        including, but not limited to ongoing or active infection, symptomatic congestive heart\n        failure, unstable angina pectoris and cardiac arrhythmia are ineligible. Furthermore,\n        patients with unstable angina and/or congestive heart failure requiring hospitalization\n        within the past 6 months are ineligible; 3.2.5.2 Patients with active infection requiring\n        systemic therapy (oral or IV) or those currently receiving antibiotics that cannot\n        discontinue prior to dosing are ineligible.\n\n        3.2.5.3 Transmural myocardial infarction within the last 6 months; 3.2.5.4 Acute bacterial\n        or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.5.5\n        Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring\n        hospitalization or precluding study therapy at the time of registration; 3.2.5.6 Hepatic\n        insufficiency resulting in clinical jaundice and/or coagulation defects; 3.2.6 Patients\n        known to be seropositive for HIV and/or active hepatitis, even if liver function studies\n        are in the eligible range.\n\n        3.2.7 Other immunocompromised status (e.g., organ transplant or chronic glucocorticoid\n        use).If patient has diagnosis of immunodeficiency, is dependent on or has received systemic\n        steroids therapy or any form of immunosuppressive therapy within 7 days prior to the first\n        dose of ADXS11-001 they are ineligible. Topical corticosteroid or occasional inhaled\n        corticosteroids are allowed.\n\n        3.2.8 Women who are pregnant or lactating are ineligible because the treatment involved in\n        this study may be significantly teratogenic and there is the potential for transmission of\n        listeria to the infant.\n\n        3.2.9 Patients allergic to or with a sensitivity to penicillin, ampicillin,\n        trimethoprim-sulfa and quinolones (including history of rash or anaphylaxis).\n\n        3.2.10 Patients allergic to naproxen. 3.2.11 Patients receiving oral or IV antibiotics\n        3.2.12 Patients with a prior history of a splenectomy and/or sickle cell trait/disease\n        3.2.13 Patient has implanted medical device(s) that pose a high risk for colonization\n        and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves,\n        pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous\n        implant(s)). NOTE: More common devices and prosthetics which include arterial and venous\n        stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport)\n        are permitted. Sponsor must be contacted prior to consenting any subject who has any other\n        device and/or implant. Site is required to submit to BrUOG ALL surgical implants patient\n        has ever had in their medical history and ALL surgeries regardless of link to this cancer\n        diagnosis.\n\n        3.2.14 Patients who are receiving or may receive future treatment with PI3K or TNF?\n        inhibitors. To be confirmed by treating medical oncologist in writing 3.2.15 Has undergone\n        a major surgery, including surgery for a new artificial implant and/or device, within 6\n        weeks prior to the initiation of ADXS11-001 treatment. NOTE: if patient underwent surgery >\n        6 weeks from start of ADSX11-001, all toxicities and/or complications must have recovered\n        to baseline or Grade 1 prior to the initiation of ADXS11-001 study therapy.\n\n        3.2.16 Patient not being willing to have new infusion line placed for each infusion of\n        ADXS11-001 as existing or newly placed central venous catheter or infusion ports are not\n        allowed to be used for ADXS11-001 administration. Must be confirmed as discussed with\n        patient and that they agreed.\n\n        3.2.17 Patient not willing to comply with requirement of central venous catheter or\n        infusion port must not be used for 72 hours following the completion of the ADXS11-001\n        infusion and the patient receives the first post-treatment dose of oral antibiotics. Must\n        be confirmed as discussed with patient and that they agreed.\n\n        3.2.18 Live vaccines within 30 days prior to the first dose of trial treatment and while\n        participating in the trial. Examples of live vaccines include, but are not limited to, the\n        following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid\n        (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus\n        vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live\n        attenuated vaccines and are not allowed. All recent vaccines (within 30 days) to be listed\n        on conmed log 3.2.19 Patient has a history of listeriosis or prior ADXS11-001 therapy.
+Inclusion Criteria:\n\n        • Cytomorphologically documented diagnosis of acute myeloid leukemia (AML). Acute\n        promyelocytic leukemia patients will be excluded (FAB M3). FAB classification, cytogenetics\n        and molecular markers (if applicable) must be available at registration.\n\n        Phase I Enrollment:\n\n          -  Must be in first or second complete remission, e.g., no evidence of active disease in\n             blood, bone marrow (<5% blasts), or other tissues.\n\n          -  For each remission, may have received no more than 2 cycles of induction treatment\n             (any type).\n\n          -  May have received no more than one course of consolidation for the current remission\n             prior to enrollment (any type)\n\n        Phase II Enrollment:\n\n          -  Must be in first complete remission, e.g., no evidence of active disease in blood,\n             bone marrow (<5% blasts), or other tissues.\n\n          -  May have received no more than 2 cycles of induction treatment (any type).\n\n        Enrollment in Either Phase:\n\n          -  Remission status must be documented by a bone marrow examination up to 28 days prior\n             to study registration.\n\n          -  Have recovered from induction and first consolidation (if applicable) therapy side\n             effects (or ?grade 1).\n\n          -  ?18 years of age and ?70 years of age.\n\n          -  ECOG performance status 0, 1, 2.\n\n          -  Have not received cytotoxic drug therapy within 21 days of registration.\n\n          -  Have not received hematopoietic colony stimulating growth factors within 14 days of\n             registration.\n\n          -  Have not received packed red blood cells or platelets within 7 days of registration.\n\n          -  Have not received investigational agents within 30 days of registration and will not\n             receive any investigational agents other than eltrombopag/placebo during study.\n\n          -  Signed IRB-approved informed consent.\n\n          -  Willing to provide blood samples for research purposes.\n\n          -  Adequate organ function obtained within 28 days prior to registration:\n\n               -  Absolute neutrophil count >1 x 10?/L\n\n               -  Platelet count >100 x 10?/L\n\n               -  Total direct serum bilirubin ?1.5x upper limit of normal (ULN)\n\n               -  ALT and AST ?3x ULN\n\n               -  BUN and serum creatinine <2x ULN\n\n               -  Albumin ?2.5 g/dL\n\n               -  PT and PTT 80-120% of institutional normal range\n\n          -  Women of childbearing potential must have a negative serum pregnancy test within 14\n             days of registration.\n\n          -  Not pregnant nor breast feeding.\n\n          -  Women of childbearing potential and sexually active males must use an accepted and\n             effective method of contraception.\n\n          -  Patients of known East Asian ancestry (Chinese, Japanese, Taiwanese, and Korean) are\n             excluded from protocol participation for safety and efficacy reasons.\n\n          -  Able to swallow and retain orally administered medication.\n\n          -  No clinically significant gastrointestinal abnormalities such as malabsorption\n             syndrome or major resection of the stomach or bowels.\n\n          -  No clinical evidence of hepatomegaly or splenomegaly.\n\n          -  No known risk for Torsades de Pointes. (Eltrombopag use has not been shown to be\n             associated with Torsades de Pointes.)\n\n          -  No active or unresolved infection and must be off all antibiotics for at least 7 days\n             prior to registration.\n\n          -  No current evidence of invasive fungal infection.\n\n          -  No known Hepatitis B, Hepatitis C active disease.\n\n          -  No known Human Immunodeficiency Virus (HIV) seropositivity. The risk for potential\n             toxicities secondary to HIV (e.g., increased risk for fatal opportunistic infection)\n             may confound the toxicity profile of eltrombopag.\n\n          -  Patients with a history of Central Nervous System (CNS) leukemia are eligible if there\n             is documentation of no current CNS involvement on cerebrospinal fluid (CSF)\n             examination (e.g., negative CSF by lumbar puncture) within 28 days of registration.\n\n          -  No prior or concomitant malignancy in the past 5 years which is currently active and\n             likely to interfere with the patient's treatment for AML or which is likely to\n             increase the patient's morbidity or mortality. No prior chemotherapy or radiation\n             therapy allowed (unless related to AML treatment).\n\n          -  No concurrent organ damage or medical problems that would prohibit therapy.
+Subjects with an active infection or with a fever >/+ 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
+Any major operation must have occurred at least 28 days before study enrollment
+RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have received their last dose of known myelosuppressive anticancer therapy or immunotherapy at least 21 days prior to enrollment (42 days if prior nitrosourea)
+RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have had their last fraction of: \r\n* Craniospinal irradiation or radiation to >= 50% of pelvis > 3 months prior to enrollment\r\n* Focal irradiation to the primary site > 42 days prior to enrollment\r\n* Local palliative irradiation other than previously irradiated primary site (small port) >= 14 days
+RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must be off all colony-forming growth factor(s) for at least 7 days prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have elapsed if patients received poly(ethylene glycol) (PEG) formulations
+RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had valproic acid within 28 days prior to enrollment
+NON-PROGRESSED DIPG (STRATUM 2): Patients must be off all colony-forming growth factor(s) for at least 7 days prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have elapsed if patients received PEG formulations
+Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization
+Neutrophils >= 1.5 K/microliter should be obtained with 28 days prior to randomization
+Platelets >= 100 K/microliter should be obtained with 28 days prior to randomization
+Active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. Concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)
+Platelet >= 75,000 cells/mm^3, +/- 7 days from date of ICF signing
+Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ?28 days prior to day 1 of cycle 1.
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
+Patients who have received hematopoietic growth factors (filgrastim, pegfilgrastim, or sargramostim) within 28 days of first dose of screening
+Thiazide therapy within 7 days from entering the study
+Patients with biliary obstruction for which a stent has been placed are eligible, provided the stent has been in place for at least 10 days prior to the first dose of belinostat and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
+Prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past 30 days
+Patient must be able to be treated with remestemcel-L within 4 days of study entry.
+Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
+The patient has a caregiver for 28 days after dosing.
+Treatment with antibiotics within 2 weeks (14 days) of dosing.
+The subject has concurrent uncompensated hypothyroidism or thyroid dysfunction within 10 days before the first dose of study treatment
+Immunotherapy =< 28 days prior to pre-registration (e.g. intravesical Bacillus Calmette-Guerin [BCG])
+Patient has fully recovered from the acute effects of all prior therapy and must meet the following criteria\r\n* At least 14 days must have elapsed since the completion of myelosuppressive therapy\r\n* At least 24 hours must have elapsed since the completion of low-dose of low-dose or non-myelosuppressive therapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day)\r\n* At least 30 days must have elapsed since the use of investigational agents\r\n* For patients who have received prior HSCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HSCT; patients cannot be receiving therapy, including steroids, for GVHD; all such medications must be discontinued at least 72 hours prior to enrollment
+Transplant was more than (>) 100 days prior to study enrollment
+WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug FS102 plus 30 days (duration of ovulatory cycle) for a total of 30 days post-treatment completion.
+Receipt of lapatinib within 7 days of scheduled dosing day 1.
+At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair
+At least 7 days must have passed after the last treatment with a biologic agent; for agents that have known adverse events occurring beyond 7 days from administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
+An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed\n             therapy until the time of randomization
+endocrine therapy, immunotherapy, transfusion, hematopoietic factors within 14 days prior to planned first dose of study drug (Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria, eg. transfusions and hematopoietic growth factors.)
+mitomycin-C or nitrosoureas within 42 days
+endocrine therapy, immunotherapy, transfusion, or hematopoietic factors within 14 days prior to planned first dose of study drug (Note: Patients with AML are not required to meet these hematologic criteria, eg, transfusions and hematopoietic growth factors.),
+Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.
+Hematopoietic grow factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).
+Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.
+Radiotherapy within 28 days prior to first dose.
+The two measurements are spaced at least 14 days apart;
+Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/day for more than 1 day out of 7 days
+Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days
+Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
+Uncorrected coagulopathy:\r\n* Plavix usage at the time of vertebroplasty or history of taking Plavix less than 7 days prior to procedure (in selected cases, radiation treatment can be initiated, the antiplatelet agent stopped, and vertebroplasty performed after 7 days)
+Treatment within 28 days prior to Dose 1 with:
+Recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-days from enrolment.
+Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
+Protocol treatment is to begin within 2 working days of patient randomization.
+Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of BBI608/placebo within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of BBI608/placebo.Radiotherapy, immunotherapy, or investigational agents within four weeks of first planned dose of BBI608/placebo, with the exception of a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
+Subjects with biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent has been in place for at least 10 days prior to the first dose of Tivantinib, and the subject's liver function has stabilized as defined by 2 measurements at least 5 days apart that put the subject in the same hepatic impairment group
+14 days must have elapsed since the completion of cytotoxic therapy
+At least 7 days since the completion of therapy with hematopoietic growth factors
+At least 7 days since the completion of therapy with a biologic agent
+At least 60 days from prior total body irradiation (TBI)
+Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
+Patients may have received palliative radiotherapy to non-target lesions within 14 days prior to registration provided all radiotherapy related toxicities have resolved to =< grade 1 prior to registration; patients must not have received any major surgery within 28 days prior to registration
+Male patients must have free and total testosterone level obtained within 28 days prior to registration
+Radiotherapy within 14 days before the first dose of study treatment.
+Persistent diarrhea (>= Grade 2) lasting greater than (>) 3 days within 2 weeks before the first dose of study treatment.
+Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entry
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3), or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3).
+Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks (28 days) prior to or after any dose of ipilimumab
+Planned treatment with NovoTTF therapy alone per Food and Drug Administration (FDA)-approved indication; NovoTTF therapy must start within 14 days of registration, but not less than 7 days or more than 21 days from stereotactic biopsy (if applicable) and not less than 21 days or more than 42 days from open resection (if applicable)
+Radiotherapy (RT) completed within 14 days prior to the first dose of study therapy.
+All pre-study labs required for determination of eligibility are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday)
+X-rays and/or scans to assess all disease sites are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday)
+Anti-thymocyte globulin, alemtuzumab, bortezomib, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT
+Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 21 days of first dose
+At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for \limited palliative radiotherapy\, defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
+At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.
+Immunotherapy within 21 days prior to randomization
+Platelets (PLT) >= 100,000/?L obtained =< 7 days prior to registration
+Platelets >= 50,000/mm^3 or 30,000 (if marrow infiltrated with myeloma; no platelet transfusions are allowed in the 7 days prior to screening)
+Receiving antibiotic therapy within 14 days before the first dose of study treatment
+Persistent diarrhea (greater than Grade 2) lasting > 3 days within 2 weeks before the first dose of study treatment
+Radiotherapy within 14 days preceding the first dose of study treatment
+Treatment with CYP3A inducers within 14 days before the first dose of MLN4924. Treatment with CYP3A inhibitors within 14 days before the first dose of MLN4924; however, voriconazole and fluconazole need only be stopped for 3 days before MLN4924. Patients must have no history of amiodarone use in the 6 months before the first dose of MLN4924
+For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be tested within 7 days of starting the study treatment:
+For subjects with SEVERELY IMPAIRED renal function; to be tested within 7 days of starting the study treatment:
+Peripheral blood blast ? 5% Be able to start study therapy between 42 to 84 days following allogeneic HSCT Post transplant bone marrow blast count ? 5% confirmed within 21 days prior to starting study therapy Adequate engraftment within 14 days prior to starting study therapy:
+Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
+Trastuzumab =< 21 days before first study treatment
+Lapatinib =< 14 days before first study treatment
+Patients who have not discontinued all prior medical therapy for breast cancer (with the exception of bisphosphonates or denosumab) at least 21 days prior to first dose of orteronel; this includes patients who have received other investigational agents within 21 days prior to the first dose of orteronel
+Continuous corticosteroid therapy within 21 days prior to first dose of orteronel
+Has been on mechanical ventilation for > 28 days
+ANC > 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published ASCO guidelines.
+Platelets ? 75 x 109/L without transfusions within 21 days before 1st treatment.
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to randomization and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to randomization
+Subject has been transfused within the past 14 days
+Chemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatment
+Bilirubin =< 2 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 7 days prior to study day 1)
+Serum creatinine =< 1.5 x IULN (assessed within 7 days prior to study day 1)
+Any of the following recent therapies:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration\r\n* Anthracyclines =< 14 days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< 7 days prior to registration
+Participants with persistent phosphate greater than upper limit of normal during screening (within 14 days prior to Day 1 of Cycle 1 up until pre-dose of Cycle 1) and despite medical management of phosphate levels
+For purposes of determining prior drug regimens the following should be used as a standard; radiation therapy counts as 1 treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, and rituximab alone is not considered a treatment; all prior therapy must have been completed at least 30 days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (e.g., vorinostat, romidepsin), for at least 30 days prior to registration; patients must have recovered from any toxicities related to therapies prior to registration
+Patients must have an electrocardiogram (EKG) with no significant abnormalities within 28 days prior to registration
+The last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment
+Prior chemotherapy or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
+Growth factors that support platelet or white cell number or function must not have been administered within 7 days of blood draw documenting hematopoietic function (ANC, Platelets) eligibility. .
+ANC: 1000/ul (no short acting hematopoietic growth factors within 7 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors within 14 days of blood draw documenting eligibility)
+Prior treatment with: anti-cancer therapy (e.g., chemotherapy with delayed toxicity, immunotherapy, biologic therapy or chemoradiation) within 21 days (or within 42 days if prior nitrosourea or mitomycin C containing therapy) prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrolment. Subjects may remain on luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide, goserelin, triptorelin or histrelin). Subjects must have prior enzalutamide treatment; Any PI3K, AKT or mammalian target of rapamycin (mTOR) inhibitors; Investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to enrollment
+Hematologic parameters must be assessed at least 14 days after a prior transfusion, if any
+Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of: \r\n* 28 days from the administration of any investigational agent\r\n* 28 days from administration of prior cytotoxic therapy with the following exceptions: \r\n** 14 days from administration of vincristine\r\n** 42 days from administration of nitrosoureas\r\n** 21 days from administration of procarbazine\r\n* 7 days from administration of non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. [radiosensitizer does not count])\r\n* 28 days from prior radiation therapy
+Residual disease following resection of recurrent tumor is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, an MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks postoperatively, within 14 days prior to registration; if the \within 96-hour of surgery\ scan is more than 14 days before registration, the scan needs to be repeated
+Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days prior to registration
+Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
+CAR-T infusion or other cellular therapy within 30 days
+Radiotherapy within 14 days of study treatment
+Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
+Immunotherapy within 21 days prior to randomization.
+Treatment with valproic acid within 14 days prior to initiation of study and during the study
+Patients who have not yet completed at least 28 days (30 days for prior monoclonal antibody therapy) since receiving other investigational drugs
+At least 30 days must have elapsed since any prior experimental therapy
+Systemic corticosteroid therapy <7 days prior to first dose of the study medication
+Use of valproic acid for any medical condition while receiving protocol treatment or within 5 days prior to first panobinostat dose
+Hematocrit > 29% within 14 days prior to treatment initiation
+Used any systemic steroids within 28 days of study treatment
+Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac
+Investigative drugs within 21 days
+Patients with unhealed wounds for more than 30 days
+Treatment with any anti-cancer agents within 28 days of study entry
+Treatment with any anti-cancer agents within 28 days of study entry
+Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.
+Subjects must receive 1st dose of sorafenib 5-7 days prior to administration of SRS
+Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617
+Radiotherapy to multiple sites or immunotherapy within 14 days of initiation of study drug treatment (localized radiotherapy to a single site at least 7 days before start is permissible)
+Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The participant may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
+Subjects who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.
+Corticosteroids discontinued ?7 days of initiating therapy
+Donation of blood within the preceding 60 days prior to study registration.
+Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
+Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
+One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
+Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
+Failed previous antifungal therapy or expected to live < 3 days.
+Patient must begin therapy within 7 calendar days of registration
+Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
+Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment
+Minor procedures (such as a central line placement, needle biopsy, thoracentesis, or paracentesis) =< 3 days prior to registration
+Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin; occasional use of nonsteroidal antiinflammatory drug (NSAID)s and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken < 7 days per 28 days; however, if the patient requires chronic use (>= 7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded
+Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment
+Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 or meet the inclusion/exclusion criteria prior to enrollment\r\n* Myelosuppressive chemotherapy: \r\n** Must be 14 days after the last dose of myelosuppressive chemotherapy (excluding hydroxyurea)\r\n** Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy\r\n* Intrathecal cytotoxic therapy:\r\n** No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone\r\n** At least 14 days must have elapsed since receiving liposomal cytarabine (DepoCyte) by intrathecal injection\r\n** Intrathecal cytarabine given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* Biologic (anti-neoplastic agent): \r\n** At least 7 days since the completion of therapy with a biologic agent such retinoids, or DLI (donor lymphocyte infusion without conditioning)\r\n** Note: for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which acute adverse events are known to occur\r\n* Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): \r\n** >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n* Antibodies: \r\n** >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n* Radiation therapy (RT):\r\n** At least 14 days after local palliative x-ray telescope (XRT) (small port); at least 84 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\r\n* Stem Cell Transplant (SCT) without TBI: \r\n** No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion\r\n** Patients must be off all systemic immunosuppressive therapy for at least 2 weeks, excluding hydrocortisone for physiologic cortisol replacement\r\n* Growth factors: \r\n** At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair\r\n* Patients must not have received prior exposure to AZD1775
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy must not be given within 28 days prior to study enrollment; for daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days prior to enrollment may be acceptable, and questions related to this can be discussed with study principal investigator
+Radiotherapy (external beam or CyberKnife) =< 28 days prior to starting study drug, or =< 14 days prior to study registration 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
+Has the ability to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post procedure,
+Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
+At least 7 days since the completion of therapy with a growth factor and at least 14 days since pegfilgrastim (Neulasta) administration
+Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation
+Have had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =< 5 days)
+Self-reported psychotic symptoms in the last 30 days
+Patient participants must also be a current smoker, defined as anyone who responds “every day” or “some days” to the question: “Do you smoke cigarettes every day, some days, or not at all?” (Behavioral Risk Factor Surveillance System [BRFSS])
+Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days
+Participants may not be receiving any other study agents within 21 days prior to entry on the study
+Are participating or have participated in another clinical trial in the last 30 days
+Chronic systemic corticosteroid use (>14 days) at the time of study enrollment.
+Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
+Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
+Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
+Patient treated with antifibrinolytic agents (including EACA) within 14 days prior to screening
+6-MMP:6-TGN ratio >= 40 within 21 days prior to enrollment
+6-MMP >= 12,000/8 x 10^8 red blood cell (RBC) within 21 days prior to enrollment
+Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
+Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
+Serum creatinine < 2.0 x IULN within 28 days prior to registration
+Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function; patients must meet the following minimum washout periods prior to enrollment:\r\n* At least 14 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C)\r\n* Radiotherapy:\r\n** At least 14 days after local palliative radiation therapy (XRT) (small port);\r\n** At least 90 days must have elapsed after prior total body irradiation (TBI), craniospinal XRT or if > 50% radiation of pelvis;\r\n** At least 42 must have elapsed if other substantial bone marrow (BM) radiation;\r\n** At least 42 days must have passed since last iobenguane (MIBG) or other radionuclide therapy\r\n* At least 7 days following the last dose of a biologic agent; for agents with known adverse events occurring beyond 7 days, this duration must be extended beyond the time in which adverse events are known to occur; if extended duration is required, this should be discussed and approved by the study chair\r\n* Monoclonal antibody: At least 21 days must have elapsed after the last dose of antibody\r\n* At least 14 days following the last dose of long-acting growth factor (e.g. Neulasta) or 7 days following short-acting growth factor\r\n* The patient must have no evidence of graft versus host disease and at least 42 days must have elapsed after transplant, stem cell infusion, or cellular therapy\r\n* At least 3 weeks from prior major surgical procedure; Note: Biopsy and central line placement/removal are not considered major\r\n* The patient must not have received prior CUDC-907 therapy; prior treatment with individual PI3K or HDAC inhibitors is allowed; patients must not have received therapy with the combination of PI3K and HDAC inhibitors
+ALT and AST ? 3.0 x ULN within 14 days prior to registration
+14 days from administration of vincristine or irinotecan
+42 days from administration of nitrosoureas
+21 days from administration of procarbazine
+Minimum interval since completion of radiation treatment at the time of registration is 90 days.
+Radiotherapy for RCC within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms
+Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
+Reports moderate fatigue on most days within the past week (i.e., at least 4 out of the last 7 days), rated as >= 4 on a 0 (no fatigue) to 10 (worst fatigue) scale
+7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =< 30 days after registration
+Obtained =< 30 days prior to registration: Triglycerides < 500 mg/dL
+Taking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =< 7 days prior to registration; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
+Subjects who have taken a neurokinin antagonist within 14 days prior to beginning the BEAM regimen
+Treatment with virus – specific T cells within 6 weeks (42 days) of planned infusion
+AI use > 21 days prior to study enrollment
+Protein levels within normal limits (lab results must be within 45 days prior enrollment)
+Normal blood counts (lab results must be within 45 days prior enrollment)
+Normal chemistries (lab results must be within 45 days prior enrollment)
+Participation in a therapeutic research study within 30 days of baseline
+Registration >= 3 days after placement of a new stent or >= 1 days after a stent exchange
+Willingness to refrain from grapefruit juice for 7 days prior to and for 7 days during the study
+Reports a fall in the past 30 days
+Patients will have to present on one of the three days per week that geriatric assessments are available, and be willing to be seen for geriatric co-management on one of the two geriatrician clinic days
+Patient should describe fatigue as being present for a minimum of four days
+Conditioning regimens 30 days (d) prior to trial participation and up to d28 post-HCT
+Treatment has been completed (except hormone therapy) for >= 90 days prior to registration
+Presence of CRF >= 30 days prior to registration
+Currently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for >= 30 days after registration; erythropoietin agents to treat anemia are allowed
+New use of Ambien and/or other benzodiazepines =< 30 days prior to registration
+New use of sleep aids including melatonin =< 30 days prior to registration
+Estimated length of hospital stay is 10 days or more
+Initiating or within 30 days of initiating ADT
+Patients with a previous or current line infection are ineligible until 14 days after the completion of antibiotics
+Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days prior to registration and plans to continue for at least an additional 180 days after registration; patients may have received any number of prior AI therapies, but the first AI therapy must have started no more than 36 months prior to registration:\r\n* Anastrozole (Arimidex) 1 mg daily\r\n* Letrozole (Femara) 2.5 mg daily\r\n* Exemestane (Aromasin) 25 mg daily
+Grade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool =< 7 days prior to registration
+Use of antibiotics =< 3 days prior to registration
+Presence of hot flashes for > 30 days prior to study entry
+Reports a fall in the past 30 days
+Treatment with an anticoagulant for more than 7 days for the current blood clot, prior to randomization
+Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.
+At least 28 days since the last chemotherapy or immunotherapy prior to the first dose; at least 14 days since the last radiation prior to the first dose (exception: palliative radiotherapy for pain can be used greater than or equal to (>=) 7 days prior to or after infusion)
+Growth factor(s): Must not have received any hematopoetic growth factors within 7 days of study entry.
+Inclusion Criteria:\n\n        Inclusion Criteria for Enrollment Phase\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\n          -  Histological or cytological diagnosis of Stage IB (tumors greater than or equal to\n             [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the\n             Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee\n             on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)\n\n          -  Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less\n             than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered\n             from surgery\n\n          -  If mediastinoscopy was not performed preoperatively, it is required that, at a\n             minimum, mediastinal lymph node systematic sampling will have occurred. Systematic\n             sampling is defined as removal of at least one representative lymph node at specified\n             levels. MLND entails resection of all lymph nodes at those same levels. For a right\n             thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left\n             thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear\n             documentation in the operative report or in a separately submitted addendum by the\n             surgeon of exploration of the required lymph node areas, the participant will be\n             considered eligible if no lymph nodes are found in those areas; if participants have\n             documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition;\n             Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative\n             staging imaging results (contrast computed tomography [CT] and positron emission\n             tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the\n             participant will be considered eligible if N2 nodal sampling is not performed per\n             surgeon's decision\n\n          -  Eligible to receive a cisplatin-based chemotherapy regimen\n\n          -  Adequate hematologic and end-organ function\n\n          -  Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or\n             surgically sterile must have a negative serum pregnancy test result within 14 days\n             prior to initiation of cisplatin-based chemotherapy\n\n        Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of\n        non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy\n        test result within 14 days prior to initiation of atezolizumab or BSC\n\n        Exclusion Criteria:\n\n        Exclusion Criteria for Enrollment Phase\n\n          -  Illness or condition that may interfere with a participant's capacity to understand,\n             follow, and/or comply with study procedures\n\n          -  Pregnant and lactating women\n\n          -  Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy\n             with curative intent, provided that the last dose received was more than 5 years prior\n             to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed\n             upon approval by the Medical Monitor\n\n          -  Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years\n             before enrollment\n\n          -  Treatment with any other investigational agent with therapeutic intent within 28 days\n             prior to enrollment\n\n          -  Participants with hearing impairment\n\n          -  Known sensitivity to any component of the chemotherapy regimen the participant will be\n             assigned to, or to mannitol\n\n          -  Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune\n             checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed\n             death ligand 1 (PD-L1) therapeutic antibodies\n\n          -  Malignancies other than NSCLC within 5 years prior to randomization, with the\n             exception of those with a negligible risk of metastasis or death (e.g., expected\n             5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome\n             (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell\n             skin cancer, localized prostate cancer treated surgically with curative intent, ductal\n             carcinoma in situ treated surgically with curative intent)\n\n          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to\n             chimeric or humanized antibodies or fusion proteins\n\n          -  Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells\n             or any component of the atezolizumab formulation\n\n          -  History of autoimmune disease, including but not limited to myasthenia gravis,\n             myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,\n             inflammatory bowel disease, vascular thrombosis associated with antiphospholipid\n             syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,\n             multiple sclerosis, vasculitis, or glomerulonephritis\n\n          -  Positive test for human immunodeficiency virus (HIV)\n\n          -  Participants with active hepatitis B (chronic or acute; defined as having a positive\n             hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C\n\n          -  Active tuberculosis\n\n          -  Significant cardiovascular disease, such as New York Heart Association cardiac disease\n             (Class II or greater), myocardial infarction, or cerebrovascular accident within the\n             previous 3 months, unstable arrhythmias, or unstable angina\n\n          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis\n             obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active\n             pneumonitis on screening chest CT scan\n\n          -  Prior allogeneic bone marrow transplantation or solid organ transplant\n\n          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical\n             laboratory finding giving reasonable suspicion of a disease or condition that\n             contraindicates the use of an investigational drug or that may affect the\n             interpretation of the results or render the participant at high risk from treatment\n             complications\n\n          -  Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC)\n             assay from other clinical studies (e.g., participants whose PD-L1 expression status\n             was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1\n             antibodies but were not eligible are excluded)\n\n        Specific Exclusions for Pemetrexed Treatment\n\n        - Participants with squamous cell histology\n\n        Exclusion Criteria for Randomized Phase\n\n          -  Signs or symptoms of infection within 14 days prior to randomization (severe infection\n             within 28 days prior to randomization), including but not limited to hospitalization\n             for complications of infection, bacteremia, or severe pneumonia\n\n          -  Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to\n             randomization\n\n          -  Major surgical procedure within 28 days prior to randomization or anticipation of need\n             for a major surgical procedure during the course of the study\n\n          -  Administration of a live, attenuated vaccine within 28 days prior to randomization or\n             anticipation that such a live attenuated vaccine will be required during the study\n\n          -  Treatment with systemic immunostimulatory agents (including but not limited to\n             interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is\n             longer, prior to randomization: Prior treatment with cancer vaccines is allowed\n\n          -  Treatment with systemic corticosteroids or other immunosuppressive medications\n             (including but not limited to prednisone, dexamethasone, cyclophosphamide,\n             azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF]\n             agents) within 14 days prior to randomization
+Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
+Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration
+Inclusion Criteria:\n\n          -  Be willing and able to provide written informed consent for the trial.\n\n          -  Over 18 years of age on day of signing informed consent.\n\n          -  Have histologically confirmed muscle invasive disease of the urinary bladder, renal\n             pelvis, or ureters.\n\n          -  Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial\n             carcinoma with mixed histology/features.\n\n          -  Clinical stage cT2-4aN0M0. Please see exclusion criteria for acceptable N0\n             determination/lymph node size.\n\n          -  Have a surgical evaluation that documents the plan for multimodality therapy with a\n             consolidative radical cystectomy or nephroureterectomy.\n\n        NOTE on surgical intent: Criteria for acceptable surgical risk are not defined and per\n        treating urologist. Minimum guidance on surgical intent includes subjects who do not have\n        significant cardiovascular disease such as NHYA class III or IV heart failure, unstable\n        arrhythmias or angina, active CAD, and/or EF<25%. Specific diagnostic testing to determine\n        surgical intent is not required and per treating urologist or oncologist discretion.\n\n          -  Have an archived tumor block available to submit unstained slides for PD-L1\n             expression, basal and luminal subtype analysis; MANDATORY. If slides are not\n             available, a biopsy is strongly encouraged to obtain tissue for submission\n\n          -  Subjects on full dose anticoagulants must be on a stable regimen of warfarin or low\n             molecular weight heparin (LMWH) for at least two weeks.\n\n          -  Female subjects of childbearing potential must have a negative urine or serum\n             pregnancy test within 72 hours prior to study registration. If the urine test is\n             positive or cannot be confirmed as negative, a serum pregnancy test is required.\n\n          -  Female subjects of childbearing potential must be willing to use 2 methods of birth\n             control, be surgically sterile, or abstain from heterosexual intercourse for the\n             course of the study and through 120 days after the last dose of study medication.\n             NOTE: Subjects of childbearing potential are those who have not been surgically\n             sterilized or have not been free from menses for > 1 year.\n\n          -  Male subjects must agree to use a barrier method of male contraception starting with\n             the first dose of study therapy and through 120 days after the last dose of study\n             therapy.\n\n        COHORT I - CISPLATIN-ELIGIBLE:\n\n        In addition to the inclusion criteria listed above, Cohort I subjects must satisfy all of\n        the following criteria:\n\n          -  Glomerular filtration rate (GFR) or creatinine clearance (Ccr) ? 50 mL/min. (24 hour\n             urine preferred). The cisplatin dose will be split over two days for values between\n             50-59 mL/min\n\n          -  ECOG PS 0, 1 (and not 2)\n\n          -  Hearing impaired ? grade 1 (may or may not be enrolled in a monitoring program)\n\n          -  Peripheral neuropathy ?grade 1\n\n        COHORT II - CISPLATIN-INELIGIBLE:\n\n        In addition to the inclusion criteria listed above, Cohort II subjects must also meet any\n        ONE of the following criteria:\n\n          -  GFR or Ccr: 30-49 (24 hour urine preferred).\n\n          -  ECOG PS 2\n\n          -  Hearing impaired ?grade 2 as assessed by treating physician (may or may not be\n             enrolled in a monitoring program).\n\n          -  Peripheral neuropathy of Grade 2-4\n\n        Exclusion Criteria:\n\n        Subjects may not have any of the following:\n\n          -  A non-surgical approach recommended by the treating urologist due to any reason.\n             Criteria for surgical intent are not defined and, rather, suitability is determined\n             and documented by the subject's treating urologist. Minimum guidance on surgical\n             intent includes subjects who do not have significant cardiovascular disease such as\n             NHYA class III or IV heart failure, unstable arrhythmias or angina, active CAD, and/or\n             EF<25%. Specific cardiopulmonary diagnostic testing to determine surgical intent is\n             not required and per treating urologist or oncologist discretion.\n\n          -  Has abdomino-pelvic short axis lymph node of ?15mm without biopsy. NOTE: A subject\n             with a staging biopsy proving a non-neoplastic process/N0 will meet inclusion.\n\n          -  Is currently participating in or has participated in a study of an investigational\n             agent or using an investigational device within 28 days prior to study registration.\n\n          -  Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other\n             form of immunosuppressive therapy within 7 days prior to study registration. Subjects\n             on steroids for physiologic replacement due to a non-cancer related cause would not be\n             excluded.\n\n          -  Has had a prior monoclonal antibody ? 28 days prior to study registration or who has\n             not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to agents\n             administered more than 28 days earlier.\n\n          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy for\n             urothelial carcinoma.\n\n          -  Has a known additional malignancy that is progressing or required treatment ? 48\n             months of study registration. Exceptions include basal cell carcinoma of the skin,\n             squamous cell carcinoma of the skin, in situ cervical cancer that has undergone\n             potentially curative therapy, stable (as defined by PSA change, checked within 30\n             days) and untreated very low-risk or low-risk prostate cancer defined by current NCCN\n             guidelines.\n\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\n             meningitis. Brain imaging is not required and per discretion of treating physician.\n\n          -  Has an active autoimmune disease requiring systemic treatment within the past 3 months\n             or a documented history of clinically severe autoimmune disease, or a syndrome that\n             requires systemic steroids or immunosuppressive agents. NOTE: Subjects with vitiligo\n             or resolved childhood asthma/atopy would be an exception. Subjects that require\n             intermittent use of bronchodilators or local steroid injections would not be excluded\n             from the study. Subjects with hypothyroidism stable on hormone replacement or\n             Sjogren's syndrome will not be excluded from the study.\n\n          -  Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.\n\n          -  Has an active infection requiring systemic therapy.\n\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\n             that might confound the results of the trial, interfere with the subject's\n             participation for the full duration of the trial, or is not in the best interest of\n             the subject to participate, in the opinion of the treating investigator.\n\n          -  Has known psychiatric or substance abuse disorders that would interfere with\n             cooperation with the requirements of the trial.\n\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\n             projected duration of the trial, starting with the pre-screening or screening visit\n             through 120 days after the last dose of trial treatment.\n\n          -  Has received therapy with hematopoietic growth factor such as G-CSF or GM-CSF in the\n             14 days prior to registration.\n\n          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or\n             anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including\n             ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation\n             or checkpoint pathways).\n\n          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n\n          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\n             [qualitative] is detected).\n\n          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n             NOTE: Examples of live vaccines include, but are not limited to, the following:\n             measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral)\n             vaccines. Seasonal influenza vaccines for injection are generally killed virus\n             vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are\n             live attenuated vaccines, and are not allowed.
+Platelets >= 75 x 10^9/L and no platelet transfusion within the past 21 days prior to study registration
+Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization
+Patients taking any tetracycline within the last 15 days
+Participants must be at least 100 days after HCT
+Patients continuously taking systemic steroids within the last 15 days
+Patients taking any tetracycline in the last 15 days
+Chronic systemic corticosteroid use (> 14 days) at the time of study enrollment
+Currently taking MP or have taken it within the previous 10 days
+Patients must currently be taking a third-generation aromatase inhibitor (AI) – anastrozole, letrozole, or exemestane for at least the previous 30 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 30 days; concurrent trastuzumab (Herceptin) is allowed
+Patients must not be on narcotics within 14 days of registration
+Patients must be able to complete the baseline S1013 FACT EGFRI 18 within 3 days prior to initiation of EGFRI therapy
+Be currently taking MP or have taken it within the previous 10 days
+Received any red blood cell (RBC) transfusion within 28 days prior to randomization.
+ESA therapy within the 28 days prior to randomization.
+Insomnia present for >= 30 days per patient report
+Corticosteroid within the past 30 days prior to registration on this study for greater than one week duration
+Psychostimulant use in the past 30 days prior to registration
+Underactive (defined as physically active for less than 30 minutes per day fewer than 2 days per week)
+Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
+Participants must be at least 100 days after HCT
+Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
+Cryoablation should be performed within 14 days of baseline evaluations
+CAREGIVERS ONLY: Able to attend the last two days of the retreat with patient
+Use of antibiotics =< 3 days prior to registration
+GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:\r\n* Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\r\n** Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n*** >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\r\n** Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n** Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\r\n** Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n** Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; 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; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\r\n** Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\r\n** Stem cell infusions (with or without TBI):\r\n*** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of GVHD\r\n*** Autologous stem cell infusion including boost infusion: >= 42 days\r\n** Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)\r\n** X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment\r\n** Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
+Previous blood transfusion (7 days prior to genetic testing)
+Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another
+Women who have a screening digital mammogram on the day of CESM or within 365 days prior
+Patients must be registered between 180 days and 465 days (inclusive) of primary resection; patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and computed tomography (CT) scans* of chest, abdomen and pelvis (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration); patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed\r\n* CT scan is for high risk patients, as per National Comprehensive Cancer Network (NCCN) guidelines and at the discretion of the treating physician\r\n* NOTE: magnetic resonance imaging (MRI) evaluation is an acceptable alternative to CT scans for eligibility purposes
+Patients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registration
+Serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration
+Digital mammogram within 365 days prior to pre-registration
+Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to calendar day of vaccination
+FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: Receipt of IVIG < 27 days prior to calendar day of vaccination
+Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to vaccination
+Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment in step 1
+Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days
+Patients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment; chimerism within 30 days of study entry must be greater than, equal to, or no more than 5% less than the chimerism measured at approximately day +30 (if performed)
+Patients must be at least 28 days post systemic steroids prior to enrollment
+Glycosylated hemoglobin measurement (HbA1c) < 5.7% within 90 days of enrollment
+Willing to set a quit date in the next 30 days
+Motivated to quit within the next 30 days.
+Receipt of ART for at least 180 days prior to randomization
+Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or imiquimod (Aldara®) anywhere on the body within 30 days prior to enrollment; subjects may be reconsidered for eligibility 30 days after the last topical treatment with such medications
+Recent quitters (have not smoked in past 7 days)
+Proven, probable or possible IFI within the previous 30 days
+Use of antibiotics within the past 7 days
+Required prior to infusion of ATLCAR.CD30 cells: Platelet count >= 25,000 cells/mm^3 without transfusion over preceding 5 days
+Required prior to infusion of ATLCAR.CD30 cells: Hgb >= 8g/dL without transfusion support over preceding 5 days
+Imaging results from within 30 days prior to transplant (used as baseline measure for documentation of disease status); results may be obtained at a time point greater than 30 days from transplant if obtained per the patient’s standard of care and with prior sponsor approval
+Participation in a clinical trial evaluating another preventative or treatment strategy for chronic GVHD or ongoing participation in a clinical trial for therapy of acute GVHD; prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used > 30 days prior to enrollment
+Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first PANO treatment
+Smoke on >= 25 days of the past 30 days
+Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
+At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days
+Smoke one or more cigarettes on 25 out of the past 30 days
+Has been admitted to the hospital greater than three days
+Inflammatory eye disease requiring steroid treatment within 28 days of screening
+Smoke cigarettes 25 of the past 30 days (not including days spent in the hospital)
+Individuals who received scheduled aspirin, NSAIDs, or COX-inhibitors of any kind for more than 3 days (> 3 days) during anytime within the 2 weeks preceding baseline eligibility screening visit; individuals on cardio-protective aspirin will not be eligible
+Colonoscopy =< 45 days prior to randomization with removal of all adenomas or polyps >= 2 mm in size
+Is not expected to receive a minimum of 10 days of POS IV solution
+Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30 days or expects to do so within the following 60 days
+Greater than 30 days from completion of cytotoxic and biologic therapy and less than 120 days from previous therapy.
+Currently non-active (exercise two days or less per week)
+Leukocyte count >= 3,000/microliter obtained =< 45 days prior to randomization
+First dose of study medication must be greater than 30 days from completion of cytotoxic and antibody therapy and less than 120 days from previous therapy
+All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation
+Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP. Note that the screening serum pregnancy test can also be used as the test prior to starting IP (Investigational Product) if it is performed within the 72-hour timeframe.
+Patients who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228) are ineligible; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment
+Serum calcium < 11 mg/dL, obtained =< 42 days prior to registration; note: patients with hypercalcemia can be enrolled after the calcium is corrected with standard of care treatments
+Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
+Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose provided all treatment-related adverse events have resolved or have been deemed irreversible, with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 7 days before beginning the administration of BBI608.
+Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment
+Radiotherapy within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms
+Treatment with brivudine, sorivudine, or its chemically-related analogs ? 28 days prior to the date of Randomization
+Allogeneic HSCT within 90 days of leukapheresis
+Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment
+Inpatients who have central venous catheter (CVC) that has been in place for at least 14 days and is expected to remain in place at least for 30 days after enrollment
+Have participated in any clinical trial in the previous 30 days.
+Smoke on >= 25 days of the past 30 days
+has practiced adequate contraception for 30 days prior to vaccination, and
+Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days); participants will be asked to keep a food diary; patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times
+Total or conjugated (direct) bilirubin =< 2.5 X ULN within 45 days prior to entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
+Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry
+Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
+has practiced adequate contraception for 30 days prior to vaccination, and
+Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm, and at least 10 mm in the 3rd orthogonal direction
+Patients must be registered on study within 100 days after core needle biopsy
+Patient registered on study more than 100 days since the date of core needle biopsy
+Prior RT is allowed and must have been completed more than 7 days before planned study entry\r\n* Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue
+Absolute neutrophil count (ANC) >= 1.5 X 10^9/L without (w/o) myeloid growth factor support for 7 days preceding lab assessment, obtained within 14 days prior to PET scan
+Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan
+Patients who have had active infection within 15 days of study enrollment that may be considered to interfere with 68Ga-PSMA PET imaging by the study investigators
+Platelets >= 100,000/mm^3, obtained within 14 days prior to C11-AMT PET scan
+Adjuvant anticancer treatments are allowed if at least 30 days has elapsed between the infusion/injection and C11-AMT PET scan as part of this study
+Participation in any other study in last 30 days
+Platelets >= 100 X 10^9/L (evaluated within 28 days of randomization)
+Participation in other clinical study within the last 30 days
+Use of other anticancer therapy within 15 days before the first dose of M3541 administration and should not be within the \at risk follow-up period\ for that specific anticancer therapy. The use of any investigational agent is not allowed within 28 days before the first dose of M3541
+Systemic corticosteroid therapy within 7 days before enrollment.
+Had at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)
+Has consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire study
+For cohort 2 only: progressive disease (PD) on lenvatinib per RECIST 1.1 =< 30 days prior to registration, as confirmed by the site study PI
+Patients must have had treatment with temozolomide, lomustine (CCNU) or PCV (procarbazine, lomustine [CCNU], vincristine) chemotherapy prior to histopathologic transformation to glioblastoma or prior to identification of one of the genetic alterations specified; notes or records from the treating oncologist are required for documentation of treatment history; prior treatment with at least one of the following chemotherapy schedules is required to be eligible:\r\n* At least one 6 week course of continuous daily temozolomide\r\n* At least six 28-day cycles given in one of the following schedules:\r\n** Daily for 5 days of a 28-day cycle\r\n** Daily for 21 days of a 28-day cycle\r\n** Daily for 14 days of a 28-day cycle\r\n** Alternating 7 days on/7 days per 28-day cycle\r\n** Continuous daily dosing of a 28-day cycle\r\n* Other schedules of temozolomide may be considered after discussion with the overall principal investigator\r\n* At least 3 cycles of PCV or lomustine (CCNU) chemotherapy
+Interval of at least 6 months from the completion of any prior radiotherapy and registration; if patients have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:\r\n* New areas of tumor outside the original radiotherapy fields as determined by the investigator, or\r\n* Histologic confirmation of tumor through biopsy or resection, or\r\n* Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than pseudo progression or radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and registration
+Anti-androgenic therapy within 30 days prior to enrollment
+Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
+Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
+Patients with active and/or uncontrolled infections or who are still recovering from an infection\r\n* Actively febrile patients with uncertain etiology of febrile episode\r\n* All antibiotics should be completed at least 1 week (7 days) prior to collection\r\n* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\r\n* Note: Use of antibiotics for pre-operative prophylaxis is not an exclusion
+Medically able to undergo primary cytoreductive surgery, at least 14 days and up to 28 days after starting study drug, as determined by treating physician
+Participation in a smoking cessation program in the past 30 days
+Have taken antibiotics =< 7 days prior to registration
+Male participants are required to use a condom during the entire study period with RO6958688 and up to 90 days after last administration of RO6958688. Male participants should not donate sperm for 90 days after the last dose of RO6958688.
+Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 30 days of enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days of enrollment
+Hospitalization within 30 days of enrollment
+Medically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physician
+Ability and willingness to completely abstain from alcohol consumption for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration
+Have discontinued all disease-modifying therapy for the primary cancer for 28 days prior to initiation of study treatment.
+Biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent have been in place for at least 10 days prior to the first dose of crizotinib, and the liver function has stabilized as defined by 2 measurements at least 5 days apart that put the patient in the same hepatic dysfunction stratum as defined in Section 3.
+prior immunotherapy
+Radiographic confirmation of MBO is required prior to registration; scans may have been done before or after admission; scans done prior to admission must have been completed within 14 days prior to admission; computed tomography (CT) scans are preferred
+Patients must be current smokers who smoke at least one cigarette most days per week, or recent quitters who smoked at least one cigarette most days per week (< 3 months); and
+Have anticipated in-patient status for 14 to 20 days from the time of transplant.
+Biologic: ?7 days from anti-neoplastic biologic agent
+Immunotherapy: ?42 days after completion of immunotherapy
+Patients may receive anagrelide for up to 28 days (in countries where the product is registered). Leukapheresis is allowed up to 24 hours prior to the first treatment cycle with omacetaxine.
+Initiation of new photosensitizing drugs within 30 days of Screening.
+daily (25+ days within past 30) cigarette smoker of >5 cigs/day
+Expected survival is > 100 days
+Demonstrate adequate organ function, all screening labs must be performed within 10 days of treatment initiation; labs must meet eligibility criteria within 4 days of cycle 1 day 1
+Patients must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with AEDs must be on stable doses for at least 14 days prior to enrollment
+Should be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.
+Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
+Open wounds or unhealed fractures within 28 days of starting study treatment
+Patients who have received wide field radiotherapy ? 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to starting study treatment or those patients who have not recovered adequately from side effects of such therapy
+Inclusion Criteria:\n\n          -  Eligible patients will be considered for inclusion if they meet all of the following\n             criteria. (All necessary baseline studies for determining eligibility must be obtained\n             within 21 days prior to enrollment.)\n\n               1. Male or female patient who is at least 18 years of age.\n\n               2. Patient has given voluntary written informed consent before performance of any\n                  study-related procedures not part of standard (non-investigational) medical care.\n\n               3. Patient has been previously diagnosed with MM based on standard criteria.\n\n               4. Patient has received:\n\n                    1. At least 2 prior therapies including a proteasome inhibitor (? 2 cycles) and\n                       lenalidomide (? 2 cycles), and\n\n                    2. Has achieved at least stable disease (SD) for ? 1 cycle of treatment on ? 1\n                       prior treatment, and\n\n                    3. Has demonstrated disease progression subsequent to treatment, during or\n                       within 90 days following completion of the most recent therapy.\n\n               5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score\n                  ? 2.\n\n               6. Patient has measurable disease defined as at least 1 of the following:\n\n                    1. Serum M protein ? 0.5 /dL (?5 g/L)\n\n                    2. Urine M protein ? 200 mg/24 hours\n\n                    3. Serum free light chain (FLC) assay: Involved FLC assay ?10 mg/dL (?100 mg/L)\n                       and an abnormal serum FLC ratio (<0.26 or >1.65)\n\n               7. Clinical Laboratory Inclusion Criteria: The following laboratory results must be\n                  met within 14 days (or as stipulated) prior to study drug (treatment)\n                  administration:\n\n                    1. Absolute neutrophil count (ANC) ? 1000 cells/?l (growth factor cannot be\n                       used within the previous 7 days).\n\n                    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 ×\n                       upper limit of normal (ULN).\n\n                    3. Platelet count ? 50,000/?l (without platelet transfusion in the previous 7\n                       days).\n\n                    4. Total bilirubin ? 1.5 mg/dL.\n\n                    5. Serum creatinine ? 2.0 mL/dL and creatinine clearance ? 40 mL/min\n                       (calculated by the Cockcroft-Gault Equation or per 24 hour urine\n                       collection).\n\n                    6. Serum albumin ? 3.2 g/dL in the absence of receipt of (IV) albumin within\n                       the previous 72 hours.\n\n                    7. Serum creatine phosphokinase (CPK) ? 2.5 × the ULN.\n\n                    8. Serum calcium (corrected for albumin) level at or below the ULN range\n                       (treatment of hypercalcemia is allowed and patient may enroll if\n                       hypercalcemia returns to normal range with standard treatment).\n\n               8. Left ventricular ejection fraction (LVEF) ? institutional lower limit of normal\n                  as measured by multigated acquisition scan (MUGA) scan or 2-dimensional\n                  echocardiography (ECHO) within 28 days prior to start of therapy and no\n                  clinically significant abnormalities on a 12-lead electrocardiogram (ECG).\n\n               9. Females of childbearing potential (FCBP)* must have a negative serum or urine\n                  pregnancy test prior to initiation of the SL-401 Run in Cycle (if required) and\n                  repeated with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to\n                  and again within 24 hours of starting Pomalidomide and must either commit to\n                  continued abstinence from heterosexual intercourse or begin 2 acceptable methods\n                  of birth control, 1 highly effective method and 1 additional effective method at\n                  the same time, at least 28 days before she starts taking Pomalidomide through 30\n                  days after the last dose of Pomalidomide and 60 days after the last dose of\n                  SL-401. FCBP must also agree to ongoing pregnancy testing during the entire\n                  duration of treatment. Men must agree to use a latex or synthetic condom during\n                  sexual contact with a FCBP even if they have had a vasectomy from the time of\n                  signing the informed consent form through 60 days after the last dose of\n                  Pomalidomide or SL-401. These same patients must not donate sperm. All patients\n                  must be counseled at a minimum of every 28 days about pregnancy precautions and\n                  risks of fetal exposure. All patients enrolled into this study, must agree to be\n                  registered in and must comply with all requirements of the Pomalidomide REMS(TM)\n                  program.\n\n                    -  An FCBP is a sexually mature female who: 1) has not undergone a hysterectomy\n                       or bilateral oophorectomy; or 2) has not been naturally postmenopausal for\n                       at least 24 consecutive months (i.e., has had menses at any time in the\n                       preceding 24 consecutive months).\n\n        Exclusion Criteria:\n\n        Patients will be ineligible for this study if they meet any 1 of the following criteria:\n\n          1. The patient has an active malignancy and/or cancer history that may confound the\n             assessment of the study endpoints. Patients with a past cancer history (within 2 years\n             of entry) with substantial potential for recurrence and/or ongoing active malignancy\n             must be discussed with the Sponsor before study entry. Patients with the following\n             neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ\n             (including superficial bladder cancer), cervical intraepithelial neoplasia,\n             organ-confined prostate cancer with no evidence of progressive disease.\n\n          2. Prior therapy with SL-401 or received any investigational drug within the prior 30\n             days or 5 half-lives of the investigational drug, whichever is longer.\n\n          3. Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and\n             immunotherapy) within the prior 14 days except for alkylating agents (e.g., melphalan)\n             within the prior 28 days.\n\n          4. POM-refractory disease (i.e., non-responsive to prior POM [either as monotherapy or in\n             combination] or relapse/progressive disease within 60 days of prior POM (either as\n             monotherapy or in combination). Prior POM exposure is permitted, provided the\n             patient's MM is not considered POM-refractory as defined above.\n\n          5. Primary refractory MM defined as disease that is non-responsive in patients that have\n             never achieved at least stable disease or better with any therapy.\n\n          6. Any > grade 1 (according to the National Cancer Institute [NCI] Common Terminology\n             Criteria for Adverse Events [CTCAE], v.4.03) adverse reaction unresolved from previous\n             treatments or not readily managed and controlled with supportive care. The presence of\n             alopecia of any grade and peripheral neuropathy ? grade 2 without pain is allowed.\n\n          7. Previous allogeneic stem cell transplantation with active graft-versus-host-disease,\n             or treatment with immunosuppressive therapy in the 2 months prior to study entry.\n\n          8. Daily requirement for corticosteroids >10 mg prednisone daily (or equivalent); inhaled\n             corticosteroids are permitted.\n\n          9. Patient is known to be human immunodeficiency virus positive, or have chronic or\n             active hepatitis B (core- or surface antigen-positive) or active hepatitis C\n             infection.\n\n         10. Clinically significant cardiovascular disease (e.g., uncontrolled or any New York\n             Heart Association [NYHA] Class 3 or 4, congestive heart failure, uncontrolled or\n             unstable angina, history of myocardial infarction or stroke within 6 months prior to\n             study entry, uncontrolled hypertension or clinically significant arrhythmias not\n             controlled by medication)\n\n         11. Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive\n             pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator\n             would put the patient at significant risk for pulmonary complications during the\n             study.\n\n         12. Uncontrolled intercurrent illness including, but not limited to, uncontrolled\n             infection, disseminated intravascular coagulation, or psychiatric illness/social\n             situations that would limit compliance with study requirements.\n\n         13. History of erythema multiforme or severe hypersensitivity to prior Immunomodulatory\n             Drugs (IMiDs) such as thalidomide and lenalidomide.\n\n         14. The patient is receiving medications that are strong inhibitors of CYP1A2. Patients\n             should have discontinued strong CYP1A2 inhibitors (e.g., ciprofloxacin and\n             fluvoxamine) at least 5 half-lives before beginning study drug.\n\n         15. The patient continues to smoke cigarettes, which can induce CYP1A2.\n\n         16. Inability to tolerate thromboprophylaxis.\n\n         17. Pregnant or breast feeding. -
+Anticancer chemotherapy, biologics, immunotherapy, radiotherapy, or investigational treatment within 30 days, except for hormone therapy, which could be given up to 7 days prior to the first dose of poziotinib.