Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease
Relapsed or refractory after at least 1 front-line therapy
Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease
RANDOMIZED PHASE II (ARMS K AND L): Patients must have relapsed after first line chemotherapy; may have relapsed after autologous stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; patient must not have received a prior allogeneic stem cell transplant
Patients must be refractory or have relapsed following prior induction therapy; a standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or dexamethasone, cytarabine/anthracycline, or high dose cytarabine
Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed
Part B: Patients with relapsed or refractory neuroblastoma
Part C: Patients with relapsed or refractory medulloblastoma or CNS PNET
Part D: Patients with relapsed or refractory rhabdomyosarcoma
Patients must have had histologic verification of malignancy at original diagnosis or relapse* Parts A & C: patients with recurrent or refractory solid tumors, without central nervous system (CNS) tumors or known CNS metastases, are eligible; note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated* Part B1: patients with relapsed or refractory neuroblastoma* Part B2: patients with relapsed or refractory osteosarcoma* Part B3: patients with relapsed or refractory rhabdomyosarcoma* Part B4: patients with relapsed or refractory Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET)* Part B5: patients with relapsed or refractory Hodgkin lymphoma* Part B6: patients with relapsed or refractory non-Hodgkin lymphoma* Part B7: patients with unresectable melanoma or metastatic melanoma or relapsed melanoma or refractory melanoma* Part B8: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without Response Evaluation Criteria in Solid Tumors [RECIST] measurable lesion)* Once the dose-escalation portion of Part A is completed, cohorts that are open concurrently for eligible patients (including Parts B and C and potential pharmacokinetic [PK] expansion cohorts) may be selected at the treating physicians discretion pending slot availability; in the event a disease group cohort in Part B is completed after the initial stage of Simons optimal two-stage design, for selected disease cohorts, a corresponding cohort in the same disease group for select disease types will be open in Part D:* Part D1: Patients with relapsed or refractory neuroblastoma* Part D2: Patients with relapsed or refractory osteosarcoma* Part D3: Patients with relapsed or refractory rhabdomyosarcoma* Part D4: Patients with relapsed or refractory Ewing sarcoma or peripheral PNET * Part D5: Patients with relapsed or refractory non-Hodgkin lymphoma* Part D6: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without RECIST measurable lesion)* Part E3: Patients with relapsed or refractory rhabdomyosarcoma* Part E4: Patients with relapsed or refractory Ewing sarcoma or peripheral PNET
Relapsed disease after standard chemotherapy
Patients must have histologically confirmed, relapsed/refractory ALK+ ALCL (with ALK positivity defined by immunohistochemistry and/or fluorescence in situ hybridization [FISH]/cytogenetics from any prior biopsy), MCL, or BCL6+ DLBCL (with BCL6 positivity defined by immunohistochemistry from any prior biopsy) and meet the following criteria:
ALK+ ALCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen including an anthracycline, if not contraindicated, and prior brentuximab; prior crizotinib or other ALK inhibitor therapy, while recommended, is not mandatory; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant
MCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included a multiagent chemotherapy regimen and prior ibrutinib or other BTK inhibitor therapy; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant
BCL6+ DLBCL: patients must have disease that has relapsed and or is refractory to prior therapy, which must have included an anthracycline, if not contraindicated; patients must have relapsed following or be ineligible for, or refuse, autologous stem cell transplant
Patients must have been refractory or relapsed following front line therapy for adult T-cell leukemia (ATL); those with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) who have CD30+ disease must have progressed during or after treatment with brentuximab vedotin, or are unable to receive treatment due to allergy or intolerance
Subjects with evidence of relapsed or refractory acute myeloid leukemia (AML) OR treatment naive AML who are 75 years or older OR relapsed or refractory myelodysplastic syndrome (MDS)* For subjects with relapsed AML: evidence of >= 5% blasts in the bone marrow; or reappearance of blasts in the peripheral blood; or development of extramedullary disease (according to 2003 IWG criteria) who relapse after:** Allogeneic hematopoietic stem cell transplant, or** After one cycle of standard cytotoxic chemotherapy or two cycles of any hypomethylating agent-based therapy* For subjects with refractory AML: =< 2 prior induction regimens (example: patients who receive 7+3 followed by 5+2 would count as one induction regimen) or a minimum of two cycles of any hypomethylating agent-based therapy* For subjects with treatment-naive AML: must be 75 years and older with de novo or secondary AML to be considered eligible* For subjects with relapsed MDS: disease recurrence after CR, partial remission (PR) or hematologic improvement with bone marrow blasts >= 5% who relapse after:** Allogeneic hematopoietic stem cell transplant, or** After four cycles of any hypomethylating agent-based therapy* For subjects with refractory MDS: disease progression at any time after initiation of hypomethylating agent treatment or persistent bone marrow blasts >= 5% despite a minimum of four cycles of hypomethylating agent therapy
Patients with T cell and natural killer (NK) cell lymphomas must be refractory to, be intolerant of, have relapsed following, or have refused all standard life-prolonging therapies