This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Name: Alisertib
Description: Given orallyType: DrugArm I (neuroblastoma- measurable) Arm II (Neuroblastoma- MIBG evaluable) Arm III (rhabdomyosarcoma) Arm IV (osteosarcoma) Arm V (Ewing sarcoma/peripheral PNET) Arm VI (non-RMS soft tissue sarcoma) Arm VII (hepatoblastoma) Arm VIII (malignant germ cell tumor) Arm IX (Wilms tumor) Arm X (acute lymphoblastic leukemia) Arm XI (acute myelogenous leukemia) Arm XII (rhabdoid malignancy)
Name: Laboratory Biomarker Analysis
Description: Correlative studiesType: OtherArm I (neuroblastoma- measurable) Arm II (Neuroblastoma- MIBG evaluable) Arm III (rhabdomyosarcoma) Arm IV (osteosarcoma) Arm V (Ewing sarcoma/peripheral PNET) Arm VI (non-RMS soft tissue sarcoma) Arm VII (hepatoblastoma) Arm VIII (malignant germ cell tumor) Arm IX (Wilms tumor) Arm X (acute lymphoblastic leukemia) Arm XI (acute myelogenous leukemia) Arm XII (rhabdoid malignancy)
Name: Pharmacological Study
Description: Correlative studiesType: OtherArm I (neuroblastoma- measurable) Arm II (Neuroblastoma- MIBG evaluable) Arm III (rhabdomyosarcoma) Arm IV (osteosarcoma) Arm V (Ewing sarcoma/peripheral PNET) Arm VI (non-RMS soft tissue sarcoma) Arm VII (hepatoblastoma) Arm VIII (malignant germ cell tumor) Arm IX (Wilms tumor) Arm X (acute lymphoblastic leukemia) Arm XI (acute myelogenous leukemia) Arm XII (rhabdoid malignancy)
Description: For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.
Measure: Number of Participants With Overall Response Time: From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.Description: The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.
Measure: Number of Patients Cycles With Grade 3 or Higher Adverse Event Time: Up to 24 monthsDescription: Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib Prior to the First Day of Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose Time: day 4 of protocol therapyDescription: Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose. Time: day 7 of protocol therapyAllocation: Non-Randomized
Single Group Assignment
There are 2 SNPs
To explore the relationship between polymorphic variations in the UDP-glucuronosyltransferase gene UGT1A1 and exposure to MLN8237, and to assess 2 common polymorphic variants in the aurora A kinase gene, Phe31Ile and Val57Ile. --- Phe31Ile ---
To explore the relationship between polymorphic variations in the UDP-glucuronosyltransferase gene UGT1A1 and exposure to MLN8237, and to assess 2 common polymorphic variants in the aurora A kinase gene, Phe31Ile and Val57Ile. --- Phe31Ile --- --- Val57Ile ---