Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

Inclusion Criteria

• Patients must have had histologic verification of malignancy at original diagnosis or at relapse, to include any of the following malignancies (no other histology is eligible):
• Neuroblastoma- measurable
• Neuroblastoma- MIBG evaluable
• Rhabdomyosarcoma
• Osteosarcoma
• Ewing sarcoma/Peripheral PNET
• Non-RMS soft tissue sarcoma
• Hepatoblastoma
• Malignant germ cell tumor
• Wilms tumor
• Acute lymphoblastic leukemia
• Acute myelogenous leukemia
• Rhabdoid malignancy
• Disease status for solid tumor patients:
• Patients must have radiographically measurable disease (with the exception of neuroblastoma)
• Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 20 mm in at least one dimension; for spiral CT, measurable disease is defined as a minimum diameter of 10 mm in at least one dimension
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration
• Lesions detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans)
• Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
• Previously irradiated lesions that have not demonstrated clear progression post radiation
• Patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
• Disease status for leukemia patients:
• Patients with leukemia must be recurrent or refractory to at least two prior induction or treatment regimens, in addition to the following criteria:
• Acute lymphoid leukemia:
• 25% blasts in the bone marrow (M3 bone marrow), excluding patients with known central nervous system (CNS) disease
• Acute myeloid leukemia according to FAB classification
• ≥ 5 % blasts in the bone marrow (M2/M3 bone marrow); excluding patients with known CNS disease
• Rhabdoid tumors:
• To be eligible for enrollment in the rhabdoid tumors stratum, the patient must have a solid tumor where the institutional pathological evaluation of the tumor at initial diagnosis or relapse has confirmed:
• Morphology and immunophenotypic panel consistent with rhabdoid tumor (required)
• Loss of SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily b, member 1 (INI1) confirmed by immunohistochemistry, or
• Molecular confirmation of tumor-specific bi-allelic INI1 loss/mutation if INI1 immunohistochemistry is not available; note that molecular confirmation of tumor-specific bi-allelic INI1 loss/mutation is encouraged in cases where INI1 immunohistochemistry is equivocal
• Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age; Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
• Myelosuppressive chemotherapy:
• Solid tumors:
• Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
• Leukemia:
• Patients with leukemia who relapse while receiving standard maintenance therapy will not be required to have a waiting period before enrollment onto this study
• Patients who relapse while they are not receiving standard maintenance therapy 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 exce