Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Kidney Cancer
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring unspecified childhood solid tumor, protocol specific, recurrent childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent osteosarcoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent childhood malignant germ cell tumor, recurrent childhood liver cancer, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, childhood atypical teratoid/rhabdoid tumor, childhood low-grade cerebral astrocytoma, childhood high-grade cerebral astrocytoma, childhood choroid plexus tumor, childhood craniopharyngioma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, childhood oligodendroglioma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood brain tumor, childhood central nervous system germ cell tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, childhood teratoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including, but not limited to, any of the following: Rhabdomyosarcoma and other soft tissue sarcomas Ewing's sarcoma family of tumors Osteosarcoma Neuroblastoma Wilms' tumor Hepatic tumors Germ cell tumors Primary brain tumors In patients with brainstem or optic gliomas, requirement for histological confirmation can be waived if biopsy was not performed Patients with brainstem gliomas that did not respond to therapy but that are without radiographic evidence of disease progression must have clinical evidence of progression Patients with brain tumors must be on stable or tapering dose of corticosteroids for 7 days prior to study entry Measurable or evaluable disease Relapsed or failed to respond to frontline curative therapy, including any of the following: Surgery Radiotherapy Chemotherapy Combination of modalities No other potentially curative treatment options available PATIENT CHARACTERISTICS: ECOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8 mg/dL Platelet count ≥ 100,000/mm^3 (platelet transfusion independent) Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGPT ≤ 2.5 times ULN Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine* as follows: No more than 0.8 mg/dL (for patients ≤ 5 years of age) No more than 1.0 mg/dL (for patients 6 to 10 years of age) No more than 1.2 mg/dL (for patients 11 to 15 years of age) No more than 1.5 mg/dL (for patients > 15 years of age) NOTE: *For patients receiving carboplatin a nuclear glomerular filtration rate study, 24-hour urine collection, and serum creatinine for estimation of creatinine clearance is required if under 15 years of age OR serum creatinine and weight for estimation of creatinine clearance is required if 15-18 years of age Patients with history of seizures eligible if seizures controlled by anticonvulsants No clinically significant, unrelated systemic illness, including either of the following: Serious infections Hepatic, renal, or other organ dysfunction that would preclude study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No generalized pitting peripheral edema No sensitivity to valine-proline boronic acid PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered to ≤ grade 1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study entry Any number of prior chemotherapy regimens allowed Prior temozolomide or carboplatin as frontline therapy or in the adjuvant setting allowed provided patient did not experience severe toxicities related to the drug and tumor progressed during this therapy At least 3 weeks since last dose of all myelosuppressive chemotherapy At least 7 days since last dose of anticancer biologic agents (e.g., retinoids) At least 30 days since prior investigational agents At least 4 weeks since prior radiotherapy to > 25% of marrow-containing bones (pelvis, spine, or skull) (2 weeks for palliative [limited-port] radiotherapy) At least 2 months since prior autologous stem cell transplantation and recovered At least 1 week since prior filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa At least 2 weeks since prior pegfilgrastim No history of allogeneic stem cell transplantation No other concurrent anticancer chemotherapy, radiation therapy, or immunotherapy No other concurrent investigational agents
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office