Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, recurrent childhood brain tumor, recurrent neuroblastoma, recurrent childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, childhood central nervous system germ cell tumor, recurrent osteosarcoma, unspecified childhood solid tumor, protocol specific, childhood germ cell tumor, recurrent childhood soft tissue sarcoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood teratoma, childhood malignant testicular germ cell tumor, childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, recurrent childhood malignant germ cell tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to: Rhabdomyosarcoma and other soft tissue sarcomas Ewing's family of tumors Osteosarcoma Neuroblastoma Wilms' tumor Hepatic tumors Germ cell tumors Primary brain tumor Histological confirmation may be waived for brainstem or optic gliomas Measurable or evaluable disease Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery PATIENT CHARACTERISTICS: Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm^3 Hemoglobin greater than 8 g/dL Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin normal SGPT less than 2 times upper limit of normal No significant hepatic dysfunction Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac dysfunction Pulmonary: No significant pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to swallow capsules No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction) No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G- CSF], sargramostim [GM-CSF], or epoetin alfa) At least 4 months since prior myeloablative therapy requiring bone marrow or stem cell transplantation No concurrent anticancer immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered Prior temozolomide allowed provided not administered within past 3 months, no severe toxicities experienced during prior course, and not given in combination with other agents designed to inactivate alanine-glyoxylate aminotransferase No other concurrent investigational or standard anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids for control of brain tumor-associated edema allowed provided on stable or decreasing dose for at least 1 week prior to study Radiotherapy: See Disease Characteristics At least 4 weeks since prior limited-field radiotherapy At least 4 months since prior craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis Recovered from prior radiotherapy No concurrent anticancer radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior investigational therapy and recovered No other concurrent anticancer investigational agents
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support