A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)

Date de début de l'étude : 1 juin 2000

DISEASE CHARACTERISTICS: Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following: Anaplastic astrocytoma Mixed oligodendroglial/astrocytic tumors Oligodendroglial component must be no greater than 25% No vascular proliferation and necrosis Increased cellularity, pleomorphism, and nuclear atypia allowed No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum) Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible Study therapy must begin within 6 weeks of diagnosis No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges Pathologic evidence of local meningeal infiltration by underlying tumor allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 1 year Hematopoietic: Hemoglobin at least 10 g/dL Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine less than 1.5 times normal Pulmonary: No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or lomustine or completion of therapy Other: No other major medical illness or psychiatric impairment that would preclude study compliance No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No known hypersensitivity to 1 of the components of carmustine, lomustine, temozolomide, dacarbazine, or any other nitrosourea No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to brain or head and neck Surgery: Not specified Other: No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detected