A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)

Pt must have histologically-confirmed unifocal AA by central review, or mixed oligodendroglial/astrocytic tumors where the oligodendroglial component is < 25%. Pts w/prior biopsy-proven low grade astrocytoma who now have a biopsy-proven AA and have not been previously treated w/either RT or chemo are eligible. Pts must have a Karnofsky PS of >/= 60. Pts must have HGB >/= 10 grams, ANC >/=1500, PLTS >/=150,000, AST, ALK Phos & bili < 2 X ULN, serum creatinine < 1.5 X normal. Therapy must begin w/in 5 wks after tissue dx. Pts must have a DLCO >/= 70%, pre-and post-op contrast-enhanced MRI. If pt had only a stereotactic biopsy, a post-bx scan is not necessary. Pts must not have a major medical illness or psychiatric impairments which in the investigator's opinion will prevent admin or completion of the protocol therapy and/or interfere w/follow-up. Pts must not have any oligodendroglial component > 20%. Pts must not have tumor predominately located in the posterior fossa, spinal cord tumors, evidence of spinal drop mets or spread to non-contiguous meninges, prior malignancy, prior RT to brain and/or head/neck, prior chemo, active infectious process, pregnancy or nursing, inability or willingness to use effective contraception, known or suspected hypersensitivity to one of the components of BCNU or temozolomide or to any other nitrosourea or Dacarbazine.