Gossypol (AT-101) and Temozolomide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
• Meets 1 of the following criteria:
• Completed surgery within the past 6 weeks (group I)
• Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks prior to start of study treatment (group II)
• Must be on a stable corticosteroid regimen (no increase for 5 days)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤1.5 mg/dL
• Bilirubin ≤ 1.5 mg/dL
• ALT and AST ≤ 2.5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after completion of study treatment
• Mini Mental State Exam score ≥ 15
• Must be able to swallow and retain oral medication
• No serious concurrent infection or medical illness that would preclude study participation
• No other malignancy within the past 5 years, except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
• No sensory neuropathy ≥ grade 2
• No allergies to gossypol
• No symptomatic hypercalcemia or hypercalcemia > grade 2
• No gastrointestinal disease including any of the following:
• Malabsorption syndrome
• Disease significantly affecting gastrointestinal function
• Ulcerative colitis
• Inflammatory bowel disease
• Partial or complete small bowel obstruction

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from the immediate postoperative period
• No prior radiotherapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cells or gene therapy), or hormonal therapy for this brain tumor (group I)
• Prior glucocorticoid therapy allowed
• No prior polifeprosan 20 with carmustine implant (Gliadel wafers) (group I)
• No prior gossypol
• No prior radiosurgery or brachytherapy
• No prior resection of the stomach or small intestine
• No other concurrent anticancer therapy (i.e., chemotherapeutics or investigational agents)
• No concurrent cytochrome p450 enzyme-inducing anticonvulsant drugs
• No concurrent prophylactic filgrastim (G-CSF)
• No concurrent iron supplements
• Nutritional supplements containing iron allowed
• No concurrent intensity-modulated radiotherapy
• No concurrent electron, particle, implant, or stereotactic radiosurgery boost