Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of
conventional radiotherapy improves the median survival time of adults with newly diagnosed,
supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of
high-dose tamoxifen in these patients. III. Determine the overall survival with respect to
protein kinase C lab correlates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients
undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral
tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of
disease progression. Patients are followed every 3 months through year 1, every 4 months for
1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.

DISEASE CHARACTERISTICS: Histologically proven newly diagnosed, supratentorial
glioblastoma multiforme (with areas of necrosis) Diagnosis must be made by surgical biopsy
or excision within the past 5 weeks No recurrent malignant gliomas No metastases below the
tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 70-100% OR Zubrod 0-1
Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion
allowed) Hematocrit at least 30% (transfusion allowed) Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL
serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase
(SGOT) no greater than 2 times normal Renal: Blood urea nitrogen no greater than 25 mg/dL
Creatinine no greater than 1.5 mg/dL Cardiovascular: No active thrombophlebitis Other:
Recovered from any postoperative infection or other complications No major medical
illnesses or psychiatric impairments that would preclude study participation No active
connective tissue disorder, such as lupus or scleroderma No other malignancy within the
past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or
bladder No prior endometrial cancer or atypical endometrial hyperplasia No AIDS Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: At least 12 months since prior tamoxifen Radiotherapy: See Disease
Characteristics No prior radiotherapy to head or neck Surgery: See Disease Characteristics
Recovered from prior surgery