A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratnetorial Glioblastoma Multiforme (GBM)

Inclusion Criteria

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
SGPT or 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