A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme or gliosarcoma

- Biopsy or surgical resection within the past 28 days

- MRI* with gadolinium performed before registration

- Patients who undergo a simple biopsy only require preoperative MRI* with
gadolinium

- No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)*

- No prior radiotherapy-delivered cephalad to the interspace between the seventh
cervical and the first thoracic vertebral body NOTE: *If an MRI is not medically
feasible, patients may have a CT scan with contrast

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

- PT/PTT no greater than 1.2 times ULN

Renal:

- Not specified

Cardiac:

- No severe cardiac disease, including any of the following:

- Uncontrolled arrhythmias or conduction defects

- Major problems with edema (e.g., residual swelling in the legs from deep vein
thrombosis)

- Recent coronary artery disease

- Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110
mm Hg and/or systolic blood pressure greater than 180 mm Hg)

Pulmonary:

- DLCO at least 70% of predicted

- No severe pulmonary disease

Other:

- HIV negative

- No severe Cushing's syndrome

- No known allergies to any of the study drugs

- No major psychiatric illness

- No poorly controlled diabetes complicated by steroid treatment

- No other medical illness that cannot be adequately controlled or that would preclude
study participation

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent antitumor chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except postmenopausal estrogen replacement therapy

- Corticosteroids at stable or decreasing dose for tumor edema allowed

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy

- No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the
index lesion(s)

Surgery:

- See Disease Characteristics

- No concurrent antitumor surgery

Other:

- No other concurrent investigational drugs

- No other concurrent antineoplastic drugs or therapy