A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial glioblastoma multiforme (with areas of
necrosis) by surgical biopsy or excision within 4 weeks of study

- Tumor and/or any associated edema limited to one hemisphere and unifocal

- No gross invasion of a ventricular surface

- Tumor accessible

- No other astrocytoma

- No multifocal or recurrent malignant glioma

- No disease below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS:

Age:

- Adult

Performance status:

- Zubrod 0-1

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Hemoglobin at least 10 g/dL (transfusion allowed)

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT or SGPT no greater than 2 times normal

Renal:

- BUN no greater than 25 mg/dL

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No hypersensitive or idiosyncratic reaction to bleomycin

- No other prior malignancies within the past 2 years except nonmelanomatous skin
cancer or carcinoma in situ of the cervix or urinary bladder

- No other major medical illness or psychiatric impairment that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for glioblastoma multiforme

- No prior radiosensitizer for glioblastoma multiforme

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the head or neck resulting in overlapping radiotherapy
fields

Surgery:

- See Disease Characteristics

- Recovered from prior surgery