Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

OBJECTIVES:

- Determine the median survival time of patients with newly diagnosed supratentorial
glioblastoma multiforme treated with radiotherapy followed by sustained release
intratumoral bleomycin.

- Determine the feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study.

Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week
for 6 weeks.

Within 2-6 weeks after completion of radiotherapy or at disease progression during
radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within
the central area of the tumor. Patients then receive sustained release bleomycin
intratumorally via the reservoir once a week for up to 2 years in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.

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

- Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase
(SGPT) no greater than 2 times normal

Renal:

- Blood Urea Nitrogen (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