Overview

Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carmustine
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or
resection within 5 weeks of study

- Postoperative residual contrast enhancing tumor and resection tumor cavity together no
greater than 60 mm in maximum diameter

- No well-differentiated or anaplastic astrocytomas or multifocal glioma

- No tumors originating in the brainstem

- No residual tumor within 10 mm of optic chiasm

- No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin greater than 9 g/dL

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate
transaminase (SGOT) less than 2 times normal

Renal:

- Creatinine less than 1.8 mg/dL

- Blood urea nitrogen (BUN) less than 30 mg/dL

Pulmonary:

- Chest x-ray normal OR

- Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Neurologic functional status 0-3

- No other prior malignancy within the past 5 years except carcinoma in situ of the
cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin
cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Concurrent steroids allowed

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- Concurrent anticonvulsants allowed