Overview

Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Status:
Withdrawn
Trial end date:
2002-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining carmustine with O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carmustine
O(6)-benzylguanine
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme not
requiring immediate radiotherapy

- Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with a
medical contraindication for MRI) with a baseline scan obtained at the corticosteroid
dose the patient is receiving on the day of treatment

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin greater than 10 g/dL

Hepatic

- Bilirubin normal

- SGOT no greater than 2.5 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

- BUN no greater than 25 mg/dL

Pulmonary

- DLCO greater than 75% predicted

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- See Disease Characteristics

- Concurrent corticosteroids allowed if on stable dose for 3 days before study

Radiotherapy

- See Disease Characteristics

Surgery

- No more than 28 days since prior surgical resection or biopsy