Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic Gliomas
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duke University
- Locations
- 1
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma.
Detailed Description
OBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18 months.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided