Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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.
|Brain and Central Nervous System Tumors||Drug: O6-benzylguanine Drug: carmustine||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme|
|Study Completion Date:||August 2002|
- Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046878
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|