NCT00005081

Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	O6-benzylguanine
DRUG	carmustine

Timeline

• Start date: 2000-08-01
• Primary completion: 2001-04-01
• Completion: 2001-04-01
• First posted: 2004-05-03
• Last updated: 2014-08-21

Locations

1 site across 1 country: United States