Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme
OBJECTIVES:
- Define the activity of Gliadel® wafers in combination with a 5-day infusion of
O6-benzylguanine in patients with recurrent glioblastoma multiforme.
- Define the toxicity of Gliadel® wafers in combination with 5-day infusion of
O6-benzylguanine in patients with recurrent glioblastoma multiforme.
OUTLINE: This is an open-label study.
Patients undergo surgical resection of tumor followed by placement of Gliadel® wafers .
Within 6 hours after completion of surgery, patients receive a 1 hour high dose infusion of
O6-benzylguanine followed by a lower dose continuous infusion for 5 days. Every 48 hours a
repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses.
After completion of study treatment, patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 50 patients should be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month overall survival
6 months
No
Jennifer A. Quinn, MD
Study Chair
Duke Cancer Institute
United States: Food and Drug Administration
Pro00004127 (CDR0000483768)
NCT00362921
April 2004
July 2008
Name | Location |
---|---|
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |