Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.
|Recurrent Adult Brain Tumor||Drug: Gliadel wafers in combination with O6-benzylguanine||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme|
- 6-month overall survival [ Time Frame: 6 months ]
- One year overall survival [ Time Frame: 1 year ]
- 2 year overall survival [ Time Frame: 2 years ]
- Median overall survival [ Time Frame: 2 years ]
- Toxicity prevalence [ Time Frame: 2 years ]
|Study Start Date:||April 2004|
|Study Completion Date:||July 2008|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Experimental: Gliadel wafers in combination with O6-benzylguanine||
Drug: Gliadel wafers in combination with O6-benzylguanine
Other Name: Gliadel wafer (carmustine)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362921
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Jennifer A. Quinn, MD||Duke Cancer Institute|