Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00362921|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : July 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Adult Brain Tumor||Drug: Gliadel wafers in combination with O6-benzylguanine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme|
|Study Start Date :||April 2004|
|Primary Completion Date :||August 2007|
|Study Completion Date :||July 2008|
|Experimental: Gliadel wafers in combination with O6-benzylguanine||
Drug: Gliadel wafers in combination with O6-benzylguanine
Other Name: Gliadel wafer (carmustine)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362921
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Jennifer A. Quinn, MD||Duke Cancer Institute|