Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Recurrent Adult Brain Tumor
• Interventions: Drug: Gliadel wafers in combination with O6-benzylguanine

• Registration Number: NCT00362921
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Primary Completion: 2007-08
• Study Completion: 2008-07
• Status Verified: 2013-02
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gliadel wafers in combination with O6-benzylguanine	Gliadel wafers in combination with O6-benzylguanine	-

Primary Outcome Measures

Name	Time	Method
6-month overall survival	6 months

Secondary Outcome Measures

Name	Time	Method
One year overall survival	1 year
2 year overall survival	2 years
Median overall survival	2 years
Toxicity prevalence	2 years

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States