Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DUMC-5515-06-1R2 DUMC-5515-04-1R0, GP-DUMC-5515-06-1R2, NCT00362921

Objectives

1. Define the activity of polifeprosan 20 with carmustine implant (Gliadel wafer^®) in combination with O6-benzylguanine in patients with recurrent glioblastoma multiforme.
2. Define the toxicity of Gliadel wafer^® in combination with O6-benzylguanine in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed recurrent glioblastoma multiforme (including gliosarcoma)



• Evidence of a unilateral, single focus of measurable CNS neoplasm on contrast-enhanced MRI or CT scan that is supratentorial and measures ≥ 1.0 cm in diameter

Prior/Concurrent Therapy:

• At least 2 weeks since prior surgical resection* and recovered
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)*
• No prior polifeprosan 20 with carmustine implant (Gliadel wafer^®)
• At least 4 weeks since prior radiotherapy*

 [Note: * Unless there is unequivocal evidence of tumor progression]

Patient Characteristics:

• Karnofsky performance status 60-100%
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin < 2 times upper limit of normal (ULN)
• SGOT < 3 times ULN
• BUN < 1.5 times ULN
• Creatinine < 1.5 times ULN
• Negative pregnancy test

Expected Enrollment

A total of 50 patients will be accrued for this study.

Outcomes

Activity of polifeprosan 20 with carmustine implant (Gliadel wafer) in combination with O6-benzylguanine
Toxicity

Outline

This is an open-label study.

Patients undergo surgical resection of tumor followed by placement of polifeprosan 20 with carmustine implant (Gliadel wafer^®) . Within 6 hours after surgery, patients receive high-dose O6-benzylguanine IV over 1 hour on days 1, 3, and 5 and low-dose O6-benzylguanine IV continuously on days 1-5.

After completion of study treatment, patients are followed every 8 weeks.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Jennifer Quinn, MD, Protocol chair		Ph: 919-684-5301

Registry Information
Official Title		Phase II Trial of Gliadel® Plus 06-Benzylguanine for Patients with Recurrent Glioblastoma Multiforme
Trial Start Date		2004-04-15
Trial Completion Date		2008-09-01 (estimated)
Registered in ClinicalTrials.gov		NCT00362921
Date Submitted to PDQ		2006-06-09
Information Last Verified		2006-10-19
NCI Grant/Contract Number		CA14236