Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Phase 2

Withdrawn

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00046878
• Lead Sponsor: Duke University

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining carmustine with O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Detailed Description

OBJECTIVES:

* Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.

* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy.

PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Study Timeline

• Study Completion: 2002-08
• Study First Submitted: 2002-10-03
• Study First Submitted QC: 2003-08-08
• Study First Posted: 2003-08-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified