ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00016991
• Lead Sponsor: Duke University

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.

Detailed Description

OBJECTIVES:

* Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse.

* Determine the pharmacokinetics and toxicity of this drug in these patients.

* Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2005-04
• Status Verified: 2009-10
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

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