A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Brain and Central Nervous System Tumors
- Sponsor
- Duke University
- Locations
- 1
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified