NCT00016991

ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2001-06-01
• Completion: 2005-04-01
• First posted: 2003-01-27
• Last updated: 2013-06-20

Locations

1 site across 1 country: United States