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Clinical Trial 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.


Clinical Trial 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00016991
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 2
Start date June 2001
Completion date April 2005

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