Spots Global Cancer Trial Database for ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

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Trial Identification

Brief Title: ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

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

Study ID: NCT00016991

Conditions

Brain and Central Nervous System Tumors

Interventions

gefitinib

Study Description

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.