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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Durham, North Carolina, United States

Duke Comprehensive Cancer Center
πŸ‡ΊπŸ‡ΈDurham, North Carolina, United States

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