ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
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|ClinicalTrials.gov Identifier: NCT00016991|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: gefitinib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme|
|Study Start Date :||June 2001|
|Actual Study Completion Date :||April 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016991
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|