Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016991
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-06-06
Brief Title:
ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of ZD 1839 NSC 715055 for Patients With First Relapse Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068639 | OTHER | NCI | None |
| DUMC-2421-03-2R2 | None | None | None |
| DUMC-2421-01-2 | None | None | None |
| NCI-1253 | None | None | None |