Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250887
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2005-11-04
Brief Title:
Pre- and Postoperative Use of ZD1839 Iressa in Recurrent Glioblastoma Including Translational Research
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 Iressa in Recurrent Glioblastoma Including Translational Research
Status:
COMPLETED
Status Verified Date:
2007-10
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:
This study aims to determine effectiveness of Gefitinib Iressa in recurrent glioblastoma after standard treatment surgery radiationtherapy and at least a first line chemotherapy Gefitinib is a specific inhibitor of the epidermal growth factor receptor EGFR EGFR is elevated in more than 50 of malignant gliomas At recurrence secondary surgery and pre- and postoperative Gefitinib is offered to patients in good performance status Clinical outcome of patients and correlation to translational research will be evaluated
Detailed Description:
Glioblastoma GBM patients who relapse and are in good performance status without serious neurological deficits are offered secondary surgery and participation in the trial Eligible patients must have had standard treatment including primary surgery radiation therapy and at least a first line chemotherapy Patients on cytochrome P450 isoenzyme CYP3A4-inducing antiepileptic drugs EIAE are excluded due to ensuing interactions of these drugs with gefitinib metabolism reducing systemic availability After giving written informed consent patients receive gefitinib 500 mg daily starting at least 5 days prior to re-operation allowing a steady state conditionTreatment continues until tumor progression or occurrence of intolerable side effectsThe specimens collected at surgery will undergo translational research aiming to correlate drug accumulation and molecular signatures of GBM samples with clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None