Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362921
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2006-08-10
Brief Title:
Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-02
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 Drugs used in chemotherapy such as Gliadel wafer and O6-benzylguanine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme
PURPOSE This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES
Define the activity of Gliadel wafers in combination with a 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme
Define the toxicity of Gliadel wafers in combination with 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme
OUTLINE This is an open-label study
Patients undergo surgical resection of tumor followed by placement of Gliadel wafers Within 6 hours after completion of surgery patients receive a 1 hour high dose infusion of O6-benzylguanine followed by a lower dose continuous infusion for 5 days Every 48 hours a repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses
After completion of study treatment patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 50 patients should be accrued for this study
Define the activity of Gliadel wafers in combination with a 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme
Define the toxicity of Gliadel wafers in combination with 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme
OUTLINE This is an open-label study
Patients undergo surgical resection of tumor followed by placement of Gliadel wafers Within 6 hours after completion of surgery patients receive a 1 hour high dose infusion of O6-benzylguanine followed by a lower dose continuous infusion for 5 days Every 48 hours a repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses
After completion of study treatment patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 50 patients should be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000483768 | None | None | None |
| DUMC-5515-06-1R2 | None | None | None |
| DUMC-5515-04-1R0 | None | None | None |
| GP-DUMC-5515-06-1R2 | None | None | None |