Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479765
Status:
TERMINATED
Last Update Posted:
2022-06-22
First Post:
2007-05-24
Brief Title:
A Phase 1 2 Dose Escalation Study of Locally-Administered OncoGel in Subjects With Recurrent Glioma
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Phase 1 2 Dose Escalation Study of Locally-Administered OncoGel in Subjects With Recurrent Glioma
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor business decision not based on safety or efficacy data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel an approved intravenous anticancer drug from a gel ReGel over a long period of time The gel will disappear in 4 to 6 weeks as it releases the paclitaxel
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients and watching the patients closely for side effects before moving to the next dose level The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients and watching the patients closely for side effects before moving to the next dose level The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing
Detailed Description:
This study is for patients with recurrent glioblastoma multiforme Because most recurrences are in the area of the original resection local delivery of a chemotherapeutic agent may prevent or delay additional recurrences Paclitaxel has demonstrated activity against 9L glioma tumor lines but has poor central nervous system penetration after intravenous administration OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be administered directly to the brain thereby bypassing the blood-brain barrier
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 |
|---|---|---|---|
| OGL-109 | None | None | None |