Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773326
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-03-06
Brief Title:
Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG
Sponsor:
Nader Sanai
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
A Phase 0 Single-center Open-label Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma
Status:
RECRUITING
Status Verified Date:
2024-08
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 is a single-center open-label dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma grade 3 or 4 per WHO criteria targeting the mTOR pathway Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None