Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05052957
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-09-13
Brief Title:
hSTAR GBM Hematopoetic Stem Cell HPC Rescue for GBM
Sponsor:
Leland Metheny
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial O6-benzylguanineBG and TemozolomideTMZ Therapy of Glioblastoma Multiforme GBM With Infusion of Autologous P140K MGMTHematopoietic Progenitors to Protect Hematopoiesis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
hSTAR GBM
Brief Summary:
This phase II trial studies the effect of P140K MGMT hematopoietic stem cells O6-benzylguanine temozolomide and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor resected Chemotherapy drugs such as 6-benzylguanine temozolomide and carmustine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing Placing P140K MGMT a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01CA236215-01 | NIH | None | httpsreporternihgovquickSearch1U01CA236215-01 |