Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279767
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-31
Brief Title:
Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Glioblastoma the most prevalent malignant tumor in the central nervous system is characterized by high invasiveness and a propensity to recur contributing to a relatively elevated mortality rate Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months Presently the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis Temozolomide TMZ a cutting-edge oral alkylating agent known for its advantageous properties including easy traversal of the blood-brain barrier induces DNA alkylation in tumor cells fostering apoptosis Currently it serves as a frontline medication for postoperative chemotherapy in glioblastoma However clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages We have recently discovered and validated that 5-aminoimidazole-4-carboxamide AICA derived from TMZ can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate AICAR in GBM cells Hypoxanthine phosphoribosyltransferase 1 HPRT1 has been identified as the catalyst for the AICA reaction generating AICAR AICAR acts as an endogenous activator of AMP-activated protein kinase AMPK fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway 6-mercaptopurine 6-MP competes effectively to inhibit HPRT1 activity thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ In this project we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma
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?:
True
Is an FDA AA801 Violation?:
None