Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01700569
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2012-09-12
Brief Title:
Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Phase I Study of Escalated Pharmacologic Dose of Oral Folinic Acid in Combination With Temozolomide According to Stupp R Regimen in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
changing the standard of care
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOLAGLI
Brief Summary:
O6-méthylguanine méthyltransférase MGMT is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma GBM in StuppR et al published regimen In preclinical models it has been demonstrated that MGMT methylation which is silencing the DNA repair process is achievable by folic acid About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM
Detailed Description:
Glioblastoma treated by Stupp regimen Temozolomide radiation therapy have a different outcome depending on the methylation status of MGMT gene when the gene is unmethylated the repair process is active and the prognostic poor In pre-clinical models it has been demonstrated that Folic acid could re-methylate the MGMT gene and therefore the repair process to radiation and temozolomide could be limited allowing a better prognosis The proposed phase-1 study will explore the safety and efficacy of escalated doses of oral Folinic acid concomitantly with Stupp regimen To determine the MTD is the main objective of the study then the toxicty profile the RDP2 and the methylation process efficacy at the MGMT gene level
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 |
|---|---|---|---|
| 2012-000774-31 | EUDRACT_NUMBER | None | None |