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Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma

NCT01700569 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-21

No results posted yet for this study

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 Stupp.R 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.

Conditions

Interventions

DRUG

Temozolomide

All the Patients are treated by oral Temozolomide 75 mg/m²/day every day during 42 days, 30 minutes after Folinic acid and 120 min before the radiation dose to the brain tumor. After one month rest, the maintenance phase consists of:Temozolomide is given orally (30 min after Folinic acid), at 200 mg/m²/day every day during 5 days: one course every month during 6 months (6 maintenance course).

DRUG

folinic acid at pharmacological dose is the escalated drug

RADIATION

High voltage radiation therapy (linear accelerator)

Brain tumor field is irradiated Five days a week, during Stupp regimen during 6 weeks. During the sams time, Folinic acid and Temozolomide are given orally every days (six weeks).

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Mario CAMPONE, MD, PhD · Institut Cancerologie de l'Ouest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-12-12
Completion
2021-04-16

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700569 on ClinicalTrials.gov