TerminatedPhase 1

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

Stopped: changing the standard of care

France24 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Operated GBM (complete or near complete resection) * Un-methylated MGMT gene Exclusion Criteria: * Non operable GBM * Methylated MGMT

What they're measuring

Maximal Tolerated Dose

Timeframe: day 43

Trial details

NCT IDNCT01700569

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-12

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