Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma
Status:
Terminated
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.