Condition: Glioblastoma, IDH-wildtype · Sponsor: Hopital Foch
Tailored approaches targeting crucial oncogenes and pathways have shown successful results in a number of cancer types and offer exciting perspective in neuro-oncology. IDH (Isocitrate dehydrogenase) wild-type (IDHwt) glioblastoma (GBM) (10%) present a unique and homogenous energetic metabolism which is specifically dependent on the oxidative phosphorylation (OXPHOS) rather than on the aerobic glycolysis. OXPHOS+ IDHwt GBMs overexpress mitochondrial markers and can be specifically inhibited by mitochondrial inhibitors in vitro and in vivo. Metformin is an oral inhibitor of mitochondrial complex I and is a widely used drug in diabetic and non-diabetic patients, safe and well tolerated in association with radiotherapy and chemotherapy. Basing on drastic effect, the investigators have observed in vivo (reduction of \>50% of tumor growth) and hypothesize that metformin could be specifically efficient to treat up-front patients affected by OXPHOS+ GBM, in association with the standard first-line treatment with radiotherapy and temozolomide (RT-TMZ). The investigators set up a dedicated molecular analysis including RNA assay and expression of OXPHOS markers for formalin-fixed paraffin-embedded tumors (FFPE), which allows to detect OXPHOS+ GBM at diagnosis. Here a phase II, open label, non-randomized multicenter trial including five French neurooncology centers (H. Foch-Suresnes, Pitié-Salpêtrière-Paris, Saint Louis-Paris, Lyon, Marseille) and one in Italy (Istituto Besta, Milan…
This description comes directly from the study's public registry record.
Anna Luisa DI STEFANO, MD · 01 46 25 37 22 · al.di-stefano@hopital-foch.com
Elisabeth HULIER-AMMAR, PhD · 01 46 25 11 75 · drci-promotion@hopital-foch.com
Always discuss trial participation with your own doctor first.
| Foch Hospital | Suresnes, Hauts de Seine, France | Recruiting |
| Hôpital Neurologique Pierre Wertheimer | Bron, Lyon, France | Recruiting |
| Timone Hospital | Marseille, Marseille, France | Recruiting |
| Saint Louis Hospital | Paris, Paris, France | Recruiting |
| Pitié Salpêtrière Hospital | Paris, PARIS, France | Recruiting |
| Istituto Nazionale Carlo Besta | Milan, Milano, Italy | Not Yet Recruiting |
| Spidali Riuniti Di Livorno | Livorno, Toscana Nord Ouest, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT04945148