Glioblastoma, IDH-wildtype Clinical Trial
Official title:
Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide
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) is proposed. Newly diagnosed IDH wild-type GBM patients with the OXPHOS+ signature will be eligible for inclusion in this trial. The investigators expect to screen 640 patients and to include 64 patients over a period of 24 months with 24 months of follow-up.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05941234 -
Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma
|
N/A | |
| Recruiting |
NCT04528680 -
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06160596 -
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
|
||
| Recruiting |
NCT06047379 -
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05879250 -
WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
|
Phase 2 | |
| Not yet recruiting |
NCT05842746 -
Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
|
Phase 2 | |
| Not yet recruiting |
NCT06419946 -
Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
|
Phase 3 | |
| Completed |
NCT03434262 -
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
|
Phase 1 | |
| Recruiting |
NCT06418113 -
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
|
Phase 1 | |
| Recruiting |
NCT05326334 -
THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation (THERABIOME-GBM)
|
||
| Recruiting |
NCT05375318 -
BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels
|
||
| Not yet recruiting |
NCT06359379 -
Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
|
Phase 2 | |
| Recruiting |
NCT06095375 -
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
|
Phase 1 | |
| Recruiting |
NCT05879367 -
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
|
Phase 1 | |
| Recruiting |
NCT05759195 -
Biomolecular Analysis for Predicting Response to Regorafenib
|
N/A | |
| Recruiting |
NCT06273176 -
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
|
||
| Recruiting |
NCT06146725 -
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
|
||
| Recruiting |
NCT06146738 -
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
|
||
| Recruiting |
NCT06283927 -
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
|
||
| Recruiting |
NCT06118723 -
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
|