RecruitingPhase 2NCT05929495

Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma


Sponsor

University of Milano Bicocca

Enrollment

25 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether metformin (a common diabetes drug) can be safely combined with standard radiation and chemotherapy (the Stupp protocol) to improve outcomes in people with newly diagnosed glioblastoma — the most aggressive type of brain tumor. **You may be eligible if...** - You are 18 or older with newly diagnosed glioblastoma (WHO grade IV) confirmed by surgery - You are starting the standard radiation and chemotherapy (Stupp protocol) - Your performance status (Karnofsky score) is above 60 after surgery - Your estimated survival is at least 6 months - You do not have diabetes **You may NOT be eligible if...** - You have diabetes or are taking insulin, metformin, or any biguanide drugs - Your cancer involves multiple parts of the brain (multicentric GBM) - You have poor kidney or liver function that would make metformin unsafe - You are pregnant or breastfeeding - You are allergic to metformin - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

The investigator will identify potential participants and confirm the diagnosis of GBM. Subjects will be screened within 6 weeks before starting treatment. Treatment will involve: * Administration of the standard or partial Stupp protocol (Radiotherapy + Temozolomide) in combination with Metformin for 6 weeks, * Treatment with only Metformin for 4 weeks; * Resumption of adjuvant TMZ + Metformin treatment continuously until the end of the enrollment period.


Locations(1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, Italy

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NCT05929495


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