NCT05929495

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

About 75% of CNS malignant tumors are classified as gliomas, tumors of neuroectodermal origin arising from glial cells or glial cell precursors. The World Health Organization classification distinguishes gliomas into low-grade gliomas (low-grade gliomas, grade I and II) and high-grade gliomas (high-grade gliomas, grade III and IV). IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. Over the past century, numerous epidemiological and experimental observations have reported a preventive and beneficial antitumor effect of metformin, which has suggested the possibility of using it as adjunctive therapy in many cancer subtypes, including GBM. The aim of this study is to evaluate the effect of Metformin as adjuvant therapy to TMZ in the treatment of patients with GBM. Patients will start with a Metformin dose of 1 g/day orally in two administrations (500 mg tablets) during the first two weeks of treatment, increasing to 2 g/day in two 1 g tablets thereafter. The approximate total duration of the study is 32 months, and 25 patients will be enrolled

Conditions

• Glioblastoma, IDH-wildtype
• Metformin
• Malignancies

Interventions

Type	Name	Description
DRUG	Metformin	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.

Timeline

• Start date: 2024-02-12
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-07-03
• Last updated: 2025-07-25

Locations

1 site across 1 country: Italy