Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;
hypomethylation or hypermethylation of MGMT assessed post-surgery;
adult patients (≥18 years), both sexes;
Patients undergoing Stupp protocol including patients aged > 70 years performing the hypofractionated protocol and three weeks of chemotherapy;
Disqualifiers
Multicenter GBMs;
Patients diagnosed with diabetes or diabetes-related conditions;
other active malignancies;
hypersensitivity, intolerance to metformin or excipients;
Trial design
Design model
Single group
Treatments tested in this trial
Metformin
DrugThe 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: MetforminExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Value of PFS at 6 months after the start of treatment
It allow us to determine the efficacy at the recommended dose (RD) of metformin in patients with GBM
Time frame
Frome baseline to 6 monthsSecondary outcomes
1
EORTC QLQ-C30 questionnaire at 6 months after the start of treatment
The Quality of Life of Cancer Patients questionnaire allow us to evaluate the change in the level of health-related quality of life. It consists of several questions that the patient must answer by choosing a value from 1 (minimum) to 4/7 (maximum), depending on the question.
Time frame
Frome baseline to 6 months2
MMSE questionnaire at 6 months after the start of treatment
The Mini Mental State Evaluation questionnaire allow us to evaluate the change in the level of health-related quality of life. It consists of several questions for the patient to answer, but there are no minimum or maximum values for the patient to choose from.
Time frame
Frome baseline to 6 months3
Safety and tolerability assessment of treatment
Safety will be assessed throughout the study as type, frequency and severity of grade III and IV events. Tolerability will be assessed as number of discontinuations or dose reduction and by evaluation of clinical and hematochemical parameters
Time frame
From baseline through study completion, an average of 32 months4
Plasma measurement of circulating metabolites
Peri-operative plasma will be taken from each patient for hematochemical analysis, in order to research of prognostic biomarkers.
Time frame
At study completion, an average of 32 monthsSponsors and contacts
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Source ClinicalTrials.gov