Study on the Use of Metformin in Addition to Standard Treatment for Patients with Glioblastoma

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What is this study about?

This clinical trial is focused on studying the effects of adding metformin to the standard treatment for patients with a type of brain cancer called glioblastoma. Glioblastoma is a fast-growing and aggressive form of brain tumor. The study aims to see how effective metformin is when used alongside the usual treatment for this condition.

Participants in the study will receive metformin in addition to their regular cancer treatment. The study will monitor the progress of the disease over a period of six months using MRI scans, which are imaging tests that help doctors see inside the body. The goal is to determine if metformin can help slow down the progression of the cancer. The study will also look at the quality of life of the participants and monitor any side effects they may experience.

Throughout the study, researchers will collect various health data, including blood tests to check for any changes in liver and kidney function, as well as blood sugar levels. The study will also involve analyzing tissue samples taken during surgery to understand how the cancer cells respond to the treatment. This research is expected to provide valuable insights into the potential benefits of metformin for patients with glioblastoma.

1 enrollment and initial assessment

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of high-grade glioma and other health factors.

Initial assessments include a review of medical history, physical examination, and baseline imaging tests such as MRI to establish the current condition.

2 treatment initiation

The treatment involves the administration of metformin as an additional therapy to the standard treatment for glioblastoma.

Metformin is taken orally. The dosage and frequency are determined by the study protocol and are adjusted based on individual tolerance and response.

3 ongoing monitoring and assessments

Regular follow-up visits are scheduled to monitor health status, treatment response, and any side effects.

Progression-free survival (PFS) is assessed approximately 6 months after starting treatment using imaging tests and specific criteria to evaluate disease progression.

4 quality of life and safety evaluations

Health-related quality of life is measured using specific questionnaires at the beginning and at 6 months into the study.

Safety is continuously monitored by tracking the type, frequency, and severity of any adverse events, as well as changes in clinical and laboratory parameters.

5 end of study assessments

At the end of the study, additional analyses are conducted, including the evaluation of circulating metabolites and tissue samples to understand treatment response.

Final assessments include a comprehensive review of all collected data to determine the overall efficacy and safety of the treatment.

Who Can Join the Study?

Patients must have a newly diagnosed glioblastoma (a type of brain tumor) that is confirmed by a test called histology. It should be IDH-wildtype, which is a specific genetic characteristic of the tumor.
Patients must have undergone surgical resection, which means the tumor has been surgically removed.
Patients must have their MGMT status evaluated after surgery. MGMT is a gene that can be either hypomethylated or hypermethylated, which refers to specific changes in the gene that can affect treatment response.
Patients must be adults, meaning they are 18 years or older, and can be of any gender.
Patients must be undergoing the Stupp protocol, a standard treatment for glioblastoma, including those over 70 years old who are on a modified version of this treatment.
Patients must have a Karnofsky Performance Status (KPS) greater than 60 after surgery. KPS is a scale that measures a patient’s ability to perform everyday activities, with higher scores indicating better function.
Patients must have a life expectancy of at least 6 months, which is determined by the size and location of the tumor.
Patients must provide written informed consent before participating in the study, meaning they agree to join the study after understanding all the details. They must also be able to communicate with the study team and follow the study procedures.
Women of childbearing age must test negative for pregnancy when joining the study. If they are sexually active, they must agree to use specific contraceptive methods to prevent pregnancy during the study and for four weeks after the last treatment dose.
Men with female partners of childbearing age must use condoms during the study and until the end of the treatment period to prevent pregnancy.

Who Cannot Join the Study?

Patients with a type of brain tumor called IDH-wildtype glioblastoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who do not meet the specific health conditions required for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.04.2023

Trial locations

Investigated drugs:

Metformin Embonate

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being studied as an additional treatment for patients with high-grade glioma, a type of brain cancer. The goal is to see if metformin can help improve the effectiveness of existing treatments by assessing the progression-free survival of patients six months after starting the treatment. The trial will also evaluate changes in the tumor using specific imaging criteria.

Investigated diseases:

Glioblastoma

Glioblastoma, IDH-wildtype – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. The IDH-wildtype variant does not have mutations in the IDH1 or IDH2 genes, which are often found in other types of gliomas. This form of glioblastoma is known for its aggressive growth and rapid progression. It typically presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor’s location in the brain. As the disease progresses, it can lead to increased pressure within the skull and further neurological impairment. The progression is often monitored through imaging techniques like MRI to assess changes in tumor size and characteristics.

Trial ID:

2024-520228-28-00

Protocol code:

GBM-MET

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Use of Metformin in Addition to Standard Treatment for Patients with Glioblastoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?