Active not recruitingPHASE2INTERVENTIONAL

Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM

This study is for adults with a type of aggressive brain cancer called Glioblastoma (GBM). Current treatments often involve surgery, then a combination of chemotherapy (Temozolomide or TMZ) and radiotherapy. Sadly, GBM often comes back, and people typically live for about 16 months. Researchers are investigating whether adding Metformin, a common and safe diabetes drug, to the usual GBM treatment can improve its effectiveness. Previous research suggests Metformin might help with some other cancers. In this study, Metformin will be given along with a slightly shorter course of radiotherapy and chemotherapy. The aim is to see if this new combination is safe, and if it could help people with GBM live longer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

01 Mar 2015

Estimated completion

28 Feb 2027

Glioblastoma Multiforme

What is this study about?

This study focuses on a type of aggressive brain cancer in adults called Glioblastoma Multiforme, or GBM for short. Sadly, it's one of the most common and difficult brain tumours to treat. Most patients find their cancer returns, and on average, people live for about 16 months after being diagnosed. We know this is a very difficult diagnosis, and doctors are always looking for better ways to help people.

The current standard treatment for newly diagnosed GBM usually involves surgery, if possible, to remove as much of the tumour as safely can be done. After surgery, patients typically have a combination of chemotherapy (using a drug called Temozolomide, or TMZ) and radiotherapy, which uses X-rays to kill cancer cells. This is often followed by more cycles of TMZ chemotherapy.

Recent scientific studies have suggested that Metformin, a common and generally well-tolerated drug used to treat diabetes, might also be helpful in treating some cancers, like breast, colon, and prostate cancer. Metformin is considered a very safe medication with few side effects, which makes it an attractive drug to explore in other conditions. Doctors involved in this study have already been using a slightly different schedule for radiotherapy (a shorter course over 4 weeks instead of 6) along with TMZ, and have seen encouraging results, with patients living longer (around 20 months on average). This study wants to see if adding Metformin to this already promising treatment schedule can improve things even further, hopefully helping people live longer and with good quality of life.

Key takeaways

Targets aggressive adult brain cancer (Glioblastoma).
Tests adding a common diabetes drug (Metformin) to standard treatment.
Aims to improve treatment effectiveness and prolong life.
Uses a slightly shorter, accelerated radiotherapy schedule.
Involves chemotherapy (Temozolomide) alongside Metformin.
Metformin is generally considered safe with low side effects.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed diagnosis of Glioblastoma Multiforme (GBM) in the upper part of your brain. Your doctors need to confirm this from a tissue sample.

Your general health, including how well you can carry out daily activities, is important. You'll need to have certain blood tests to check your bone marrow, kidney, and liver function are within healthy ranges. Your doctor will also check your nervous system. You must have recovered properly from any surgery you've had for your brain tumour before starting the study treatments.

If you're a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study drugs and use reliable contraception throughout. Men involved in the study also need to use adequate contraception. This is to make sure the unborn baby isn't accidentally exposed to the study drugs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a confirmed diagnosis of Glioblastoma (GBM)?
Have you generally recovered well from your brain surgery?
Are you able to perform most of your daily activities?
Are your blood test results (for blood counts, kidney, and liver function) within healthy ranges?
If you are a woman of childbearing potential or a man, are you willing to use contraception during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive additional Metformin alongside your standard treatment. This will start within four weeks of your initial surgery. You'll take Metformin at the same time as Temozolomide (chemotherapy) and a special type of radiotherapy. The radiotherapy will be a 'hypo-accelerated' course, meaning it's given over a shorter period (4 weeks) than standard. After this, you'll continue with Metformin and Temozolomide for several months (between 6 and 12 cycles).

You'll have regular medical checks, including physical exams, neurological exams, and blood tests, to monitor your health and how you're responding to the treatment. You'll also have MRI or CT scans of your brain to track the tumour. The exact number and timing of visits will be detailed by the study team, but expect regular appointments during the treatment phase and follow-up period. The total duration of your participation, including follow-up, will be explained by your study doctor.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving how well your current GBM treatment works, potentially helping you live longer. Metformin is generally considered safe and well-tolerated, but like all medications, it can have side effects. These are usually mild, but you might experience stomach upset. The study team will carefully monitor you for any side effects from all treatments. Keep in mind that there's no guarantee the experimental treatment will work for everyone, or that it won't have unexpected risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Montreal Neurological Institute - McGill University Health Centre
Verified postcode
Montreal, Canada

Common questions

What is Glioblastoma (GBM)?

GBM is a serious and aggressive type of brain tumour that grows quickly. It's one of the most common brain cancers in adults.

What is Metformin?

Metformin is a common and generally safe medication often used to treat type 2 diabetes. It helps the body use sugar more effectively.

Why are you using Metformin for brain cancer?

Early research suggests Metformin might help slow down cancer growth in some other cancers. This study explores if it can boost the effects of standard GBM treatments.

Will I still get my usual cancer treatment?

Yes, you will still receive the standard chemotherapy (Temozolomide) and radiotherapy. Metformin is being added to these existing treatments.

How long will the study last?

The study involves taking Metformin and chemotherapy for several cycles after your surgery and radiotherapy. Your study team will explain the full expected duration, including follow-up checks.