Recruiting

Study on Glioblastoma Treatment with Metformin, Temozolomide, and Radiotherapy for Newly Diagnosed Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer called glioblastoma, which is a very aggressive form of cancer. The study will use a combination of treatments to see if they can help patients with this disease. The treatments being tested include a medication called Temozolomide, which is often used in cancer treatment, and Metformin, a drug commonly used to treat diabetes. In this study, Metformin will be used alongside radiotherapy, which is a treatment that uses high-energy rays to kill cancer cells.

The purpose of the study is to see if this combination of treatments can help patients live longer without the cancer getting worse. Patients who participate in the study will receive these treatments over a period of time, and their health will be monitored regularly. The study will look at how long patients live without the cancer progressing, as well as their overall survival and response to the treatment. Safety will also be closely monitored, including any side effects that may occur.

Participants will take the medications by mouth, and the study will follow them for several years to gather information on the effectiveness and safety of the treatment. The study aims to provide new insights into treating glioblastoma and potentially improve outcomes for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be required to provide a signed informed consent. This is a document that confirms your agreement to participate in the trial and that you understand the procedures involved.
You will undergo a series of initial assessments to ensure you meet the eligibility criteria. These assessments include blood tests to check your bone marrow, liver, and kidney functions, as well as a pregnancy test if applicable.
Step 2
Treatment initiation
The treatment phase begins with the administration of temozolomide and metformin hydrochloride. Temozolomide is provided in the form of 20 mg hard capsules, and metformin is provided as 500 mg film-coated tablets. Both medications are taken orally.
The dosage and frequency of these medications will be determined by your healthcare provider based on your specific condition and response to treatment.
Step 3
Radiotherapy
You will receive radiotherapy as part of your treatment plan. This is a type of cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.
The radiotherapy will be administered according to the Stupp protocol, which involves a total dose of 60 Gy. Your healthcare provider will explain the schedule and duration of the radiotherapy sessions.
Step 4
Ongoing assessments
Throughout the trial, you will have regular visits to monitor your health and the effectiveness of the treatment. These visits will include physical examinations, blood tests, and imaging studies as needed.
Your healthcare team will also monitor for any side effects or adverse reactions to the medications and radiotherapy. It is important to report any new symptoms or concerns during these visits.
Step 5
End of treatment
At the end of the treatment phase, you will undergo a final assessment to evaluate the overall response to the therapy. This will include a review of your medical condition and any changes in your symptoms.
Your healthcare provider will discuss the results with you and outline any further steps or follow-up care that may be necessary.

Who can join the trial?

20 criteria

Sign a consent form to participate in the study. If you cannot sign it yourself, a legal representative can do it for you.
Have a newly-diagnosed **glioblastoma** (a type of brain tumor) that is confirmed by a lab test.
Be at least **18 years old**.
Have a life expectancy of at least **16 weeks**.
Be able to start radiation therapy within **7 weeks** after diagnosis.
Have not received any treatment for glioblastoma other than surgery.
Have recovered well from surgery without major ongoing issues like infections.
Have adequate **bone marrow** function and normal **liver** function.
Have a **creatinine clearance** (a measure of kidney function) of at least **30 mL/min**.
Have a **white blood cell count** of at least **2000/μL** and **neutrophils** (a type of white blood cell) of at least **1500/μL**.
Have **platelets** (cells that help with blood clotting) of at least **100,000/μL**.
Have **hemoglobin** (a protein in red blood cells) of at least **9.0 g/dL**.
Have **serum creatinine** (a waste product in the blood) of no more than **1.5 times the upper limit of normal**.
Have **AST** and **ALT** (liver enzymes) levels no more than **3 times the upper limit of normal** and **total bilirubin** no more than **1.5 times the upper limit of normal**.
Be able to receive combined radiation and chemotherapy according to the **Stupp protocol** (a specific treatment plan).
Have an **ECOG performance status** of 0-2, which means you are fully active or have some symptoms but can take care of yourself.
If you are a woman of childbearing potential, have a negative pregnancy test before starting the study and agree to use contraception during the study and for 6 months after.
If you are a man, agree to use contraception if you are sexually active with a woman of childbearing potential during the study and for 6 months after.
Be affiliated with a health insurance system.
Be willing and able to follow the study protocol, including attending visits and undergoing tests.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides glioblastoma grade 4 cannot participate.
Patients who have had another cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver or kidney disease are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to take oral medications are not eligible.
Patients with a known allergy to any of the study drugs cannot join.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with any condition that, in the opinion of the study doctor, makes participation unsafe are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Hopitaux Universitaires Pitie Salpetriere
Verified
Paris, France

Trial locations

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Investigated drugs

Metformin
is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being used to target a specific process in cancer cells called oxidative phosphorylation. The goal is to see if metformin can help improve the effectiveness of other cancer treatments by interfering with the energy production in cancer cells, potentially slowing down their growth.
Temozolomide
is a type of chemotherapy drug that is used to treat certain brain cancers, including glioblastoma. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this trial, temozolomide is used alongside other treatments to see if it can help improve patient outcomes by further attacking the cancer cells.
Radiotherapy
is a treatment that uses high-energy rays, like X-rays, to kill cancer cells. It is a common treatment for many types of cancer, including brain tumors. In this trial, radiotherapy is used in combination with other treatments to try to increase the chances of controlling the cancer and preventing it from coming back.

What is already known about the treatment

Metformin
Metformin is taken orally in the form of a tablet and is currently being studied for its potential use in treating glioblastoma, a type of brain cancer. It is commonly known for its use in managing type 2 diabetes, but researchers are exploring its effects on cancer cells when combined with radiotherapy and temozolomide. Metformin works by affecting the energy production in cells, specifically targeting a process called oxidative phosphorylation, which cancer cells rely on for growth. It is classified as a biguanide, a type of medication that helps control blood sugar levels.
Temozolomide
Temozolomide is administered orally in capsule form and is an established treatment for certain brain cancers, including glioblastoma. It is being studied in combination with metformin and radiotherapy to improve outcomes for patients with this aggressive cancer. Temozolomide works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent, a type of chemotherapy drug that interferes with the DNA of cancer cells to stop their growth.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth. The disease typically begins in the cerebral hemispheres but can occur in other parts of the brain or spinal cord. As it progresses, glioblastoma can cause symptoms such as headaches, seizures, and neurological deficits, depending on the tumor's location. The tumor infiltrates surrounding brain tissue, making it difficult to remove completely. Over time, it can lead to increased pressure within the skull, affecting brain function.