Actively Recruiting
Oxidative Phosphorylation Targeting in Malignant Glioma Using Metformin Combined with Radiotherapy and Temozolomide
Led by Hopital Foch · Updated on 2025-11-21
640
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hopital Foch
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with newly diagnosed IDH wild-type glioblastoma (GBM) that have a specific metabolic profile called OXPHOS+. This type of brain tumor depends on oxidative phosphorylation for energy, and metformin, a drug commonly used for diabetes, may inhibit this process. The trial aims to study metformin combined with standard radiotherapy and chemotherapy to see if it affects tumor growth and patient outcomes. Participants who test positive for the OXPHOS+ signature will receive metformin starting about six weeks after diagnosis, alongside radiation therapy and temozolomide chemotherapy. Radiation will be given daily for six weeks, and temozolomide will be given daily during radiation and then in cycles for up to 12 cycles. After this, patients who remain in remission will continue metformin alone until their disease progresses. During the study, patients will be closely monitored for tumor progression, overall survival, treatment response, safety, and tolerability over a 24-month follow-up period. Assessments will include clinical visits, laboratory tests, imaging, and molecular analysis of tumor tissue. The study plans to enroll 64 patients after screening about 640 over two years, with monitoring continuing for two additional years to evaluate outcomes.
CONDITIONS
Brief Title
Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any study procedures
- Willingness and ability to comply with study protocol and visits
- Newly diagnosed, histologically confirmed supra-tentorial IDH wild-type glioblastoma
- OXPHOS+ tumor subtype confirmed by central laboratory
- No prior glioblastoma treatment except surgery
- Substantial recovery from surgery without major safety issues
- No corticosteroids or stable corticosteroid dose
- ECOG performance status of 0 to 2
- Able to receive concomitant radiotherapy and chemotherapy
- Adequate bone marrow and liver function
- Creatinine clearance of at least 30 mL/min (dose adjustment if 30-50 mL/min)
- Able to start radiotherapy within 7 weeks after diagnosis
- Life expectancy of at least 16 weeks
- Affiliated with appropriate health insurance
- Age 18 years or older
- Women of childbearing potential must have a negative pregnancy test and agree to contraception
- Sexually active males must agree to contraception
- Adequate blood counts and liver enzyme levels within specified limits
You will not qualify if you...
- Prior glioblastoma treatment other than surgery, including Gliadel wafer
- Second primary cancer except certain treated cancers with no evidence for 5 years
- Known metastatic or leptomeningeal disease
- IDH mutant or secondary glioblastoma
- Serious or uncontrolled medical disorders increasing risk or interfering with treatment
- Unable to swallow oral medication or gastrointestinal disorders affecting absorption
- Pregnant or breastfeeding women
- Immunocompromised status such as HIV infection on treatment
- Active hepatitis B or C infection
- Known hypersensitivity to metformin, temozolomide, or excipients
- Severe renal insufficiency (creatinine clearance less than 30 mL/min)
- Other central nervous system conditions unrelated to cancer unless controlled
- Unable or unwilling to have contrast-enhanced MRI
- Acute medical conditions affecting renal function
- Diseases causing tissue hypoxia like heart failure or recent heart attack
- History of diabetic precoma or acute metabolic acidosis
- Alcohol intoxication or alcoholism
- Persons under legal protection or involuntary incarceration
- Patients compulsorily detained for psychiatric or infectious diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 38 weeks or until disease progression
Participants receive metformin daily starting by 6 weeks after diagnosis and 7 days before radiotherapy with temozolomide. Radiotherapy with temozolomide is given for 6 weeks. After concurrent treatment, participants continue adjuvant temozolomide with metformin for up to 12 cycles, followed by metformin alone until disease progression.
Weekly visits during radiotherapy and temozolomide; visits every 28 days during adjuvant temozolomide cycles
Duration - Up to 24 months after treatment
Participants are monitored for progression-free survival, overall survival, response, safety, and tolerability for up to 24 months after treatment.
Visits as scheduled during follow-up period
Trial Site Locations
Total: 7 locations
1
Foch Hospital
Suresnes, Hauts de Seine, France, 92150
Actively Recruiting
2
Hôpital Neurologique Pierre Wertheimer
Bron, Lyon, France, 69500
Actively Recruiting
3
Timone Hospital
Marseille, Marseille, France, 13354
Actively Recruiting
4
Saint Louis Hospital
Paris, Paris, France, 75010
Actively Recruiting
5
Pitié Salpêtrière Hospital
Paris, PARIS, France, 75013
Actively Recruiting
6
Istituto Nazionale Carlo Besta
Milan, Milano, Italy, 20131
Not Yet Recruiting
7
Spidali Riuniti Di Livorno
Livorno, Toscana Nord Ouest, Italy, 57100
Not Yet Recruiting
Research Team
A
Anna Luisa DI STEFANO, MD
E
Elisabeth HULIER-AMMAR, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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