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Oxidative Phosphorylation Targeting In Malignant glioma Using Metformin plus radiotherapy temozolomide
EU CTIS ID: 2024-511026-31-01
What this study is testing
To assess the progression free survival of patients with newly-diagnosed GBM IDH wild-type OXPHOS + (either with or without FGFR3-TACC3 gene fusion) treated with RT plus TMZ combined with metformin.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of signed informed consent for selection and treatment phase obtained from the patient/legal representative (for patients unable to give their consent by themselves according to the article L1121-8 of “Code de la Santé Publique”) prior to performing any protocol-related procedures
- Adequate bone marrow and normal hepatic function
- Creatinine clearance ≥30 mL/min (between 30 and 50ml/min, patients will be prescribed no more than 1500mg of metformin)
- Able to start RT within 7 weeks after histological diagnosis
- Patients must have life expectancy ≥ 16 weeks
- Patients affiliated to an appropriate health insurance system.
You likely can't join if
- Prior treatment for GBM (other than surgical resection) including Gliadel Wafer
- Alcohol intoxication and Alcoholism
- Persons protected by a legal regime (guardianship, trusteeship
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- Prisoners or patients who are involuntarily incarcerated
- Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
See the full eligibility criteria
Who can join
- Provision of signed informed consent for selection and treatment phase obtained from the patient/legal representative (for patients unable to give their consent by themselves according to the article L1121-8 of “Code de la Santé Publique”) prior to performing any protocol-related procedures
- Adequate bone marrow and normal hepatic function
- Creatinine clearance ≥30 mL/min (between 30 and 50ml/min, patients will be prescribed no more than 1500mg of metformin)
- Able to start RT within 7 weeks after histological diagnosis
- Patients must have life expectancy ≥ 16 weeks
- Patients affiliated to an appropriate health insurance system.
- Age ≥ 18 years old
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of study drug
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception from the signing of the informed consent and continue throughout period of taking study treatment and for 6 months after last dose of study drug plus the time required for the investigational drug to undergo five half-lives (both TMZ and metformin). The terminal half-life of temozolomide is 1.8 hours. The terminal half-life for metformin is 6.5 hours.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception throughout the period of taking study treatment and for 6 months plus the time required for the both investigational drug (metformin) and TMZ to undergo five half-lives. The terminal half-life of temozolomide is 1.8 hours. The terminal half-life for metformin is 6.5 hours
- WBC ≥ 2000/μL t) Neutrophils ≥ 1500/μL
- Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations including follow-up
- Platelets ≥ 100 x103/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 30 mL/min (using the Cockcroft-Gault formula)
- AST ≤ 3.0 x ULN and ALT ≤ 3.0 x ULN and Total Bilirubin ≤ 1.5 x ULN (except patients with Gilbert Syndrome who may have a total bilirubin < 3.0 x ULN)
- Newly-diagnosed histologically-confirmed supra-tentorial glioblastoma IDH wild-type (Grade IV 4 malignant glioma by World Health Organization, including gliosarcoma)
- OXPHOS+ subtype by the central laboratory
- No prior treatment for GBM other than surgery
- Substantial recovery from surgical resection, no major ongoing safety issues (eg, infection requiring IV antibiotics) following surgery
- Without corticosteroids or with stable dose of corticosteroids (ie ≤ dexamethasone 6 mg, methylprednisolone 32 mg or prednisone 40mg)
- ECOG performance status 0-2
- Able to receive concomitant radio-chemotherapy according to the Stupp protocol (60Gy) based on investigator judgment
What rules you out
- Prior treatment for GBM (other than surgical resection) including Gliadel Wafer
- Alcohol intoxication and Alcoholism
- Persons protected by a legal regime (guardianship, trusteeship
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- Prisoners or patients who are involuntarily incarcerated
- Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
- Any known metastatic extracranial or leptomeningeal disease
- IDH mutant, K27 and NTRK alterations
- Secondary GBM (ie, progression from prior low-grade or anaplastic glioma)
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results g) Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication (inflammatory bowel disease, major bowel resection) h) Pregnant or breast-feeding women
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving anti-viral therapy
- Patients with hypersensitivity to dacarbazine and rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Patients with known active hepatitis (i.e., HBV or HCV)
- Patients with a known hypersensitivity to metformin and temozolomide or any of the excipients of the products
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication (inflammatory bowel disease, major bowel resection)
- Pregnant or breast-feeding women
- Patients with severe renal insufficiency ie, CrCl < 30 mL/min (who should not receive contrast materials)
- History or evidence upon physical/neurological examination of other central nervous system condition (eg, seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment
- Patients unable (eg, due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head
- Any acute medical condition that may impair renal function such as dehydration, severe infection, shock
- Any disease which may cause tissue hypoxia such as decompensated heart failure, respiratory failure, recent myocardial infarction
- Past diabetic precoma
- Past acute metabolic acidosis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.