Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who have been newly diagnosed with a specific type of brain tumour called IDH wild-type glioblastoma (Grade 4), located in the upper part of the brain, confirmed by tissue testing — including a type called gliosarcoma
• People whose tumour tests positive for a specific biological marker called "OXPHOS+" as determined by the trial's central laboratory
• People who have had surgery as the only treatment for their brain tumour so far
• People who have recovered well enough from surgery, with no major ongoing health problems such as infections requiring intravenous antibiotics
• People who are either not taking corticosteroids (steroid medicines) or are on a stable, low dose (confirm specific dose limits with trial site)
• People who are well enough to carry out basic daily activities, as measured by a standard medical scale called ECOG performance status 0–2 (confirm with trial site)
• People whose treating doctor considers them able to receive the standard combined radiation and chemotherapy treatment (called the Stupp protocol, involving 60Gy of radiation)
• People whose bone marrow and liver are functioning adequately, based on blood test results meeting specific thresholds set by the trial
• People whose kidneys are functioning at a certain level, measured by a calculation called creatinine clearance of at least 30 mL/min (those between 30 and 50 mL/min may receive a lower dose of one of the study drugs)
• People who are able to start radiation therapy within 7 weeks of their tissue diagnosis
• People with a life expectancy of at least 16 weeks
• People covered by an appropriate health insurance system
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study treatment
• Women who could become pregnant must agree to use contraception from the time of signing consent, throughout treatment, and for a defined period after the last dose (confirm exact timeframe with trial site)
• Men who are sexually active with women who could become pregnant must agree to use contraception throughout treatment and for a defined period after the last dose (confirm exact timeframe with trial site)
• People with blood test results meeting specific thresholds for white blood cells, neutrophils (a type of infection-fighting cell), platelets, haemoglobin, kidney function markers, and liver function markers (confirm exact values with trial site)

Who may not be able to join:

• People who have already received any treatment for their brain tumour other than surgery, including a type of chemotherapy wafer placed during surgery
• People with a second active cancer, except for certain cancers that have been fully treated — such as some skin cancers, cervical cancer caught early, or other solid tumours with no sign of return for at least 5 years
• People whose cancer has spread outside the brain or into the lining around the brain or spinal cord
• People whose tumour has a genetic change called an IDH mutation
• People whose glioblastoma developed from a previously diagnosed lower-grade brain tumour
• People with a serious or uncontrolled medical condition that, in the treating doctor's judgement, could make participation unsafe or affect the trial results
• People who are unable to swallow tablets or capsules, or who have digestive conditions that may prevent proper absorption of the study medicines (such as inflammatory bowel disease or major bowel surgery)
• People who are pregnant or breastfeeding
• People with a weakened immune system, such as those known to be HIV-positive and receiving antiviral treatment
• People with known active hepatitis B or hepatitis C infection
• People with a known allergy or sensitivity to either of the study drugs (metformin or temozolomide) or their ingredients
• People with severely reduced kidney function (creatinine clearance below 30 mL/min)
• People with a history of, or currently experiencing, other brain or nervous system conditions unrelated to their cancer — unless the condition is well controlled and unlikely to interfere with treatment (confirm with trial site)
• People who are unable or unwilling to have a contrast-enhanced MRI scan of the head, for example due to having a pacemaker or implanted heart device
• People with an acute medical condition that could reduce kidney function, such as severe dehydration, serious infection, or shock
• People with a condition that reduces oxygen supply to body tissues, such as severe heart failure, respiratory failure, or a recent heart attack
• People with a history of a diabetic pre-coma episode
• People with a history of acute metabolic acidosis (a condition where the body's acid levels become dangerously high)
• People with alcohol intoxication or alcoholism
• People under a legal protection arrangement such as guardianship or trusteeship
• People who are currently imprisoned or involuntarily detained
• People who are being held involuntarily for treatment of a psychiatric or physical illness

Important: Always verify eligibility with the trial site directly before applying.