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New treatment option for Medulloblastoma, Childhood
Official title Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
ClinicalTrials.gov ID: NCT05230758
What this study is testing
What is Metformin hydrochloride (HCl) 500mg tablet?
Metformin hydrochloride (HCl) 500mg tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for medulloblastoma, childhood.
Also referred to as Glucophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents treated for a brain tumour will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children/adolescents aged 7 years to 21 years and 11 months who have completed treatment for a brain tumour, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 21
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- No less than 3 weeks after completion of:
- Primary therapy for:
- medulloblastoma OR
- ependymoma OR
You likely can't join if
- Participants who meet any of the following criteria will not be eligible to take part in the trial:
- Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (or other Wechsler Scale...
- Have a known hypersensitivity to metformin hydrochloride
- Have unstable and/or insulin-dependent (Type 1) diabetes
- Have a history of hypoglycemia after 2 years of age
- Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or if bicarbonate (Total CO2) is less than 22 mmol/L at the...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- No less than 3 weeks after completion of:
- Primary therapy for:
- medulloblastoma OR
- ependymoma OR
- craniopharyngioma OR
- germ cell tumours OR
- Primary therapy for any other brain tumour treated with cranial radiation - at the discretion of the Study PI OR
- Cranial radiation for relapsed ependymoma
- Age 7 years to 21 years and 11 months at the time of enrollment
- Either declare English (or French in accepting sites) as their native language or have had at least two years of schooling in English (or French in accepting sites) at the time of consent
- Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen
- Meet criteria for normal organ function requirements as described below:
- Normal renal function defined as: Estimated glomerular filtration rate (eGFR) \> 75ml/min/1.73m²
- eGFR is calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL
- Normal liver function defined as:
- Serum glutamic-oxaloacetic transaminase (SGOT) (AST) ≤2.5 x institutional upper limit of normal (ULN) for age and gender
- Serum glutamic pyruvic transaminase (SGPT) (ALT) ≤2.5 x institutional ULN for age and gender
- Total bilirubin \<1.5x institutional ULN for age and gender (patients with documented Gilbert's Disease may be enrolled with Sponsor approval and total bilirubin ≤2.0 x institutional ULN)
- Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardian(s) by study team members delegated to consent for this study
- Participants who meet any of the following criteria will not be eligible to take part in the trial:
- Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (or other Wechsler Scale of Intelligence for English speaking participants) or pro-rated IQ...
- Have a known hypersensitivity to metformin hydrochloride
- Have unstable and/or insulin-dependent (Type 1) diabetes
- Have a history of hypoglycemia after 2 years of age
- Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or if bicarbonate (Total CO2) is less than 22 mmol/L at the Screening visit
- Have a history of renal disease or renal dysfunction pre-existing to the diagnosis of Medulloblastoma
- Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry
- Currently taking part in a cognitive rehabilitation intervention study
- Treatment or planned treatment involving diuretics
- Current or planned treatment with cationic drugs excreted by the kidneys (e.g. amiloride, cimetidine, digoxin, morphine, nifedipine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and...
- Current or planned treatment with concomitant medications with potential unacceptable interaction with metformin including, lamotrigine, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, glycopyrrolate, and...
- Pernicious anemia (according to results of the Screening visit blood draw)
- Current use of metformin hydrochloride
- Any condition or diagnosis, that could in the opinion of the Site PI or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put...
- Are receiving palliative care
The study team makes the final eligibility decision.
Where it's taking place
- New Lambton Heights, New South Wales, Australia
- Westmead, New South Wales, Australia
- Adelaide, North Adelaide, Australia
- Clayton, Victoria, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
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, 7 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Lambton Heights, New South Wales, Australia; Westmead, New South Wales, Australia; Adelaide, North Adelaide, Australia; Clayton, Victoria, Australia; Parkville, Victoria, Australia; Nedlands, Western Australia, Australia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.