Trial purpose
Side effect and wellbeing
Tumor type
Multi-Cancer
Age
7 - 21
Clinical summary
Summary
Specifically, this trial is investigating in children/adolescents aged 7 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?
You may be eligible if you are aged 7 years to 21 years and 11 months, and are no less than 3 weeks after the completion of primary therapy for: medulloblastoma, ependymoma, craniopharyngioma, germ cell tmours or any other brain tumour treated with cranial radiation.
Eligibe participants will be randomly assigned to one of the two treatments where they will either complete a 16-week cycle of metformin or a 16-week cycle of placebo.
Cognitive outcomes will be measured using tests of working memory, declarative memory, and processing speed. Increased white matter brain growth will be measured using diffusion MRI metrics.
Conditions
This trial is treating people with brain tumours who have completed primary treatment
Eligibility
Inclusion
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
Exclusion
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 score on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) for French speaking participants at Screening visit
- 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 vancomycin)
- Current or planned treatment with concomitant medications with potential unacceptable interaction with metformin including, lamotrigine, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, glycopyrrolate, and carbonic anhydrase inhibitors, or at the discretion of the Site PI or delegate for medications with potential interactions such as sertraline, lansoprazole and omeprazole.
- 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 the participant at risk
- Are receiving palliative care
Inclusion
- You have had a certain type of treatment or surgical procedure.
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Donald Mabbott
Scientific Title
Phase III Randomized Double-blind Placebo-controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Patients With a Brain Tumour
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