Cannabinoids in Pediatric Cancer: Tolerability in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, adaptive, dose-escalation study to determine tolerability of Cannabis Herbal Extracts in children with relapsed or refractory cancers. Participants are assigned to three arms with THC:CBD ratios 1:25, 1:5, and 1:1, aiming to enroll 60 children total. The study progresses in baseline, treatment, and maintenance phases, with a staged design to identify the maximum tolerated dose. The lead sponsor is the University of Manitoba, with support from CCS and CIHR, at BC Children's Hospital, IWK Health Centre, and The Hospital for Sick Children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ages 4-17 years old at the time of enrollment
2. Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
3. Currently receiving active cancer treatment or supportive and palliative care
4. Estimated survival of at least 4 months at the time of enrollment

Exclusion Criteria:

1. History of cardiovascular disease, severe hepatic or renal impairment defined by alanine transaminase (ALT)/ aspartate aminotransferase (AST) more than 5x upper limit of normal (ULN), creatinine more than 5x ULN or glomerular filtration rate (GFR less than) \<60 mL/min/1.73 m273m2, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99th centile for age or history of myocardial infarction
2. Nabilone or other cannabis-based products use (including for recreational purposes) within the past 2 weeks or planned nabilone use for the duration of their enrollment in the trial. Current use/continued use of recreational cannabis, or not willing to abstain from recreational cannabis use during the trial
3. Anyone who is pregnant or breast/chest-feeding throughout the duration of the study or has the intention to become pregnant within 3 months of study completion
4. Participation in other clinical trials that prohibit the concurrent use of cannabis
5. Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
6. Unwilling or unable to use effective form of contraception and refrain from driving motorized vehicles (cars, motorcycles, boats, etc.) throughout the study period
7. Anyone who is currently receiving cell therapies or immune checkpoint inhibitors

Where it's running

• BC Children's Hospital
  Vancouver, British Columbia, Canada Recruiting
• IWK Health Centre
  Halifax, Nova Scotia, Canada Recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Rod Rassekh, MD — University of British Columbia
• Study coordinator: Lauren Kelly, PhD
• Email: lauren.kelly@umanitoba.ca
• Phone: 204-242-3179

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.