CANnabinoids in Pediatric ONCology
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversity of Manitoba
About this trial
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.
Eligibility criteria
Qualifiers
Ages 4-17 years old at the time of enrollment
Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
Currently receiving active cancer treatment or supportive and palliative care
Estimated survival of at least 4 months at the time of enrollment
Disqualifiers
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
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
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
Participation in other clinical trials that prohibit the concurrent use of cannabis
Trial design
Treatments tested in this trial
- MPL-001
- MPL-005
- MPL-009
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Manitoba
Lead sponsor
Canadian Cancer Society (CCS)
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov