Clinical trial NCT05754840: CANnabinoids in Pediatric ONCology
Official title: A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Childhood Cancer
Cancer
Keywords: cannabinoids
CBD
THC
pediatrics
cannabis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.

To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.

All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (Tolerability)
timeFrame: 14 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: daily for 14 weeks
measure: Symptom burden
timeFrame: 3 times per week for 14 weeks
measure: Quality of life (child)
timeFrame: once per week for 14 weeks
measure: Sleep (hours per night)
timeFrame: daily for 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Rod Rassekh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Bruce Crooks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Adam Rappoport, MD
role: PRINCIPAL_INVESTIGATOR
References: