CANnabinoids in Pediatric ONCology

Trial Title: CANnabinoids in Pediatric ONCology

NCT ID: NCT05754840

Condition: Childhood Cancer
Cancer

Conditions: Keywords:
cannabinoids
CBD
THC
pediatrics
cannabis

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: MPL-001
Description: High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.
Arm group label: Arm 1. High-CBD arm (MPL-001)

Intervention type: Drug
Intervention name: MPL-005
Description: Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.
Arm group label: Arm 2. Medium-CBD arm (MPL-005)

Intervention type: Drug
Intervention name: MPL-009
Description: Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.
Arm group label: Arm 3. Balanced arm (MPL-009)

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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Ages 4-18 years old at the time of enrollment 2. Diagnosed with relapsed or refractory solid or hematologic malignancy 3. Currently receiving active cancer treatment or 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 ALT/AST more than 5x ULN, creatinine more than 5x ULN or GFR >60, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99%ile 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 throughout the study period

Gender: All

Minimum age: 4 Years

Maximum age: 18 Years

Healthy volunteers: No

Start date: March 2024

Completion date: December 2025

Lead sponsor:
Agency: University of Manitoba
Agency class: Other

Collaborator:
Agency: The Canadian Collaborative for Childhood Cannabinoid Therapeutics
Agency class: Other

Collaborator:
Agency: Canadian Cancer Society (CCS)
Agency class: Other

Collaborator:
Agency: Canadian Institutes of Health Research (CIHR)
Agency class: Other

Source: University of Manitoba

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05754840