CANnabinoids in Pediatric ONCology

NCT05754840 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CAN-PONC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Cancer; Cancer

Keywords

cannabinoids; CBD; THC; pediatrics; cannabis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (Tolerability)

  Reported through study completion

  14 weeks

Secondary Outcomes (4)

• Pain intensity

  daily for 14 weeks

• Symptom burden

  3 times per week for 14 weeks

• Quality of life (child)

  once per week for 14 weeks

• Sleep (hours per night)

  daily for 14 weeks

Study Arms (3)

Arm 1. High-CBD arm (MPL-001)

EXPERIMENTAL

High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD.

Drug: MPL-001

Arm 2. Medium-CBD arm (MPL-005)

EXPERIMENTAL

Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD.

Drug: MPL-005

Arm 3. Balanced arm (MPL-009)

EXPERIMENTAL

Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD.

Drug: MPL-009

Interventions

MPL-001 DRUG

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 1. High-CBD arm (MPL-001)

MPL-005 DRUG

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 2. Medium-CBD arm (MPL-005)

MPL-009 DRUG

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 3. Balanced arm (MPL-009)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
• Unwilling or unable to use effective form of contraception and refrain from driving motorized vehicles (cars, motorcycles, boats, etc.) throughout the study period
• Anyone who is currently receiving cell therapies or immune checkpoint inhibitors

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Neoplasms; Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rod Rassekh, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Bruce Crooks, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Adam Rappoport, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Kelly, PhD

CONTACT

204-242-3179; lauren.kelly@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05