Menu
Recruiting NCT05754840

CANnabinoids in Pediatric ONCology

Phase I / Phase II Interventional Childhood Cancer Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MPL-001, MPL-005, MPL-009.
Who it may be relevant to
Registry conditions: Childhood Cancer, Cancer. Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial

Overview

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).

Interventions

  • Drug MPL-001
    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.
  • Drug MPL-005
    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.
  • Drug MPL-009
    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.

Primary outcome measures

  • Incidence of adverse events (Tolerability) [Time frame: 14 weeks]
Secondary outcome measures (4)
  • Pain intensity [Time frame: daily for 14 weeks]
  • Symptom burden [Time frame: 3 times per week for 14 weeks]
  • Quality of life (child) [Time frame: once per week for 14 weeks]
  • Sleep (hours per night) [Time frame: daily for 14 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Canada · 3 centers
  • BC Children's Hospital — Vancouver
  • IWK Health Centre — Halifax
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT05754840 · CAN-PONC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗