CANnabinoids in Pediatric ONCology

Phase 1

Not yet recruiting

• Conditions: Childhood Cancer; Cancer
• Interventions: Drug: MPL-001; Drug: MPL-005; Drug: MPL-009

• Registration Number: NCT05754840
• Lead Sponsor: University of Manitoba

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).

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30
• Study Start: 2024-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1. High-CBD arm (MPL-001)	MPL-001	High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD.
Arm 2. Medium-CBD arm (MPL-005)	MPL-005	Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD.
Arm 3. Balanced arm (MPL-009)	MPL-009	Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (Tolerability)	14 weeks	Reported through study completion

Secondary Outcome Measures

Name	Time	Method
Symptom burden	3 times per week for 14 weeks	Symptom burden is measured using the score of Symptom Screening in Pediatrics Tool (SSPedi) assessed three times a week throughout the study and will be reported as a weekly average and percentage change from baseline.
Pain intensity	daily for 14 weeks	Pain will be measured using Faces Pain Scale-Revised reported by the participants daily throughout the study. Pain will be reported for each study visit as a percentage change from the weekly average documented at baseline.
Quality of life (child)	once per week for 14 weeks	Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study
Sleep (hours per night)	daily for 14 weeks	Sleep, will be reported as the number of hours per night, measured using Actigraphy and/or parent report, will be reported as an average over a one-week time period.