Cannabinoids for Childhood Cancer

(CAN-PONC Trial)

This trial explores the tolerance of cannabinoids, compounds found in cannabis, in children with cancer. Researchers are testing three different cannabis extracts, including MPL-001 (also known as Epidiolex or CBD), with varying levels of CBD and THC, the active ingredients in cannabis, to observe their interaction with ongoing cancer treatments. The trial is suitable for children and teens aged 4 to 17 who have relapsed or difficult-to-treat cancers and are receiving active cancer treatment or supportive care. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

In earlier studies, cannabidiol (CBD), as in MPL-001, has generally been well-tolerated. The FDA approved Epidiolex, a CBD medication, for treating certain seizures in children as young as one year old. This approval suggests CBD is considered safe for children, though the specific safety of MPL-001 in cancer treatment still requires exploration.

For MPL-005, direct safety data is not yet available. However, its testing in a pediatric cancer trial indicates that researchers are primarily focused on ensuring its safety for children.

Regarding MPL-009, which contains a balanced mix of THC and CBD, specific safety data is also unavailable. Like MPL-005, the trial phase aims to assess children's tolerance.

Researchers are excited about these treatments for childhood cancer because they explore the potential of cannabinoids, specifically different ratios of THC and CBD, to provide therapeutic benefits. MPL-001 is unique with its high-CBD composition, offering a 1:25 ratio of THC to CBD, which may help reduce inflammation and pain without significant psychoactive effects. MPL-005, with a medium-CBD profile, has a 1:5 ratio, potentially balancing pain relief with mild psychoactive effects. MPL-009 is balanced, with equal parts THC and CBD (1:1 ratio), which might offer a more comprehensive range of benefits, including both pain relief and enhanced mood. These formulations are particularly exciting because they could offer alternative options to traditional chemotherapy and radiation, aiming to improve quality of life and symptom management in young patients.

This trial will compare different cannabinoid formulations for childhood cancer. Research has shown that cannabidiol (CBD), a main ingredient in MPL-001, reduces seizures in children with epilepsy. In several studies, CBD treatment significantly lowered seizure frequency, with some children experiencing more than a 50% decrease. While this research focuses on epilepsy, it suggests that CBD might also alleviate symptoms in other conditions. For participants in the MPL-005 and MPL-009 arms, which also contain CBD, there is less specific research related to cancer. However, cannabinoids are believed to help with symptoms like pain and nausea, potentially providing relief for children undergoing cancer treatments. Although the exact benefits for children with cancer are still under investigation, current evidence on CBD's effects in other conditions supports further research.¹²⁶⁷⁸