Charity-funded clinical trial on cannabis and brain cancer gets underway

A clinical trial researching the efficacy of cannabis as a treatment for the severe brain cancer, glioblastoma, is now underway thanks to a major fundraising initiative. 

In September, the first patient entered the University Hospital 12 de Octubre in Spain as part of an independent clinical trial researching the efficacy of cannabis as a potential treatment glioblastoma, the most aggressive form of brain cancer.

Glioblastomas are the most common form of cancerous brain tumour in adults, and are fast-growing with an average survival of less than 10 months after recurrence.

The trial will recruit 30 patients across eight specialised neuro-oncology medical sites in Spain.

Over the next 18 months, researchers led by coordinating investigator Dr Juan Manuel Sepúlveda Sánchez from GEINO (Spanish Group of Neuro-Oncology Research) will study the synergistic anti-tumor effect observed in the pre-clinical stage of combining Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) with traditional cancer treatments using temozolomide and radiotherapy.

The trial is the culmination of a 10 year collaboration between the scientific sector and the medical cannabis community. Partners include scientists from Complutense University of Madrid, Canadian medical cannabis provider Tilray Medical which provided the pharmaceutical-grade medication for the trial (THC/CBD, 1:1), and the Medical Cannabis Bike Tour Foundation charity which raised over €400,000 in independent funding for the trial.

Dr Guillermo Velasco, of Complutense University and IdISSC, commented: “This trial represents a crucial milestone in the study of the anti-tumoral action of cannabinoids, a long-term project that we have developed for more than 20 years now. Stemming from initial almost serendipitous observations that THC has the ability to promote glioma cell death, our work led us to understand the mechanism by which cannabinoids exert their anticancer actions in brain tumour cells. Likewise, our preclinical studies in animal models demonstrated a promising synergistic anti-tumor effect when combining THC and CBD with temozolomide thereby contributing to set the scientific bases for the development of this clinical study.”

He added: “As a basic scientist, being able to translate our findings into something potentially useful for patients is the maximal aspiration and therefore we are thrilled to see that the study is commencing. We are extremely thankful to all who have made possible this trial including our partners in this exciting long-term project: Medical Cannabis Bike tour, GEINO, Tilray and MFAR as well as past and present researchers in our group and all our national and international collaborators. Hopefully the results of the trial will contribute to provide a new hope and therapeutic option for glioblastoma patients.”

The Medical Cannabis Bike Tour 

Founded by Luc Krol from the Netherlands based cannabis genetics seed bank, Paradise Seeds and Matej Munih from Snail Rolling Papers, in 2013 the Medical Cannabis Bike Tour began raising funds to support the work of the Complutense University team researching the effects of cannabinoids on cancer cells and the potential as a glioblastoma treatment. 

The charity held five bike tours across Europe. Photo: Medical Cannabis Bike Tour.

In total they raised over €400,000 in sponsorship through organising five bike tours across the continent.

“The world was very different when we began the MCBT 10 years ago,” Krol said.

“In the pre-legalization era, the term ‘medical cannabis’ was still seen by many people as a fantasy. However we believed in the outstanding work of doctors Velasco and Guzman and their team and asked the cannabis community to support it. 

“The fact that the MCBT can independently fund a clinical trial in the name of science, not profit, is amazing thanks to the sponsors and riders who made it happen. We hope this trial will reflect the hope illuminated by the scientific research for the participants involved.” 

Photo: Medical Cannabis Bike Tour

UK research into cannabis and glioblastoma

A similar trial examining the efficacy of the licensed cannabis-based drug, Sativex, in the treatment of glioblastoma is ongoing in the UK.

In 2021, a phase I clinical trial in 27 patients found that nabiximols (Sativex) could be tolerated by patients in combination with chemotherapy, and has the potential to extend the lives of those with recurrent glioblastoma.

Phase II is now recruiting patients at 14 NHS hospitals with the hope it could lead to the drug being recognised as a new treatment for the disease.