University of Leeds researchers are set to launch a major trial of a cannabis-based drug to treat the most aggressive form of brain tumour.
The three-year phase II trial, which will be led by Susan Short, Professor of Clinical Oncology and Neuro-Oncology in the School of Medicine, will assess whether adding Sativex to chemotherapy could extend the lives of thousands of people with a recurrent glioblastoma brain tumour. Sativex is an oral spray containing the cannabinoids THC and CBD.
The research team will recruit more than 230 patients at 15 NHS hospitals across the UK from March.
We’re really excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomised trial.
Glioblastomas are the most common and most aggressive form of brain cancer, with around 2,200 people diagnosed each year in England alone. Almost all glioblastomas recur even after intensive treatment and average survival is just 12-18 months from first diagnosis.
Professor Short said: “The treatment of glioblastomas remains extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year, and unfortunately there are very few options for patients once this occurs.
“Cannabinoids have well-described effects in the brain and there has been a lot of interest in their use across different cancers for a long time now. Glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surface, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.
“It’s really exciting that our research team can now run a definitive, well-designed study that will tell us the answer to whether these agents could help treat the most aggressive form of brain tumour. Having recently shown that a specific cannabinoid combination given by oral spray could be safely added to temozolomide chemotherapy, we’re really excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomised trial.”
Over the last decade, both patient and scientific communities around the world have been interested in the activity of cannabinoids in brain tumours, with many suggesting that cannabinoid-based products may not only help relieve symptoms but that they could boost survival.
The new trial will measure whether adding Sativex to temozolomide chemotherapy extends the overall length of patients’ lives, delays the progression of their disease and/or improves quality of life.
Dr David Jenkinson, Interim CEO at The Brain Tumour Charity, which is funding the trial, said: “We know there has been significant interest among patients and researchers alike for some time about the potential activity of cannabinoids in treating glioblastomas. We’re really excited that this world-first trial here in the UK could help accelerate these answers.
“The recent early-stage findings were really promising and we now look forward to understanding whether adding Sativex to chemotherapy could help offer life-extension and improved quality of life, which would be a major step forward in our ability to treat this devastating disease.”
Results of a phase 1 trial reported in the British Journal of Cancer in February revealed that the drug could be tolerated with mild to moderate side effects. In the second part of that study, 12 patients received Sativex with temozolomide and nine were given a placebo with temozolomide for 12 months. 10 of the 12 (83.3%) patients receiving Sativex were still alive after one year, compared to 4 out of 9 (44.4%) patients who were given the placebo.