In a world-first, a UK trial will test if a cannabis-based mouth spray can be used to treat aggressive brain tumours.
A major trial of cannabis-based drug Sativex in treating the most aggressive form of brain tumour is set to launch at 15 NHS hospitals around the UK.
The new phase II trial, led by the University of Leeds, will assess whether adding Sativex – an oral spray containing cannabinoids THC and CBD – to chemotherapy, could extend life for thousands diagnosed with a recurrent glioblastoma.
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 including surgery, radiotherapy and chemotherapy, and average survival is just 12-18 months from first diagnosis.
Several pre-clinical laboratory studies have suggested that cannabinoids THC and CBD may reduce brain tumour cell growth and could disrupt the blood supply to tumours – but to date, clinical evidence that they could treat brain tumours has been limited.
Sativex, already used in treating multiple sclerosis, was found to be tolerable in combination with chemotherapy, with the potential to extend survival, in a phase I trial in glioblastomas earlier this year.
The phase I study observed that more patients who were given Sativex were alive after one year compared to those taking a placebo.
The next stage will measure whether adding Sativex to chemotherapy extends the overall length of patients’ lives, delays the progression of their disease or improves quality of life.
Experts hope that, should the trial prove successful, Sativex could represent one of the first additions to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.
Professor Susan Short, principal investigator on the trial and Professor of Clinical Oncology and Neuro-Oncology at Leeds, 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.
“Glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surfaces, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.
“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.”
‘Life beyond a glioblastoma diagnosis’
Stephen Lee, 62 from Leyland in Lancashire, took part in the phase I trial of Sativex in 2015 after his glioblastoma returned following initial treatment.
Stephen was first diagnosed in 2010, just a few months after he had very sadly lost his older brother to the same disease.
He commented: “My diagnosis was very sudden and was one of those days you never forget.
“I joined the early trial of Sativex in the hope that it could improve my quality of life, but I also thought it was important to do so as the chemotherapy and radiotherapy I was having had all been trialled by other people before it could be used safely. I thought it only right and proper that I followed in their footsteps and joined a trial to help prove a new drug which could benefit so many people in the future with a recurring glioblastoma.
“I took the oral spray 10 times a day, and it was easy as I could take it wherever we were going, even while out for dinner. While I don’t know whether I had Sativex or the placebo, since the trial finished in 2016, all my MRI scans have been clear.
“This new trial is so important as it will give people hope that there could be life beyond a glioblastoma diagnosis and that there are other treatments being trialled to support them to live their lives.”
Funding appeal launched
The new three-year phase II trial, funded by The Brain Tumour Charity and co-ordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, will begin recruiting more than 230 patients across all UK nations in early 2022, should it receive the funding required.
Having seen its income drop by more than 25 percent last year due to the pandemic, The Brain Tumour Charity has launched an appeal to raise the £450,000 needed to open the trial as soon as possible.
Dr David Jenkinson, interim CEO at The Brain Tumour Charity, said: “We hope this trial could pave the way for a long-awaited new lifeline that could help offer glioblastoma patients precious extra months to live and make memories with their loved ones.
“With so few treatments available and average survival still so heartbreakingly short, thousands affected by a glioblastoma in the UK each year are in urgent need of new options and new hope.
“We know there is significant interest among our community about the potential activity of cannabinoids in treating glioblastomas, and we’re really excited that this world-first trial here in the UK could help accelerate these answers. T
he 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.
“Anyone affected by a glioblastoma can speak to us for support and information on 0808 800 0004 or by emailing [email protected]. If you need someone to talk to, we’re here for you.”
The post UK to trial cannabis-based drug in treatment of brain tumours appeared first on Cannabis Health News.
