We are delighted to announce that, thanks to your support, the phase II trial of cannabis-based drug Sativex in treating the most aggressive form of brain tumour at 15 NHS hospitals (ARISTOCRAT) will open in summer 2022.
Following promising results in a phase I trial earlier this year, we launched an urgent fundraising appeal in August to help open a phase II trial as soon as possible, and we are so grateful to have seen over £400,000 donated in just three months.
The trial, funded by The Brain Tumour Charity and led by University of Leeds researchers, will now assess whether adding Sativex (an oral spray containing cannabinoids THC and CBD) to chemotherapy could extend life for those living with a recurrent glioblastoma brain tumour.
Sativex — which is already used in treating multiple sclerosis — was initially found to be tolerable in combination with chemotherapy with the potential to extend survival in the phase I trial in 27 patients with a glioblastoma earlier this year.
Thanks to the support of the public and global research community including a generous donation of £45,000 from Leeds Hospitals Charity, the trial has been approved and will begin recruiting over 230 patients at 15 NHS hospitals across all UK nations in summer 2022.
The three-year trial is being led by Professor Susan Short at the University of Leeds and co-ordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham,
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.
Dr David Jenkinson, Interim CEO at The Brain Tumour Charity, said: “We are delighted to announce that, thanks to the support and generosity of so many in our community, the ARISTOCRAT trial will begin recruitment of patients in summer 2022.
“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 and are so grateful to everyone who has donated to help us make this study possible – thank you.
“We’d also particularly like to thank Leeds Hospitals Charity for their significant contribution, which will enable up to 25 patients to access the trial at Leeds Teaching Hospitals.
“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.
“In the meantime, while other cannabis-based products may help alleviate symptoms, there is insufficient evidence to recommend their use to help treat brain tumours. For anyone considering using cannabis-based products or other complementary therapies, it’s vital that you discuss these with your medical team first, as they could interact with other treatments such as anti-epileptic medicines or steroids.”
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.
Stephen said:“My diagnosis was very sudden and definitely one of those days that you never forget. Having left work early with a severe headache and a stabbing pain in my right eye, my wife insisted that we go straight to hospital. I was admitted that same day, had an urgent scan which found the brain tumour and surgery followed the next week.
My wife and I had agreed early on that we wanted to stay positive, to keep living our lives and to enjoy however much time we had together. So, I joined the early trial of Sativex in the hope that it could improve my quality of life. I also thought it was important to do so as the chemotherapy and radiotherapy I was having had 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 other people in the future. Whilst I don’t know whether I had Sativex or the placebo, since the trial finished in 2016, all my MRI scans have been clear.
The astounding fundraising for this trial so far is the best Christmas present that people like me, who have been diagnosed with a glioblastoma, could receive this year. Never in my wildest dreams did I foresee this happening in such a short space of time and I am excited about what can now take place. It will hopefully bring light into the hearts of those who have been living under the dark clouds of a brain tumour diagnosis – and give people hope that there could be new treatments to support them to live their lives.”
Principal Investigator, Professor Susan Short, Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds
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 we’re now at the point where we can 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.”
Glioblastomas are the most common and most aggressive form of brain cancer, with around 2,200 people diagnosed each year in England alone. They are usually fast-growing and diffuse, with poorly-defined boundaries and thread-like tendrils that extend into other parts of the brain.
Almost all glioblastomas recur even after intensive treatment including surgery, radiotherapy and chemotherapy, and average survival is just 12-18 months from first diagnosis.
Over the last decade, there has been significant global interest within both patient and scientific communities about the activity of cannabinoids in brain tumours, with the view that cannabinoid-based products may not only help relieve symptoms but could also have a positive impact on survival.
In this new phase II trial, researchers will assess whether adding Sativex to the current standard chemotherapy treatment (temozolomide) could offer extra time to live for adults diagnosed with a recurrence of their glioblastoma after initial treatment.
Two thirds of participants will be given temozolomide plus Sativex, while one third will be given temozolomide plus placebo.
Sativex, manufactured by GW Pharma, is an oromucosal spray containing 1:1 THC (Delta-9-tetrahydrocannabinol) and CBD (cannabidiol), with the active ingredients being absorbed in the lining of the mouth, either under the tongue or inside the cheek.
Participants will be asked to administer up to 12 sprays per day (or to the maximum dose they can tolerate if fewer than 12) of Sativex or placebo oral sprays.
Participants will then undergo regular follow-up including clinical assessment (every four weeks), blood tests, MRI scans (every eight weeks), and they will complete quality of life questionnaires. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.
The trial will measure whether adding Sativex to chemotherapy extends the overall length of patients’ lives (overall survival), delays the progression of their disease (progression-free survival) or improves quality of life.
In the initial phase I study, the most common side-effects reported were fatigue, headache, vomiting and nausea, which were mostly classed as being mild-moderate in severity.
How can I take part in the trial?
The trial will begin recruiting from summer 2022, but this will be phased and the participating hospitals won’t all open at once. Your treating oncologist will be aware of the study if it is open in your hospital or can refer you to a treating centre if necessary. If you have any other questions about the trial, you can call us on 0808 800 0004 or email firstname.lastname@example.org.