A trial of the cannabis-based drug, Sativex, in treating aggressive brain tumours, has been given the green light.
A Phase II trial of Sativex, in 27 patients with the most severe form of brain tumour, will open in 2022.
The Brain Tumour Charity announced on Thursday 25 November, that the trial has been approved and will begin recruiting over 230 patients at 15 NHS hospitals across the UK in March.
Following promising results in a phase I trial earlier this year, the charity launched a fundraising appeal in August to undertake a phase II trial as soon as possible.
This has 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 on the NHS, 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.
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.
A major step forward
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 March 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.”
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.
Dr Jenkinson continued: “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.”
Could Sativex extend life expectancy?
In this new 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.
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.
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.
Lead investigator Professor Susan Short, commented: “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.”
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