A major UK clinical trial examining the role of the cannabis-based drug, Sativex, in treating the most aggressive brain tumour, has recruited its first patients.
A pioneering research project, which is thought to be the first-of-its-kind on the role of a cannabis-based drug in the treatment of brain tumours is now underway at Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust in Manchester.
The ARISTOCRAT trial aims to investigate whether combining nabiximols (also known as Sativex) and chemotherapy can help extend the lives of people diagnosed with recurrent glioblastoma.
The study, which is being led by researchers at the University of Leeds and the Cancer Research UK Clinical Trials Unit at the University of Birmingham, aims to recruit more than 230 glioblastoma patients at 14 NHS hospitals across England, Scotland and Wales in 2023.
A fundraising campaign by The Brain Tumour Charity in August 2021, backed by Olympic champion Tom Daley, raised the £450,000 needed to carry out the trial.
Glioblastomas are the most aggressive form of brain cancer, with an average survival of less than 10 months after recurrence. According to The Brain Tumour Charity, there are currently very few treatment options for people once their glioblastoma has grown back.
Early findings show promise
In 2021, a phase I clinical trial in 27 patients found that nabiximols could be tolerated by patients in combination with chemotherapy, and has the potential to extend the lives of those with recurrent glioblastoma.
Should the phase II trial prove successful, experts hope that nabiximols could represent a new, promising addition to NHS treatment for glioblastoma patients – the first since temozolomide chemotherapy in 2007.
Dr David Jenkinson, chief scientific officer at The Brain Tumour Charity, said: “We are delighted to announce that, thanks to the support and generosity of so many in the brain tumour community, the ARISTOCRAT trial has recruited its first patients.
“We are really excited that this world-first trial, being run here in the UK, could help accelerate a cure for this devastating disease. In the last decade there has been significant interest from both patients and researchers about the potential for cannabinoids to treat glioblastomas. And we are so grateful to everyone across the world who helped to fund such an important study.
“The early-stage findings were really promising. We now look forward to understanding whether adding nabiximols to chemotherapy could help improve quality of life and extend life for those affected by a glioblastoma diagnosis. We hope that this will offer the first new drug to treat glioblastoma in over 15 years.”
A ‘first-of-a-kind’ randomised control 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.
They will then undergo regular follow-up including clinical assessment (every four weeks), blood tests, MRI scans (every eight weeks), and 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.
Professor Susan Short, principal investigator on the trial at the University of Leeds, commented: “We are very excited to open this trial here in Leeds. And very much look forward to running the study which will tell us whether cannabinoid-based drugs could help treat the most aggressive form of brain tumour. The treatment of glioblastomas is extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year. Unfortunately there are very few options for patients once this occurs.
“Cannabinoid-based drugs 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. Glioblastomas 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.
“We now have the opportunity to take these laboratory results, and those from the phase I trial and investigate whether this drug could help glioblastoma patients live longer in this first-of-a-kind randomised clinical trial.”
Exercising caution with cannabis-based therapies
The potential for cannabis to treat and even prevent certain types of cancers is an evolving field of research.
Cannabis-based products have been found anecdotally – and in an increasing number of scientific studies – to help patients in a number of ways, from palliative pain management to reducing the side-effects of standard treatments such as chemotherapy.
However, to date there is a lack of robust evidence for its use in the treatment of brain tumours.
As Dr Jenkinson cautioned: “In the meantime, while other cannabinoid-based products may help alleviate symptoms, there is insufficient evidence to recommend their use to help treat brain tumours. For anyone considering using cannabinoid-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.
“Anyone affected by a glioblastoma can speak to us for support and information on 0808 800 0004 or by emailing email@example.com. If you need someone to talk to, we’re here for you.”
Are you eligible?
The trial will be recruiting patients from the following NHS hospitals:
- Queen Elizabeth Hospital, Birmingham
- Bristol Haematology & Oncology Centre, Bristol
- Addenbrooke’s Hospital, Cambridge
- Velindre Cancer Centre, Cardiff
- Western General Hospital, Edinburgh
- Beatson West of Scotland Cancer Centre, Glasgow
- St James’s University Hospital, London
- Guy’s Hospital, London
- Charing Cross Hospital, London
- Clatterbridge Cancer Centre, Liverpool (Wirral)
- The Christie Hospital, Manchester
- City Hospital, Nottingham
- John Radcliffe Hospital, Oxford
- Southampton General Hospital, Southampton
Anyone interested in this study should speak to their medical team first to ensure they are eligible to participate.
For the most up-to-date information about which trial centres are open visit the ClinicalTrials.gov website
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