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ARISTOCRAT – a pioneering trial using a cannabinoid-based drug to treat brain tumours

A major UK clinical trial of an oral spray containing cannabinoids to treat the most aggressive brain tumour has opened at Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust, Manchester.

Following a fundraising appeal by The Brain Tumour Charity in August 2021, backed by Olympic champion Tom Daley, we raised the £450,000 needed to fund the ARISTOCRAT trial.

In this post, we’ll discuss:

What is the ARISTOCRAT trial?

The trial will investigate whether combining nabiximols (also known as Sativex) and chemotherapy can help extend the lives of people diagnosed with recurrent glioblastoma.

The three-year phase II trial known as ARISTOCRAT is led by Professor Susan Short at the University of Leeds. And it’s coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

Participants will self-administer nabiximols or a placebo spray and will undergo regular follow-ups with the clinical trial team, including blood tests and MRI scans. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.

The study will recruit more than 230 glioblastoma patients at 14 NHS hospitals across England, Scotland and Wales in 2023.

This includes:

  • 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, Leeds
  • 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

For a more information, visit the University of Birmingham’s website.

Why is this trial important?

Glioblastomas are the most aggressive form of brain cancer. They have an average survival of less than 10 months after recurrence.

There are currently very few treatment options for people once their glioblastoma has grown back.

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 the most promising new addition to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.

Am I eligible for ARISTOCRAT?

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.

For more information or if you have other questions, please see our FAQs here.

What do our experts think?

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.

 “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 support@thebraintumourcharity.org. If you need someone to talk to, we’re here for you.”

Dr David Jenkinson, Chief Scientific Officer at The Brain Tumour Charity

Principal Investigator, Professor Susan Short, Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds, said:

“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.”

Image of Professor Susam Short who is working on the ARISTOCRAT trial to treat glioblastoma brain tumours

Find about more about the trial

Learn more about clinical trials

Would you would like to know more about clinical trials and how to take part in one? Take a look at our information on these by clicking the link below: