A major clinical trial using cannabis-derived drugs to treat the most aggressive brain tumour has opened in the UK.

Funded by The Brain Tumour Charity, the trial will investigate whether nabiximols (trade name Sativex), combined with 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 School of Medicine, and coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

It will recruit more than 230 glioblastoma patients at 14 National Health Service (NHS) hospitals across England, Scotland and Wales in 2023. Glioblastoma is the most aggressive form of brain cancer with an average survival of less than 10 months after recurrence.

In 2021, a phase I clinical trial in 27 patients found nabiximols could be tolerated in combination with chemotherapy, with the potential to extend the lives of those with recurrent glioblastoma.

Should the next phase of the trial prove successful, experts hope nabiximols could represent a new, promising addition to NHS treatment for glioblastoma patients alongside temozolomide chemotherapy.

Professor Short said: “The treatment of glioblastomas is 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.

Professor Susan Short: “The treatment of glioblastomas is extremely challenging.”

“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 August 2021, a fundraising appeal by The Brain Tumour Charity, backed by Olympic champion diver Tom Daley, raised UK£450,000 for the phase II trial in just three months.

Leeds Hospitals Charity also donated £48,000 to the appeal, which will fund access to the trial in the city for 25 patients.

Meanwhile, Jazz Pharmaceuticals has agreed to provide nabiximols and matched placebo free of charge to patients on the trial.

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. 

Chief scientific officer at The Brain Tumour Charity Dr David Jenkinson 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… could help accelerate a cure for this devastating disease.

“The early-stage findings were really promising and 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.”

Prior to launching Cannabiz, Martin was co-founder and CEO of Asia-Pac’s leading B2B media and marketing information brand Mumbrella, overseeing its sale to Diversified Communications in 2017. A journalist...

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