A significant clinical trial examining the use of a cannabis-derived medication against one of the deadliest forms of brain cancer has launched in the United Kingdom.
Backed by The Brain Tumour Charity, the study will assess whether nabiximols (sold under the brand name Sativex), when given alongside chemotherapy, can prolong survival for patients with recurrent glioblastoma.
The three-year phase II study, named Aristocrat, is headed by Professor Susan Short from the University of Leeds School of Medicine and administered by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.
The trial aims to enrol more than 230 glioblastoma patients across 14 National Health Service (NHS) hospitals in England, Scotland and Wales in 2023. Glioblastoma is the most aggressive form of brain cancer, with patients surviving an average of fewer than 10 months following recurrence.
In 2021, a phase I study involving 27 patients demonstrated that nabiximols was well-tolerated when administered alongside chemotherapy and showed potential for extending survival in those with recurrent glioblastoma.
If the current phase of the trial delivers positive results, there is hope that nabiximols could become a new treatment option within the NHS for glioblastoma patients, used in combination with 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.
"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."
A fundraising campaign launched by The Brain Tumour Charity in August 2021, supported by Olympic champion diver Tom Daley, gathered UK£450,000 for the phase II trial over just three months.
Leeds Hospitals Charity contributed a further £48,000 to the campaign, which will cover trial access for 25 patients in the city.
Jazz Pharmaceuticals has committed to supplying nabiximols and a matched placebo at no cost to trial participants.
Participants will apply nabiximols or a placebo spray themselves and attend scheduled check-ins with the research team, which will include 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."
