A major clinical trial examining the role of cannabis-based drug Sativex in treating the most aggressive brain tumors has recruited its first patients in the UK/
A pioneering research project, considered the first of its kind on the role of a cannabis-based drug in the treatment of brain tumors, is currently underway in Leeds Teaching Hospitals NHS Trust and at Christie NHS Foundation Trust in Manchester.
The ARISTOCRAT trial aims to find out if the combination of nabiximols (also known as Sativex) and chemotherapy can help prolong the lives of people with recurrent glioblastoma.
The study, led by researchers from the University of Leeds and the Clinical Trials Unit of Cancer Research UK at the University of Birmingham, aims to recruit more than 230 glioblastoma patients from 14 NHS hospitals across England, Scotland and Wales in 2023.
A fundraising campaign led by The Brain Tumor Charity in August 2021, with the backing of Olympic champion Tom Daley, raised the £450,000 needed to complete the trial.
Glioblastomas are the most aggressive form of brain cancer, with an average survival of less than 10 months after a recurrence. According The Brain Tumor Charitythere are currently very few treatment options for people whose glioblastoma has come back.
The first results are promising
In 2021, a phase I clinical trial in 27 patients showed that nabiximols could be tolerated by patients in combination with chemotherapy and had the potential to prolong the lives of people with recurrent glioblastoma
If the phase II trial proves successful, experts hope nabiximols could be a new boon for patients with glioblastoma – the first since temozolomide chemotherapy in 2007.
Dr. David Jenkinson, Scientific Director of The Brain Tumor Charity, said, “We are delighted to announce that, thanks to the support and generosity of many members of the brain tumor community, the ARISTOCRAT trial has enrolled its first patients. »
“We are very excited that this first global trial, conducted here in the UK, can help speed recovery from this devastating disease. Over the past decade, patients and researchers have shown great interest in the potential of cannabinoids in the treatment of glioblastomas. We are very grateful to everyone around the world who helped fund such an important study. »
“The first results are very promising. We are now eager to understand whether adding nabiximols to chemotherapy could help improve quality of life and prolong life for those affected by a diagnosis of glioblastoma. We hope this will be the first new drug to treat glioblastoma in over 15 years.”
A “one-of-a-kind” randomized controlled trial
Researchers will assess whether adding Sativex to current standard chemotherapy treatment (temozolomide) could provide extra life 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 the maximum dose they can tolerate if it is less than 12) of Sativex or placebo by mouth.
They will then undergo regular follow-up including clinical evaluation (every four weeks), blood tests, MRI scans (every eight weeks) and answer quality of life questionnaires.
The trial will determine whether adding Sativex to chemotherapy prolongs patients’ lifespan (overall survival), delays the progression of their disease (progression-free survival) or improves their quality of life.
Professor Susan Short, principal investigator of the trial at the University of Leeds, commented: “We are very excited to be opening this trial here in Leeds. We look forward to conducting this study which will tell us if cannabinoid-based drugs can help treat the most aggressive form of brain tumour. The treatment of glioblastomas is extremely difficult. Even with surgery, radiation and chemotherapy, almost all of these brain tumors grow back within a year. Unfortunately, there are very few options for patients when this happens. »
“Cannabinoid drugs have well-described effects on the brain and their use in different types of cancer has long been of great interest. Glioblastomas have cannabinoid receptors on the surface of their cells. Laboratory studies in glioblastoma cells have shown that these drugs can slow tumor growth and are especially effective when used with temozolomide. »
“We now have the opportunity to use these lab results and those from the Phase I trial and study whether this drug could help patients with glioblastoma live longer in this randomized clinical trial, the first of its kind. »
Exercise caution with cannabis therapies
The potential of cannabis to treat and even prevent certain types of cancer is an evolving area of research.
Cannabis products have been shown, anecdotally and in a growing number of scientific studies, to benefit patients in a variety of ways, from managing palliative pain to reducing the side effects of standard treatments. such as chemotherapy.
However, to date, there is no strong evidence for its use in the treatment of brain tumours.
As Dr. Jenkinson points out: “In the meantime, while other cannabinoid products may help relieve symptoms, there is insufficient evidence to recommend their use in the treatment of brain tumours. If you are considering using cannabinoid products or other complementary therapies, it is essential that you discuss these with your medical team first, as they may interact with other treatments such as anti-epileptic drugs or antiepileptics. steroids. »