It was today announced that hundreds of patients with brain cancer in the UK will receive a cannabis-based treatment to their severe tumors.
The Brain Tumour Charity raised £400,000 to back the three-year study, which will supplement glioblastoma patients’ chemotherapy treatment with Sativex — an oral spray containing cannabinoids.
The University of Leeds experts will examine whether adding the drug to the mix can prolong the lives of people with cancer.
In the UK, the trial will start recruiting patients from 15 hospitals early next year.
It could be the first NHS addition for glioblastoma treatment in over a decade if it works.
Chief trial investigator Professor Susan Short is an expert in neuro-oncology at Leeds University and clinical oncology. She stated that cannabinoids are able to have “well-described” effects in the brain. The trial will test whether or not they treat aggressive forms of brain cancer.
Every year, around 2,200 individuals are diagnosed in England with glioblastoma. Even after intensive treatment, almost all glioblastomas recur and the average survival is just 12 to 18 months after diagnosis.
The trial — dubbed ARISTOCRAT — will determine whether adding Sativex to chemotherapy extends the patients’ lives, slows the progression of their disease or improves their quality of life. Sativex, which is administered by spraying into the mouth, contains THC and CBD. Image: Medical cannabis
The trial — dubbed ARISTOCRAT — will determine whether adding Sativex to chemotherapy extends the patients’ lives, slows the progression of their disease or improves their quality of life.
This will mark the beginning of a major clinical trial to test the drug for glioblastoma.
Sativex, a cannabinoid THC and CBD, is sprayed in the mouth by GW Pharma of Cambridge.
Lab studies suggest that cannabinoids could reduce the brain tumour cell growth. Clinical evidence has not been provided for their effectiveness.
In a phase 1 trial, more patients survived after one year than those who were given a placebo.
But the study — which involved 27 patients — was too small to confirm the treatment increased survival rates.
Fatigue, nausea, vomiting, and headache were the most frequent side effects reported in phase 1. Most volunteers stated that they were either mild or moderate.
Hospitals including Leeds General Infirmary, Guy’s and St Thomas’ in London and Queen Elizabeth Hospital in Birmingham will recruit participants for the trial’s second phase.
Two-thirds of the patients will receive the current standard chemotherapy treatment, called temozolomide, plus Sativex, while one third will be given temozolomide with a placebo spray.
Participants are required to apply up to 12 doses of Sativex and placebo oral sprays daily.
The follow-up appointments will take place every 4 weeks. Blood tests, MRI scans and quality questionnaires are completed every 8 weeks.
Sativex, if the trial is successful could become one of the NHS treatments for patients with glioblastoma. It will be the first NHS addition since the 2007 temozolomide chemotherapy.
Sativex, currently available in the UK, is licensed for multiple sclerosis-related muscular spasticity. This condition has not improved with any other treatment.
It is only available in limited quantities on the NHS. Sativex isn’t recommended by the National Institute for Health and Care Excellence, (NICE), because it doesn’t cost effectively.
Professor Short stated that glioblastomas treatment is still extremely difficult.
“Even with radiotherapy, surgery and chemotherapy, most brain tumours will regrow within one year. Patients have very limited options once that happens.
The brain-enhancing effects of cannabisbinoids are well known and widely used.
“Glioblastoma” brain tumors are known to contain receptors for cannabinoids. Laboratory studies of glioblastoma cell lines have demonstrated that these drugs could slow down tumour growth. They also work well with temozolomide.
“It’s exciting that we are now able to conduct a comprehensive, well-designed research that will answer the question of whether these agents might help in the treatment for the most advanced form of brain tumor.
“We have recently demonstrated that the oral combination of cannabinoid and temozolomide chemotherapy could be safe added to it. We are really excited to expand on this finding to see if we could make glioblastoma sufferers live longer with this drug in an randomized trial.”
Dr. David Jenkinson is the interim chief executive of the Brain Tumour Charity. He stated: “We know that there has been considerable interest from patients and researchers alike about the potential action of cannabinoids for treating glioblastomas.
“We’re excited that the UK’s first world-first clinical trial could accelerate the answers to these questions and are very grateful for the support of Leeds Hospitals Charity, and all those around the world who help make this happen.
The funding campaign was backed by Olympian Tom Daley, whose father died in 2011 aged 40 from a brain tumour.
It was also bolstered by a £45,000 donation from Leeds Hospitals Charity.