Hundreds of cancer patients at 15 UK hospitals will be given Sativex, an oral spray containing cannabinoids, along with chemotherapy to treat their aggressive brain tumours, as part of a world first trial.
Laboratory studies have suggested that these cannabinoids may reduce brain tumour cell growth and could disrupt the blood supply to tumours. But clinical evidence of their effect has so far been limited.
A phase one trial earlier this year found more patients were alive after one year compared with the group, which received a placebo treatment. But the study — which involved 27 patients — was too small to confirm the treatment increased survival rates.
The Brain Tumour Charity raised £400,000 to back the three-year study , reports the Daily Mail.
Experts at the University of Leeds will look at whether the addition of the drug extends life for people diagnosed with the cancer. The trial will begin recruiting 230 patients across the UK early next year. If it works, it could become the first addition to NHS treatment for glioblastoma in more than a decade.
Professor Susan Short, chief trial investigator and an expert in clinical oncology and neuro-oncology at Leeds University, said cannabinoids have “well-described effects” in the brain and the trial will determine whether they help treat the most common and aggressive form of brain cancer.
Around 2,200 people are diagnosed with glioblastoma every year in England. 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.
It will be the first major trial in the world to use the drug to treat glioblastoma.
Sativex, made by Cambridge-based GW Pharma, is sprayed into the mouth and contains cannabinoids THC and CBD.
The most common side-effects reported during the phase one study were fatigue, headache, vomiting and nausea, which most volunteers said were mild or moderate.
Hospitals including Leeds General Infirmary, Guyʼs and St Thomas in London and Queen Elizabeth Hospital in Birmingham will recruit participants for the trial's second phase, adds the Daily Mail.
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 will be asked to administer up to 12 sprays per day of Sativex or placebo oral sprays.
They will have a follow-up appointment every four weeks, blood tests and MRI scans every eight weeks and complete regular quality of life questionnaires.
If the study is successful, Sativex could be one of the first additions to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.
Sativex is currently licensed in the UK for people suffering from multiple sclerosis-related muscle spasticity, which hasn’t improved with other treatments.
Short said: “The treatment of glioblastomas remains extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours regrow within a year, and unfortunately there are very few options for patients once this occurs.
“Cannabinoids 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. Glioblastoma brain tumours have been shown to 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.
“It’s exciting that we’re at the point where we can run a definitive, well-designed study that will tell us whether these agents could help treat the most aggressive form of brain tumour. Having recently shown that a specific cannabinoid combination given by oral spray could be safely added to temozolomide chemotherapy, we’re excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomised trial.”
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