Cancer charities and the NHS are preparing to investigate whether a cannabis-based oral spray can treat brain tumors and help patients live longer.
Doctors across the UK will give patients with a recurring brain tumor called glioblastoma the drug known as Sativex along with a chemotherapy drug – temozolomide – in a clinical trial to kill cancer cells.
It will be the first such study anywhere in the world.
Glioblastoma is an aggressive and difficult-to-treat form of brain tumor that almost always comes back, although doctors use surgery, radiation, and chemotherapy to control it. The diagnosed patients only live 12 to 18 months, while those with recurrent glioblastoma only survive 10 months.
Around 2,200 people in England are diagnosed with the disease each year, making it the most common type of brain tumor.
Sativex is already being given to patients with multiple sclerosis whose condition has not improved despite treatment to reduce their spasticity. It is one of three cannabis-based medicines currently used in the NHS.
“We believe that Sativex can kill glioblastoma tumor cells and that it can be particularly effective when given with temozolomide chemotherapy for clinical oncology and neuro-oncology at Leeds University, who is the lead researcher on the study. “We want to test that in the study,” she says.
The Brain Tumor Charity, which is funding the study, will be recruiting 232 patients from at least 15 hospitals, including specialized cancer centers, across the UK early next year. Two-thirds get Sativex and temozolomide, while the other third get the chemotherapy drug and a placebo.
Sativex contains equal amounts of two cannabinoids: the psychoactive substance delta-9-tetrahydrocannabinol (THC), which gives users a “high”, and cannabidiol (CBD), which can help relieve pain, inflammation and anxiety without any psychoactive effects to evoke.
“We hope that this study could pave the way for a long-awaited new lifeline that could provide glioblastoma patients with valuable additional months to live and remember with loved ones,” said Dr. David Jenkinson, the interim head of the Brain Tumor Charity.
“We know there is a lot of interest in our community in the potential activity of cannabinoids in the treatment of glioblastoma, and we are thrilled that this world’s first study here in the UK could help accelerate those responses.”
The study follows on from an earlier study – a Phase 1 study – solely concerned with the safety of co-administration of Sativex and temozolomide, in which 27 patients participated. The new three-year study, dubbed the Aristocrat Study, will examine both the safety of this regimen and its effects on patient outcome, including survival.
“The recent early-stage results have been really encouraging and we now look forward to understanding whether adding Sativex to chemotherapy could extend life and improve the quality of life, which would be a huge step forward in our ability to treat this devastating disease,” added added Jenkinson.
Short said the first study suggested the drug might give some people extra lives. A year later, more participants who received Sativex were still alive than those who received a placebo.
“This combination was shown to be safe, although some patients had problems with side effects such as nausea, tiredness and dizziness.
“The study wasn’t designed to test whether Sativex was better for survival. But it did indicate that some patients who received Sativex were better than expected and better than those who received chemotherapy alone, ”she said.
The Brain Tumor Charity plans to move the study forward, but stressed that it would depend on the results of an appeal to cover the £ 450,000 associated cost. It suspended its usual program of research grants after losing 25% of its revenue during the Covid-19 pandemic.
The new study is coordinated by the Clinical Trials Division of Cancer Research UK at the University of Birmingham. “It is critical that such studies be conducted to examine the role of cannabis or the chemicals it contains in treating cancer,” said Prof. Pam Kearns, director of the department.