An oral spray containing cannabis-derived chemical extracts could be tolerated in combination with chemotherapy in patients with recurrent glioblastoma, and may in future prove to offer life-extension, the results from an early UK clinical trial suggest.
In a new phase 1b trial, researchers led by Professor Susan Short at the University of Leeds (pictured) assessed the safety and potential effectiveness of adding cannabis-based drug Sativex to temozolomide, for patients with a newly recurrent glioblastoma (GBM).
While the study observed better one-year survival in the group receiving Sativex, the researchers caution that a larger, randomised trial is needed to assess whether adding Sativex to temozolomide could offer additional life-extension. The study also showed that Sativex did not appear to interfere with temozolomide treatment.
The findings come as The Brain Tumour Charity has launched an exceptional grant round with a view to funding a phase II/III multi-centre placebo-controlled clinical trial of cannabinoids in the treatment of high-grade gliomas later this year.
Sativex – also known as nabiximols – is a complex botanical formulation containing cannabinoids THC and CBD, alongside other components. It is currently licensed and used in treating muscle stiffness and spasms in certain people with multiple sclerosis.
In the first part of the study, 6 patients received a personalised regime of Sativex of up to 12 sprays per day, alongside their temozolomide therapy – and the side-effects were recorded and reviewed.
The most common side-effects reported were fatigue, headache, vomiting and nausea, which were mostly classed as being mild-moderate in severity.
In the second part of the study, 21 patients were randomised to receive either Sativex with temozolomide (12 patients) or placebo with temozolomide (9 patients) for a total duration of 12 months.
10 out of 12 (83.3%) patients receiving Sativex were still alive after one year, compared to 4 out of 9 (44.4%) patients in the placebo arm. However, two patients in the placebo arm died within 40 days of enrolling and the researchers caution that these patients may have been predisposed to a shorter survival due to features of their tumour, which could skew the comparison with the Sativex arm.
Sarah Lindsell, CEO at The Brain Tumour Charity, said:
“These are really promising findings and we now urgently need to see a larger clinical trial to understand whether adding cannabinoids to chemotherapy could offer precious extra time to live for people living with a glioblastoma.
“With so few options available, thousands affected by a glioblastoma in the UK each year are in urgent need of new treatments, and of new hope. It’s fantastic to see that Sativex could be well-tolerated alongside temozolomide, and that this combination is showing promise in potentially improving outcomes.
“We know there is significant interest among our community about the potential activity of cannabinoids in helping relieve symptoms and as a treatment, and we need to do all we can to accelerate these answers and to drive progress.
“A cure really can’t wait – and we are really excited to be launching an exceptional grant round to fund a major clinical trial in the UK later this year to fully understand the potential of cannabinoids.
“In the meantime, and beyond, anyone affected by a glioblastoma can speak to us on 0808 800 0004 or by emailing email@example.com. If you need someone to talk to or advice on where to get help, we’re here for you.”
The study is published in the British Journal of Cancer (BJC).
In an accompanying editorial, leading UK experts argue the findings “warrant urgent exploration of the combination of temozolomide and nabiximols in a sufficiently powered larger study” alongside research to identify any biomarkers that could help predict their effectiveness for individuals.
The BJC editorial, by Dr Gary Doherty at Cambridge University Hospitals NHS Trust and Dr Bruno de Paula at the University of Cambridge, also cautions against the use of off-label nabiximols or other cannabinoid products in patients with GBM until sufficient high-quality evidence supports their use, particularly given the significant side-effect profile.
We would always recommend that any supplements, alternative or complementary treatments that you or your loved one wish to use are discussed with your/their medical team. This is because it may, for example, interact with other medications, such as anti-epileptic medicines, steroids or chemotherapy.
For further information, you can read more about cannabis-derivatives here.