A phase II trial is being planned to test the cannabis-derived drug Sativex, in patients with aggressive brain tumors.
The trial is set to take place in 15 hospitals in the UK, and will be coordinated by the Cancer Research UK Clinical Trials Unit and researchers at the University of Leeds, in northern England .
The Brain Tumour Charity, also UK based, is fund-raising to cover the trial’s estimated costs, which are £450,00 ($627,000).
Sativex, made by GW Pharma, is a cannabis drug that comes in the form of an oral spray, containing the cannabinoids THC and CBD. The intention is to use Sativex in conjunction with chemotherapy in patients who have recurrence of a glioblastoma brain tumor following initial treatment.
According to chief investigator Dr Susan Short, glioblastomas that are initially successfully treated nearly always regrow within a year, and there are few treatment options once this happens. However glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surfaces, which has intrigued researchers and offered some hope that cannabis-based drugs may offer a more positive prognosis for brain tumor patients.
“Laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide,” Dr Short explained.
A previous Phase I study of Sativex in 27 patients found that more patients were alive after one year on the drug versus placebo arm, but the trial was too small to show any significant difference in survival.
By comparison the new Phase II trial will involve ten times as many patients. It will begin early 2022, subject to the funding target being met.