A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma

What this Trial Is About

Researchers are evaluating the cannabinoid Nabiximols (Sativex®) added to the standard chemotherapy temozolomide (TMZ) in patients with recurrent MGMT methylated glioblastoma (GBM). This phase II, multi-center, double-blind, placebo-controlled, randomized trial aims to compare Nabiximols with a matched placebo alongside TMZ treatment. The study is linked with the Tessa Jowell BRAIN MATRIX program to streamline patient entry and data sharing while providing additional oversight. Participants will be randomly assigned in a 2:1 ratio to receive either Nabiximols or placebo, both combined with temozolomide. Temozolomide is given orally once daily on days 1-5 of each 28-day cycle, starting at 150mg/m2 in cycle 1 and increasing to 200mg/m2 in subsequent cycles, for up to six cycles. Nabiximols or placebo sprays are self-titrated up to 12 sprays per day over the first 14 days of cycle 1, continuing for up to six cycles. Patients will attend 4-weekly follow-up visits for at least 52 weeks or until death. MRI scans are scheduled at screening, weeks 10, 22, 30, and then every three months after starting treatment. Researchers will monitor overall survival, progression-free survival, health-related quality of life, and adverse events. The initial 40 patients will be evaluated for safety, compliance, and recruitment feasibility before continuing the trial. Total participation may last up to a year or more depending on individual outcomes.

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids