CTNI-18. DESIGNING AND DELIVERING A RANDOMISED CONTROLLED TRIAL OF MEDICINAL CANNABINOIDS IN RECURRENT GLIOBLASTOMA - THE ARISTOCRAT TRIAL

Abstract

Abstract BACKGROUND ARISTOCRAT is a randomised, double-blind, placebo-controlled phase II trial of temozolomide chemotherapy, with or without cannabinoids (Nabixomols) in patients with MGMT-methylated recurrent GBM and has recently opened to recruitment across the UK. METHODS A multi-disciplinary team of co-applicants and trial management group (TMG) members was assembled comprising clinicians, statisticians, trialists, Patient & Public Involvement (PPI), pharmacists and quality of life (QoL) researchers to design a pragmatic phase II randomised study. The protocol randomises on a 2:1 ratio between Nabiximols or matched placebo alongside standard dose temozolomide in patients at first recurrence of IDH wild-type GBM. Patients titrate to an individualised dose based on tolerance to a maximum of 12 oro-mucosal sprays per day. The primary outcome measure is overall survival time with key secondary outcomes including survival at 6, 12 and 24 months, progression-free survival time, health-related QoL and adverse events. Intermediate assessment of feasibility to confirm safety, compliance and achievability of recruitment will be undertaken after 40 patients are randomised. PPI input has been critical in ensuring sensitive and appropriate patient & public messaging and in developing patient information videos. RESULTS ARISTOCRAT was rapidly funded via a novel crowdfunding campaign organised by The Brain Tumour Charity during the COVID-19 pandemic. The trial office has since responded to >150 patient enquiries, demonstrating the high level of patient and public enthusiasm for this trial. Coverage in the press also shows a more broad level of interest in the use of cannabis-derived medicines. The study opened to recruitment on 03-Feb-2023 and the first patient was recruited on 08-Mar-2023. The study aims to recruit a total of 234 patients over an 18 month period. CONCLUSION ARISTOCRAT will provide robust clinical data on the role of cannabinoids in improving overall survival and the impact on QoL for patients with recurrent GBM.