ARISTOCRAT: A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma

Glioblastoma multiforme is a type of brain tumour. When it is first diagnosed, patients are usually treated with surgery and then a combination of radiotherapy and chemotherapy with temozolomide (TMZ). Unfortunately, although this often slows or stops the disease from growing for a period of time, in most cases, usually a few months after the end of the original treatment, the tumour starts to grow again. This can be detected by an MRI scan. When this happens patients may experience new symptoms or a repeat of previous symptoms.

There are few treatments available that work well at this stage to slow the growth of the tumour. Therefore, we need to develop new and better treatments to make patients live longer and feel better.

The ARISTOCRAT trial is investigating whether adding a second drug (Sativex, a cannabinoid or cannabis-based medicine) to the drug already used, TMZ, works better than TMZ alone. TMZ is the chemotherapy drug that you had before, both with radiotherapy and then afterwards by itself.

We are aiming to include 234 patients with recurrent glioblastoma to find out whether the addition of Sativex to standard TMZ treatment improves how long patients live, delays the growth of their tumour and/or improves their quality of life.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Overview and Summary

Chief Investigator: Professor Susan Short
Sponsor: University of Birmingham
Funders: The Brain Tumour Charity
Disease Site: Glioblastoma
Trial Type: Clinical Trial of an Investigational Medicinal Product
Status: Design
EudraCT Number: 2021-005214-34
IRAS Number: 1004427
Anticipated Recruitment start date: 01 March 2022
Anticipated Recruitment end date: 01 September 2023
CRCTU Trial Management Team: Early Drug Development Team
Trial E-mail Address: