ARISTOCRAT
Research type
Research Study
Full title
A randomised controlled phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma
IRAS ID
1004427
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-005214-34
ISRCTN Number
ISRCTN11460478
Research summary
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. 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, temozolomide, works better than temozolomide alone. Temozolomide is the chemotherapy drug that patients will have had before, both with radiotherapy and then afterwards by itself.
In a small trial already completed investigating the combination of temozolomide and Sativex, there were some interesting results suggesting that taking both drugs together were safe to give and may have an effect on the growth of brain tumours. To see if this treatment does work we need to do a much larger trial and compare the new treatment (temozolomide plus Sativex) to temozolomide (temozolomide plus placebo).
We are aiming to include 234 patients with recurrent glioblastoma to find out whether the addition of Sativex to standard temozolomide treatment improves how long patients live, delays the growth of their tumour and/or improves their quality of life.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0630
Date of REC Opinion
19 Oct 2022
REC opinion
Further Information Favourable Opinion