About the trial

ARISTOCRAT logo

The ARISTOCRAT trial is a phase II clinical trial to explore whether combining Sativex with temozolomide works better than using temozolomide alone and whether participants receiving Sativex live longer, better lives.

Find out more about the background and design of the trial, as well as how you can get involved in the trial. 

About the trial

Glioblastoma multiforme is a type of brain tumour. When it is first diagnosed, patients might be 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 patients will have had before, both with radiotherapy and then afterwards by itself.

The trial will recruit 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.

Trial design

This is a phase II, double-blind randomised trial. This means that for those who enter the trial, a computer will randomly put each participant into one of two groups, called ‘arms’. Participants in one ‘arm’ will be given the drug combination of temozolomide and Sativex. Participants in the other ‘arm’ will be given temozolomide and a placebo – a ‘dummy’ drug that is also a mouth spray and looks like Sativex but does not contain any active drug. 

Those who take part in the trial will not know which ‘arm’ they are in. Their doctor and medical team, as well as the trial team, will also not know this (this is the double blind part).

Participants will be randomised to the two arms on a 2:1 ratio, which means that there is a greater chance of receiving temozolomide with Sativex than temozolomide with placebo.

What will I need to do if I take part?

Patients will undergo screening assessments to ensure that it is appropriate and safe for them to take part. Once eligibility is confirmed, patients will be randomised to take part in the trial. Once randomised into the trial, patients will receive temozolomide with Sativex or placebo for up to a maximum of 6 cycles.

During trial treatment, patients will need to attend clinic appointments every 4 weeks whilst receiving treatment so that their progress can be assessed. After patients stop taking the trial drugs, they will continue to be followed up for up to 6 months to see how the trial affected their health.

The diagram below shows a summary of the ARISTOCRAT trial:

 ARISTOCRAT trial summary

Aims of the study

The trial aims to compare the effects of temozolomide plus a cannabis-based drug (Sativex) against temozolomide with a placebo to see if patients treated with Sativex plus temozolomide live longer.

It will also assess how patients feel on the treatment and how it affects their quality of life.

How many participants are needed?

The trial is aiming to recruit 234 patients with recurrent glioblastoma from across the UK over a period of 18 months.

Who can enter the study?

The trial will be open to any adult (aged over 16 years) with recurrent MGMT promotor methylated, IDH wild type (WT), glioblastoma (GBM), which has recurred for the first time, at least 4 months after completion of their standard treatment.

There are additional inclusion and exclusion criteria for the trial which your treating doctor should be able to discuss with you.

How to get involved

If you think you would be eligible to enter the trial, then you should first talk to your oncologist at your next hospital visit about how to be involved.

If you are not being treated at one of the primary recruitment centres and are interested in the trial, please discuss it with your consultant. You may still be able to be involved; however, you will need to be able to travel to one of the participating centres.

Please note that the staff at the ARISTOCRAT Trial Office are not able to directly recruit you onto the study.

Which hospitals are running the study?

Patients and Public Involvement

Involving members of the public in designing and running clinical trials, and related projects, is very important. Not only does it help us ensure the best interests of patients are always at the forefront of researchers’ minds, but it provides valuable insights into patients’ experiences that help to shape our research.

Our Trial Management Group benefits greatly from patient and carer representation with the involvement of Peter Buckle, an ex-carer of a glioblastoma patient. Peter is an integral part of the trial as a co-applicant. His role has included regularly attending meetings from the outset and being involved in the development of our patient information documents and consent procedures.

Similarly, there will be patient and/or (ex) carer representatives on our Trial Steering Committee to help bring a patient perspective to these meetings.

If you are a member of the public and would like to be involved in ARISTOCRAT, please get in touch with the ARISTOCRAT Trial Office.

What are cannabinoids?

Cannabinoids are the parts of cannabis that are considered to have medicinal roles. For more information about cannabinoids, please see the dedicated information page on The Brain Tumour Charity’s website.