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.

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.

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:

 

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.

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

When cancer comes back after treatment, doctors call it recurrence or recurrent cancer. Only patients with recurrent disease are eligible for the ARISTOCRAT trial. For more information, please visit the Cancer Research UK website on why some cancers come back.

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.

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 trial.

The following hospitals are now open for recruitment to take part in the trial:

St James's University Hospital, Leeds

The Christie, Manchester

Velindre Cancer Centre, Cardiff

Clatterbridge Cancer Centre, Liverpool

Charing Cross Hospital, London

City Hospital, Nottingham

Mount Vernon, Middlesex

Churchill Hospital, Oxford

The following hospitals are planning to open in the future:

Queen Elizabeth Hospital, Birmingham

Bristol Haematology & Oncology Centre, Bristol

Addenbrooke’s Hospital, Cambridge

Western General Hospital, Edinburgh

Beatson West of Scotland Cancer Centre, Glasgow

Guy’s and St Thomas’, London

Southampton General Hospital, Southampton

If your local hospital is not listed here, please speak to your doctor who may be able to refer you to a participating hospital if you both feel this is suitable for you.

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 (TMG) benefits greatly from patient and carer representation. Peter Buckle was a carer to his wife Wendy before her death from a brain tumour in 2011 and has been 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 and consent procedures. Peter is a committed national patient advocate and recently contributed to a blog article about shared decision-making focussing on quality of life for patients with glioblastoma.

Once the trial opened we also welcomed Laura Smallbone to the TMG; Laura sadly lost her husband Peter to a brain tumour in 2022, you can read more about her story here. 

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.

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.