A clinical trial adding Sativex (a cannabis-based medicine) to standard treatment, temozolomide, to find out if it is beneficial for patients whose glioblastoma brain tumour has returned after treatment
Glioblastoma is an aggressive type of brain tumour. Initial treatment usually involves surgery, radiotherapy, and chemotherapy with a drug called temozolomide. Although this often keeps the tumour under control for a time, it usually begins to grow again after several months. When this happens, further treatment options are very limited. The ARISTOCRAT study is a UK-wide phase II clinical trial exploring whether adding Sativex—a mouth spray made from cannabis—to standard temozolomide tablets can help. An earlier, smaller trial suggested the combination is safe and might slow tumour growth. In this larger study, half of the participants will receive temozolomide alongside Sativex, while the other half will receive temozolomide with a dummy spray (placebo). Researchers want to find out whether Sativex helps people live longer, slows tumour regrowth, and supports their overall quality of life.
At a glance
What is this study about?
Glioblastoma multiforme is a fast-growing brain tumour. When first diagnosed, patients are usually treated with surgery, radiotherapy, and a chemotherapy drug called temozolomide. While this initial treatment can shrink or pause the tumour's growth, glioblastoma almost always returns after several months. Finding effective ways to treat the tumour once it comes back is a major challenge for doctors and families.
The ARISTOCRAT trial is investigating a new treatment combination for recurrent glioblastoma. It is testing whether adding Sativex—an approved cannabis-based mouth spray—to standard temozolomide tablets works better than chemotherapy on its own. Early laboratory work and a small initial trial showed encouraging signs that cannabinoids might work alongside temozolomide to slow the growth of brain tumour cells safely.
Because scientists need clearer proof before this combination can become standard practice, a larger trial is needed. Half the participants will receive temozolomide plus Sativex, and the other half will receive temozolomide plus a dummy spray called a placebo. Neither you nor your doctor will know which spray you are receiving, ensuring the results are fair and reliable.
The main aim of the study is to see if Sativex delays tumour growth, extends survival, and helps people feel better. Even if the trial does not provide a personal cure, every piece of information gathered will help doctors improve care for people facing recurrent glioblastoma in the future.
Key takeaways
- ARISTOCRAT tests whether adding Sativex (a cannabis mouth spray) to standard chemotherapy helps treat recurrent glioblastoma.
- The trial is open to people aged 16 and over whose brain tumour has returned after standard therapy.
- Participants are randomly assigned to receive either Sativex or a placebo spray alongside their chemotherapy tablets.
- The study looks at tumour control, survival time, and overall quality of life.
- The study is funded by The Brain Tumour Charity and coordinated by the University of Birmingham.
Who may be eligible?
This trial is for people aged 16 and older who have been diagnosed with glioblastoma that has started to grow back after previous treatment. To take part, you must have already completed standard treatment, which includes radiotherapy and at least three rounds of temozolomide chemotherapy. It must also be at least three months since your last chemotherapy cycle ended.
Your medical team will look at tests from your earlier tumour biopsy to make sure your tumour has specific genetic markers suitable for this study (known as MGMT methylated and IDH wild-type). You will also need to be reasonably independent in your daily activities and have blood tests showing that your liver, kidneys, and bone marrow are working well enough to safely handle the treatment.
If you have had further surgery for your recurring tumour, your surgical wound must be fully healed before you can join. You cannot take part if you are using other cannabis-based products, and both men and women must use reliable contraception, as these treatments could harm an unborn baby.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 16 or older.
- I have been diagnosed with glioblastoma that has started to grow again after previous treatment.
- I finished my initial radiotherapy and chemotherapy at least three months ago.
- I am well enough to carry out most of my daily self-care activities.
- I am willing to stop using any other cannabis or CBD products.
- I am willing to use reliable contraception during the trial and for at least six months afterwards.
What does participation involve?
If you join the trial, you will take standard temozolomide chemotherapy tablets and use a mouth spray (either Sativex or a dummy placebo spray). You will attend regular hospital clinic appointments for check-ups, where doctors will monitor how you are feeling and check for any side effects. You will have routine blood tests to ensure the treatment remains safe, as well as urine tests to check for other cannabinoid use. You will also have periodic MRI brain scans to see how your tumour is responding, and you will be asked to complete short questionnaires about your health and quality of life. The study runs over several months, with patient check-ups continuing until the trial finishes in 2027.
Potential risks and benefits
Locations (17)
- Addenbrooke's HospitalUnverifiedCambridge, England
- Bristol Haematology & Oncology CentreUnverifiedBristol, England
- Charing Cross HospitalUnverifiedLondon, England
- Nottingham City HospitalUnverifiedNottingham, England
- Clatterbridge Cancer CentreUnverifiedWirral, England
- Guy's HospitalUnverifiedLondon, England
- Queen Elizabeth HospitalUnverifiedBirmingham, England
- St James University HospitalUnverifiedLeeds, England
- The ChristieUnverifiedManchester, England
- Velindre Cancer CentreUnverifiedCardiff, Wales
- Churchill HospitalUnverifiedOxford, England
- Mount Vernon Cancer CentreUnverifiedNorthwood, England
Common questions
Will I definitely receive the cannabis-based medicine?
No. A computer will randomly decide whether you receive Sativex or a dummy spray (placebo). You have a 50% chance of receiving Sativex, and neither you nor your doctor will know which one you have.
Can I use over-the-counter CBD oils or cannabis products during the study?
No. You must not use any other cannabis or CBD products while taking part, as this could interfere with the study results. Routine urine tests will be used to monitor this.
Can I drive while taking part in this trial?
No. People with a recurring glioblastoma are not legally permitted to drive in the UK. In addition, trial medicines can cause tiredness and dizziness that affect your reaction times.
Is Sativex the same as smoking or taking illegal cannabis?
No. Sativex is a carefully measured, pharmaceutical-grade mouth spray containing specific cannabis extracts. It is produced under strict medical standards and taken as a prescribed medicine.
What happens if I decide I want to leave the study?
You are free to leave the trial at any point, for any reason. Deciding to leave will not affect the quality of your care or your relationship with your medical team.
How to find out more
Rhys Mant
Always speak to your GP or specialist before deciding to take part in a study.
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