ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

To join this study, you must have a specific type of brain tumour called glioblastoma, which has a particular genetic marker (MGMT methylated) and has come back after your first treatment. Your medical team must agree that this is the best time for you to start new treatment for the recurrence. You also need to have already received standard radiotherapy and at least three cycles of the chemotherapy drug Temozolomide (TMZ), and your tumour should have been stable or improved after that first treatment.

There are also some general health requirements. For example, your body needs to have recovered well from any previous treatment side effects. Your blood tests, kidney function, and liver function should be within healthy ranges. If you've had surgery for the returning tumour, the wound needs to have healed, and there must still be some tumour visible on scans.

Finally, you need to be generally well enough to take part, as measured by a score called the Karnofsky Performance Status (a score of 60 or higher). If you are taking steroid medication, your dose needs to have been stable or decreasing for at least a week before joining the study.

If you decide to take part in the ARISTOCRAT study, you would first have a screening appointment to check if you meet all the requirements. If you do, you would then be randomly assigned to either receive Nabiximols or a dummy medicine (placebo), in addition to your standard Temozolomide treatment. Neither you nor your doctor will know which one you are receiving.

Your health will be closely monitored with assessments every four weeks for at least 52 weeks (about a year), or until your death, whichever happens first. You'll have MRI scans at the beginning, then at weeks 10, 22, and 30, and every three months after that, which is similar to routine care. Throughout the study, the research team will keep an eye on how you're feeling, any side effects you might experience, and how your tumour is responding. You will have regular appointments at the hospital for these checks and to receive your study medication.