A trial looking at Sativex for people with glioblastoma (ARISTOCRAT)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply.

• You have glioblastoma where the cells and tissue are the same and of a certain type and also has certain gene characteristics. Your doctor will know about this.
• You have glioblastoma that has come back for the first time after treatment and have further treatment planned. You might be able to join if your glioblastoma has come back a second time and you only had surgery to remove it. You can talk to your doctor about this.
• You have had first line treatment  that was the standard treatment  of radiotherapy and temozolomide.
• You have not had temozolomide for at least the past 4 months.
• You can mostly care for yourself but may need help from time to time (Karnofsky performance score 60 and above).
• You have satisfactory blood test results.
• You have recovered from previous treatment. Minor side effects are acceptable.
• If you are taking steroids, you must be on a stable or decreasing dose.
• You are able to start treatment within 28 days of being put into a treatment group (randomisation ).
• You are willing to use reliable contraception during treatment and for 6 months after completing treatment if you or your partner could become pregnant.
• You are at least 16 years old.

Who can’t take part

Cancer related
You cannot join this trial if any of these apply.

• You have glioblastoma that has particular characteristics such as certain gene changes (mutations ) or the type of brain tumour is not only glioblastoma. Your doctor will know about this.
• You have had stereotactic radiotherapy  or brachytherapy . Or have had a device where a drug such as chemotherapy is delivered directly to the tumour in the brain (convection-enhanced delivery).
• You have already had treatment for the first time your tumour came back. This is apart from surgery to remove as much of the tumour as possible (de bulking ).
• You have another cancer apart from non melanoma skin cancer . You might be able to join if you have had another cancer before as long as there has been no sign of it for at least a year.
• You are taking part in another clinical trial looking at treatment. You might be able to take part if the treatment part of the other trial is finished and you are in the follow up part. 
• You had an allergic reaction or very bad side effects when you took temozolomide before.

Medical conditions
You cannot join this trial if any of these apply.

• You have or had a mental health problem such as schizophrenia, severe personality disorder or any other significant mental illness due to your glioblastoma. This is apart from depression.
• You are using or recently used cannabis or cannabinoid medication within 30 days of starting trial treatment. You also must be willing to stop using them during the trial.
• You are not able to have an MRI scan  or you are not able to have the contrast medium  called gadolinium.
• You are not able to have galactose, lactose or your body can’t absorb glucose or galactose. You can ask your doctor about this.
• You have hepatitis B, cytomegalovirus (CMV) or an infection because you have an immune system  that isn’t working very well.
• You have mouth problems that may prevent you from using the medication such as ulcers.
• You have any other medical condition, mental health problem or social situation that could affect you taking part.

Other
You cannot join this trial if any of these apply.

• You have or had a dependence on alcohol or drugs.
• You are allergic or very sensitive to the trial treatments or any of their ingredients.
• You have a live vaccine  within 28 days before being randomised. The COVID-19 vaccines are not live vaccines.
• You are pregnant or breastfeeding.