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

Cancer type:

Brain (and spinal cord) tumours

Status:

Open

Phase:

Phase 2

This trial is looking at whether having a drug called Sativex with temozolomide works better than temozolomide on its own for glioblastoma.

It is open to people with glioblastoma that has come back after first line treatment Open a glossary item.

More about this trial

Doctors can treat glioblastoma with surgery followed by radiotherapy and or chemotherapy. This can stop the glioblastoma from getting worse or slow down the growth for a while. Unfortunately, a few months after treatment, the tumour can start to grow again.

Researchers are looking for treatments to help people in this situation. In this trial they are looking at a drug called Sativex.

Sativex is a mouth spray that contains cannabinoids. Doctors already use Sativex to treat people with the nervous system condition multiple sclerosis. It is not used to treat people with cancer.

Temozolomide is one of the chemotherapy drugs doctors use to treat glioblastoma.

Researchers think that Sativex in combination with temozolomide could help people whose glioblastoma has started to grow again after treatment.

In this trial they are comparing:

  • temozolomide and a dummy drug (placebo Open a glossary item) with
  • temozolomide and Sativex

The aims of the trial are to find out:

  • how well the combination of Sativex and temozolomide works
  • the side effects of this combination
  • how it affects quality of life Open a glossary item

Who can enter

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 Open a glossary item that was the standard treatment Open a glossary item 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 Open a glossary item).
  • 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 Open a glossary item) or the type of brain tumour is not only glioblastoma. Your doctor will know about this.
  • You have had stereotactic radiotherapy Open a glossary item or brachytherapy Open a glossary item. 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 Open a glossary item).
  • You have another cancer apart from non melanoma skin cancer Open a glossary item. 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 Open a glossary item 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 Open a glossary item or you are not able to have the contrast medium Open a glossary item 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 Open a glossary item 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 Open a glossary item within 28 days before being randomised. The COVID-19 vaccines are not live vaccines.
  • You are pregnant or breastfeeding.

Trial design

This is a phase 2 trial. The trial team aim to have 234 people in the trial.

It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you go into. And neither you nor your doctor will know which group you are in (a double blind trial Open a glossary item).

Your doctor will be able to find out which group you are in if this becomes necessary.

The 2 groups are:

  • temozolomide and Sativex
  • temozolomide and a dummy drug (placebo Open a glossary item)

Every 2 out of 3 people who join will go into the temozolomide and Sativex group.

You have treatment in cycles. Each treatment cycle Open a glossary item is 4 weeks.

Temozolomide
Temozolomide are capsules. You take the capsules once a day every day for the first 5 days of each treatment cycle. You take the capsules on an empty stomach for example an hour before a meal or 2 hours after a meal. Your doctor will tell you how many capsules to take.

Sativex and dummy drug
Sativex and the dummy drug come as a mouth spray. Your doctor or nurse will show you how to use the mouth spray.

You use the mouth spray every day of the treatment cycle. You start by using 1 spray. You increase the number of sprays until you find the best dose for you. The best dose is one that works well and has the least side effects. The maximum dose you can take is 12 sprays a day.

Your doctor or nurse will tell you how and when you increase the number of sprays.

You have up to 6 cycles of treatment as long as it is helping and the side effects aren’t too bad.

Quality of life
You fill in questionnaires:

  • when you start treatment
  • twice during treatment
  • at the end of treatment

The questions ask about:

  • your general health and wellbeing
  • side effects

These are quality of life questionnaires.

Diary
You have a diary to write down when you take your capsules and use the spray. You can also use the diary to write down any side effects.

You must bring this diary with you to all your hospital appointments.

Hospital visits

You see the doctor for tests before taking part. These tests include:

  • a physical examination Open a glossary item
  • blood tests
  • heart trace (ECG)
  • MRI scan

You see the doctor regularly while having treatment. This is:

  • for blood tests
  • to see how you are
  • to ask about any side effects
  • to ask about any other medication you are taking

You have MRI scans as part of your standard care. You will also have a urine test at the start of cycle 3.

At the end of treatment you see the doctor for:

  • a physical examination
  • blood tests
  • urine test

Your doctor will then tell you how often and when they want to see you after this.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
 
The most common side effects of Sativex are dizziness and tiredness. Dizziness occurs most often in the first few weeks of starting Sativex. Your doctor will assess the dizziness if it happens.

You should not have alcohol while using Sativex as this may increase the risk of falls and other accidents.

We have information about temozolomide and its side effects.

Your doctor will talk to you about the possible side effects of the treatments before you agree to take part and answer any questions you have.

Location

Birmingham
Bristol
Cardiff
Hull
Leeds
London
Manchester
Northwood
Nottingham
Oxford
Plymouth
Wirral

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Susan Short

Supported by

The Brain Tumour Charity
GW Pharma/Jazz Pharmaceuticals (provide Sativex and placebo free of charge)
Cancer Research UK Clinical Trials Unit (CRCTU) Birmingham
University of Birmingham
University of Leeds

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18081

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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