
"He went through six operations and was placed on a clinical trial so he could try new treatments.”
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 .
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:
The aims of the trial are to find out:
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.
Who can’t take part
Cancer related
You cannot join this trial if any of these apply.
Medical conditions
You cannot join this trial if any of these apply.
Other
You cannot join this trial if any of these apply.
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 ).
Your doctor will be able to find out which group you are in if this becomes necessary.
The 2 groups are:
Every 2 out of 3 people who join will go into the temozolomide and Sativex group.
You have treatment in cycles. Each 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:
The questions ask about:
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.
You see the doctor for tests before taking part. These tests include:
You see the doctor regularly while having treatment. This is:
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:
Your doctor will then tell you how often and when they want to see you after this.
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Susan Short
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
"He went through six operations and was placed on a clinical trial so he could try new treatments.”