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A trial looking at Sativex with temozolomide for glioblastoma multiforme brain tumour (GWCA1208)

This trial is looking at Sativex with temozolomide (Temodal) for a type of brain tumour called glioblastoma multiforme. It is for people whose tumour has come back after treatment.  

Doctors can treat glioblastoma multiforme with surgery followed by radiotherapy or chemotherapy. Unfortunately the tumour may start to grow again. In this case, they may use chemotherapy. One chemotherapy drug doctors use is temozolomide. This helps but they are always looking for ways to improve treatment.

In this trial, researchers are looking at a drug called Sativex. The main active ingredients of Sativex are tetrahydrocannabinol (THC) and cannabidiol (CBD). Both of these molecules come from the cannabis (marijuana) plant.

The researchers think that Sativex with temozolomide may work better than temozolomide only for glioblastoma multiforme that has come back.

The aims of this trial are to find out

  • About the side effects of Sativex when you have it at the same time as temozolomide
  • How well Sativex with temozolomide works

Recruitment

Start 25/09/2013
End 30/09/2014

Phase

Phase 1

Who can enter

You may be able to enter this trial if

  • You have grade 4 glioblastoma multiforme
  • Your tumour started to grow again after having surgery, radiotherapy and temozolomide
  • You can take care of yourself but may need help from time to time (Karnosfky performance scale 60 and above)
  • You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • You had a lower grade brain tumour that changed into glioblastoma multiforme
  • Your tumour has spread to another part of your body
  • You are already having treatment for your glioma that has come back
  • You had chemotherapy in the past month
  • You had surgery in the past 2 weeks
  • You haven’t fully recovered from any earlier surgery
  • You had chemotherapy, apart from temozolomide, as your first course of treatment (first line treatment)
  • You had another cancer in the past 3 years, apart from some types of cancer diagnosed at an early stage, and there is a low risk of the cancer coming back
  • You have cancer in the tissue covering the brain
  • You have had stereotactic radiotherapy to your brain
  • You have had chemotherapy to your brain through a fine tube (a catheter) into your brain
  • You have used cannabis, or medication containing the active ingredient of cannabis, in the past month and aren’t willing to stop using it during the trial
  • Your doctor thinks you may have a problem with alcohol or drugs
  • You or a close family member have had schizophrenia, or any other serious mental illness
  • You have had a heart attack in the past year, or any other serious heart problem
  • You still have any serious side effects from previous treatment
  • You have had an experimental drug as part of another clinical trial in  the past month
  • You are very sensitive to the drugs, or their ingredients, used in this trial
  • You have another medical condition that could affect you taking part in this trial
  • You are pregnant, planning to start a family during the trial or in the 3 months afterwards
  • You plan to travel outside the UK during the study

While taking part in this trial you will not be able to donate blood.

Trial design

This is an international phase 1 trial. It will recruit 26 people. The trial is in 2 parts.

In the first part of the trial everybody will have Sativex and temozolomide. This part is called an open label trial because both the people taking part and their doctor know what they are having.

To begin with 3 people will have Sativex and temozolomide. After 7 weeks of treatment, the doctors will look at the side effects reported by these 3 people. If they think it is safe and are happy to continue, another 3 people will be recruited. When the 2nd group have had 7 weeks of treatment, the doctors will look at the side effects reported by both groups. If the doctors are happy, all 6 people will continue as part of the open label trial. The doctors will then start recruiting new people to the 2nd part of the trial.

The 2nd part of this trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

  • People in group 1 will have Sativex and temozolomide
  • People in group 2 will have a dummy drug (placebo) and temozolomide

GWCA1208 trial diagram

Temozolomide comes in capsules. You swallow them whole with a glass of water. You take them on an empty stomach, for example an hour before or after meals.

You have Sativex, or the dummy drug, as a mouth spray. Your doctor will tell you how to use it.

You continue treatment for a year if the side effects aren’t too bad. You can carry on having both drugs for a year. But you can choose to stop Sativex or temozolomide if the side effects are too bad. You may be able to continue taking temozolomide for longer than a year if your doctor thinks it is helping you.

The researchers will ask for some blood samples. They will use these to check that you are healthy and also to look for a substance (biomarker) that may show how well Sativex is working.

They will also ask for a sample of your cancer that was removed when you had surgery. If you don’t want to give this sample for research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the trial team before taking Sativex for the first time in this trial. This is to check that you are suitable for the trial, by having tests. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG)
  • MRI scan (if needed)

The trial doctor will ask you questions about your health and any medication that you are taking.

If everything is ok you will return after about 2 weeks. You then see the doctor after 3 weeks of treatment to check everything is ok. After this visit you see the doctor every 2 weeks for 2 months and then every month for 10 months.

At the end of the trial, you will stop taking Sativex, or the dummy drug. After a month a member of the trial team will contact you by phone to see how you are.

The doctor will talk to you about your options to carry on taking temozolomide when you are close to the end of the trial.

Side effects

There may be some side effects of Sativex that we don’t know about yet. The most common known side effects include

  • Feeling dizzy
  • Tiredness
  • Feeling sick

We have information about temozolomide.  

Your doctor will talk to you about the possible side effects of the medications before you agree to take part in this trial.

Location of trial

  • Leeds
  • Manchester
  • Wirral

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Susan Short

Supported by

Experimental Cancer Medicine Centre (ECMC)
GW Pharma
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Updated: 24 March 2014