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

Cancer type:

Brain (and spinal cord) tumours

Status:

Results

Phase:

Phase 1

This trial looked at nabiximols (Sativex) with temozolomide (Temodal) for a type of brain tumour called glioblastoma. It was for people whose cancer had come back after treatment.

This trial was open for people to join between 2013 and 2015. The team published the results in 2021.

More about this trial

Glioblastoma is a type of brain tumour. Doctors often treat glioblastoma with surgery followed by radiotherapy or chemotherapy. After treatment the tumour may start to grow again. When this happens, treatment might include chemotherapy such as temozolomide.

In this trial, researchers wanted to find out more about using Sativex to treat glioblastomas. Sativex is a cannabis based medicine. The main active ingredients are tetrahydrocannabinol (THC) and cannabidiol (CBD).

The researchers hoped that Sativex with temozolomide may work better than temozolomide alone, for glioblastoma that has come back.

The main aims of this trial were to find out:

the side effects of having Sativex and temozolomide at the same time
how well Sativex with temozolomide works

Summary of results

This trial showed that Sativex didn’t cause too many side effects. And it may be a useful treatment for glioblastoma that has come back after other treatment.

Trial design
This trial was for people with glioblastoma that had started to grow again after other treatment.

The trial had two parts.

The people in part 1 all had temozolomide capsules and Sativex mouth spray.

The people in part 2 were put into a treatment group at random. Some had temozolomide capsules and Sativex mouth spray. Others had temozolomide capsules and a dummy (placebo) mouth spray.

Results
A total of 27 people joined this trial in total.

The 6 people in part 1 all had temozolomide and Sativex.

The 21 people in part 2 were put into a treatment group at random:

12 had temozolomide and Sativex
9 had temozolomide and a dummy drug (placebo)

A total of 18 people had both temozolomide and Sativex.

Side effects
Most people who had temozolomide and Sativex had a least 1 side effect. Many of these were mild or didn’t last long. A few people had more severe side effects.

The most common side effects were:

being sick
dizziness
extreme tiredness (fatigue)
feeling sick
headache

The research team also looked at whether having Sativex affected how temozolomide was handled in the body. They found it didn’t have any effect on this.

We have information about the side effects of temozolomide in our Cancer drugs section.

How well treatment worked
First, they looked at how many people’s brain tumour had not grown, 6 months after joining the trial. They found it was:

1 out of 6 people in part 1 (17%)
4 out of 12 people in part 2 who had Sativex (33%)
3 out of 9 people in part 2 who had the placebo (33%)

Then they looked at how many people were living, 1 year after joining the trial. They found it was:

3 out of 6 people in part 1 (50%)
10 out of 12 people in part 2 who had Sativex (83%)
4 out of 9 people in part 2 who had the placebo (44%)

These results show that more people who had Sativex were living, a year after joining the trial. But the number of people in each group is small, so it’s hard to draw any firm conclusions.

Conclusion
The trial team concluded that Sativex didn’t cause too many side effects when given with temozolomide. They also said that it could be a useful treatment for glioblastoma that has come back after treatment.

They suggest larger trials are done to find out more about how well it works as a treatment.

More detailed information
There is more information about this research in the reference below.

Please note, the article we link to here is not in plain English. It has been written for health care professionals and researchers.

A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma
C Twelves and others
Br J Cancer, 2021. Volume 124, issue 8, pages 1379 to 1387.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.