
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
The trial was looking at vandetanib and radiotherapy for melanoma that had spread to the brain. It was for people who were unable to have surgery to remove the melanoma in their brain.
Doctors can treat melanoma that has spread to the brain with radiotherapy to the whole brain (whole brain radiotherapy). Earlier research had shown that vandetanib can make cancer cells more sensitive to radiotherapy. Doctors wanted to find out if using vandetanib with radiotherapy could improve treatment for melanoma that has spread to the brain.
Vandetanib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.
The aims of this trial were to find out
The researchers were not able to produce any firm results because they were not able to get enough people to take part in the trial.
This was a phase 2 trial. 6 people took part in the first part of the trial to confirm that the dose of vandetanib was safe to have with radiotherapy.
The second part was randomised. 18 people took part. The people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor their doctor chose which group they were in. And they did not know which group they were in. This is called a double blind trial.
2 people from the vandetanib group, and 5 people from the placebo group (7 in total) were unable to complete the full course of treatment. The reasons for not completing treatment included
Everyone else had treatment as planned. They had 10 doses () of radiotherapy to the brain and took the vandetanib or placebo every day for a total of 21 days. They started taking the drugs 4 days before they started the radiotherapy.
The trial closed after 1 year because of the low numbers of people able to take part. The researchers originally wanted 86 people to take part. But they found it difficult because
In the people who took part, the researchers looked at the time it took for the cancer to start growing again in the brain.
On average this was
The researchers also looked at how long people lived for. On average it was
People who had vandetanib and radiotherapy had a slightly longer time until their cancer in the brain started to grow again. And they did live for slightly longer than the group having the placebo. But the researchers did not think the difference between the groups was significant (not ).
They also pointed out that, because there were a small number of people in the trial, it was not possible to make any firm conclusions.
The most common side effects reported in both groups were
Finding suitable people to join this trial was difficult. The researchers concluded that this problem should be considered when planning future trials.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
Cancer Research UK
AstraZeneca
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Oxford
This is Cancer Research UK trial number CRUKE/11/017.
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”