A trial looking at vandetanib and radiotherapy for melanoma that has spread to the brain (RADVAN)

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.

• 9 people had radiotherapy to the brain and vandetanib (1 person was randomised to this group but did not have treatment)
• 7 people had radiotherapy to the brain and a dummy drug (placebo ). 1 person was randomised to this group but did not have treatment. 

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

• The cancer started to grow again
• Severe side effects  

Everyone else had treatment as planned. They had 10 doses (fractions ) 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

• Many people were not fit enough to take part in the trial
• There were other treatment options available 

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

• Just over 3 months for those who had vandetanib and radiotherapy
• 2 ½ months for those who had placebo tablets and radiotherapy

The researchers also looked at how long people lived for. On average it was

• Just over 4 ½ months for those who had vandetanib and radiotherapy
• 2 ½ months for those who had placebo tablets and radiotherapy

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 statistically significant ).

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

• Tiredness (fatigue)
• Confusion
• Hair loss

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 (peer reviewed ) 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.