Clinical trial yields positive results

A metastatic melanoma clinical trial involving people whose disease had spread to their brain, has yielded positive results. The early stage trial, which involved 10 people, has been testing an experimental drug called GSK2118436.

According to researchers, the drug has shown promise as a way of shrinking melanoma tumours in the brain. In fact, 9 of the 10 study participants experienced shrinkage of their brain metastases. The overall reductions ranged from 20 to 100% of brain metastases.

It's possible the drug might have a positive impact on melanoma outside the brain, too.

The findings of the study were presented at the 35th Congress of the European Society for Medical Oncology by Dr Georgina Long from Melanoma Institute Australia and Westmead Hospital.

The results are potentially significant. This is because the chances of metastatic melanoma reaching the brain are high. In fact, 15 to 20% of people first diagnosed with the disease already have it in their brain. At death, tumours are to be found in the brain of 75% of patients.

What’s more, the median overall survival time for those with metastatic melanoma to the brain is 16 weeks from diagnosis of brain involvement. Unfortunately, no life extending treatments are currently available.

The test drug is being seen as a potential treatment for people who have a particular common mutation of the gene for a protein called BRAF. BRAF is mutated in half of human melanomas. The drug binds to the activated form of the BRAF protein in the melanoma cell. This stops the cell proliferating. In some cases it also causes it to die.

The clinical trial team will present more information about the study drug at the meeting of the Society for Melanoma Research. The meeting is being held in Sydney in November 2010.

Meanwhile, the team hopes to launch a Phase II study of the drug in people with V600 BRAF mutant metastatic melanoma involving the brain. It’s possible this clinical trial could start in November or December 2010.