REO13 Melanoma GMCSF
Research type
Research Study
Full title
A clinical study to evaluate the biological effects of intravenous wild-type reovirus (REOLYSIN®), with or without GM-CSF, in advanced melanoma
IRAS ID
180684
Contact name
Christy Ralph
Contact email
Sponsor organisation
University of Leeds
Eudract number
2015-001606-34
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We have a research interest in using viruses to target cancer cells. We have given several of these oncolytic (“cancer killing”) viruses safely to patients in clinical trials. Reovirus, which is found in the environment and can cause mild symptoms such as cough, colds or diarrhoea, is one of these viruses. Reovirus has been shown to target, infect and selectively kill cancer cells. Most side effects were mild and short-lived and there was evidence that the virus can reach and target bowel and brain cancer cells. In some patients in previous studies, reovirus has been shown to stabilise tumours for a period of time.
This is a small single-centre study in patients with the skin cancer melanoma that has spread. Treatment options in this situation are often palliative and sometimes toxic. We plan to investigate whether reovirus, given via a drip, can reach melanoma if given shortly before planned surgery for metastatic spread. Some patients will also be given an immune modulating drug Granulocyte-macrophage colony-stimulating factor (GM-CSF) to investigate whether this improves the anti-cancer effects of the virus. Study treatment will be completed within three weeks. Blood samples will be taken to look for the virus and immune effects. After surgery the melanoma will be examined to see whether it was effectively targeted by reovirus. If this study is positive it will support future development of reovirus as a potential treatment option for patients with melanoma; if it is negative we would hope to learn why and so understand how we might modify this approach for future patient benefit.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0316
Date of REC Opinion
11 Sep 2015
REC opinion
Further Information Favourable Opinion