Title: A phase I/II study of immunotherapy of melanoma with dendritic cells pulsed with melanoma peptides or tumour lysates.

Lay Summary: The purpose of this study is to determine whether injection of components of melanoma cells (peptides) on specialized immune cells, called dendritic cells, will increase immune responses to melanoma and be an effective treatment for melanoma.

Many patients with melanoma have immune responses against their tumour. This can be shown in the laboratory by mixing white blood cells (lymphocytes) with the melanoma cells and observing that the lymphocytes kill the melanoma cells. The structures recognised on melanoma by the lymphocytes are peptides. The peptides can be synthesised in a laboratory and can be readily purified. They can also be isolated from your melanoma cells.

Dendritic cells are specialised cells that allow peptides to induce immune responses by lymphocytes against melanoma. They capture and present the peptides to other immune cells of the body, killer T cells, which then attack the cancer cells. They are found in almost every type of tissue, including the lymphatics, blood and skin. The most important function of a dendritic cell is its ability to present a tumour peptide to the immune system and invoke a killer T cell response.

We are now able to create a vaccine by culturing dendritic cells taken from a blood sample and adding to them either an extract of your own tumour or a mixture of selected protein fragments synthesized in the laboratory.

A course of 7 vaccines will be injected over a 14-week programme. In some patients a drug called Interleukin-2 will be self-administered. The injection is in the superficial layer of your skin. If the treatment appears to be having an effect on the tumour, the vaccine may be repeated for a further 14 weeks or until the tumour disappears or until the tumour starts to increase in size again.

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