Number: 201103308 Principal Investigator: Linette, Gerald
Title: Mature Dendritic Vaccination Against gp100 in Patients with Advanced Melanoma
Phase: I Disease Site: Melanoma, Skin
Participating Site(s):
Main Campus
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You may be asked to participate in this study because you have been diagnosed with metastatic melanoma. Although there are treatments that can control your disease for a period of time, there are no treatments that have been shown to cure melanoma once it has spread to distant sites in the body (such as the lung and liver). The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

This research study is designed to evaluate the effects (good and bad) of giving you a vaccine against your melanoma. The vaccine used in this study is considered investigational. It has not been approved by the U.S. Food and Drug Administration (FDA). Cyclophosphamide has been approved by the FDA for other types of cancer, but not for treatment of melanoma. It is considered investigational for this study. Cyclophosphamide is a chemotherapy (anti-cancer) drug that increases the immune response if given in a low dose.

The vaccine will be prepared at a laboratory at Washington University from your own white blood cells. These cells are called dendritic cells. Dendritic cel1s will be obtained from your blood using a process called apheresis, a process very similar to donating blood. The isolated dendritic cells will be grown in the laboratory and exposed to a protein that is present on your melanoma tumor cells. After exposure to this protein, the dendritic cells will be collected and injected back into your body. There is evidence that this process may stimulate an immune response to your disease, and possibly help fight your cancer.

About 12 people will participate in this study at Washington University.
More Information: Entry
Internal Protocol Documents (requires Siteman administrative database password)