Stage IV Melanoma Clinical Trial
Official title:
Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma
The purpose of this research is to evaluate the safety and effectiveness of tumor cell
therapy.
This research study is evaluating if a patient-specific experimental therapy for metastatic
melanoma will lengthen survival with minimal harmful effects. It is called an experimental
therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug
Administration (FDA). This research study will use the patient's own tumor cells,the
patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony
stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that
stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a
standard treatment to help increase the number of white blood cells after chemotherapy.
The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the
growth factor. The resulting solution is called the study therapy. The intent of the study
therapy is to make the dendritic cells more effective at fighting the tumor when they are
injected back into the patient.
Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window. ;
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