Number: 201104229 Principal Investigator: Hawkins, William
Title: A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute-Pancreas (algenpantucel-L) Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer
Phase: III Disease Site: Pancreas
Participating Site(s):
Main Campus
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You have been diagnosed with cancer of the pancreas. Different treatments or combinations of treatments including surgery, chemotherapy, and radiation therapy may be used to treat pancreatic cancer. Because of the potential for continued growth of your pancreatic cancer, you may wish to consider the investigational immunotherapy offered in this clinical study. An investigational immunotherapy is one that is not approved for use by the U.S. Food and Drug Administration (FDA). The purpose of this study is to compare the effects (good and/or bad) of giving subjects with pancreatic cancer the HyperAcute® Pancreas immunotherapy (investigational) along with chemotherapy alone or in combination with chemoradiation (standard of care) to find out which treatment is better. The study immunotherapy drug is made of two (2) genetically engineered (altered in a laboratory) human pancreatic cancer cell types.

The immunotherapy (HyperAcute®-Pancreas) we will be testing in this study is designed to help your immune system learn how to attack your tumor. To do this we have taken human pancreatic cancer cells that can grow outside the body (isolated many years ago from another patient) and modified them so that they can be easily recognized as not belonging in your body--this change makes it easy for your body to recognize them as a threat that needs to be eliminated. In the process of destroying these "foreign" modified cells, the immune system can learn to recognize many characteristics, including signs of danger and disease, present in the modified cells. This cancer vaccine will program your immune system to attack cancer cells. Some of these characteristic signs of danger are thought to be shared by both the modified cells (HyperAcute®-Pancreas immunotherapy) and your pancreatic tumor cells. When your immune system learns to recognize these new signs of danger in the modified immunotherapy cells, they can also attack your pancreatic cancer cells just as they attack the modified immunotherapy cells.

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