A phase III study of FOLFIRINOX with or without HyperAcute®-Pancreas (algenpantucel-l) Immunotherapy in subjects with borderline resectable or locally advanced unresectable pancreatic cancer
ID Number 13-1705Principal Investigator(s)
Daniel M Labow
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (either a chemotherapy regimen called FOLFIRINOX or gemcitabine/nab-paclitaxel) with or without the addition of algenpantucel-L immunotherapy to find out which treatment is better. You may qualify to take part in this research study because you have been diagnosed with cancer of the pancreas that is either borderline surgically removable (may or may not be completely successful) or cannot be surgically removed at this time. 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 (experimental) immunotherapy offered in this clinical study. An investigational immunotherapy is one that is not licensed for use by the U.S. Food and Drug Administration (FDA). The purpose of this study is to determine the efficacy and safety of giving subjects with pancreatic cancer the algenpantucel-L immunotherapy (experimental) along with chemotherapy (standard). The study immunotherapy drug is made of two (2) genetically engineered human pancreatic cancer cell types.
The immunotherapy (algenpantucel-L) 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.
Recruiting Patients: Yes