A phase III study of chemotherapy and chemoradiotherapy with or without hyperacute- pancreatic vaccine in subjects with surgically resected pancreatic cancer
ID Number 10-0967Principal Investigator(s)
Daniel M. Labow
Department(s) or Division(s)
The purpose of this study is to compare the effects, of standard of care therapy (gemcitabine alone or with chemoradiation) with or without the addition of HyperAcute®-Pancreatic Cancer Vaccine to find out which treatment is better.
You may qualify for participation in this study because you have been diagnosed with cancer of the pancreas. Different treatments or combination 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) vaccine offered in this clinical study. An investigational vaccine is one that is not approved for use by the U.S. Food and Drug Administration (FDA). The purpose of this study is to determine the efficacy of giving subjects with pancreatic cancer the HyperAcute®-Pancreatic Cancer Vaccine (experimental) along with chemotherapy and chemoradiation (standard).
The study vaccine is made of two (2) genetically engineered human pancreatic cancer cell types. A gene, the genetic message for a protein from a mouse has been removed and placed into human pancreatic cancer cell types that can be grown in the laboratory. The mouse gene that is put into the pancreatic cancer cells carries a protein called α(1,3)galactosyltransferase, or alpha-gal (agal) for short. These human pancreatic cancer cells are then exposed to radiation to prevent them from growing. The cells do not become radioactive as a result of this treatment. The irradiated pancreatic cancer cells with the mouse gene will then be injected under your skin. The way we put the mouse gene into the human pancreatic cancer cells is to use an artificially made virus to carry the genes into the cells. For example, if you want to send a letter you need an envelope to put it in before it is sent. The envelope in this case is a specific type of virus that can grow in mice, called a retrovirus. Before it was changed, this virus could cause tumors in the mice. It has now been inactivated, so that it cannot grow and make new viruses, but it can be made to carry new genes. We inserted the mouse gene (letter) into the artificial virus (envelope) and the virus carries (delivers) the gene into the pancreatic cancer cells that will be given to you as a vaccine, by injection into your skin.
You may be aware, that many people with failing organs must wait a long time for donated organs for transplant. A major reason that organs from other large animals such as sheep, pigs or cattle cannot be substituted for human organs is that these animals express alpha-gal galactose in their cells. This protein (enzyme) attaches a type of naturally occurring sugar called galactose in certain patterns on many other proteins of cells in animals that express alpha-gal. These patterns of sugar-proteins are not found in humans or apes because our cells do not have the gene that makes the alpha-gal. Because this is different from our own sugar-proteins, the human body rapidly (within minutes to hours) rejects cells or tissues that express alpha-gal. This phenomenon is called “hyperacute rejection”. In this clinical study we will look at the antitumor effects of chemotherapy, radiation and the HyperAcute-Pancreatic vaccine.
Recruiting Patients: Yes