This a phase I/II clinical research study to determine if the human immune system can be educated by vaccination to recognize the danger that cancer poses to the body and then be stimulated to attack the cancer and protect from the cancer returning.  A vaccine normally contains antigens (unique proteins from a disease organism) and an adjuvant (an immune stimulant which promotes development of immunity against the antigens). This study creates a vaccine within the body.  Tumor tissue is killed by extreme cold (cryoablation) which provides the antigen source and the intratumoral injection of the experimental drug, AlloStim™, is injected into the dead tumor is used as an adjuvant.

Scientists believe that since, unlike an invading bacteria, the cancer derives from self tissues, that the immune system is not aware of the danger the cancer poses to the body.  The immune system has built-in regulatory systems which protect self tissues from immune attack to prevent autoimmune disease.  It is believed that cancer is able to harness these regulatory systems to prevent destruction by the immune system.  Therefore, this study uses lessons learned from autoimmune disease to develop a strategy to overcome the ability of cancer to evade immune attack.  It is believed that autoimmune disease occurs when normal tissue is killed pathologically in the presence of inflammation, which signals danger to the immune system.  In this protocol tumor is killed pathologically by freezing and the inflammation is created by injecting AlloStim™ cells.