Phase I Study to the Immunotherapy of Metastatic Malignant Melanoma by a Cancer Vaccine Consisting of Autologous Cancer Cells Transfected with the Human IL-2 Gene. University of Vienna, Austria

Abstract

The direct modification of tumor cells using cytokine genes as a strategy to enhance host immunity against cancer has been studied extensively in animal models. Results obtained showed that mice injected with IL-2-transfected cancer cells mount a tumor-specific immune response that is sufficient in magnitude to protect the animals against a challenge with a tumorigenic dose of wild-type parental cancer cells. Currently, trials are ongoing to determine the feasibility of such a treatment in patients with renal cell carcinoma, colon carcinoma and melanoma. We now propose a cancer vaccine trial for stage IV melanoma patients with no hope for cure by either chemotherapy, surgery or irradiation. The vaccine consists of irradiated, autologous melanoma cells which had been genetically engineered by means of receptor-mediated, adenovirus-augmented gene delivery (transferrinfection) to produce human IL-2. Patients receive repeated injections of two different doses of the vaccine and will be monitored for the occurrence of any adverse reactions to it. In addition, we will determine whether the administration of the vaccine induces and/or enhances tumor-specific host responses at the immunological and/or clinical level.