In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation

This is a Phase I/II clinical study to investigate the feasibility of creating a personalized anti-tumor vaccine within the body of patients with advanced cancers. The aim of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine protocol that has three separate phases. Cancer patients generally present with an immune response to cancer biased to a Th2 response, while a Th1 response is considered necessary for mediating anti-tumor immunity. The first step of the study consists of three (3) weekly intradermal priming doses of AlloStim. The aim of this step is to create Th1 immunity to the alloantigens in AlloStim, thus increasing the number of Th1 cells in circulation. The second step of the protocol involves the cryoablation of a selected tumor lesion followed by an intratumoral AlloStimTM injection. The aim of this step is to generate tumor-specific CTL killer cells in the circulation. The final step is an intravenous infusion of AlloStim. The aim of this step is to activate circulating Th1 cells, killer cells, and natural killer cells The further aim of this step is to create an inflammatory environment that can break-down the ability of the tumor to avoid an anti-tumor immune response.