Prostate SPORE Project 4

A Randomized Phase II Clinical Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With or Without Autologous Myeloid Dendritic Cells to Patients Suffering From Androgen Independent Prostate Carcinoma

Principal Investigator: Stanimir Vuk-Pavlovic, Ph.D.

The specific aims of this study are:

• To conduct a two-arm randomized phase II clinical trial of the allogeneic prostate cancer whole-cell vaccine administered alone or in combination with autologous mature DCs and evaluate the clinical endpoints of overall survival, cause-specific survival, progression free survival and PSA-based responses in patients with hormone refractory non-metastatic prostate cancer. From the enrolled patients' sera, we will quantify the levels of human kallikrein-2 (hK2) and pro-hK2 for a preliminary determination of their role as survival predictors in the hormone refractory prostate cancer patients vaccinated as described.
• To identify and characterize the type, extent, and duration of the immune response in patients treated by allogeneic prostate cancer whole-cell vaccine alone or in combination with autologous mature DCs.
• To transduce dendritic cells with the IL-2 gene and test the effects on expansion of tumor-specific T cells and suppression of T-regulatory cells in vitro.

To execute the clinical trial, we are collaborating with the vaccine manufacturer Onyvax Ltd, Tooting, England. The proposed clinical trial is technically, medically and ethically feasible. It is based on technologies and clinical-grade products that have been approved and tested for human use or are amenable to rapid approval. These cellular products are minimally toxic, particularly in comparison to systemic cytotoxic agents. Our combined resources, expertise, past experience and operating infrastructure provide a unique environment to continue pushing the limits of immunotherapy of prostate cancer.