A phase I pilot study of autologous heat shock protein vaccine HSPPC-96 in patients with resected pancreatic adenocarcinoma.

Abstract	We performed a phase I pilot study to determine if autologous vaccine HSPPC-96 (gp96, Oncophage) could be purified from completely resected pancreas adenocarcinomas, to determine patient tolerance of vaccine and to explore immune responses and clinical outcomes of these patients. Subjects were vaccinated with 5 microg of autologous HSPPC-96 weekly for 4 doses. Serial ELISPOT assays of T cells for antitumor reactivity were performed. Subjects received neither adjuvant chemotherapy nor radiation. Ten patients received a full course of vaccinations. No dose-limiting toxicities were encountered. Immediate freezing in liquid nitrogen of the tumor specimen resulted in improved vaccine yield. Median overall survival is 2.2 years (Kaplan-Meier estimate). Autologous anti-HSPPC-96 ELISPOT reactivity increased significantly in 1 of 5 patients examined and a second had an increase of unclear significance. Three of 10 treated patients are alive without disease at 2.6, 2.7, and 5.0 years follow-up. There was no observed correlation between immune response and prognosis. This study demonstrates the feasibility of preparing HSPPC-96 from pancreatic adenocarcinomas. Examination of this novel approach using multiple dose levels is 1 approach to further investigate the immunogenicity and clinical utility of HSPPC-96 vaccination in this setting.
Authors	Robert G Maki, Philip O Livingston, Jonathan J Lewis, Sylvia Janetzki, David Klimstra, Diann Desantis, Pramod K Srivastava, Murray F Brennan
Journal	Digestive diseases and sciences (Dig Dis Sci) Vol. 52 Issue 8 Pg. 1964-72 (Aug 2007) ISSN: 0163-2116 [Print] United States
PMID	17420942 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References	Cancer Vaccines Heat-Shock Proteins vitespin
Topics	Adenocarcinoma (mortality, surgery, therapy) Aged Cancer Vaccines (therapeutic use, toxicity) Female Heat-Shock Proteins (therapeutic use, toxicity) Humans Immune Tolerance Immunization Schedule Male Middle Aged Pancreatic Neoplasms (surgery, therapy) Pilot Projects T-Lymphocytes (immunology) Treatment Outcome

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