Published in:
01-08-2007 | Original Paper
A Phase I Pilot Study of Autologous Heat Shock Protein Vaccine HSPPC-96 in Patients With Resected Pancreatic Adenocarcinoma
Authors:
Robert G. Maki, Philip O. Livingston, Jonathan J. Lewis, Sylvia Janetzki, David Klimstra, Diann DeSantis, Pramod K. Srivastava, Murray F. Brennan
Published in:
Digestive Diseases and Sciences
|
Issue 8/2007
Login to get access
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 μg 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.