Digestive Diseases and Sciences

, Volume 52, Issue 8, pp 1964–1972

A Phase I Pilot Study of Autologous Heat Shock Protein Vaccine HSPPC-96 in Patients With Resected Pancreatic Adenocarcinoma

  • Robert G. Maki
  • Philip O. Livingston
  • Jonathan J. Lewis
  • Sylvia Janetzki
  • David Klimstra
  • Diann DeSantis
  • Pramod K. Srivastava
  • Murray F. Brennan
Original Paper

DOI: 10.1007/s10620-006-9205-2

Cite this article as:
Maki, R.G., Livingston, P.O., Lewis, J.J. et al. Dig Dis Sci (2007) 52: 1964. doi:10.1007/s10620-006-9205-2

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.

Keywords

Adjuvant therapyELISPOTGp96HSPPC-96Pancreas cancer

Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • Robert G. Maki
    • 1
  • Philip O. Livingston
    • 1
  • Jonathan J. Lewis
    • 2
  • Sylvia Janetzki
    • 2
  • David Klimstra
    • 3
  • Diann DeSantis
    • 2
  • Pramod K. Srivastava
    • 4
  • Murray F. Brennan
    • 2
  1. 1.Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.Department of SurgeryMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  3. 3.Department of PathologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Center for Immunotherapy of Cancer and Infectious DiseasesUniversity of Connecticut School of MedicineFarmingtonUSA