A phase I pilot study of autologous heat shock protein vaccine HSPPC-96 in patients with resected pancreatic adenocarcinoma Journal Article
| Authors: | Maki, R. G.; Livingston, P. O.; Lewis, J. J.; Janetzki, S.; Klimstra, D.; Desantis, D.; Srivastava, P. K.; Brennan, M. F. |
| Article Title: | 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 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. © 2006 Springer Science+Business Media, Inc. |
| Keywords: | adult; controlled study; human tissue; treatment outcome; aged; middle aged; unclassified drug; human cell; overall survival; clinical trial; drug tolerability; fatigue; side effect; adjuvant therapy; pancreas cancer; pancreatic neoplasms; outcome assessment; follow up; adenocarcinoma; t lymphocyte; t-lymphocytes; controlled clinical trial; gastrointestinal symptom; abdominal pain; fever; injection site reaction; pruritus; drug induced headache; immune tolerance; correlation analysis; immune response; cancer vaccine; cancer vaccines; pilot projects; vaccination; peripheral edema; pancreas adenocarcinoma; skin disease; phase 1 clinical trial; kaplan meier method; enzyme linked immunospot assay; flatulence; neurologic disease; liquid nitrogen; subcutaneous nodule; sweating; injection site swelling; heat-shock proteins; freezing; glycoprotein gp 96; gp96; injection site burning; elispot; oncophage; hsppc-96; heat shock protein vaccine; immunization schedule |
| Journal Title: | Digestive Diseases and Sciences |
| Volume: | 52 |
| Issue: | 8 |
| ISSN: | 0163-2116 |
| Publisher: | Springer |
| Date Published: | 2007-08-01 |
| Start Page: | 1964 |
| End Page: | 1972 |
| Language: | English |
| DOI: | 10.1007/s10620-006-9205-2 |
| PUBMED: | 17420942 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 16" - "Export Date: 17 November 2011" - "CODEN: DDSCD" - "Source: Scopus" |
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