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A Lethally Irradiated Allogeneic Granulocyte-Macrophage Colony Stimulating Factor-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation

Eric, Lutz PhD*,¶¶; Yeo, Charles J. MD**; Lillemoe, Keith D. MD††; Biedrzycki, Barbara NP*; Kobrin, Barry PhD*; Herman, Joseph MD, MSc; Sugar, Elizabeth PhD; Piantadosi, Steven MD, PhD***; Cameron, John L. MD; Solt, Sara BS*; Onners, Beth RN*; Tartakovsky, Irena MS*; Choi, Miri BS*; Sharma, Rajni PhD§; Illei, Peter B. MD§; Ralph H., Hruban MD*,§; Abrams, Ross A. MD‡‡; Le, Dung MD*; Elizabeth, Jaffee MD***,**,¶¶; Laheru, Dan MD*

doi: 10.1097/SLA.0b013e3181fd271c
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Our study tested the safety and efficacy of a granulocyte-macrophage colony-stimulating factor (GM-CSF)-based immunotherapy administered in patients with resected pancreatic adenocarcinoma. Our results demonstrate that an immunotherapy approach integrated with chemoradiation is safe and demonstrates an overall survival that compares favorably with published data for resected pancreatic cancer. These data suggest additional boost immunotherapies given at regular intervals beyond 1 year postsurgery should be tested in future studies and provide the rationale for conducting a randomized phase III study.

* The Departments of Oncology

Molecular and Radiation Sciences

Surgery

§ Pathology, at The Sidney Kimmel Comprehensive Cancer Center and The Sol Goldman Pancreatic Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland

Departments of Epidemiology and Biostatistics, The Bloomberg School of Public Health at the Johns Hopkins University, Baltimore, Maryland

** The Department of Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania

†† Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana

‡‡ The Department of Radiation Oncology, Rush University, Chicago, Illinois.

§§ The Program in Immunology

¶¶ Cell and Molecular Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

*** Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California.

Supported by: NCI K23 Award # CA093566–01A1, NCI RO1CA88058–01, NCI RAID Program, NCI SPORE Program in Gastrointestinal Cancers, the Lustgarten Foundation, the Viragh Family Foundation, and the Skip Viragh Charities.

Also supported in part by Cell Genesys, Inc and Cerus Corp.

Under a licensing agreement between Cell Genesys and the Johns Hopkins University, the University is entitled to milestone payments and royalties on sales of the vaccine product described in this manuscript. Funding for some of the studies described was provided by Cerus (now Anza) Corporation. Under a licensing agreement involving mesothelin, between Anza and the Johns Hopkins University, Drs. Jaffee and Hruban are entitled to a share of royalties received by the University. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.

Trial Registration Clinicaltrials.gov identifier: NCT00084383.

Reprints: Dan Laheru, MD, Department of Oncology, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, The Sol Goldman Pancreatic Cancer Research Center, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Bunting-Blaustein Cancer Research Building, Room G89, 1650 Orleans St., Baltimore, MD 21231. Email: laherda@jhmi.edu.

Copyright © 2011 Wolters Kluwer Health, Inc. All rights reserved.