Phase I Clinical Trial of an Adenovirus/Prostate-Specific Antigen Vaccine for Prostate Cancer: Safety and Immunologic Results

David M LUBAROFF; Badrinath R KONETY; Richard D WILLIAMS; Brian LINK; Jack GERSTBREIN; Tammy MADSEN; Mary SHANNON; Jeanne HOWARD; Jennifer PAISLEY; Diana BOEGLIN; Timothy L RATLIFF

doi:10.1158/1078-0432.CCR-09-1910

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Phase I Clinical Trial of an Adenovirus/Prostate-Specific Antigen Vaccine for Prostate Cancer: Safety and Immunologic Results

Journal article

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Peer reviewed

Phase I Clinical Trial of an Adenovirus/Prostate-Specific Antigen Vaccine for Prostate Cancer: Safety and Immunologic Results

David M LUBAROFF, Badrinath R KONETY, Richard D WILLIAMS, Brian LINK, Jack GERSTBREIN, Tammy MADSEN, Mary SHANNON, Jeanne HOWARD, Jennifer PAISLEY, Diana BOEGLIN, …

Clinical cancer research, Vol.15(23), pp.7375-7380

2009

DOI: 10.1158/1078-0432.CCR-09-1910

PMID: 19920098

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Abstract

Purpose: We performed a phase I clinical trial of adenovirus/prostate-specific antigen (PSA) vaccine in men with measurable metastatic hormone-refractory disease. Experimental design: Men with measurable metastatic disease received one vaccine injection. Toxicity, immune responses, changes in PSA doubling times, and patient survival were assessed. Thirty-two patients with hormone-refractory metastatic prostate cancer were treated with a single s.c. vaccine injection at one of three dose levels, either as an aqueous solution or suspended in a Gelfoam matrix. All patients returned for physical and clinical chemistry examinations at regular intervals up to 12 months after injections. Results: The vaccine was deemed safe at all doses in both administration forms. There were no serious vaccine-related adverse events; the most prevalent were localized erythema/ecchymoses and cold/flu-like symptoms. Anti-PSA antibodies were produced by 34% of patients and anti-PSA T-cell responses were produced by 68%. PSA doubling time was increased in 48%, whereas 55% survived longer than predicted by the Halabi nomogram. Conclusions: The adenovirus/PSA vaccine was proven safe with no serious vaccine-related adverse events. The majority of vaccinated patients produced anti-PSA T-cell responses and over half survived longer than predicted by nomogram. Although the latter data are only derived from a small number of patients in this phase I trial, they are encouraging enough to pursue further studies.

Antineoplastic Agents

Tumors

Tumors of the urinary system

Urinary tract. Prostate gland

Gynecology. Andrology. Obstetrics

Pharmacology. Drug treatments

Nephrology. Urinary tract diseases

Biological and medical sciences

Medical sciences

Male genital diseases

Details

Title: Subtitle: Phase I Clinical Trial of an Adenovirus/Prostate-Specific Antigen Vaccine for Prostate Cancer: Safety and Immunologic Results
Creators: David M LUBAROFF - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Badrinath R KONETY - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Richard D WILLIAMS - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Brian LINK - Department of Internal Medicine, University of Iowa, Iowa City, Iowa, United States
Jack GERSTBREIN - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Tammy MADSEN - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Mary SHANNON - Department of Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, United States
Jeanne HOWARD - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Jennifer PAISLEY - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Diana BOEGLIN - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Timothy L RATLIFF - Department of Urology, University of Iowa, Iowa City, Iowa, United States
Resource Type: Journal article
Publication Details: Clinical cancer research, Vol.15(23), pp.7375-7380
DOI: 10.1158/1078-0432.CCR-09-1910
PMID: 19920098
NLM abbreviation: Clin Cancer Res
ISSN: 1078-0432
eISSN: 1557-3265
Publisher: American Association for Cancer Research
Language: English
Date published: 2009
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Urology; Internal Medicine
Record Identifier: 9984094396102771

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