Phase I clinical trial of an adenovirus/prostate-specific antigen vaccine for prostate cancer: Safety and immunologic results

David M. Lubaroff, Badrinath R. Konety, Brian Link, Jack Gerstbrein, Tammy Madsen, Mary Shannon, Jeanne Howard, Jennifer Paisley, Diana Boeglin, Timothy L. Ratliff, Richard D. Williams

Research output: Contribution to journalArticlepeer-review

71 Scopus citations

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 patientsin thisphas e I trial, they are encouraging enough to pursue further studies.

Original languageEnglish (US)
Pages (from-to)7375-7380
Number of pages6
JournalClinical Cancer Research
Volume15
Issue number23
DOIs
StatePublished - Dec 1 2009

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