Evidence map›Paper›PMID 19636017›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Safety and immunological efficacy of a DNA vaccine encoding prostatic acid phosphatase in patients with stage D0 prostate cancer.

Douglas G McNeel, Edward J Dunphy, James G Davies, Thomas P Frye, Laura E Johnson, Mary Jane Staab, Dorothea L Horvath, Jane Straus, Dona Alberti, Rebecca Marnocha and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 145 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 1 synthesis or guideline pooled it, 248 citations in OpenAlex.

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85 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 2 countries.

Douglas G McNeelUniversity of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Department of Biostatistics, University of Wisconsin, Madison, WI, USA. dm3@medicine.wisc.edu
Edward J Dunphy
James G Davies
Thomas P Frye
Laura E Johnson
Mary Jane Staab
Dorothea L Horvath
Jane Straus
Dona Alberti
Rebecca Marnocha
Glenn Liu
Jens C Eickhoff
George Wilding
Wisconsin Institutes for Discovery · USUniversity of Wisconsin–Madison · USSpanish Oncology Genitourinary Group · ES

Funding

INSTITUTIONAL CTSA (UW-MADISON): CLINICAL TRIALSUL1RR025011 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$29.5M
A Phase 1 Study/DNA-Based Vaccine vs Prostatic Acid PaseK23RR016489 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI MCNEEL, DOUGLAS G · 2002 to 2006
$709k
NCRR NIH HHS 1UL1RR025011NCRR NIH HHS K23 RR016489NCRR NIH HHS K23 RR16489NCRR NIH HHS UL1 RR025011
6 · The paper itself

Abstract

purposeProstatic acid phosphatase (PAP) is a prostate tumor antigen. We have previously demonstrated that a DNA vaccine encoding PAP can elicit antigen-specific CD8+ T cells in rodents. We report here the results of a phase I/IIa trial conducted with a DNA vaccine encoding human PAP in patients with stage D0 prostate cancer. PATIENTS AND

methodsTwenty-two patients were treated in a dose-escalation trial with 100 microg, 500 microg, or 1,500 microg plasmid DNA, coadministered intradermally with 200 microg granulocyte-macrophage colony-stimulating factor as a vaccine adjuvant, six times at 14-day intervals. All patients were observed for 1 year after treatment.

resultsNo significant adverse events were observed. Three (14%) of 22 patients developed PAP-specific IFN gamma-secreting CD8+ T-cells immediately after the treatment course, as determined by enzyme-linked immunospot. Nine (41%) of 22 patients developed PAP-specific CD4+ and/or CD8+ T-cell proliferation. Antibody responses to PAP were not detected. Overall, the prostate-specific antigen (PSA) doubling time was observed to increase from a median 6.5 months pretreatment to 8.5 months on-treatment (P = .033), and 9.3 months in the 1-year post-treatment period (P = .054).

conclusionThe demonstration that a DNA vaccine encoding PAP is safe, elicits an antigen-specific T-cell response, and may be associated with an increased PSA doubling time suggests that a multi-institutional phase II trial designed to evaluate clinical efficacy is warranted.

Indexed as

Acid PhosphataseAdenocarcinomaAdjuvants, ImmunologicAdultAgedCancer VaccinesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunotherapyInjections, IntradermalInterferon-gammaMaleMaximum Tolerated DoseMiddle AgedAcid PhosphataseAdjuvants, ImmunologicCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorInterferon-gammaProstate-Specific Antigenprostatic acid phosphataseProtein Tyrosine PhosphatasesRecombinant ProteinssargramostimVaccines, DNA

Identifiers

PMID19636017
PMCPMC2734418
OpenAlexW2121290865

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.