Evidence map›Paper›PMID 19890632›Full record

Trial reportCancer immunology, immunotherapy : CII2010

Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer.

James L Gulley, Philip M Arlen, Ravi A Madan, Kwong-Yok Tsang, Mary P Pazdur, Lisa Skarupa, Jacquin L Jones, Diane J Poole, Jack P Higgins, James W Hodge and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00060528 (A Phase I/II Pilot Study of Sequential Vaccinations With rFowlpox-PSA), which is not on this map. Cited by 175 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 2 pooled it
10.9field-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.

NCT00060528 phase1 / phase2completednot on this map

A Phase I/II Pilot Study of Sequential Vaccinations With rFowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) Alone, or in Combination With rVaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), and the Role of GM-CSF, in Men With Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2003 to 2009Enrolled32ConditionsProstatic NeoplasmsArmsRecombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM), Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), Recombinant Human GM-CSF
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 2 syntheses or guidelines pooled it, 297 citations in OpenAlex.

  1. Pooled it
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  5. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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  10. Humoral response to a viral glycan correlates with survival on PROSTVAC-VF.Proceedings of the National Academy of Sciences of the United States of America · 2014
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  18. A viral vaccine encoding prostate-specific antigen induces antigen spreading to a common set of self-proteins in prostate cancer patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
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115 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 5 institutions in 1 country.

James L GulleyLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.
Philip M Arlen
Ravi A Madan
Kwong-Yok Tsang
Mary P Pazdur
Lisa Skarupa
Jacquin L Jones
Diane J Poole
Jack P Higgins
James W Hodge
Vittore Cereda
Matteo Vergati
Seth M Steinberg
Susan Halabi
Elizabeth Jones
Clara Chen
Howard Parnes
John J Wright
William L Dahut
Jeffrey Schlom
Center for Cancer Research · USNational Institutes of Health · USNational Cancer Institute · USNational Institutes of Health Clinical Center · USDuke University · US

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
Vaccine and Drug Combination Therapy for Human CancersZIABC010661 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HODGE, JAMES · 2009 to 2025
$11.2M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
Identification of human tumor-associated antigensZIABC010972 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$6.0M
Vaccine Clinical TrialsZ01BC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2005 to 2008
$1.7M
Cancer Therapy Trials using novel vaccine platformsZIABC011280 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MADAN, RAVI · 2010 to 2013
$343k
Intramural NIH HHS Z01 BC010666
6 · The paper itself

Abstract

A concurrent multicenter, randomized Phase II trial employing a recombinant poxviral vaccine provided evidence of enhanced median overall survival (OS) (p = 0.0061) in patients with metastatic castrate-resistant prostate cancer (mCRPC). The study reported here employed the identical vaccine in mCRPC to investigate the influence of GM-CSF with vaccine, and the influence of immunologic and prognostic factors on median OS. Thirty-two patients were vaccinated once with recombinant vaccinia containing the transgenes for prostate-specific antigen (PSA) and three costimulatory molecules. Patients received boosters with recombinant fowlpox containing the same four transgenes. Twelve of 32 patients showed declines in serum PSA post-vaccination and 2/12 showed decreases in index lesions. Median OS was 26.6 months (predicted median OS by the Halabi nomogram was 17.4 months). Patients with greater PSA-specific T-cell responses showed a trend (p = 0.055) toward enhanced survival. There was no difference in T-cell responses or survival in cohorts of patients receiving GM-CSF versus no GM-CSF. Patients with a Halabi predicted survival of <18 months (median predicted 12.3 months) had an actual median OS of 14.6 months, while those with a Halabi predicted survival of > or =18 months (median predicted survival 20.9 months) will meet or exceed 37.3 months, with 12/15 patients living longer than predicted (p = 0.035). Treg suppressive function was shown to decrease following vaccine in patients surviving longer than predicted, and increase in patients surviving less than predicted. This hypothesis-generating study provides evidence that patients with more indolent mCRPC (Halabi predicted survival > or =18 months) may best benefit from vaccine therapy.

Indexed as

AgedAndrogen AntagonistsAntigens, NeoplasmAntineoplastic AgentsCancer VaccinesDocetaxelGranulocyte-Macrophage Colony-Stimulating FactorHumansKaplan-Meier EstimateMalePoxviridaePrognosisProstate-Specific AntigenProstatic NeoplasmsTaxoidsTransgenesAndrogen AntagonistsAntigens, NeoplasmAntineoplastic AgentsCancer VaccinesDocetaxelGranulocyte-Macrophage Colony-Stimulating FactorProstate-Specific AntigenTaxoids

Identifiers

PMID19890632
PMCPMC2832083
OpenAlexW2114156781

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.