Evidence map›Paper›PMID 18698048›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Safety and immunologic response of a viral vaccine to prostate-specific antigen in combination with radiation therapy when metronomic-dose interleukin 2 is used as an adjuvant.

Robert J Lechleider, Philip M Arlen, Kwong-Yok Tsang, Seth M Steinberg, Junko Yokokawa, Vittore Cereda, Kevin Camphausen, Jeffrey Schlom, William L Dahut, James L Gulley

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00005916 (A Randomized Phase II Study of a PSA-Based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
7.4field-weighted citation impact, top 2% 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.

NCT00005916 phase2completednot on this map

A Randomized Phase II Study of a PSA-Based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2000 to 2005Enrolled48ConditionsProstate Cancer, Prostate NeoplasmArmsrV-PSA, rF-PSA, rV-B7.1
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it, 106 citations in OpenAlex.

  1. Pooled it
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  6. 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
    Trial
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  8. Review
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  19. Prostate cancer vaccines: the long road to clinical application.Cancer immunology, immunotherapy : CII · 2015
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Robert J LechleiderLaboratory of Tumor Immunology and Biology, National Cancer Institute, NIH, Bethesda, Maryland, USA.
Philip M Arlen
Kwong-Yok Tsang
Seth M Steinberg
Junko Yokokawa
Vittore Cereda
Kevin Camphausen
Jeffrey Schlom
William L Dahut
James L Gulley
Center for Drug Evaluation and Research · USData Management (Italy) · ITNational Cancer Institute · 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
Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
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
Analyses of human T regulatory cellsZIABC010973 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$3.7M
Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZ01BC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2005 to 2008
$2.9M
Vaccines /Vaccine Strategies for Human CancerZ01BC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2000 to 2008
$2.7M
Vaccine Clinical TrialsZ01BC010662 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ARLEN, PHILIP M · 2005 to 2008
$1.7M
BIOSTATISTICS AND DATA MANAGEMENT SECTIONZ01SC007202 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI STEINBERG, SETH M · 1996 to 2008
$1.5M
Control of the immune response for cancer vaccine developmentZ01BC010944 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2008 to 2008
$361k
Intramural NIH HHS Z01 BC010425
6 · The paper itself

Abstract

purposeWe have previously reported on the safety and immunologic response of a poxvirus-based vaccine encoding prostate-specific antigen (PSA) used in combination with radiation therapy in patients with localized prostate cancer. We hypothesized that a "metronomic" dose of interleukin 2 (IL-2) as a biological adjuvant would cause less toxicity while maintaining immunologic response. EXPERIMENTAL

designEighteen patients with localized prostate cancer were treated in a single-arm trial using previously established doses of vaccine and radiation therapy. The vaccine used was a recombinant vaccinia virus engineered to encode PSA admixed with a recombinant vaccinia encoding the costimulatory molecule B7.1, followed by booster vaccinations with a recombinant fowlpox vector expressing PSA. Patients received a total of eight planned vaccination cycles, once every 4 weeks, with granulocyte-macrophage colony-stimulating factor given on days 1 to 4 and interleukin 2 (IL-2) at a dose of 0.6 MIU/M2 given from days 8 to 21 after each vaccination. Definitive external beam radiation therapy was initiated after the third vaccination cycle. Patients were evaluated for safety and immunologic response. Toxicity and immunologic activity were compared with the previously reported regimen containing a higher dose of IL-2.

resultsSeventeen of 18 patients received all eight cycles of vaccine with IL-2. Five of eight HLA-A2+ patients evaluated had an increase in PSA-specific T cells of > or =3-fold. Toxicities were generally mild, with only seven vaccination cycles of 140 given resulting in grade 3 toxicities possibly attributable to IL-2.

conclusionsMetronomic-dose IL-2 in combination with vaccine and radiation therapy is safe, can induce prostate-specific immune responses, and has immunologic activity similar to low-dose IL-2, with markedly reduced toxicities.

Indexed as

Adjuvants, ImmunologicAgedCancer VaccinesCombined Modality TherapyFlow CytometryFowlpox virusGenetic VectorsGranulocyte-Macrophage Colony-Stimulating FactorHumansInterleukin-2Killer Cells, NaturalMaleMiddle AgedProstate-Specific AntigenProstatic NeoplasmsRadiotherapyAdjuvants, ImmunologicCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorInterleukin-2Prostate-Specific Antigen

Identifiers

PMID18698048
PMCPMC2639763
OpenAlexW2135445993

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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.