Evidence map›Paper›PMID 19228745›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2009

Immunogenicity and antitumor effects of vaccination with peptide vaccine+/-granulocyte-monocyte colony-stimulating factor and/or IFN-alpha2b in advanced metastatic melanoma: Eastern Cooperative Oncology Group Phase II Trial E1696.

John M Kirkwood, Sandra Lee, Stergios J Moschos, Mark R Albertini, John C Michalak, Cindy Sander, Theresa Whiteside, Lisa H Butterfield, Louis Weiner

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006385 (Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1), which is not on this map. Cited by 81 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 3 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT00006385 phase2completednot on this map

Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2000ConditionsMelanoma (Skin)ArmsMART-1 antigen, gp100 antigen, incomplete Freund's adjuvant, recombinant interferon alfa, sargramostim
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 3 syntheses or guidelines pooled it, 138 citations in OpenAlex.

  1. Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
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  4. Immune Correlates of GM-CSF and Melanoma Peptide Vaccination in a Randomized Trial for the Adjuvant Therapy of Resected High-Risk Melanoma (E4697).Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
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  20. Leveraging T cells for cancer immunotherapy.Immunity & inflammation · 2025
    Review

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

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

9 authors at 5 institutions in 1 country.

John M KirkwoodDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15213-2584, USA. KirkwoodJM@upmc.edu
Sandra Lee
Stergios J Moschos
Mark R Albertini
John C Michalak
Cindy Sander
Theresa Whiteside
Lisa H Butterfield
Louis Weiner
University of Pittsburgh · USDana-Farber Cancer Institute · USFox Chase Cancer Center · USHematology Oncology Associates · USUniversity of Wisconsin–Madison · US

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
ONCOLOGYU10CA039229 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 1985 to 2013
$3.3M
NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA39229NCI NIH HHS CA66636NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA039229NCI NIH HHS U10 CA066636NCI NIH HHS U24 CA114737NCI NIH HHS UG1 CA233184
6 · The paper itself

Abstract

purposeNo therapy has ever shown prolongation of survival in stage IV metastatic melanoma. The association of cytokine-induced autoimmunity with improved prognosis led us to investigate the effect of multi-epitope melanoma vaccines alone and in combination with cytokines in this Eastern Cooperative Oncology Group multicenter phase II trial. EXPERIMENTAL

designEligible patients were required to have failed prior therapies and to be HLA-A2 positive. Three HLA class I-restricted lineage antigen epitopes were administered in a factorial 2x2 design. Peptide vaccine alone (arm A), or combined with granulocyte-monocyte colony-stimulating factor (GM-CSF; Immunex) 250 microg/d subcutaneously for 14 of 28 days each month (arm B), or combined with IFN-alpha2b (Intron A; Schering-Plough) 10 million units/m2 three times a week (arm C), or combined with both IFN-alpha2b and GM-CSF (arm D). The primary endpoint was immune response measured by enzyme-linked immunospot assay; secondary endpoints were clinical antitumor response, disease-free survival, and overall survival.

resultsOne hundred twenty patients enrolled and 115 patients were analyzed. Immune responses to at least one melanoma antigen were observed in 26 of 75 (35%) patients with serial samples. Neither IFN-alpha2b nor GM-CSF significantly improved immune responses. Six objective clinical responses were documented. At a median follow-up of 25.4 months, the median overall survival of patients with vaccine immune response was significantly longer than that of patients with no immune response (21.3 versus 13.4 months; P=0.046).

conclusionImmune response to vaccination correlates with prolonged survival in patients with metastatic melanoma and is not enhanced by immunomodulatory cytokines as tested in this trial.

Indexed as

AdultAgedAged, 80 and overCancer VaccinesFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansInterferon-alphaInterferon alpha-2MaleMelanomaMiddle AgedRecombinant ProteinsVaccinationCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorInterferon-alphaInterferon alpha-2Recombinant Proteins

Identifiers

PMID19228745
PMCPMC2759898
OpenAlexW2089346214

What OpenQuestion holds

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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.