Evidence map›Paper›PMID 18797450›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2008

Phase I/II study of GM-CSF DNA as an adjuvant for a multipeptide cancer vaccine in patients with advanced melanoma.

Miguel-Angel Perales, Jianda Yuan, Sarah Powel, Humilidad F Gallardo, Teresa S Rasalan, Christina Gonzalez, Gregor Manukian, Jian Wang, Yan Zhang, Paul B Chapman and 8 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
3.7field-weighted citation impact, top 6% 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

52 citing papers in PubMed, 98 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Immunologic response to xenogeneic gp100 DNA in melanoma patients: comparison of particle-mediated epidermal delivery with intramuscular injection.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
    Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Advances in nucleic acid-based cancer vaccines.Journal of biomedical science · 2025
    Review
  10. Review
  11. Review
  12. Article
  13. Multi-epitope vaccines: a promising strategy against viral diseases in swine.Frontiers in cellular and infection microbiology · 2024
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Adjuvanted influenza vaccines.Human vaccines & immunotherapeutics · 2018
    Review
  19. Review
  20. Article
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

18 authors at 1 institution in 1 country.

Miguel-Angel PeralesDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Jianda Yuan
Sarah Powel
Humilidad F Gallardo
Teresa S Rasalan
Christina Gonzalez
Gregor Manukian
Jian Wang
Yan Zhang
Paul B Chapman
Susan E Krown
Philip O Livingston
Samuel Ejadi
Katherine S Panageas
Manuel E Engelhorn
Stephanie L Terzulli
Alan N Houghton
Jedd D Wolchok
Memorial Sloan Kettering Cancer Center · US

Funding

TUMORICIDAL FUNCTIONS OF T LYMPHOCYTES IN PSMA TUMORSP01CA059350 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI O'REILLY, RICHARD JOHN · 1992 to 2012
$21.4M
TREATMENT OF CANCER PATIENTS WITH THYMIC FACTORSP01CA033049 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI LIVINGSTON, PHILIP O. · 1985 to 2009
$19.8M
Optimizing T cell Immunity to Cancer VaccinesK08CA102606 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI PERALES, MIGUEL-ANGEL · 2003 to 2006
$538k
NCI NIH HHS CA10260NCI NIH HHS CA33049NCI NIH HHS CA59350NCI NIH HHS K08 CA102606NCI NIH HHS P01 CA033049NCI NIH HHS P01 CA059350
6 · The paper itself

Abstract

Granulocyte-macrophage colony-stimulating factor (GM-CSF) enhances immune responses by inducing proliferation, maturation, and migration of dendritic cells (DCs) as well as expansion and differentiation of B and T lymphocytes. The potency of DNA vaccines can be enhanced by the addition of DNA encoding cytokines, acting as molecular adjuvants. We conducted a phase I/II trial of human GM-CSF DNA in conjunction with a multipeptide vaccine (gp100 and tyrosinase) in stage III/IV melanoma patients. Nineteen human leukocyte antigen (HLA)-A*0201+ patients were treated. Three dose levels were studied: 100, 400, and 800 microg DNA/injection, administered subcutaneously every month with 500 microg of each peptide. In the dose-ranging study, three patients were treated at each dose level. The remaining patients were then treated at the highest dose. Most toxicities were grade 1 injection-site reactions. Eight patients (42%) developed CD8+ T-cell responses, defined by a > or =3 SD increase in baseline reactivity to tyrosinase or gp100 peptide in tetramer or intracellular cytokine staining (ICS) assays. There was no relationship between dose and T-cell response. Responding T cells had an effector memory cell phenotype. Polyfunctional T cells were also demonstrated. At a median of 31 months follow-up, median survival has not been reached. Human GM-CSF DNA was found to be a safe adjuvant.

Indexed as

Genetic TherapyAdjuvants, ImmunologicCancer VaccinesCD8-Positive T-LymphocytesGranulocyte-Macrophage Colony-Stimulating FactorHumansMelanomaNeoplasm StagingPeptidesPhenotypeRecombinant ProteinsVaccines, DNAVaccines, SubunitAdjuvants, ImmunologicCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorPeptidesRecombinant ProteinsVaccines, DNAVaccines, Subunit

Identifiers

PMID18797450
PMCPMC3909666
OpenAlexW2067930723

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.