Evidence map›Paper›PMID 18528294›Full record

Trial reportJournal of immunotherapy (Hagerstown, Md. : 1997)

Phase Ib trial assessing autologous, tumor-pulsed dendritic cells as a vaccine administered with or without IL-2 in patients with metastatic melanoma.

Bruce G Redman, Alfred E Chang, Joel Whitfield, Peg Esper, Guihua Jiang, Thomas Braun, Blake Roessler, James J Mulé

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunotherapy (Hagerstown, Md. : 1997). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

37 citing papers in PubMed, 83 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. CD24Global medical genetics · 2022
    Article
  5. Article
  6. Targeting cancer stem cellsOncotarget · 2021
    Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Dual Role of GM-CSF as a Pro-Inflammatory and a Regulatory Cytokine: Implications for Immune Therapy.Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research · 2015
    Review
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

8 authors at 4 institutions in 1 country.

Bruce G RedmanDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109, USA. redmanb@umich.edu
Alfred E Chang
Joel Whitfield
Peg Esper
Guihua Jiang
Thomas Braun
Blake Roessler
James J Mulé
University of Michigan–Ann Arbor · USMichigan Medicine · USPalmetto Hematology Oncology · USUniversity of South Florida · US

Funding

ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RUBENFIRE, MELVYN · 1985 to 2007
$40.8M
SLC and dendritic cells in antitumor immunity &therapyP01CA059327 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CHANG, ALFRED E · 1992 to 2005
$8.2M
NCI NIH HHS P01 CA059327NCI NIH HHS P01 CA 59327NCRR NIH HHS M01 RR 000042NCRR NIH HHS M01 RR000042
6 · The paper itself

Abstract

Twenty-four subjects with metastatic melanoma were treated on a randomized Phase Ib trial evaluating an autologous tumor lysate-pulsed dendritic cell (DC) vaccine with or without interleukin (IL)-2. The vaccine consisted of autologous DCs obtained from peripheral blood mononuclear cells (PBMCs) cultured in granulocyte macrophage-colony stimulating factor and IL-4 then pulsed with autologous tumor cell lysate and keyhole limpet hemocyanin (KLH). The primary end points of the trial were safety and immune response to vaccine. Subjects were randomized to vaccine administered every other week times 3, vaccine x 3 followed by low-dose IL-2, or vaccine x 3 followed by high-dose IL-2. Immune response was monitored pretreatment and at 2 and 4 weeks after the third vaccine administration. Disease evaluation was performed at 4 weeks after the third vaccination. Therapy was well tolerated with no local vaccine toxicity greater than grade 1 in any arm. IL-2 toxicity was as expected without additional toxicity from the addition of IL-2 to vaccine. Immune response defined as delayed-type hypersensitivity, PBMC interferon-gamma enzyme-linked immunosorbent spot, and PBMC proliferation, to both autologous tumor and KLH were detected in all arms. Interferon-gamma enzyme-linked immunosorbent spot response to KLH (7 of 10 patients) and autologous tumor (4 of 10 patients) were also detected in subjects with available vaccine draining lymph node cells. There were no differences in immune response between treatment arms. No clinical responses were seen. Autologous tumor lysate-pulsed DC vaccine with or without IL-2 was well tolerated and immunogenic but failed to induce clinical response in patients with advanced melanoma.

Indexed as

AdultAgedCancer VaccinesDendritic CellsFemaleHumansHypersensitivity, DelayedInterferon-gammaInterleukin-2MaleMelanomaMiddle AgedVaccinationCancer VaccinesInterferon-gammaInterleukin-2

Identifiers

PMID18528294
PMCPMC2642589
OpenAlexW2005381406

What OpenQuestion holds

Textmetadata
LicenceTDM
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.