Evidence map›Paper›PMID 19920098›Full record

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

Phase I clinical trial of an adenovirus/prostate-specific antigen vaccine for prostate cancer: safety and immunologic results.

David M Lubaroff, Badrinath R Konety, Brian Link, Jack Gerstbrein, Tammy Madsen, Mary Shannon, Jeanne Howard, Jennifer Paisley, Diana Boeglin, Timothy L Ratliff and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article 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. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
6.3field-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.

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

41 citing papers in PubMed, 90 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. The Journey ofFrontiers in immunology · 2018
    Review
  17. Article
  18. Article
  19. Article
  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

11 authors at 1 institution in 1 country.

David M LubaroffDepartment of Urology, University of Iowa, Iowa City, Iowa 52242, USA. david-lubaroff@uiowa.edu
Badrinath R Konety
Brian Link
Jack Gerstbrein
Tammy Madsen
Mary Shannon
Jeanne Howard
Jennifer Paisley
Diana Boeglin
Timothy L Ratliff
Richard D Williams
University of Iowa · US

Funding

UNIVERSITY OF IOWA CTSA FOR PEDIATRIC RESEARCHUL1RR024979 · NCRR · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2007 to 2011
$31.8M
XANTHINE OXIDASE PRODUCTS IN MODULATION OF ENDOTHELIAL DYSFUNCTIONM01RR000059 · NCRR · UNIVERSITY OF IOWA · PI ASHARE, ALIX · 1985 to 2007
$22.3M
Enhancement of Gene Transfer &Prostate Cancer ImmunityR01CA096691 · NCI · UNIVERSITY OF IOWA · PI RATLIFF, TIMOTHY L · 2002 to 2006
$1.6M
NCI NIH HHS CA096691NCI NIH HHS R01 CA096691NCRR NIH HHS M01 RR000059NCRR NIH HHS M01 RR00059NCRR NIH HHS UL1 RR024979
6 · The paper itself

Abstract

purposeWe performed a phase I clinical trial of adenovirus/prostate-specific antigen (PSA) vaccine in men with measurable metastatic hormone-refractory disease. EXPERIMENTAL

designMen with measurable metastatic disease received one vaccine injection. Toxicity, immune responses, changes in PSA doubling times, and patient survival were assessed. Thirty-two patients with hormone-refractory metastatic prostate cancer were treated with a single s.c. vaccine injection at one of three dose levels, either as an aqueous solution or suspended in a Gelfoam matrix. All patients returned for physical and clinical chemistry examinations at regular intervals up to 12 months after injections.

resultsThe vaccine was deemed safe at all doses in both administration forms. There were no serious vaccine-related adverse events; the most prevalent were localized erythema/ecchymoses and cold/flu-like symptoms. Anti-PSA antibodies were produced by 34% of patients and anti-PSA T-cell responses were produced by 68%. PSA doubling time was increased in 48%, whereas 55% survived longer than predicted by the Halabi nomogram.

conclusionsThe adenovirus/PSA vaccine was proven safe with no serious vaccine-related adverse events. The majority of vaccinated patients produced anti-PSA T-cell responses and over half survived longer than predicted by nomogram. Although the latter data are only derived from a small number of patients in this phase I trial, they are encouraging enough to pursue further studies.

Indexed as

AdenoviridaeAgedAged, 80 and overCancer VaccinesCollagenGelatin Sponge, AbsorbableHormonesHumansMaleMiddle AgedNeoplasm MetastasisProstate-Specific AntigenProstatic NeoplasmsT-LymphocytesCancer VaccinesCollagenHormonesProstate-Specific Antigen

Identifiers

PMID19920098
PMCPMC2787649
OpenAlexW2152105813

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.