Evidence map›Paper›PMID 20978148›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2010

A phase I study of a tropism-modified conditionally replicative adenovirus for recurrent malignant gynecologic diseases.

Kristopher J Kimball, Meredith A Preuss, Mack N Barnes, Minghui Wang, Gene P Siegal, Wen Wan, Huichien Kuo, Souheil Saddekni, Cecil R Stockard, William E Grizzle and 4 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 4% 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

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 109 citations in OpenAlex.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  2. Article
  3. Review
  4. Article
  5. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
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  19. Delta-24-RGD, an Oncolytic Adenovirus, Increases Survival and Promotes Proinflammatory Immune Landscape Remodeling in Models of AT/RT and CNS-PNET.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Article
  20. Review

2 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

14 authors at 2 institutions in 1 country.

Kristopher J KimballThe University of Alabama at Birmingham, Birmingham, Alabama, USA.
Meredith A Preuss
Mack N Barnes
Minghui Wang
Gene P Siegal
Wen Wan
Huichien Kuo
Souheil Saddekni
Cecil R Stockard
William E Grizzle
Raymond D Harris
Rosemarie Aurigemma
David T Curiel
Ronald D Alvarez
National Cancer Institute · USUniversity of Alabama at Birmingham · US

Funding

Targeted immunotherapy programP50CA083591 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI PARTRIDGE, EDWARD E · 1999 to 2005
$9.6M
Monitoring of advanced virotherapy for ovarian cancerR01CA121187 · NCI · WASHINGTON UNIVERSITY · PI CURIEL, DAVID TERRY · 2007 to 2011
$2.0M
Infectivity Enhanced Virotherapy For Ovarian CancerR21CA128222 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI ALVAREZ, RONALD DAVID · 2007 to 2008
$551k
NCI NIH HHS 5R01CA121187NCI NIH HHS N01 CO012400NCI NIH HHS N01-CO-12400NCI NIH HHS P50 CA083591NCI NIH HHS P50-CA83591NCI NIH HHS R01 CA121187NCI NIH HHS R21 CA128222
6 · The paper itself

Abstract

purposeTo determine the maximum tolerated dose (MTD), toxicity spectrum, clinical activity, and biological effects of the tropism-modified, infectivity-enhanced conditionally replicative adenovirus (CRAd), Ad5-Δ24-Arg-Gly-Asp (RGD), in patients with malignant gynecologic diseases. EXPERIMENTAL

designCohorts of eligible patients were treated daily for 3 days through an i.p. catheter. Vector doses ranged from 1 × 10(9) to 1 × 10(12) viral particles per day. Toxicity was evaluated using CTCv3.0. CA-125 and Response Evaluation Criteria in Solid Tumors (RECIST) criteria were used to determine clinical efficacy. Corollary biological studies included assessment of CRAd replication, wild-type virus generation, viral shedding, and neutralizing antibody response.

resultsTwenty-one patients were treated. Adverse clinical effects were limited to grade 1/2 fever, fatigue, or abdominal pain. No vector-related grade 3/4 toxicities were noted. No clinically significant laboratory abnormalities were noted. The maximum tolerated dose was not reached. Over a 1 month follow-up, 15 (71%) patients had stable disease and six (29%) had progressive disease. No partial or complete responses were noted. Seven patients had a decrease in CA-125; four had a >20% drop. RGD-specific PCR showed the presence of study vector in ascites of 16 patients. Seven revealed an increase in virus after day 3, suggesting replication of Ad5-Δ24-RGD. Minimal wild-type virus generation was detected. Viral shedding studies showed insignificant shedding in the serum, saliva, and urine. Anti-adenoviral neutralizing antibody effects were prevalent.

conclusionsThis study, the first to evaluate an infectivity-enhanced CRAd in human cancer, shows the feasibility, safety, potential antitumor response, and biological activity of this approach in ovarian cancer. Further evaluation of infectivity enhanced virotherapy approaches for malignant gynecologic diseases is warranted.

Indexed as

AdenoviridaeAgedAged, 80 and overCancer VaccinesCarcinomaFemaleGenital Neoplasms, FemaleHumansMiddle AgedOligopeptidesOncolytic VirotherapyOrganisms, Genetically ModifiedRecurrenceTumor Cells, CulturedVaccines, DNAViral Tropismarginyl-glycyl-aspartic acidCancer VaccinesOligopeptidesVaccines, DNA

Identifiers

PMID20978148
PMCPMC2970766
OpenAlexW2147649350

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.