Evidence map›Paper›PMID 23756180›Full record

ArticleGynecologic oncology2013

A phase I clinical trial of Ad5/3-Δ24, a novel serotype-chimeric, infectivity-enhanced, conditionally-replicative adenovirus (CRAd), in patients with recurrent ovarian cancer.

Kenneth H Kim, Igor P Dmitriev, Souheil Saddekni, Elena A Kashentseva, Raymond D Harris, Rosemarie Aurigemma, Sejong Bae, Karan P Singh, Gene P Siegal, David T Curiel and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Gynecologic oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
8.3field-weighted citation impact, top 2% 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

58 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
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  14. Advances in the clinical development of oncolytic viruses.American journal of translational research · 2022
    Review
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  16. Viral vector platforms within the gene therapy landscape.Signal transduction and targeted therapy · 2021
    Review
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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 5 institutions in 1 country.

Kenneth H KimThe Division of Gynecologic Oncology, The University of North Carolina, USA.
Igor P Dmitriev
Souheil Saddekni
Elena A Kashentseva
Raymond D Harris
Rosemarie Aurigemma
Sejong Bae
Karan P Singh
Gene P Siegal
David T Curiel
Ronald D Alvarez
University of Alabama at Birmingham · USUniversity of Washington · USGynecologic Oncology Group · USNational Cancer Institute · USNational Institutes of Health · US

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001ENCI NIH HHS P30 CA013148
6 · The paper itself

Abstract

objectiveThe conditionally replicative adenovirus Ad5/3-Δ24 has a type-3 knob incorporated into the type-5 fiber that facilitates enhanced ovarian cancer infectivity. Preclinical studies have shown that Ad5/3-Δ24 achieves significant oncolysis and anti-tumor activity in ovarian cancer models. The purpose of this study was to evaluate in a phase I trial the feasibility and safety of intraperitoneal (IP) Ad5/3-Δ24 in recurrent ovarian cancer patients.

methodsEligible patients were treated with IP Ad5/3-Δ24 for 3 consecutive days in one of three dose cohorts ranging 1 × 10(10)-1 × 10(12)vp. Toxicity was assessed utilizing CTC grading and efficacy with RECIST. Ascites, serum, and other samples were obtained to evaluate gene transfer, generation of wildtype virus, viral shedding, and antibody response.

resultsNine of 10 patients completed treatment per protocol. A total of 15 vector-related adverse events were experienced in 5 patients. These events included fever or chills, nausea, fatigue, and myalgia. All were grades 1-2 in nature, transient, and medically managed. Of the 8 treated patients evaluable for response, six patients had stable disease and 2 patients had progressive disease. Three patients had decreased CA-125 from pretreatment levels one month after treatment. Ancillary biologic studies indicated Ad5/3-Δ24 replication in patients in the higher dose cohorts. All patients experienced an anti-adenoviral neutralizing antibody effect.

conclusionsThis study suggests the feasibility and safety of a serotype chimeric infectivity-enhanced CRAd, Ad5/3-Δ24, as a potential therapeutic option for recurrent ovarian cancer patients.

Indexed as

AdenoviridaeOncolytic VirotherapyOncolytic VirusesAgedAged, 80 and overAntibodies, ViralAscitesCA-125 AntigenChillsDisease ProgressionFatigueFemaleFeverGene ExpressionHumansMaximum Tolerated DoseAntibodies, ViralCA-125 AntigenCRAdGene therapyInfectivity-enhanced adenoviral vectorsOvarian cancer

Identifiers

PMID23756180
PMCPMC3748258
OpenAlexW2011195144

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.