Evidence map›Paper›PMID 22510347›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012

A phase I clinical trial of Ad5.SSTR/TK.RGD, a novel infectivity-enhanced bicistronic adenovirus, in patients with recurrent gynecologic cancer.

Kenneth H Kim, Igor Dmitriev, Janis P O'Malley, Minghui Wang, Souheil Saddekni, Zhiying You, Meredith A Preuss, Raymond D Harris, Rosemarie Aurigemma, Gene P Siegal and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00964756 (A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
6.8field-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.

NCT00964756 phase1completednot on this map

A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2009 to 2012Enrolled11ConditionsOvarian CancerArmsAd5.SSTR/TK.RGD, Ganciclovir (GCV)
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 58 citations in OpenAlex.

  1. Review
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  9. Article
  10. Recent Progress in Gene Therapy for Ovarian Cancer.International journal of molecular sciences · 2018
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Enzyme/Prodrug Systems for Cancer Gene Therapy.Current pharmacology reports · 2016
    Article
  18. Review
  19. Article
  20. 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

13 authors at 2 institutions in 1 country.

Kenneth H KimThe Division of Gynecologic Oncology, Department of Radiology, The University of Alabama at Birmingham, Birmingham, Alabama 35249, USA.
Igor Dmitriev
Janis P O'Malley
Minghui Wang
Souheil Saddekni
Zhiying You
Meredith A Preuss
Raymond D Harris
Rosemarie Aurigemma
Gene P Siegal
Kurt R Zinn
David T Curiel
Ronald D Alvarez
National Cancer Institute · USUniversity of Alabama at Birmingham · US

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
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
Enhanced Adenoviral Vectors for Ovarian CancerR01CA090547 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI ALVAREZ, RONALD DAVID · 2001 to 2007
$1.3M
NCI NIH HHS 2P30CA013148NCI NIH HHS N01 CO012400NCI NIH HHS N01-CO-12400NCI NIH HHS NCI R01CA121187NCI NIH HHS P30 CA013148NCI NIH HHS P50 CA083591NCI NIH HHS P50-CA83591NCI NIH HHS R01 CA090547NCI NIH HHS R01 CA121187NCI NIH HHS R01CA90547
6 · The paper itself

Abstract

purposeAd5.SSTR/TK.RGD is an infectivity-enhanced adenovirus expressing a therapeutic thymidine kinase suicide gene and a somatostatin receptor (SSTR) that allows for noninvasive gene transfer imaging. The purpose of this study was to identify the maximum tolerated dose (MTD), toxicities, clinical efficacy, and biologic effects of Ad5.SSTR/TK.RGD in patients with recurrent gynecologic cancer. EXPERIMENTAL

designEligible patients were treated intraperitoneally for 3 days with 1 × 10(9) to 1 × 10(12) vp/dose of Ad5.SSTR/TK.RGD followed by intravenous ganciclovir for 14 days. Toxicity and clinical efficacy were assessed using Common Toxicity Criteria (CTC) Adverse Events grading and Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Imaging using In-111 pentetreotide was obtained before and after treatment. Tissue samples were obtained to evaluate for gene transfer, generation of wild-type virus, viral shedding, and antibody response.

resultsTwelve patients were treated in three cohorts. The most common vector-related clinical toxicities were grade I/II constitutional or pain symptoms, experienced most often in patients treated at the highest dose. MTD was not identified. Five patients showed stable disease; all others experienced progressive disease. One patient with stable disease experienced complete resolution of disease and normalization of CA125 on further follow-up. Imaging detected increased In-111 pentetreotide retention in patients treated at the highest dose. Ancillary studies showed presence of Ad5.SSTR/TK.RGD virus and HSV1-tk expression in ascites samples collected at various time points in most patients treated within the higher dose cohorts.

conclusionsThis study shows the safety, potential efficacy, and possible gene transfer imaging capacity of Ad5.SSTR/TK.RGD in patients with recurrent gynecologic cancer. Further development of this novel gene therapeutic appears to be warranted.

Indexed as

Genes, Transgenic, SuicideAdenoviridaeAgedCA-125 AntigenCombined Modality TherapyEndometrial NeoplasmsFemaleGanciclovirGenetic TherapyGenetic VectorsHumansMembrane ProteinsMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsReceptors, SomatostatinCA-125 AntigenGanciclovirMembrane ProteinsMUC16 protein, humanReceptors, SomatostatinSomatostatin

Identifiers

PMID22510347
PMCPMC4065594
OpenAlexW2168595271

What OpenQuestion holds

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Registered trials

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.