Evidence map›Paper›PMID 19935775›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2010

A phase I study of telomerase-specific replication competent oncolytic adenovirus (telomelysin) for various solid tumors.

John Nemunaitis, Alex W Tong, Michael Nemunaitis, Neil Senzer, Anagha P Phadke, Cynthia Bedell, Ned Adams, Yu-An Zhang, Phillip B Maples, Salina Chen and 5 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 146 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
146citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

146 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  2. Review
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  17. Translation of oncolytic viruses in sarcoma.Molecular therapy. Oncology · 2024
    Review
  18. Exploring treatment options in cancer: Tumor treatment strategies.Signal transduction and targeted therapy · 2024
    Review
  19. Review
  20. Article

86 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

15 authors.

John NemunaitisMary Crowley Cancer Research Centers, Dallas, Texas, USA. jnemunaitis@marycrowley.org
Alex W Tong
Michael Nemunaitis
Neil Senzer
Anagha P Phadke
Cynthia Bedell
Ned Adams
Yu-An Zhang
Phillip B Maples
Salina Chen
Beena Pappen
James Burke
Daiju Ichimaru
Yasuo Urata
Toshiyoshi Fujiwara

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A phase I clinical trial was conducted to determine the clinical safety of Telomelysin, a human telomerase reverse transcriptase (hTERT) promoter driven modified oncolytic adenovirus, in patients with advanced solid tumors. A single intratumoral injection (IT) of Telomelysin was administered to three cohorts of patients (1 x 10(10), 1 x 10(11), 1 x 10(12) viral particles). Safety, response and pharmacodynamics were evaluated. Sixteen patients with a variety of solid tumors were enrolled. IT of Telomelysin was well tolerated at all dose levels. Common grade 1 and 2 toxicities included injection site reactions (pain, induration) and systemic reactions (fever, chills). hTERT expression was demonstrated at biopsy in 9 of 12 patients. Viral DNA was transiently detected in plasma in 13 of 16 patients. Viral DNA was detectable in four patients in plasma or sputum at day 7 and 14 post-treatment despite below detectable levels at 24 h, suggesting viral replication. One patient had a partial response of the injected malignant lesion. Seven patients fulfilled Response Evaluation Criteria in Solid Tumors (RECIST) definition for stable disease at day 56 after treatment. Telomelysin was well tolerated. Evidence of antitumor activity was suggested.

Indexed as

AdenoviridaeAdultAgedFemaleFlow CytometryHumansImmunohistochemistryMaleMiddle AgedNeoplasmsOncolytic VirotherapyOncolytic VirusesTelomeraseTelomerase

Identifiers

PMID19935775
PMCPMC2839300

What OpenQuestion holds

Textmetadata
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.