Document Detail


A phase I study of telomerase-specific replication competent oncolytic adenovirus (telomelysin) for various solid tumors.
MedLine Citation:
PMID:  19935775     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
John Nemunaitis; 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
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article     Date:  2009-11-24
Journal Detail:
Title:  Molecular therapy : the journal of the American Society of Gene Therapy     Volume:  18     ISSN:  1525-0024     ISO Abbreviation:  Mol. Ther.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-03     Completed Date:  2010-04-22     Revised Date:  2013-05-31    
Medline Journal Info:
Nlm Unique ID:  100890581     Medline TA:  Mol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  429-34     Citation Subset:  IM    
Affiliation:
Mary Crowley Cancer Research Centers, Dallas, Texas, USA. jnemunaitis@marycrowley.org
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MeSH Terms
Descriptor/Qualifier:
Adenoviridae / genetics,  metabolism*
Adult
Aged
Female
Flow Cytometry
Humans
Immunohistochemistry
Male
Middle Aged
Neoplasms / genetics,  metabolism,  therapy*
Oncolytic Virotherapy / adverse effects,  methods*
Oncolytic Viruses / genetics,  metabolism*
Telomerase / genetics,  metabolism*
Chemical
Reg. No./Substance:
EC 2.7.7.49/Telomerase
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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