Pilot trial of genetically modified, attenuated Salmonella expressing the E. coli cytosine deaminase gene in refractory cancer patients View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2003-09-22

AUTHORS

John Nemunaitis, Casey Cunningham, Neil Senzer, Joseph Kuhn, Jennifer Cramm, Craig Litz, Robert Cavagnolo, Ann Cahill, Caroline Clairmont, Mario Sznol

ABSTRACT

We performed a pilot trial in refractory cancer patients to investigate the feasibility of intratumoral injection of TAPET-CD, an attenuated Salmonella bacterium expressing the E. coli cytosine deaminase gene. A total of three patients received three dose levels of TAPET-CD (3 × 106–3 × 107 CFU/m2) via intratumoral injection once every 28 days as long as progression of disease or intolerable toxicity was not observed. From days 4 to 14 of each 28 day cycle, patients also received 5-fluorocytosine (5-FC) at a dose of 100 mg/kg/day p.o. divided three times daily. Six cycles of treatment were administered. No significant adverse events clearly attributable to TAPET-CD were demonstrated. Two patients had intratumor evidence of bacterial colonization with TAPET-CD, which persisted for at least 15 days after initial injection. Conversion of 5-FC to 5-fluorouracil (5-FU) as a result of cytosine deaminase expression was demonstrated in these two patients. The tumor to plasma ratio of 5-FU for these two colonized patients was 3.0, demonstrating significantly increased levels of 5-FU at the site of TAPET-CD colonization and insignificant systemic spread of the bacteria. In contrast, the tumor to plasma ratio of 5-FU of the patient who did not show colonization of TAPET-CD was less than 1.0. These results support the principle that a Salmonella bacterium can be utilized as a delivery vehicle of the cytosine deaminase gene to malignant tissue and that the delivered gene is functional (i.e. able to convert 5-FC to 5-FU) at doses at or below 3 × 107 CFU/m2. More... »

PAGES

737-744

Journal

TITLE

Cancer Gene Therapy

ISSUE

10

VOLUME

10

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.cgt.7700634

DOI

http://dx.doi.org/10.1038/sj.cgt.7700634

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1002373000

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/14502226


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