Journal
HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK
Volume 24, Issue 7, Pages 661-669Publisher
WILEY
DOI: 10.1002/hed.10107
Keywords
gene transfer; adenovirus E1A gene; liposome; E1A-Lipid Complex; head and neck cancer
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Background, The anti-cancer gene, E1A, can be complexed to a lipid carrier, DC-Cholesterol: DOPE, to form tgDCC-E1A, which can be injected directly into tumors. Methods. Twenty-four patients with recurrent, unresectable, head and neck cancer were treated with intratumoral injections of tgDCC-E1A over 8 weeks. Tumor response was assessed using CT scans. Time to progression and overall survival were calculated. Results. Intratumoral tgDCC-E1A was well tolerated in all patients. No significant toxicities related to tgDCC-E1A were reported. One patient (4.2%) had a complete response, two patients (8.3%) had minor response, and seven patients (29.2%) had stable disease by two-dimensional cross-products on blinded CT scans. The median time to progression was 8.6 weeks (range, 3.3-43.7 weeks), and median survival was 4.6 months (range, 1.3-15.6 months). Conclusions, Intratumoral injections of tgDCC-E1A were safe and well tolerated. Modest tumor response was observed. Further development of tgDCC-E1A is warranted in combination with other treatment modalities. (C) 2002 Wiley Periodicals, Inc.
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