A multicenter phase II study of tgDCC-E1A for the intratumoral treatment of patients with recurrent head and neck squamous cell carcinoma

• Published in: Head & neck 2002-07, Vol.24 (7), p.661-669
• Main Authors: Villaret, Doug, Glisson, Bonnie, Kenady, Daniel, Hanna, Ehab, Carey, Mary, Gleich, Lyon, Yoo, George H., Futran, Neal, Hung, Mien-Chie, Anklesaria, Pervin, Heald, Alison E.
• Format: Article
• Language: English
• Subjects: adenovirus E1A gene; Adenovirus E1A Proteins - administration & dosage; Adenovirus E1A Proteins - metabolism; Adult; Aged; Biological and medical sciences; Carcinoma, Squamous Cell - genetics; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - therapy; Cholesterol - analogs & derivatives; Drug Carriers; E1A-Lipid Complex; Female; Gene Expression; gene transfer; Gene Transfer Techniques; head and neck cancer; Head and Neck Neoplasms - genetics; Head and Neck Neoplasms - mortality; Head and Neck Neoplasms - therapy; Humans; Immunohistochemistry; Injections, Intralesional; liposome; Liposomes; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - genetics; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - therapy; Otorhinolaryngology (head neck, general aspects and miscellaneous); Otorhinolaryngology. Stomatology; Reverse Transcriptase Polymerase Chain Reaction; Tumors
• ISSN: 1043-3074; 1097-0347
• DOI: 10.1002/hed.10107

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. © 2002 Wiley Periodicals, Inc.