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

✍ Scribed by Doug Villaret; Bonnie Glisson; Daniel Kenady; Ehab Hanna; Mary Carey; Lyon Gleich; George H. Yoo; Neal Futran; Mien-Chie Hung; Pervin Anklesaria; Alison E. Heald

• Publisher: John Wiley and Sons
• Year: 2002
• Tongue: English
• Weight: 114 KB
• Volume: 24
• Category: Article
• ISSN: 1043-3074
• DOI: 10.1002/hed.10107

✦ Synopsis

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.