multicenter phase II study of tgDCC-E1A for the intratumoral treatment
of patients with recurrent head and neck squamous cell carcinoma.
D, Glisson B, Kenady D, Hanna E, Carey M, Gleich L, Yoo GH, Futran N,
Hung MC, Anklesaria P, Heald AE.
of Otolaryngology, University of Florida, PO Box 100264, Gainesville,
Florida 32610-0264, USA. [email protected]
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. Copyright 2002 Wiley Periodicals, Inc.
Neck 2002 Jul;24(7):661-9