A multicenter phase II study of tgDCC-E1A for the intratumoral treatment of patients with recurrent head and neck squamous cell carcinoma.
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.
Department of Otolaryngology, University of Florida, PO Box 100264, Gainesville, Florida 32610-0264, USA. villadb@ent.ufl.edu
Doug
D
Villaret
Bonnie
B
Glisson
Daniel
D
Kenady
Ehab
E
Hanna
Mary
M
Carey
Lyon
L
Gleich
George H
GH
Yoo
Neal
N
Futran
Mien-Chie
MC
Hung
Pervin
P
Anklesaria
Alison E
AE
Heald
D017500:Adenovirus E1A Proteins / Q000008:administration & dosage* / Q000378:metabolism; D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000235:genetics / Q000401:mortality / Q000628:therapy*; D002784:Cholesterol / Q000031:analogs & derivatives*; D004337:Drug Carriers; D005260:Female; D015870:Gene Expression; D018014:Gene Transfer Techniques; D006258:Head and Neck Neoplasms / Q000235:genetics / Q000401:mortality / Q000628:therapy*; D006801:Humans; D007150:Immunohistochemistry; D015552:Injections, Intralesional; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000235:genetics / Q000401:mortality / Q000628:therapy*; D020133:Reverse Transcriptase Polymerase Chain Reaction
D017500:Adenovirus E1A Proteins; D004337:Drug Carriers; D008081:Liposomes; C070648:3-(N-(N',N'-dimethylaminoethane)carbamoyl)cholesterol; D002784:Cholesterol