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A multicenter phase II study of tgDCC‐E1A for the intratumoral treatment of patients with recurrent head and neck squamous cell carcinoma
Author(s) -
Villaret Doug,
Glisson Bonnie,
Kenady Daniel,
Hanna Ehab,
Carey Mary,
Gleich Lyon,
Yoo George H.,
Futran Neal,
Hung MienChie,
Anklesaria Pervin,
Heald Alison E.
Publication year - 2002
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.10107
Subject(s) - medicine , head and neck cancer , head and neck , head and neck squamous cell carcinoma , phases of clinical research , cancer , basal cell , carcinoma , tumor progression , oncology , chemotherapy , gastroenterology , surgery
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.