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

Head Neck. 2002 Jul;24(7):661-9. 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenovirus E1A Proteins / administration & dosage*
  • Adenovirus E1A Proteins / metabolism
  • Adult
  • Aged
  • Carcinoma, Squamous Cell / genetics
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / therapy*
  • Cholesterol / analogs & derivatives*
  • Drug Carriers
  • Female
  • Gene Expression
  • Gene Transfer Techniques
  • Head and Neck Neoplasms / genetics
  • Head and Neck Neoplasms / mortality
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Immunohistochemistry
  • Injections, Intralesional
  • Liposomes
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / genetics
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / therapy*
  • Reverse Transcriptase Polymerase Chain Reaction


  • Adenovirus E1A Proteins
  • Drug Carriers
  • Liposomes
  • 3-(N-(N',N'-dimethylaminoethane)carbamoyl)cholesterol
  • Cholesterol