Phase I study of autologous dendritic cell tumor vaccine in patients with non-small cell lung cancer

Abstract 

Background

A dendritic cell vaccine has been developed as a novel strategy for generating antitumor immunity in the treatment of cancer. The purpose of this study was to assess the maximal tolerated dose, safety, and immunologic response of a new dendritic cell vaccine (DC-Vac) into which tumor lysate was loaded by electroporation and pulse in patients with advanced non-small cell lung cancer (NSCLC).

Patients and methods

Fifteen patients with inoperable stage III or IV NSCLC were assigned to cohorts that received 3, 6, or 12×10⁶ DC-Vac intradermally 3 times at 2 week intervals. We also evaluated immunologic and tumor responses.

Results

The maximum dose of DC-Vac (12×10⁶) was shown to be safe. In 5 of 9 patients, the vaccine resulted in increased interferon (IFN)-γ production by CD8+ cells after exposure to tumor lysate. Additionally, there were mixed responses which do fulfill progressive disease definition but demonstrate some clinical benefit in two patients.

Conclusion

The administration of tumor lysate-loaded autologous dendritic cells by electroporation and pulse was non-toxic and induced immunologic responses to tumor antigens. The two mixed tumor responses which were achieved may represent a potential benefit of this new DC-Vac.

Keywords: Dendritic cells, Electroporation, Immunotherapy, Non-small cell lung carcinoma, Tumor vaccines