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

BackgroundA 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 methodsFifteen 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.ResultsThe 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.ConclusionThe 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.