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

Soo-Jung Uma1, Young Jin Choib, Ho-Jin Shinb, Cheol Hun Sonc, You-Soo Parkc, Mee Sook Rohd, Yun Seong Kimb, Young Dae Kime, Soo-Keol Leea, Min Ho Jungf, Min Ki Leeb1, Choonhee SonaCorresponding Author Informationemail address, Pil Jo Choig, Jooseop ChungbCorresponding Author Informationemail address, Chi-Dug Kangh, Eun-Yup Leei

Received 16 October 2009; received in revised form 8 February 2010; accepted 9 February 2010. published online 11 March 2010.
Corrected Proof

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.

a Department of Internal Medicine, Dong-A University College of Medicine, 3-Ga Dongdaeshin-dong, Seo-gu, Busan 602-715, Republic of Korea

b Department of Internal Medicine, Pusan National University School of Medicine, Ami-dong, Seo-gu, Busan, Republic of Korea

c Binex Research Institute, Binex Co. Ltd., Busan, Republic of Korea

d Department of Pathology, Dong-A University College of Medicine, Busan, Republic of Korea

e Department of Thoracic Surgery, Pusan National University School of Medicine, Busan, Republic of Korea

f Department of Microbiology, Dong-A University College of Medicine, Busan, Republic of Korea

g Department of Thoracic and Cardio-vascular Surgery, Dong-A University College of Medicine, Busan, Republic of Korea

h Department of Biochemistry, Pusan National University School of Medicine, Busan, Republic of Korea

i Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Republic of Korea

Corresponding Author InformationCorresponding author. Tel.: +82 51 240 2874; fax: +82 51 242 5852.

Corresponding Author InformationCo-corresponding author.

1 Both these authors contributed equally to this paper.

PII: S0169-5002(10)00071-1

doi:10.1016/j.lungcan.2010.02.006