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


METHODS
Fifteen patients with inoperable stage III or IV NSCLC were assigned to cohorts that received 3, 6, or 12 × 10(6) DC-Vac intradermally 3 times at 2 week intervals. We also evaluated immunologic and tumor responses.


RESULTS
The maximum dose of DC-Vac (12 × 10(6)) 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.


CONCLUSIONS
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.
Um
Soo-Jung
SJ
Department of Internal Medicine, Dong-A University College of Medicine, 3-Ga Dongdaeshin-dong, Seo-gu, Busan 602-715, Republic of Korea.
Choi
Young Jin
YJ
Shin
Ho-Jin
HJ
Son
Cheol Hun
CH
Park
You-Soo
YS
Roh
Mee Sook
MS
Kim
Yun Seong
YS
Kim
Young Dae
YD
Lee
Soo-Keol
SK
Jung
Min Ho
MH
Lee
Min Ki
MK
Son
Choonhee
C
Choi
Pil Jo
PJ
Chung
Jooseop
J
Kang
Chi-Dug
CD
Lee
Eun-Yup
EY
D000328:Adult; D000368:Aged; D000951:Antigens, Neoplasm / Q000276:immunology* / Q000378:metabolism; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology / Q000378:metabolism* / Q000473:pathology; D019496:Cancer Vaccines; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D003713:Dendritic Cells / Q000276:immunology / Q000378:metabolism* / Q000473:pathology / Q000637:transplantation; D018450:Disease Progression; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000378:metabolism; D008175:Lung Neoplasms / Q000276:immunology / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D008213:Lymphocyte Activation; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D014182:Transplantation, Autologous
D000951:Antigens, Neoplasm; D019496:Cancer Vaccines; D007371:Interferon-gamma