MUC1 peptide vaccination in patients with advanced pancreas or biliary tract cancer.
BACKGROUND
To evaluate the immunogenicity of MUC1 peptide vaccine in advanced pancreatic and bile duct cancers, a phase I clinical trial was conducted.


METHODS
A 100-mer MUC1 peptide consisting of the extracellular tandem repeat domain and incomplete Freund's adjuvant were subcutaneously administered to 6 pancreatic and 3 bile duct cancer patients at weeks 1, 3 and 5 and doses ranging from 300 to 3000 microg. Circulating intracytoplasmic cytokine-positive CD4+ T cells and anti-MUC1 IgG antibodies were measured before and after vaccination.


RESULTS
There were no adverse events, except for mild reddening and swelling at the vaccination site. In 8 patients eligible for clinical evaluation, 7 had progressive disease and 1 stable disease with a tendency for increased circulating anti-MUC1 IgG antibody after vaccination.


CONCLUSIONS
This phase I clinical trial revealed the safety of a vaccine containing 100-mer MUC1 peptides and incomplete Freund's adjuvant.
Yamamoto
Kotaro
K
Department of Surgery II, Yamaguchi University School of Medicine, 1-1-1 Minami-Kogushi, Ube 755-8505, Japan.
Ueno
Tomio
T
Kawaoka
Toru
T
Hazama
Shoichi
S
Fukui
Mikiko
M
Suehiro
Yutaka
Y
Hamanaka
Yuichiro
Y
Ikematsu
Yoshito
Y
Imai
Kohzoh
K
Oka
Masaaki
M
Hinoda
Yuji
Y
D000368:Aged; D001661:Biliary Tract Neoplasms / Q000276:immunology / Q000628:therapy*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D019496:Cancer Vaccines / Q000008:administration & dosage*; D005260:Female; D005620:Freund's Adjuvant / Q000008:administration & dosage; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D018396:Mucin-1 / Q000276:immunology*; D009364:Neoplasm Recurrence, Local / Q000276:immunology / Q000628:therapy*; D010190:Pancreatic Neoplasms / Q000276:immunology / Q000628:therapy*; D010446:Peptide Fragments / Q000276:immunology*; D020080:Tandem Repeat Sequences / Q000276:immunology
D019496:Cancer Vaccines; D007074:Immunoglobulin G; C116055:MUC1 tandem repeat peptide; D018396:Mucin-1; D010446:Peptide Fragments; D005620:Freund's Adjuvant