2005 Fiscal Year Final Research Report Summary
Combination therapy with immunotherapy and chemotherapy for pancreatic cancer. -Aim at the standardization of clinical trial for immuno-chemotherapy-
| Project/Area Number |
16591324
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Digestive surgery
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| Research Institution | Yamaguchi University |
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Principal Investigator |
YAMAMOTO Koutaro Yamaguchi University, Faculty of Medicine, Researcher, 医学部, 非常勤研究員 (50304481)
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| Co-Investigator(Kenkyū-buntansha) |
YOSHINO Shigefumi Yamaguchi University, Faculty of Medicine, Assistant Professor, 医学部, 講師 (60294633)
UENO Tomio Yamaguchi University, Hospital, Research Associate, 医学部附属病院, 助手 (70284255)
HAZAMA Shoichi Yamaguchi University, Hospital, Assistant Professor, 医学部附属病院, 講師 (50253159)
OKA Masaaki Yamaguchi University, Faculty of Medicine, Professor, 医学部, 教授 (70144946)
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| Project Period (FY) |
2004 – 2005
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| Keywords | Pancreatic cancer / Immunotherapy / Chemotherapy / Peptide vaccination / Gemcitabine |
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| Research Abstract |
On this project, we attempted to find clinically effective therapy against pancreatic cancer using the combination with immunotherapy and chemotherapy. We reported two phase I trials of MUC1 peptide vaccination and personalized peptide vaccination within the term of this project. We vaccinated 9 patients with 300,1000,or 3000 mg of the 105 amino acid MUC1 peptide. 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. Secondary we applied another phase I study with personalized peptide vaccination to 11 patients with pancreatic cancer. Namely, pre-vaccinated peripheral blood mononuclear cells were screened for the reactivity in vitro to each of 14 or 16 peptide candidates in HLA-A24^+ or -A2^+ patients, and then only the reactive peptides were vaccinated in vivo. This regimen was generally well tolerated without hematological toxicity, although inflammatory reactions at the injection site were observed in 7 patients. Increased cellular and humoral immune responses to at least one of peptides used for vaccination were observed in the post-vaccination PBMCs and sera from 4 of 8 patients and 4 of 10 patients tested, respectively. The 6- and 12-month survival rates for patients who received more than 3 vaccinations (n=10) were 80% and 20%, respectively. On the base of two phase I study, we conducted a phase I trial of combination therapy with personalized peptide immunotherapy and chemotherapy using GEM for pancreatic cancer. We vaccinated 13 patients with 1,2,or 3 mg of the reactive peptides. There were no adverse events, and a dose of 3 mg was recommended. After this project, a phase II study of combination therapy with personalized peptide immunotherapy and chemotherapy using GEM for pancreatic cancer is warranted.
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