Pancreatic Cancer Clinical Trial
Official title:
Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no
combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor
receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor
vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted
the study to confirm the safety and efficacy of combined modality intervention using
conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific
VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000 mg/m^2 (body surface area) will be administered on day 1, day 8, day 15,
day 29, day 36, and day 43, respectively.
VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with
Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).
HLA-A*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained
from HLA-A2/Kd transgenic murine model.
HLA-A*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood
mononuclear cells of healthy volunteer donors.
These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in
vitro.
Vaccination of HLA-A*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice
markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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