NCT00683085

Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Tokyo University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Pancreatic Cancer
• Pancreas Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	HLA-A*02:01-restricted VEGFR1-derived peptide vaccination	VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m\^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the feasibility and efficacy of this type of peptide.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-05-23
• Last updated: 2011-07-22
• Results posted: 2010-12-17

Locations

1 site across 1 country: Japan