Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer
Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor
angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2
expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in
vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have
HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved
against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore
synergistic effect between vaccine therapy and chemotherapy will be expected. In this
clinical trial, we evaluate the safety, tolerability and immune response of different doses
of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to
determine the recommended phase II dose of peptide.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety(toxicities as assessed by NCI CTCAE version 3)
3 months
Yes
Hiroki Yamaue, MD
Study Chair
Wakayama Medical University, Second Department of Surgery
Japan: Ministry of Health, Labor and Welfare
WPR2-0710
NCT00622622
November 2006
February 2009
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