The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
toxicities as assessed by NCI-CACAE ver3)
Time frame: 3 months
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
Time frame: 3months
CD8 population
Time frame: 3months
Change in level of regulatory T cells
Time frame: 3months
Objective response rate
Time frame: 1year
feasibility
Time frame: 1year
Survival
Time frame: 1year
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