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| Name | Class |
|---|---|
| Human Genome Center, Institute of Medical Science, University of Tokyo | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1/2 study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGFR1-1084, VEGFR2-169 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| toxicities as assessed by NCI-CACAE ver3) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration | 3months | |
| CD8 population | 3months | |
| Change in level of regulatory T cells |
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Inclusion Criteria:
DISEASE CHARACTERISTICS
PATIENTS CHARACTERISTICS
ECOG performance status 0-2
Life expectancy > 3 months
Laboratory values as follows:
HLA-A*2402
Able and willing to give valid written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitsukazu Gotoh, M.D. & Ph.D | Fukushima Medical University, Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12415261 | Background | Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4. | |
| 17020992 | Background | Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17 |
|
| 3months |
| Objective response rate | 1year |
| feasibility | 1year |
| Survival | 1year |
| 15930316 | Background | Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |