Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Recruitment status was: Active, not recruiting
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
|Pancreatic Cancer Pancreas Neoplasms||Biological: VEGFR1-A24-1084 (SYGVLLWEI)||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer|
- PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST) [ Time Frame: 1 year ]
- Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.) [ Time Frame: 1 year ]
- Tumor regression(Imaging study, tumor marker, etc.) [ Time Frame: 1 year ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||April 2009|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Biological: VEGFR1-A24-1084 (SYGVLLWEI)
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.
HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683358
|Research Hospital, The Institute of Medical Science, The University of Tokyo|
|Minato-ku, Tokyo, Japan, 108-8639|
|Study Director:||Naohide Yamashita, MD, PhD||Director, Research Hospital, Institute of Medical Science, Tokyo University|