Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00683358|
Recruitment Status : Unknown
Verified January 2009 by Tokyo University.
Recruitment status was: Active, not recruiting
First Posted : May 23, 2008
Last Update Posted : May 7, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreas Neoplasms||Biological: VEGFR1-A24-1084 (SYGVLLWEI)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||April 2009|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|