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| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2008 | ||||
| Last Updated Date | May 6, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ;time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00683358 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: VEGFR1-A24-1084 (SYGVLLWEI) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 14 | ||||
| Estimated Completion Date | April 2009 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00683358 | ||||
| Responsible Party | Naohide Yamashita MD, PhD, Research Hospital, Institute of Medical Science, The University of Tokyo | ||||
| Study ID Numbers ICMJE | IMSUT-PPKVEGFR12402 | ||||
| Study Sponsor ICMJE | Tokyo University | ||||
| Collaborators ICMJE | Human Genome Center, Institute of Medical Science, University of Tokyo | ||||
| Investigators ICMJE |
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| Information Provided By | Tokyo University | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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