Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-05 @ 2:04 PM
Study NCT ID:
NCT00683358
Status:
UNKNOWN
Last Update Posted:
2009-05-07
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-07-24', 'releaseDate': '2009-06-09'}, {'resetDate': '2009-11-23', 'releaseDate': '2009-10-23'}, {'resetDate': '2010-08-19', 'releaseDate': '2010-07-23'}, {'resetDate': '2010-11-17', 'releaseDate': '2010-10-19'}, {'releaseDate': '2011-07-19', 'unreleaseDateUnknown': True}, {'resetDate': '2011-08-15', 'releaseDate': '2011-07-20'}], 'estimatedResultsFirstSubmitDate': '2009-06-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C438506', 'term': 'HLA-A*24:02 antigen'}, {'id': 'D020794', 'term': 'Receptor Protein-Tyrosine Kinases'}, {'id': 'C477385', 'term': 'montanide ISA 51'}], 'ancestors': [{'id': 'D011505', 'term': 'Protein-Tyrosine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-06', 'studyFirstSubmitDate': '2008-05-16', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)', 'timeFrame': '1 year'}, {'measure': 'Tumor regression(Imaging study, tumor marker, etc.)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'pancreas', 'advanced', 'peptide', 'vaccination', 'VEGFR1', 'HLA', 'gemcitabine', 'IFA', 'Cancer of Pancreas', 'Neoplasms, Pancreatic', 'Pancreas Cancer'], 'conditions': ['Pancreatic Cancer', 'Pancreas Neoplasms']}, 'referencesModule': {'references': [{'pmid': '17020992', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14512794', 'type': 'BACKGROUND', 'citation': 'Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.'}], 'seeAlsoLinks': [{'url': 'http://www.transrec.jp/english/index.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nGemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.\n\nHLA-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).', 'detailedDescription': 'HLA-A\\*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.\n\nThese CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heterozygote or homozygote of HLA-A\\*2402 allele\n* Inoperable or recurrent pancreatic cancer with or without any prior therapy\n* Difficult to continue the prior therapy due to treatment-related toxicities\n* ECOG performance status 0-2\n* Evaluable primary or metastatic lesion with RECIST criteria\n* Clearance period from prior therapy more than 4 weeks\n* Life expectancy more than 3 months\n* Laboratory values as follows 2,000/μL\\<WBC\\<15,000/μL Platelet count\\>100,000/μL AST\\<150IU/L ALT\\<150IU/L Total bilirubin\\<3.0mg/dl Serum creatinine\\<3.0mg/dl\n\nExclusion Criteria:\n\n* Pregnancy (refusal or inability to use effective contraceptives)\n* Breastfeeding\n* Active or uncontrolled infection\n* Systemic use of corticosteroids or immunosuppressants\n* Uncontrollable brain metastasis and/or meningeal infiltration\n* Unhealed external wound\n* Possibilities of complicated paralytic ileus or interstitial pneumonitis\n* Decision of not eligible determined by principal investigator or attending doctor'}, 'identificationModule': {'nctId': 'NCT00683358', 'briefTitle': 'Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IMSUT-PPKVEGFR12402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: VEGFR1-A24-1084 (SYGVLLWEI)']}], 'interventions': [{'name': 'VEGFR1-A24-1084 (SYGVLLWEI)', 'type': 'BIOLOGICAL', 'otherNames': ['HLA-A*2402', 'advanced pancreatic cancer', 'VEGFR1', 'VEGFR1-A24-1084', 'SYGVLLWEI', 'IFA', 'Montanide ISA51'], 'description': '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.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '108-8639', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Hospital, The Institute of Medical Science, The University of Tokyo'}], 'overallOfficials': [{'name': 'Naohide Yamashita, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Research Hospital, Institute of Medical Science, Tokyo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Genome Center, Institute of Medical Science, University of Tokyo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Naohide Yamashita MD, PhD', 'oldOrganization': 'Research Hospital, Institute of Medical Science, The University of Tokyo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-06-09', 'type': 'RELEASE'}, {'date': '2009-07-24', 'type': 'RESET'}, {'date': '2009-10-23', 'type': 'RELEASE'}, {'date': '2009-11-23', 'type': 'RESET'}, {'date': '2010-07-23', 'type': 'RELEASE'}, {'date': '2010-08-19', 'type': 'RESET'}, {'date': '2010-10-19', 'type': 'RELEASE'}, {'date': '2010-11-17', 'type': 'RESET'}, {'date': '2011-07-19', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2011-07-20', 'type': 'RELEASE'}, {'date': '2011-08-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Research Hospital, Institute of Medical Science, The University of Tokyo (Naohide Yamashita MD, PhD)'}}}}