Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01266720
Status:
UNKNOWN
Last Update Posted:
2010-12-24
First Post:
2010-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D020794', 'term': 'Receptor Protein-Tyrosine Kinases'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-23', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicities as assessed by NCI-CACAE ver3', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration', 'timeFrame': '3 months'}, {'measure': 'CD8 population', 'timeFrame': '3 months'}, {'measure': 'Change in level of regulatory T cells', 'timeFrame': '3 months'}, {'measure': 'Objective response rate', 'timeFrame': '1 year'}, {'measure': 'Feasibility', 'timeFrame': '1 year'}, {'measure': 'Survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'peptide vaccine', 'VEGFR', 'gemcitabine'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '12415261', 'type': 'BACKGROUND', 'citation': '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.'}, {'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': '15930316', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\\*0201 restricted patient with non-resectable pancreatic cancer.', 'detailedDescription': 'The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer\n* Measurable disease by CT scan\n* ECOG performance status 0-2\n* Life expectancy \\> 3 months\n* laboratory values as follows: 2,000/mm3 \\< WBC \\< 15,000/mm3, Platelet count \\>75,000/mm3, Total Bilirubin \\<1.5 mg/dl, Asparate transaminase \\<150IU/L, Alanine transaminase \\< 150 IU/L, Creatinine \\< 3.0mg/dl\n* HLA-A\\*0201\n* Able and willing to give valid written infromed consent\n\nExclusion Criteria:\n\n* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)\n* Breast-feeder\n* Active or uncontrolled infection\n* Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks\n* Serious or uncured wound\n* Active or uncontrolled other malignancy\n* Steroids or immunosuppressing agent dependent status\n* Interstitial pneumonia\n* Ileus\n* Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT01266720', 'briefTitle': 'HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)', 'organization': {'class': 'OTHER', 'fullName': 'Fukushima Medical University'}, 'officialTitle': 'Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 study', 'description': 'Interventions:\n\nBiological: VEGFR1, VEGFR2 Drug: Gemcitabine', 'interventionNames': ['Biological: VEGFR1, VEGFR2', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'VEGFR1, VEGFR2', 'type': 'BIOLOGICAL', 'otherNames': ['VEGFR1 and VEGFR2 specific epitope vaccine'], 'description': 'One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22', 'armGroupLabels': ['Phase 1 study']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.', 'armGroupLabels': ['Phase 1 study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '960-1295', 'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}], 'overallOfficials': [{'name': 'Mitsukazu Gotoh, MD & PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fukushima Medical University, Department of Regeneration Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fukushima Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Genome Center, Institute of Medical Science, University of Tokyo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fukushima Medical University (Department of Regeneration Surgery)', 'oldOrganization': 'Fukushima Medical University'}}}}