Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-03-18 @ 5:03 PM
Study NCT ID:
NCT00674258
Status:
UNKNOWN
Last Update Posted:
2008-05-14
First Post:
2008-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525725', 'term': 'LY6K protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-12', 'studyFirstSubmitDate': '2008-05-05', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)', 'timeFrame': 'two months'}], 'secondaryOutcomes': [{'measure': 'To evaluate immunological responses', 'timeFrame': 'two months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HLA-A*2402', 'Peptide Vaccine', 'URLC10', 'TTK', 'KOC1'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17784873', 'type': 'BACKGROUND', 'citation': 'Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.'}, {'pmid': '18297458', 'type': 'BACKGROUND', 'citation': 'Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24.'}, {'pmid': '16630140', 'type': 'BACKGROUND', 'citation': 'Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.'}, {'pmid': '9500606', 'type': 'BACKGROUND', 'citation': 'Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321.'}, {'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 purpose of this study is to evaluate the safety and time to progression of HLA-A\\*2402 restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.', 'detailedDescription': 'URLC10,TTK and KOC1 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\\*2402 restricted epitope peptides derived from these molecules and identified that these peptides significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-177 peptide(1mg), TTK-567 peptide(1mg) and KOC1-508 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDisease characteristics\n\n* Advanced or recurrent non small cell lung cancer\n* Second line or later therapeutic status Patient characteristics\n* ECOG performance status 0-2\n* Life expectancy \\> 3 months\n* HLA-A\\*2402\n* Laboratory values as follows\n\n * 2000/mm3\\<WBC\\<15000/mm3\n * Platelet count\\>100000/mm3\n * Bilirubin \\< 3.0mg/dl\n * Asparate transaminase \\< 150IU/L\n * Alanine transaminase \\< 150IU/L\n * Creatinine \\< 3.0mg/dl\n* Able and willing to give valid written informed consent\n\nExclusion Criteria:\n\n* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)\n* Breastfeeding\n* Active or uncontrolled infection\n* Concurrent treatment with steroids or immunosuppressing agent\n* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks\n* Uncontrolled brain and/or intraspinal metastasis\n* Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT00674258', 'briefTitle': 'Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo University'}, 'officialTitle': 'Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'IMS-NSCLC24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Biological: URLC10, TTK and KOC1']}], 'interventions': [{'name': 'URLC10, TTK and KOC1', 'type': 'BIOLOGICAL', 'description': 'Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), TTK- peptide(1mg) and KOC1- peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '108-8639', 'city': 'Tokyo', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Fujii, MD/PhD', 'role': 'CONTACT', 'email': 'tmks@ims.u-tokyo.ac.jp', 'phone': '81-3-3443-8111', 'phoneExt': '75032'}], 'facility': 'The Institute of Medical Science, The University of Tokyo', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Takeshi Fujii, MD/PhD', 'role': 'CONTACT', 'email': 'tmks@ims.u-tokyo.ac.jp', 'phone': '81-3-3443-8111', 'phoneExt': '75032'}], 'overallOfficials': [{'name': 'Naohide Yamashita, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': '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': 'Department of Infectious Disease and Applied Immunology', 'oldOrganization': 'The Institute of Medical Science, The University of Tokyo'}}}}