Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01259505
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2010-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C438388', 'term': 'KIF20B protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2010-12-11', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety (Phase I: toxicities as assessed by NCI CTCAE version3)', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'to evaluate efficacy (feasibility as evaluated by RECIST)', 'timeFrame': '2 months', 'description': 'to evaluate overall survival to evaluate progression free survivial to evaluate efficacy (feasibility as evaluated by RECIST) to evaluate immunological responses to evaluate quality of life'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['no number'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of HLA-A\\*2402 restricted epitope peptides CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.', 'detailedDescription': 'CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules especially in breast 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 these peptides. Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) 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 peptides vaccine. Also 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\n* Advanced or recurrent breast cancer\n* Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)\n* Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive\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* Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT01259505', 'briefTitle': 'Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo Medical University'}, 'officialTitle': 'Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer', 'orgStudyIdInfo': {'id': 'MBCCTA-001-STT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety', 'description': 'CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.', 'interventionNames': ['Biological: CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1']}], 'interventions': [{'name': 'CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1', 'type': 'BIOLOGICAL', 'description': 'CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.', 'armGroupLabels': ['Safety']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300-0395', 'city': 'Ami Inashiki', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tokyo Medical University Ibaraki Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tokyo University', 'class': 'OTHER'}, {'name': 'Saint Luca International Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Minoru Fujimori', 'investigatorAffiliation': 'Tokyo Medical University'}}}}