Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 5:25 PM
Study NCT ID:
NCT00584766
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Combo Chemo With Autologous BM Rescue for 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': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1987-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of maximal response; time to initial disease progression; and overall survival', 'timeFrame': 'undetermined'}], 'secondaryOutcomes': [{'measure': 'to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer', 'timeFrame': 'undetermined'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* breast carcinoma at first clinical evidence of metastatic disease\n* must have measurable disease by physical exam, x-ray, or scan\n* Age \\< or equal to 55\n* performance status 0-2\n\nExclusion Criteria:\n\n* can't have had more than one prior chemotherapy regimen\n* can't have had concurrent hormonal therapy\n* no brain metastases\n* no previous pelvic radiation\n* no history of another malignancy"}, 'identificationModule': {'nctId': 'NCT00584766', 'briefTitle': 'Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study', 'orgStudyIdInfo': {'id': 'OU 8701'}, 'secondaryIdInfos': [{'id': 'OU 8701'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Procedure: High-dose chemotherapy']}], 'interventions': [{'name': 'High-dose chemotherapy', 'type': 'PROCEDURE', 'description': 'Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'George Selby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'George Selby', 'oldOrganization': 'University of Oklahoma Health Sciences Center'}}}}