Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-29 @ 3:46 PM
Study NCT ID:
NCT00003432
Status:
TERMINATED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy in Treating Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-24', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.', 'timeFrame': 'Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)'}], 'secondaryOutcomes': [{'measure': 'Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.', 'timeFrame': 'Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.", 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.\n* Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.\n\nOUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.\n\nPatients are followed every 3 months for the first year and annually thereafter.\n\nPROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)\n\n * At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity\n* Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* Greater than 6 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1000/mm\\^3\n* Absolute lymphocyte count at least 1000/mm\\^3\n* Hemoglobin at least 9 mg/dL\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n* No serious ongoing chronic or acute hepatic disease\n\nRenal:\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular:\n\n* No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV)\n\nPulmonary:\n\n* No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis\n\nOther:\n\n* No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years\n* No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis\n* No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis\n* No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* At least 4 weeks since steroids\n* No concurrent steroid therapy\n\nRadiotherapy:\n\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent immunosuppressive agents such as azathioprine or cyclosporine A'}, 'identificationModule': {'nctId': 'NCT00003432', 'briefTitle': 'Immunotherapy in Treating Patients With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support', 'orgStudyIdInfo': {'id': '2030'}, 'secondaryIdInfos': [{'id': 'IRB 2030', 'type': 'OTHER', 'domain': 'DUMC'}, {'id': 'CDR0000066458', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carcinoembryonic antigen RNA-pulsed DC cancer vaccine', 'description': 'carcinoembryonic antigen RNA-pulsed DC cancer vaccine', 'interventionNames': ['Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine']}], 'interventions': [{'name': 'carcinoembryonic antigen RNA-pulsed DC cancer vaccine', 'type': 'BIOLOGICAL', 'description': 'Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses.', 'armGroupLabels': ['carcinoembryonic antigen RNA-pulsed DC cancer vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Herbert K. Lyerly, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}