Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00376805
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], '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': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cool0023@umn.edu', 'phone': '612-625-8474', 'title': 'Sarah Cooley, MD', 'organization': 'Masonic Cancer Center, University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "All adverse events were collected up to patients' death (within 1 year of treatment).", 'eventGroups': [{'id': 'EG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 26, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 19, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 46, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 22, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis', 'notes': 'Includes pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 15, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 26, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'notes': 'Includes desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 30, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Myalgia', 'notes': 'Includes arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 16, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 16, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac function LVEF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Bone marrow cellularity', 'notes': 'Marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death - disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death due to progressive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Passenger lymphocyte syndrome', 'notes': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Had Expansion of Natural Killer Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of \\>100 cells/ul of whole blood 14 days after infusion with \\<5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-07'}, {'type': 'SECONDARY', 'title': 'Number of Patients by Disease Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'classes': [{'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months, 1 Year', 'description': 'Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:\n\n* Complete Response (CR: Disappearance of all target lesions\n* Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions\n* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD\n* Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions\n\nof clinical benefit (CB; stable disease for greater than 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-07'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Died While on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'classes': [{'title': 'Died within 100 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Died after 100 days', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 100 days, After 100 days', 'description': 'Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-07'}, {'type': 'SECONDARY', 'title': 'Overall Median Number of Days Patients Alive After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '212'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First Day of Treatment Until Death', 'description': 'Calculated median number of days of survival (patients alive days after treatment).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NK Cells With or Without Total Body Irradiation', 'description': 'Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Withdrawn due to toxicity', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2006-09-13', 'resultsFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2006-09-13', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-07-13', 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Had Expansion of Natural Killer Cells', 'timeFrame': 'Day 14', 'description': 'Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of \\>100 cells/ul of whole blood 14 days after infusion with \\<5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).'}], 'secondaryOutcomes': [{'measure': 'Number of Patients by Disease Response', 'timeFrame': '6 Months, 1 Year', 'description': 'Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:\n\n* Complete Response (CR: Disappearance of all target lesions\n* Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions\n* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD\n* Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions\n\nof clinical benefit (CB; stable disease for greater than 6 months.'}, {'measure': 'Number of Patients Who Died While on Study', 'timeFrame': 'Within 100 days, After 100 days', 'description': 'Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.'}, {'measure': 'Overall Median Number of Days Patients Alive After Treatment', 'timeFrame': 'First Day of Treatment Until Death', 'description': 'Calculated median number of days of survival (patients alive days after treatment).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'male breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. Giving NK cells from a related donor may kill the tumor cells.\n\nPURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML. This study will test the previous regimen in patients with breast cancer.", 'detailedDescription': 'We believe that administration of related allogeneic (donor) natural killer cells along with IL-2, rather than autologous natural killer cells will provide the most effective anticancer therapy in this setting, and wish to test this approach. To do this, we will select a related donor who is partially HLA-matched with the study subject, to increase the likelihood that donor natural killer cells will kill the subject\'s cancer cells. We will also give chemotherapy drugs to increase the subject\'s tolerance for the donor natural killer cells. We will test the use of donor natural killer (NK) cell infusions. The immune system has a special way that it sees and identifies cancer cells or foreign agents (like viruses). The subject\'s own NK cells may not attack their cancer because NK cells see the tumor cells as "self" (a coating on the cell surface identifies a cell as "self" or "non-self"). We have reason to believe that NK cells may not kill cancer cells because NK cells have special receptors that "turn them off" when they encounter cancer cells (by seeing them as "self"). We may be able to get around this problem by using donor NK cells. Finally, subjects will receive a dose of subcutaneous IL-2 3 times a week (for 2 weeks) which has been proven safe in our previous studies to stimulate the natural killer cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of metastatic breast cancer that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:\n\n * Measureable metastatic disease per Response Evaluation Criteria In Solid Tumor (RECIST) - bone only not eligible.\n * Disease progression while receiving prior therapy with a hormonal agent (if estrogen/progesterone receptor-positive) and/or trastuzumab (Herceptin®) (if HER2-neu positive)\n * Brain metastases allowed provided they are stable for ≥ 3 months after prior treatment\n* Related HLA-haploidentical natural killer cell donor available (by ≥ class I serologic typing)\n* Male or female\n* Performance status 50-100%\n* Platelet count ≥ 80,000/mm³ (unsupported by transfusions)\n* Hemoglobin ≥ 9 g/dL (unsupported by transfusions)\n* Absolute neutrophil count ≥ 1,000/mm³ (unsupported by sargramostim \\[GM-CSF\\] or filgrastim \\[G-CSF\\])\n* Creatinine ≤ 2.0 mg/dL\n* Liver function tests \\< 5 times normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* LVEF \\> 40%\\*\n* Pulmonary function \\> 50%\\* (DLCO corrected AND FEV\\_1)\n* No active infection (i.e., afebrile, off antibiotics, and no uninvestigated radiologic lesions)\n\nExclusion Criteria:\n\n* At least 3 days since prior prednisone or other immunosuppressive medications\n* No other concurrent therapy for cancer'}, 'identificationModule': {'nctId': 'NCT00376805', 'briefTitle': 'Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer', 'nctIdAliases': ['NCT00167193'], 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'UMN-2005LS033'}, 'secondaryIdInfos': [{'id': 'UMN-0505M70037', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}, {'id': 'UMN-MT2005-08', 'type': 'OTHER', 'domain': 'Blood and Bone Marrow Transplantation Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Treated Patients', 'description': 'All patients with advanced metastatic breast cancer treated with natural killer cells after receiving fludarabine, cyclosphosphamide and total body irradiation.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Radiation: Total body irradiation', 'Other: Natural killer cell infusion', 'Biological: Interleukin-2']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['Fludara'], 'description': 'administered intravenously 25 mg/m\\^2 times 5 doses', 'armGroupLabels': ['All Treated Patients']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan, Cytoxan, Neosar, Procytox'], 'description': 'administered intravenously 60 mg/kg days times 2 doses.', 'armGroupLabels': ['All Treated Patients']}, {'name': 'Total body irradiation', 'type': 'RADIATION', 'otherNames': ['radiation'], 'description': '200 cGy (gray) on day -1', 'armGroupLabels': ['All Treated Patients']}, {'name': 'Natural killer cell infusion', 'type': 'OTHER', 'otherNames': ['NK cells'], 'description': 'Infused cell dose is within the range of 1.5-8.0 x 10\\^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion.', 'armGroupLabels': ['All Treated Patients']}, {'name': 'Interleukin-2', 'type': 'BIOLOGICAL', 'otherNames': ['IL-2'], 'description': 'administered subcutaneously (10 MU) 3 times per week for 6 doses', 'armGroupLabels': ['All Treated Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jeffrey Miller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}, {'name': 'Sarah Cooley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}