Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT00074269
Status:
TERMINATED
Last Update Posted:
2023-06-05
First Post:
2003-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tball@ucsd.edu', 'phone': '858-822-6600', 'title': 'Dr. Edward Ball, Director BMT Program', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Terminated early due to small numbers of subjects enrolled on study'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'AEs and SAEs collected on all Patients', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'The events monitored in the treatment arm of the protocol are listed below:\n\nincidence of Toxicity\n\nadministration of filgrastim\n\nGrade of GVHD\n\nInitiation of graft-versus-tumor induction therapy\n\nDisease Status', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'aGVHD Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'aGVHD Gut', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'aGVHD Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Overall GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilteral Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ALT Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'AST Elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Capillary Leak Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Toxicity\n\nanti-thymocyte globulin\n\nfilgrastim\n\ngraft-versus-tumor induction therapy\n\ntherapeutic allogeneic lymphocytes\n\ncyclosporine\n\nfludarabine phosphate\n\nmelphalan\n\nmethotrexate\n\nperipheral blood stem cell transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years post transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients treated on protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post transplant', 'description': 'Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC \\>1000 for 3 consecutive days and platelet count of \\>50,000', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients Treated Per Protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'anti-thymocyte globulin\n\nfilgrastim\n\ngraft-versus-tumor induction therapy\n\ntherapeutic allogeneic lymphocytes\n\ncyclosporine\n\nfludarabine phosphate\n\nmelphalan\n\nmethotrexate\n\nperipheral blood stem cell transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '180'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months', 'description': 'Progression assessed by CT scan', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'patients treated on protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '279.4', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '373'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year from the time of transplant', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'SECONDARY', 'title': 'Response as Measured at 12 Months Post Allografting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients treated on protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months', 'description': 'response (partial and complete) assessed by CT scan at 12 months post allografting', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}, {'type': 'SECONDARY', 'title': 'Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients treated on protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post allografting', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed early due to lack of accrual.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'anti-thymocyte globulin\n\nfilgrastim\n\ngraft-versus-tumor induction therapy\n\ntherapeutic allogeneic lymphocytes\n\ncyclosporine\n\nfludarabine phosphate\n\nmelphalan\n\nmethotrexate\n\nperipheral blood stem cell transplantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The protocol recruited patients with Metastatic breast cancer for transplant after ATG, high-dose Melphalan and Fludarabine.This was a non-randomized, single arm pilot study. Patients received fludarabine IV days -8 to -4, ATG IV on days -7 to -4 and High dose Melphalan days -3 to -2. This protocol is closed to accrual as of March 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pilot Study of Allogeneic Transplant for Metastatic Breast Can', 'description': 'anti-thymocyte globulin\n\nfilgrastim\n\ngraft-versus-tumor induction therapy\n\ntherapeutic allogeneic lymphocytes\n\ncyclosporine\n\nfludarabine phosphate\n\nmelphalan\n\nmethotrexate\n\nperipheral blood stem cell transplantation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This is a pilot study. The original planned target accrual was 15 male or female patients age 18-60 but due to poor enrollment the study was closed to accrual early after 5 patients had been enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Terminated early due to poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2003-12-10', 'resultsFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2003-12-10', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-20', 'studyFirstPostDateStruct': {'date': '2003-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '5 years post transplant'}, {'measure': 'Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes', 'timeFrame': '30 days post transplant', 'description': 'Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC \\>1000 for 3 consecutive days and platelet count of \\>50,000'}, {'measure': 'Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)', 'timeFrame': '100 days post transplant'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months', 'description': 'Progression assessed by CT scan'}, {'measure': 'Overall Survival', 'timeFrame': '1 year from the time of transplant'}, {'measure': 'Response as Measured at 12 Months Post Allografting', 'timeFrame': 'From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months', 'description': 'response (partial and complete) assessed by CT scan at 12 months post allografting'}, {'measure': 'Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting', 'timeFrame': '1 month post allografting'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, cyclosporine, and methotrexate before or after the transplant may stop this from happening.\n\nPURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast.\n* Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients.\n* Determine the response in measurable/evaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease (GVHD) in patients treated with this regimen.\n\nSecondary\n\n* Determine the progression-free and overall survival of patients treated with this regimen.\n* Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen.\n* Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen.\n\nOUTLINE: This is a nonrandomized, pilot study.\n\n* Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4, anti-thymocyte globulin IV over 4 hours on days -7 to -4, and high-dose melphalan IV over 30 minutes on days -3 and -2.\n* Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (and then orally when tolerated) every 12 hours beginning on day -4 and tapered after day 42 (if no GVHD occurs) or after day 90 (if grade I acute GVHD occurs). Patients also receive methotrexate IV on days 1, 3, and 6.\n* Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo allogeneic PBSCT on day 0. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0 and continuing until blood counts recover.\n* Donor lymphocyte infusion (DLI): Patients who show disease progression or fail to achieve full donor type T-cell chimerism (at least 90% donor derived T-cells) by the 90-day assessment posttransplantation, and have no evidence of active GVHD may receive DLI. Patients who have unresponsive disease with no active GVHD receive subsequent DLIs every 6-8 weeks.\n\nPatients are followed at 1, 3, 6, 12, 18, 24, 30, and 36 months.\n\nPROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the breast\n\n * Metastatic disease\n* Meets 1 of the following criteria:\n\n * Chemotherapy-unresponsive disease defined as 1 of the following:\n\n * Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession\n * Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen\n * Histologically confirmed tumor involvement on bone marrow biopsy\n* Measurable or evaluable disease\\* defined as the following:\n\n * Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI\n * Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only)\n\n * Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: \\*Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease\n* Appropriate candidate for allogeneic stem cell transplantation\n* No active CNS metastases\n* Available HLA-identical sibling donor\n\n * 6/6 antigen match\n * Donor CD34 cells at least 2 times 10\\^6/kg recipient weight\n* Hormone receptor status:\n\n * Estrogen receptor negative or positive\n\n * Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 60\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Karnofsky 70-100% OR\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 1,500/mm\\^3\n* Platelet count at least 30,000/mm\\^3\n\nHepatic\n\n* Bilirubin less than 3 times normal\\*\n* AST and ALT less than 3 times normal\\* NOTE: \\*Unless abnormality due to malignancy\n\nRenal\n\n* Creatinine no greater than 1.6 mg/dL\n\nCardiovascular\n\n* LVEF greater than 40% by echocardiography or MUGA\n* No myocardial infarction within the past 6 months\n\nPulmonary\n\n* DLCO greater than 40% of predicted\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No serious localized or systemic infection\n* No hypersensitivity to E. coli-derived products\n* No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication\n* No psychological condition or social situation that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* No concurrent glucocorticoids\n\nRadiotherapy\n\n* No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No concurrent immunosuppressive medication'}, 'identificationModule': {'nctId': 'NCT00074269', 'briefTitle': 'Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '020815'}, 'secondaryIdInfos': [{'id': 'CDR0000343758', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'interventionNames': ['Biological: anti-thymocyte globulin', 'Biological: filgrastim', 'Biological: graft-versus-tumor induction therapy', 'Biological: therapeutic allogeneic lymphocytes', 'Drug: cyclosporine', 'Drug: fludarabine phosphate', 'Drug: melphalan', 'Drug: methotrexate', 'Procedure: peripheral blood stem cell transplantation']}], 'interventions': [{'name': 'anti-thymocyte globulin', 'type': 'BIOLOGICAL', 'armGroupLabels': ['treatment']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['treatment']}, {'name': 'graft-versus-tumor induction therapy', 'type': 'BIOLOGICAL', 'armGroupLabels': ['treatment']}, {'name': 'therapeutic allogeneic lymphocytes', 'type': 'BIOLOGICAL', 'armGroupLabels': ['treatment']}, {'name': 'cyclosporine', 'type': 'DRUG', 'armGroupLabels': ['treatment']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'armGroupLabels': ['treatment']}, {'name': 'melphalan', 'type': 'DRUG', 'armGroupLabels': ['treatment']}, {'name': 'methotrexate', 'type': 'DRUG', 'armGroupLabels': ['treatment']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Edward D. Ball, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Edward Ball', 'investigatorAffiliation': 'University of California, San Diego'}}}}