Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 4:31 AM
Study NCT ID:
NCT00004893
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2000-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukin-12 in Treating Patients With Metastatic or Recurrent 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': 'D053765', 'term': 'Interleukin-12 Subunit p35'}], 'ancestors': [{'id': 'D018664', 'term': 'Interleukin-12'}, {'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': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2000-03-07', 'studyFirstSubmitQcDate': '2004-04-30', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease progression', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'time to progression', 'timeFrame': 'Up to 1 year'}, {'measure': 'overall survival', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill breast cancer cells.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer.", 'detailedDescription': 'OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of patients who have not progressed after 6 months of therapy. II. Compare percentage of patients who have not progressed after six months with or without treatment regimen. III. Determine time to progression and overall survival in this patient population after this treatment.\n\nOUTLINE: This is a randomized study. Patients are stratified according to disease free interval from primary diagnosis to first metastases (less than 3 years vs 3 years and longer), estrogen receptor status (positive vs negative), and disease status (complete response, partial response, detectable disease, or stable disease). Patients are randomized to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12 subcutaneously twice a week. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no progression after 1 year, may be followed as needed for new signs or symptoms and survival for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first 6 months, patients may receive interleukin-12 as in arm I. Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for toxicity only until interleukin-12 is discontinued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent breast cancer (not confined to breast) One prior induction chemotherapy regimen for recurrent or metastatic disease (4 weeks of treatment for 4-6 courses) resulting in stable disease, partial response, or complete response Pleural or peritoneal effusion palliated by induction chemotherapy allowed No uncontrolled brain metastases Previously treated brain metastases allowed if: No evidence of progression for at least 3 months following radiotherapy and/or surgical treatment AND At least 30 days since dexamethasone or other corticosteroids AND Other metastatic site exists No bone marrow or brain as only sites of metastases No meningeal disease Hormone receptor status Estrogen receptor status known\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Menopausal status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Platelet count at least 100,000/mm3 Hepatic: SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN) Albumin at least 3.0 g/dL Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Other: No other active malignancy except nonmelanoma skin cancer Not pregnant or nursing Fertile patients must use effective contraception No inflammatory bowel disease or active gastric ulcer No prior autoimmune disease or immunodeficiency syndrome\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No concurrent interleukin-11 Chemotherapy: See Disease Characteristics No concurrent chemotherapy Prior chemotherapy with bone marrow progenitor support (bone marrow transplant and/or peripheral blood stem cell support) allowed in adjuvant setting only (not for metastases) Endocrine therapy: Prior hormone therapy for breast cancer allowed No concurrent hormones allowed except for non-cancer or cancer treatment related conditions (e.g. insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: Prior bisphosphonate therapy allowed if started at least 3 months before study No initiation of bisphosphonate therapy during study'}, 'identificationModule': {'nctId': 'NCT00004893', 'briefTitle': 'Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design', 'orgStudyIdInfo': {'id': 'CALGB-49806'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CLB-49806'}, {'id': 'CDR0000067570', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IL12 Therapy', 'description': 'Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12 subcutaneously twice a week. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no progression after 1 year, may be followed as needed for new signs or symptoms and survival for 5 years.', 'interventionNames': ['Biological: recombinant interleukin-12']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Patients are observed for 6 months. If disease progresses during first 6 months, patients may receive interleukin-12 as in arm I. Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for toxicity only until interleukin-12 is discontinued.'}], 'interventions': [{'name': 'recombinant interleukin-12', 'type': 'BIOLOGICAL', 'armGroupLabels': ['IL12 Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Cancer Center and Cancer Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center, Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20307-5000', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Health Sciences Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Chicago (Westside Hospital)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '04330', 'city': 'Togus', 'state': 'Maine', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Togus', 'geoPoint': {'lat': 44.27451, 'lon': -69.7031}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Marlene & Stewart Greenebaum Cancer Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Minneapolis', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Columbia (Truman Memorial)', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-3330', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'CCOP - Southern Nevada Cancer Research Foundation', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital - Cornell Campus', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York - Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13217', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center, UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27104-4241', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157-1082', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital - Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425-0721', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee, Memphis Cancer Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'CCOP - Southwestern Vermont Regional Cancer Center', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'zip': '05401-3498', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Cancer Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - White River Junction', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298-0037', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'MBCCOP - Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Daniel F. Hayes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}