Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT00284804
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2006-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510955', 'term': 'iratumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2006-01-30', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2006-01-30', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'Day 50/57'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Day 50/57'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["relapsed or refractory Hodgkin's Disease"], 'conditions': ["Hodgkin's Disease"]}, 'descriptionModule': {'briefSummary': "This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.", 'detailedDescription': 'Secondary objectives include:\n\n* to characterize progression-free survival\n* to characterize time to progression\n* to determine response duration\n* to characterize the effect of study drug on health-related quality of life\n* to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population\n* to characterize the immunogenicity response of MDX-060\n* to characterize the safety of MDX-060, and\n* to characterize the pharmacokinetic profile of MDX-060'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Hodgkin's disease \\[HD\\] (excluding HIV-associated HD)\n* Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained\n* Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant\n* ECOG Performance Status of 0-2\n* Patients must have bi-measurable disease\n* At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment\n* Life expectancy 12 weeks or greater\n* Screening laboratory values must be met\n* Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.\n\nExclusion Criteria:\n\n* Previous treatment with any anti-CD30 antibody\n* History of allogeneic transplant\n* Any tumor lesion 10cm or greater in diameter\n* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.\n* Any significant active or chronic infection\n* Apparent active or latent tuberculosis (TB) infection\n* Patients who are pregnant or nursing\n* Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events\n* Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy"}, 'identificationModule': {'nctId': 'NCT00284804', 'briefTitle': "A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease", 'orgStudyIdInfo': {'id': 'MDX060-05/05E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDX-060 plus standard of care', 'description': 'MDX-060 in combination with gemcitabine', 'interventionNames': ['Drug: MDX-060']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Gemcitabine', 'interventionNames': ['Drug: MDX-060']}], 'interventions': [{'name': 'MDX-060', 'type': 'DRUG', 'otherNames': ['anti-CD30'], 'description': 'anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg', 'armGroupLabels': ['MDX-060 plus standard of care', 'Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope, National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Oncology of the Central Valley', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego/Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Cancer Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Hospital Center', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Division of Hematology/Oncology, Tufts-New England Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology Institute, PLLC', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center, The University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '26506-9162', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Mary Babb Randolph Cancer Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Medarex Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medarex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}