Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00017433
Status:
TERMINATED
Last Update Posted:
2020-10-06
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide in Treating Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077237', 'term': 'Arsenic Trioxide'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2004-01-07', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['refractory multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory stage II or stage III multiple myeloma.', 'detailedDescription': 'OBJECTIVES: I. Determine the response rate of patients with relapsed or refractory stage II or III multiple myeloma treated with arsenic trioxide. II. Determine the overall and relapse-free survival rates of patients treated with this drug. III. Determine the safety profile of this drug in these patients.\n\nOUTLINE: Patients receive arsenic trioxide IV on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 6 courses. Patients are followed at 4 weeks after the last treatment dose.\n\nPROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Stage II or III (Durie-Salmon) Relapsed or refractory to conventional therapy No monoclonal gammopathy or indolent or smoldering myeloma Measurable disease by serum and urine M protein and/or plasmacytoma\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior biologic therapy Chemotherapy: No more than 3 prior chemotherapy regimens, including no more than 2 cytotoxic regimens AND 1 high-dose cytotoxic regimen as part of stem cell transplantation Endocrine therapy: At least 28 days since prior endocrine therapy Radiotherapy: At least 28 days since prior radiotherapy (except for focal radiotherapy for symptom control) Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00017433', 'briefTitle': 'Arsenic Trioxide in Treating Patients With Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'CTI BioPharma'}, 'officialTitle': 'Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CTI-1057'}, 'secondaryIdInfos': [{'id': 'CDR0000068688', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'arsenic trioxide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialist', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Carolyn Paradise, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CTI BioPharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CTI BioPharma', 'class': 'INDUSTRY'}}}}