Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00017069
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III 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'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', '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. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.\n* Determine the rates of overall and relapse-free survival in patients treated with this regimen.\n* Determine the safety profile of this treatment regimen in these patients.\n\nOUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.\n\nFinal assessments are conducted 4 weeks after the last study treatment and then annually thereafter.\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:\n\n* Diagnosis of stage II or III multiple myeloma\n* Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy\n\n * No more than 3 prior cytotoxic regimens\n * No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation\n* History of disease progression after prior steroid antimyeloma therapy\n* No smoldering myeloma\n* Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Absolute granulocyte count greater than 1,200/mm\\^3\\*\n* Platelet count greater than 75,000/mm\\^3\\*\n* Hemoglobin greater than 10 g/dL\\* NOTE: \\*Unless due to multiple myeloma\n\nHepatic:\n\n* Bilirubin no greater than 2 times upper limit of normal (ULN)\n* SGOT and SGPT no greater than 2 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels\n* No significant underlying cardiac dysfunction\n* No conduction defects\n* No unstable angina\n* No congestive heart failure\n* No New York Heart Association class II-IV cardiac disease\n* No myocardial infarction within the past 6 months\n\nOther:\n\n* No preexisting grade 2 or greater neurotoxicity/neuropathy\n* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer\n* No uncontrolled diabetes mellitus\n* No active serious infection uncontrolled by antibiotics\n* No history of grand mal seizures (other than infantile febrile seizures)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n* See Chemotherapy\n* At least 28 days since prior biologic therapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation\n* No other concurrent cytotoxic chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* At least 28 days since prior radiotherapy except for focal radiation for symptom control\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00017069', 'briefTitle': 'Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'CTI BioPharma'}, 'officialTitle': 'CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CTI-1060'}, 'secondaryIdInfos': [{'id': 'CDR0000068646', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'MSKCC-01012'}, {'id': 'NCI-G01-1951'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'arsenic trioxide', 'type': 'DRUG'}, {'name': 'dexamethasone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group - Springdale', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '92868-3849', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital Regional Cancer Center - Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Stockton Hematology Oncology Medical Group', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - Midtown', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34689', 'city': 'Tarpon Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Pinellas Cancer Center - Tarpon Springs', 'geoPoint': {'lat': 28.14612, 'lon': -82.75677}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mountain States Tumor Institute - Boise', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'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': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Care', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Scott C. Stromatt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CTI BioPharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CTI BioPharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}