Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT00020969
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': '2001-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['refractory anemia', 'refractory anemia with ringed sideroblasts', 'refractory anemia with excess blasts', 'refractory anemia with excess blasts in transformation', 'chronic myelomonocytic leukemia', 'de novo myelodysplastic syndromes', 'previously treated myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'myelodysplastic/myeloproliferative neoplasm, unclassifiable'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms']}, 'referencesModule': {'references': [{'pmid': '16651647', 'type': 'RESULT', 'citation': 'Schiller GJ, Slack J, Hainsworth JD, Mason J, Saleh M, Rizzieri D, Douer D, List AF. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol. 2006 Jun 1;24(16):2456-64. doi: 10.1200/JCO.2005.03.7903. Epub 2006 May 1.'}]}, '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 myelodysplastic syndromes.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.\n* Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.\n* Determine the durability of responses in patients treated with this drug.\n* Determine the duration of overall and progression-free survival of patients treated with this drug.\n* Assess the quality of life of patients treated with this drug.\n* Assess the toxicity profile of this drug in these patients.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk).\n\nPatients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR.\n\nQuality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion.\n\nPatients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) 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 myelodysplastic syndromes (MDS)\n\n * Refractory anemia (RA)\n * RA with ringed sideroblasts\n * RA with excess blasts (RAEB)\n * RAEB in transformation\n * Chronic myelomonocytic leukemia\n* Low-risk MDS patients:\n\n * If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial\n* No prior acute myeloid leukemia\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin no greater than 2.5 times upper limit of normal (ULN)\n* SGPT and SGOT no greater than 2.5 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 magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L\n\nOther:\n\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* At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients)\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 30 days since prior radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 30 days since prior cytotoxic agents\n* At least 30 days since prior investigational agents\n* No prior arsenic trioxide'}, 'identificationModule': {'nctId': 'NCT00020969', 'briefTitle': 'Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'CTI BioPharma'}, 'officialTitle': 'Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'CTI-1058'}, 'secondaryIdInfos': [{'id': 'CDR0000068734', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'UCLA-HSPC-010104701'}, {'id': 'NCI-G01-1971'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'arsenic trioxide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037-1027', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Green Cancer Center at Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033-0804', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1678', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'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': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lynn Regional Cancer Center West', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists - Northside Office', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '78412', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Corpus Christi Cancer Center', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}], '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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}