Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT00225992
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2005-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'whyStopped': 'terminated due to lack of accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2005-09-22', 'studyFirstSubmitQcDate': '2005-09-23', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndrome (MDS)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ccihsv.com', 'label': 'Comprehensive Cancer Institute'}]}, 'descriptionModule': {'briefSummary': 'In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.\n\nArsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation\n* Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment\n* ECOG performance status of 0-2\n* An EKG must be performed within 7 days prior to treatment to confirm QT interval \\<460msec.\n* Serum creatinine less than or equal to 2.5 times the upper limit of normal.\n* Serum bilirubin less than or equal to 2.5 times the upper limit of normal.\n* Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.\n* Patients must be 18 years of age to participate in this study\n\nExclusion Criteria:\n\n* Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.\n* Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.\n* Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.\n* Peripheral neuropathy greater than or equal to 2.\n* Evidence of active infection\n* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.\n* Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.'}, 'identificationModule': {'nctId': 'NCT00225992', 'briefTitle': 'Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)', 'organization': {'class': 'OTHER', 'fullName': 'Oncology Specialties, Alabama'}, 'officialTitle': 'A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'CCI-MDS-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Arsenic Trioxide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '358601', 'city': 'Decatur', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.60593, 'lon': -86.98334}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}], 'overallOfficials': [{'name': 'John M. Waples, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oncology Specialties, PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncology Specialties, Alabama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}