Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 1:21 PM
Study NCT ID:
NCT00006092
Status:
TERMINATED
Last Update Posted:
2012-09-26
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}], '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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Rate of Response (ORR)', 'timeFrame': '2.5 years', 'description': 'Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent adult acute lymphoblastic leukemia', 'relapsing chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'chronic myelogenous leukemia, BCR-ABL1 positive', 'lymphoid leukemia', 'myeloid and monocytic leukemia'], 'conditions': ['Leukemia']}, '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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.\n* Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.\n* Determine the pattern of clinical adverse experience in these patients when treated with this regimen.\n* Determine the pharmacokinetic profile of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.\n\nPatients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of one of the following:\n\n * Acute lymphoblastic leukemia\n\n * Philadelphia chromosome (Bcr-abl) positive\n * Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation\n * Blastic phase chronic myelogenous leukemia\n\n * Philadelphia chromosome (Bcr-abl) positive\n * Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate\n* Must not be eligible for bone marrow transplant\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin no greater than 2.0 times upper limit of normal (ULN)\n* AST/ALT no greater than 2 times ULN\n\nRenal:\n\n* Creatinine no greater than 2.0 times ULN\n* Creatinine clearance greater than 70 mL/min\n\nCardiovascular:\n\n* No uncontrolled angina\n* No New York Heart Association class III or IV heart disease\n* No second degree heart block without pacemaker\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n* HIV negative\n* No uncontrolled infection or other serious concurrent illness\n* No peripheral neuropathy\n* No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR\n* No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected\n* Electrolyte imbalances must be corrected prior to study entry\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 28 days since prior chemotherapy\n* At least 24 hours since prior hydroxyurea\n* No prior arsenic trioxide\n* No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 28 days since prior radiotherapy\n* No concurrent radiotherapy including for palliation\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 14 days since prior imatinib mesylate\n* No other concurrent investigational agents\n* No concurrent amphotericin B'}, 'identificationModule': {'nctId': 'NCT00006092', 'briefTitle': 'Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis', 'orgStudyIdInfo': {'id': 'MCC-12395'}, 'secondaryIdInfos': [{'id': 'NCI-1230', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arsenic Trioxide Treatment', 'description': 'Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.', 'interventionNames': ['Drug: Arsenic Trioxide']}], 'interventions': [{'name': 'Arsenic Trioxide', 'type': 'DRUG', 'otherNames': ['Trisenox'], 'armGroupLabels': ['Arsenic Trioxide Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Thomas P. Loughran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}