Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-28 @ 2:09 PM
Study NCT ID:
NCT00052832
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2003-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
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': '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': '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': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2003-01-24', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['chronic myelomonocytic leukemia', 'previously treated myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'de novo myelodysplastic syndromes', 'atypical chronic myeloid leukemia', 'myelodysplastic/myeloproliferative disease, unclassifiable'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Diseases']}, 'referencesModule': {'references': [{'pmid': '18203012', 'type': 'RESULT', 'citation': 'Petrich A, Kahl B, Bailey H, Kim K, Turman N, Juckett M. Phase II study of doxercalciferol for the treatment of myelodysplastic syndrome. Leuk Lymphoma. 2008 Jan;49(1):57-61. doi: 10.1080/10428190701713648.'}], 'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.\n\nPURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.\n* Determine the toxicity profile of this drug in these patients.\n* Determine the time to progression and overall survival of patients treated with this drug.\n\nOUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: Approximately 41 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* Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia\n\n * No more than 20% blasts by bone marrow biopsy\n* Must meet at least 1 of the following criteria:\n\n * Anemia\n\n * Hemoglobin less than 11 g/dL over a 2-month period\n * Thrombocytopenia\n * Neutropenia\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n\nHepatic\n\n* ALT and AST less than 1.5 times upper limit of normal\n* Bilirubin less than 3 mg/dL\n* Albumin greater than 3.0 g/dL\n\nRenal\n\n* Creatinine clearance greater than 50 mL/min\n* No history of hypercalcemia\n* No renal stones within the past 5 years\n\nCardiovascular\n\n* No clinically significant heart failure\n* No uncontrolled hypertension\n\nPulmonary\n\n* No clinically significant pulmonary failure\n\nOther\n\n* Not pregnant\n* Fertile patients must use effective contraception during and for 6 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 4 weeks since prior growth factor or cytokine therapy\n\nChemotherapy\n\n* At least 8 weeks since prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* Concurrent transfusion support allowed'}, 'identificationModule': {'nctId': 'NCT00052832', 'briefTitle': 'Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'HO02403'}, 'secondaryIdInfos': [{'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}, {'id': 'HO02403', 'type': 'OTHER', 'domain': 'University of Wisconsin Carbone Cancer Center'}, {'id': '2002-184', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A534260', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'doxercalciferol', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mark B. Juckett, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}