Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
NCT ID: NCT00052832
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2002-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.
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Detailed Description
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* Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.
* Determine the toxicity profile of this drug in these patients.
* Determine the time to progression and overall survival of patients treated with this drug.
OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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doxercalciferol
Eligibility Criteria
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Inclusion Criteria
* Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia
* No more than 20% blasts by bone marrow biopsy
* Must meet at least 1 of the following criteria:
* Anemia
* Hemoglobin less than 11 g/dL over a 2-month period
* Thrombocytopenia
* Neutropenia
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* ALT and AST less than 1.5 times upper limit of normal
* Bilirubin less than 3 mg/dL
* Albumin greater than 3.0 g/dL
Renal
* Creatinine clearance greater than 50 mL/min
* No history of hypercalcemia
* No renal stones within the past 5 years
Cardiovascular
* No clinically significant heart failure
* No uncontrolled hypertension
Pulmonary
* No clinically significant pulmonary failure
Other
* Not pregnant
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior growth factor or cytokine therapy
Chemotherapy
* At least 8 weeks since prior cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Concurrent transfusion support allowed
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Mark B. Juckett, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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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.
Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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HO02403
Identifier Type: OTHER
Identifier Source: secondary_id
2002-184
Identifier Type: OTHER
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE
Identifier Type: OTHER
Identifier Source: secondary_id
HO02403
Identifier Type: -
Identifier Source: org_study_id
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