Expired Study
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Madison, Wisconsin 53792


Purpose:

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. PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - 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


NCT ID:

NCT00052832


Primary Contact:

Study Chair
Mark B. Juckett, MD
University of Wisconsin, Madison


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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