Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Conditions
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Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Intervention / Treatment
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* Dietary Supplement: doxercalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: doxercalciferol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable