Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

University of Wisconsin, Madison

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Interventions

doxercalciferolDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Data from ClinicalTrials.gov

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