Myelodysplastic Syndrome Clinical Trial
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Madison Wisconsin, 53792, United States
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