NCT00052832CompletedPhase 2
Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 1
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •Hemoglobin less than 11 g/dL over a 2-month period
- •Thrombocytopenia
- •Neutropenia
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •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
- •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
- •No clinically significant pulmonary failure
- •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
- •Not specified
- •Concurrent transfusion support allowed
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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