Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
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.
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Dietary Supplement: doxercalciferol||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes|
|Study Start Date:||September 2002|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052832
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Mark B. Juckett, MD||University of Wisconsin, Madison|