Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00052832|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Dietary Supplement: doxercalciferol||Phase 2|
- 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 (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||July 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|