NCT00052832

Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	doxercalciferol

Timeline

• Start date: 2002-09-01
• Primary completion: 2005-07-01
• First posted: 2003-01-27
• Last updated: 2019-11-19

Locations

1 site across 1 country: United States