Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase 2

Completed

• Conditions: Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Leukemia

• Registration Number: NCT00052832
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-01-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-07
• Status Verified: 2015-09
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States