Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Phase 2

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT00064376
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells.

PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.

Detailed Description

OBJECTIVES:

* Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.

* Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.

* Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.

OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-07-08
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

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)

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States