NCT00064376

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 25 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	paricalcitol

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2003-07-09
• Last updated: 2018-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study