Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Cedars-Sinai Medical Center

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia Myelodysplastic Syndromes

Interventions

paricalcitolDRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 100 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification * Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential * Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine PATIENT CHARACTERISTICS: Age * 25 to 100 Performance status * Karnofsky 60-100% Life expectancy * At least 12 weeks Hematopoietic * See Disease Characteristics Hepatic * Bilirubin less than 2.0 mg/dL Renal * Creatinine less than 2.5 mg/dL * Calcium normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior sensitivity to paricalcitol or any component of its formulation * No prior cholecalciferol toxicity * No other concurrent acute illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 5 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 5 weeks since prior radiotherapy Surgery * Prior recent surgery allowed, if fully recovered Other * More than 5 weeks since prior megadose vitamins * No concurrent cholecalciferol, phosphate, calcium, or cholestyramine * No concurrent digoxin

Locations (1)

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, United States

Data from ClinicalTrials.gov

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