Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Conditions
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Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
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* Drug: paricalcitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia