Expired Study
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Los Angeles, California 90048


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00064376


Primary Contact:

Study Chair
H. Phillip Koeffler, MD
Cedars-Sinai Medical Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90048
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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