Paricalcitol in Treating Patients With Myelodysplastic Syndrome
This trial is active, not recruiting.
|Conditions||leukemia, myelodysplastic syndromes|
|Sponsor||Cedars-Sinai Medical Center|
|Start date||May 2003|
|Trial identifier||NCT00064376, CDR0000315451, CSMC-IRB-4107-01|
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.
Male or female participants at least 25 years old.
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
|Official title||A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes|
|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.|
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