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.
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
