Paricalcitol in Treating Patients With 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.

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