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.
- Determine the clinical effects of paricalcitol in patients with myelodysplastic
- 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
- 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
- 25 to 100
- Karnofsky 60-100%
- At least 12 weeks
- See Disease Characteristics
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 2.5 mg/dL
- Calcium normal
- 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:
- Not specified
- More than 5 weeks since prior chemotherapy
- Not specified
- More than 5 weeks since prior radiotherapy
- Prior recent surgery allowed, if fully recovered
- More than 5 weeks since prior megadose vitamins
- No concurrent cholecalciferol, phosphate, calcium, or cholestyramine
- No concurrent digoxin