Paricalcitol in Treating Patients With Myelodysplastic Syndrome
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia
Eligibility 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
Sites / Locations
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center