Overview

This trial is active, not recruiting.

Conditions leukemia, myelodysplastic syndromes
Treatment paricalcitol
Phase phase 2
Sponsor Cedars-Sinai Medical Center
Start date May 2003
Trial identifier NCT00064376, CDR0000315451, CSMC-IRB-4107-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).