Paricalcitol in Treating Patients With Myelodysplastic Syndrome

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00064376

Enrollment

Unknown

Registered

2003-07-09

Start date

2003-05-31

Completion date

2005-11-30

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelodysplastic Syndromes

Keywords

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

Brief 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.

Detailed 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.

Interventions

DRUGparicalcitol

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 100 Years

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026