Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 2

Conditions: Leukemia; Myelodysplastic Syndromes

Treatments: Drug: paricalcitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00064376

CSMC-IRB-4107-01

CDR0000315451

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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