Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

H. Phillip Koeffler

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00064376
Information obtained from ClinicalTrials.gov on December 14, 2011

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