Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	25 to 100	Other	CSMC-IRB-4107-01 NCT00064376

Objectives

1. Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.
2. Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.
3. Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.

Entry 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

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

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

Expected Enrollment

A total of 20 patients will be accrued for this study within 8 months.

Outline

Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

Trial Contact Information

Trial Lead Organizations

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

H. Phillip Koeffler, MD, Protocol chair		Ph: 310-423-4609 Email: koeffler@cshs.org

Registry Information
Official Title		A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
Trial Start Date		2003-05-31
Registered in ClinicalTrials.gov		NCT00064376
Date Submitted to PDQ		2003-06-05
Information Last Verified		2004-09-08

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