Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Leukemia Clinical Trial

Official title:

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064376
• Other study ID #: CDR0000315451
• Secondary ID: CSMC-IRB-4107-01
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: January 25, 2018
• Start date: May 2003
• Est. completion date: November 2005

Study information

• Verified date: January 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• paricalcitol

Locations

Country	Name	City	State
United States	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Abbott

Country where clinical trial is conducted

United States,