Paricalcitol in Treating Patients With Myelodysplastic Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

July 8, 2003

Last Updated Date

July 23, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00064376 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Official Title ^ICMJE

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: paricalcitol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00064376

Responsible Party

Study ID Numbers ^ICMJE

CDR0000315451, CSMC-IRB-4107-01

Study Sponsor ^ICMJE

Cedars-Sinai Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

H. Phillip Koeffler, MD

Cedars-Sinai Medical Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP