Completed

NCT Number: NCT00064376

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

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.

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Key information

Conditions

Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

Abbott

Registry information

Official study title

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Jul 9, 2003
Registry last updated: Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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