Paricalcitol in Treating Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00064376

Recruitment Status : Completed

First Posted : July 9, 2003

Last Update Posted : January 29, 2018

Sponsor:

Collaborator:

Abbott

Information provided by (Responsible Party):

H. Phillip Koeffler, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Leukemia Myelodysplastic Syndromes	Drug: paricalcitol	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
Actual Study Start Date :	May 2003
Actual Primary Completion Date :	November 2005
Actual Study Completion Date :	November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Myelodysplastic Syndromes

Drug Information available for: Paricalcitol

Genetic and Rare Diseases Information Center resources: Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Myelodysplastic Syndromes Myelodysplastic Syndrome With Excess Blasts Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	25 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064376

Locations

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United States, California
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Abbott

Investigators

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Study Chair:	H. Phillip Koeffler, MD	Cedars-Sinai Medical Center

More Information

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Responsible Party:	H. Phillip Koeffler, Director, Medicine / Hematology/Oncology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00064376
Other Study ID Numbers:	CDR0000315451 CSMC-IRB-4107-01
First Posted:	July 9, 2003 Key Record Dates
Last Update Posted:	January 29, 2018
Last Verified:	January 2018

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by H. Phillip Koeffler, Cedars-Sinai Medical Center:


de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory anemia with excess blasts in transformation	refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia chronic myelomonocytic leukemia

Additional relevant MeSH terms:

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Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes	Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions

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