Paricalcitol in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsored by:	Cedars-Sinai Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064376

Purpose

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	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Drug: paricalcitol	Phase II

MedlinePlus related topics: Anemia Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2003

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064376

Locations

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

Investigators

Study Chair:

H. Phillip Koeffler, MD

Cedars-Sinai Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000315451, CSMC-IRB-4107-01
Study First Received:	July 8, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00064376
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Myelodysplastic syndromes
Precancerous Conditions
Chronic myelomonocytic leukemia
Refractory anemia
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplasia

Anemia
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009