Paricalcitol in Treating Patients With Myelodysplastic Syndrome
NCT ID: NCT00064376
Last Updated: 2018-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-05-31
2005-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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paricalcitol
Eligibility Criteria
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Inclusion Criteria
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
25 Years
100 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Cedars-Sinai Medical Center
OTHER
Responsible Party
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H. Phillip Koeffler
Director, Medicine / Hematology/Oncology
Principal Investigators
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H. Phillip Koeffler, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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CSMC-IRB-4107-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000315451
Identifier Type: -
Identifier Source: org_study_id
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