Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
NCT ID: NCT00068276
Last Updated: 2018-08-10
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
2003-07-31
2006-09-30
Brief Summary
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PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.
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Detailed Description
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* Determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes.
* Determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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cholecalciferol
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed myelodysplastic syndromes (MDS)
* Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months
* International Prognostic Scoring System score of 0 or 1
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Any
Life expectancy
* More than 1 year
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* No history of hypercalcemia
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior stem cell transplantation allowed
* No concurrent hematopoietic growth factors
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 6 weeks since prior cholecalciferol supplements or analogs
* More than 4 weeks since any prior therapy for MDS (except supportive care)
* No other concurrent therapy for MDS
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Istvan Molnar, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Bayard L. Powell, MD
Role:
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CDR0000318802
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU-BG03-117
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-29203
Identifier Type: -
Identifier Source: org_study_id
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