Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome. PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - 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


NCT ID:

NCT00068276


Primary Contact:

Study Chair
Istvan Molnar, MD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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