Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
N/A
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Trial Information
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Istvan Molnar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CCCWFU-29203
NCT ID:
NCT00068276
Start Date:
July 2003
Completion Date:
September 2006
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- previously treated myelodysplastic syndromes
- de novo myelodysplastic syndromes
- secondary myelodysplastic syndromes
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- childhood myelodysplastic syndromes
- Neoplasms
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
