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Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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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 UniversityWinston-Salem, North Carolina  27157-1082