Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Dietary Supplement: cholecalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00068276

CCCWFU-29203

CDR0000318802 (Registry Identifier)

CCCWFU-BG03-117

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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