Cholecalciferol in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068276

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.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Drug: cholecalciferol	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2003

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068276

Locations

United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Istvan Molnar, MD	Wake Forest University
Investigator:	Bayard L. Powell, MD	Wake Forest University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000318802, CCCWFU-29203, CCCWFU-BG03-117
Study First Received:	September 10, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00068276
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

previously treated myelodysplastic syndromes
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes

atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
childhood myelodysplastic syndromes

Study placed in the following topic categories:

Myelodysplastic syndromes
Cholecalciferol
Precancerous Conditions
Chronic myelogenous leukemia
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplasia
Myelodysplastic Syndromes
Ergocalciferols
Myeloproliferative Disorders

Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia
Preleukemia
Vitamin D
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm Metastasis
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Growth Substances
Vitamins

Syndrome
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009