Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

This study has been completed.

First Received: September 10, 2003 Last Updated: February 6, 2009 History of Changes

Sponsor:	Wake Forest University
Collaborator:	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	Dietary Supplement: cholecalciferol	Phase II

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

Resource links provided by NLM:

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

Drug Information available for: Cholecalciferol

U.S. FDA Resources

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

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000318802, CCCWFU-29203, CCCWFU-BG03-117
Study First Received:	September 10, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00068276 History of Changes
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

Additional relevant MeSH terms:

Cholecalciferol
Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Myelodysplastic Syndromes
Myeloproliferative Disorders
Bone Density Conservation Agents

Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Vitamins
Syndrome
Micronutrients
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 09, 2009