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Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at Wake Forest University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2003
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00068276
Brief Title
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Official Title
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istvan Molnar, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bayard L. Powell, MD
Organizational Affiliation
Wake Forest University Health Sciences
Facility Information:
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

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Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

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