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Phase II Pilot Study of Cholecalciferol in Patients With Low- or Intermediate-Risk Myelodysplastic Syndromes

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed Any age NCI CCCWFU-29203
CCCWFU-BG03-117, NCT00068276

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.

Entry 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

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

Patient Characteristics:

Age

Any age

Performance status

Life expectancy

More than 1 year

Hematopoietic

Not specified

Hepatic

Not specified

Renal

No history of hypercalcemia

Expected Enrollment

A total of 36 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Istvan Molnar, MD, Protocol chair
Ph: 336-716-5847; 800-446-2255
Bayard Powell, MD, Protocol co-chair
Ph: 336-716-7970; 800-446-2255
Email: bpowell@wfubmc.edu

Registry Information

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

Trial Start Date		2003-07-01

Registered in ClinicalTrials.gov		NCT00068276

Date Submitted to PDQ		2003-06-30

Information Last Verified		2005-05-04

NCI Grant/Contract Number		P30-CA12197

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.