Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
| 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
- Any
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 Lead Organizations
Wake Forest University Comprehensive Cancer Center
 | | | ||
| Istvan Molnar, MD, Protocol chair | |
| ||
| ||||
| Bayard Powell, MD, Protocol co-chair | |
| ||
| ||||
| 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.
Back to Top
