Phase II Pilot Study of Cholecalciferol in Patients With Low- or Intermediate-Risk Myelodysplastic Syndromes
Last Modified: 7/12/2007 First Published: 8/24/2003
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 | Protocol IDs |
|---|
| Phase II | Treatment | Completed | Any age | 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 Endocrine therapy Radiotherapy Surgery 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 Performance status Life expectancy Hematopoietic Hepatic 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 | | | |
| 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 1 | | | 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.
Table of Links
| 1 | http://clinicaltrials.gov/ct/show/NCT00068276 |
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