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Cholecalciferol in Treating Patients With Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Cholecalciferol in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Cholecalciferol in Treating Patients With Myelodysplastic Syndrome healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Cholecalciferol in Treating Patients With Myelodysplastic Syndrome. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Cholecalciferol in Treating Patients With Myelodysplastic Syndrome clinical trial. Test subjects typically receive the most effective healthcare possible for their Cholecalciferol in Treating Patients With Myelodysplastic Syndrome condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cholecalciferol in Treating Patients With Myelodysplastic Syndrome Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
For Condition: myelodysplastic/myeloproliferative disease, unclassifiable,atypical chronic myeloid leukemia,previously treated myelodysplastic syndromes,de novo myelodysplastic syndromes,secondary myelodysplastic syndromes
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of cholecalciferol in treating patients who have myelodysplastic syndrome.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BayardPowell, , Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Istvan Molnar 336-716-5847
Additional Information:
Study ID Numbers: CDR0000318802; CCCWFU-29203,CCCWFU-BG03-117
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068276
Other De Novo Myelodysplastic Syndromes Studies:
1. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
2. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
3. R115777 in Treating Patients With Myeloproliferative Disorders
4. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
5. Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other de novo myelodysplastic syndromes Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
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