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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 Atypical Chronic Myeloid Leukemia Studies:
1. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
2. Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
3. Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
4. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
5. MS-275 in Treating Patients With Hematologic Cancer
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
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