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Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia



Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

For Condition: secondary myelodysplastic syndromes,Chronic Myelomonocytic Leukemia,atypical chronic myeloid leukemia,previously treated myelodysplastic syndromes,de novo myelodysplastic syndromes,myelodysplastic/myeloproliferative disease, unclassifiable
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia. PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.
Details: OBJECTIVES: - Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol. - Determine the toxicity profile of this drug in these patients. - Determine the time to progression and overall survival of patients treated with this drug. OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia - No more than 20% blasts by bone marrow biopsy - Must meet at least 1 of the following criteria: - Anemia - Hemoglobin less than 11 g/dL over a 2-month period - Thrombocytopenia - Neutropenia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - ALT and AST less than 1.5 times upper limit of normal - Bilirubin less than 3 mg/dL - Albumin greater than 3.0 g/dL Renal - Creatinine clearance greater than 50 mL/min - No history of hypercalcemia - No renal stones within the past 5 years Cardiovascular - No clinically significant heart failure - No uncontrolled hypertension Pulmonary - No clinically significant pulmonary failure Other - Not pregnant - Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior growth factor or cytokine therapy Chemotherapy - At least 8 weeks since prior cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Concurrent transfusion support allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MarkJuckett,  Study Chair,  University of Wisconsin Comprehensive Cancer Center

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792
United States
Recruiting Mark  Juckett 608-263-1836


Additional Information:
Study ID Numbers:
  CDR0000258754;  WCCC-HO-02403
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052832

Other Secondary Myelodysplastic Syndromes Studies:
1. Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

2. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

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