Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
18 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Mark B. Juckett, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Federal Government
Study ID:
CDR0000258754
NCT ID:
NCT00052832
Start Date:
September 2002
Completion Date:
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- chronic myelomonocytic leukemia
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- de novo myelodysplastic syndromes
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- Leukemia
- Leukemia, Myelomonocytic, Chronic
- Myelodysplastic Syndromes
- Preleukemia
- Leukemia, Myelomonocytic, Acute
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
