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.

Condition	Treatment or Intervention	Phase
Chronic Myelomonocytic Leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes de novo myelodysplastic syndromes atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable	Drug: doxercalciferol  Procedure: biological response modifier therapy  Procedure: differentiation therapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States

Study chairs or principal investigators

Mark B. Juckett, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000258754; WCCC-HO-02403; NCT00052832
Record last reviewed:  January 2005
Last Updated:  January 6, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052832
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08