Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Leukemia; Myelodysplastic/Myeloproliferative Diseases; Myelodysplastic Syndromes

Treatments: Dietary Supplement: doxercalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00052832

SMPH/MEDICINE (Other Identifier)

HO02403 (Other Identifier)

P30CA014520 (U.S. NIH Grant/Contract)

A534260 (Other Identifier)

2002-184 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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