Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Leukemia Clinical Trial

Official title:

Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052832
• Other study ID #: HO02403
• Secondary ID: P30CA014520HO024
• Status: Completed
• Phase: Phase 2
• Start date: September 2002

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Dietary Supplement:
• doxercalciferol

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Petrich A, Kahl B, Bailey H, Kim K, Turman N, Juckett M. Phase II study of doxercalciferol for the treatment of myelodysplastic syndrome. Leuk Lymphoma. 2008 Jan;49(1):57-61. doi: 10.1080/10428190701713648. — View Citation

External Links

•   University of Wisconsin Carbone Cancer Center