Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052832
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Dietary Supplement: doxercalciferol Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Study Start Date : September 2002
Actual Primary Completion Date : July 2005

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • See Disease Characteristics


  • 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


  • Creatinine clearance greater than 50 mL/min
  • No history of hypercalcemia
  • No renal stones within the past 5 years


  • No clinically significant heart failure
  • No uncontrolled hypertension


  • No clinically significant pulmonary failure


  • Not pregnant
  • Fertile patients must use effective contraception during and for 6 months after study


Biologic therapy

  • At least 4 weeks since prior growth factor or cytokine therapy


  • At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • Concurrent transfusion support allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00052832

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Mark B. Juckett, MD University of Wisconsin, Madison

Publications of Results:
Responsible Party: University of Wisconsin, Madison Identifier: NCT00052832     History of Changes
Other Study ID Numbers: CDR0000258754
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Keywords provided by University of Wisconsin, Madison:
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Myeloid
1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents