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Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
This study is ongoing, but not recruiting participants.
First Received: January 24, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: University of Wisconsin, Madison
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052832
  Purpose

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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Dietary Supplement: doxercalciferol
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052832

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: Mark B. Juckett, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000258754, WCCC-HO-02403
Study First Received: January 24, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00052832     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Disease
Neoplasms by Histologic Type
Precancerous Conditions
Hematologic Diseases
Growth Substances
Leukemia, Myelomonocytic, Chronic
Physiological Effects of Drugs
Myelodysplastic Syndromes
Ergocalciferols
Myeloproliferative Disorders
Bone Density Conservation Agents
Leukemia, Myeloid
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
1 alpha-hydroxyergocalciferol
Pathologic Processes
Vitamins
Syndrome
Micronutrients
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 09, 2009