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Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
doxercalciferol
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052832
Brief Title
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Official Title
Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Keywords
chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
doxercalciferol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark B. Juckett, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18203012
Citation
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.
Results Reference
result
Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

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