Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia - Full Text View

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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark B. Juckett, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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