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

Tracking Information

First Received Date ^ICMJE

January 24, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00052832 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Official Title ^ICMJE

Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Dietary Supplement: doxercalciferol

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00052832

Responsible Party

Study ID Numbers ^ICMJE

CDR0000258754, WCCC-HO-02403

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Mark B. Juckett, MD

University of Wisconsin, Madison

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP