NCT00052832

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

November 19, 2019

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

January 24, 2003

Last Update Submit

November 15, 2019

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

chronic myelomonocytic leukemiapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesde novo myelodysplastic syndromesatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiable

Interventions

doxercalciferolDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 18203012RESULT

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative Disorders

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark B. Juckett, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

July 1, 2005

Last Updated

November 19, 2019

Record last verified: 2015-09

Locations

US(1)