Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by Novacea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00057031
First received: March 26, 2003
Last updated: October 31, 2006
Last verified: February 2005
  Purpose

The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: DN-101 (calcitriol)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open Label Study of the Safety and Efficacy of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 46
Study Start Date: November 2002
Estimated Study Completion Date: March 2004
Detailed Description:

DN-101 is an experimental drug that has not been approved by the Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by the liver and kidney into calcitriol before it is biologically active. The body normally uses small amounts of calcitriol to regulate its blood calcium levels. However, for any possible therapeutic effect, MDS patients require much higher levels of calcitriol than the body can produce from dietary vitamin D. DN-101 provides MDS patients with high doses of calcitriol in a pill form.

Laboratory studies have demonstrated evidence supporting the use of calcitriol in MDS. High dose calcitriol slows the growth of leukemic cells (cancerous cells) and increases the growth of normal bone marrow cells. Some patients with MDS may have low levels of calcitriol in their bone marrow.

Clinical study results in patients with MDS have been mixed– some positive and some negative results. Elevated calcium in the blood occurred frequently and prevented the use of higher, more potentially therapeutic doses.

Novacea tested a new formulation of calcitriol, DN-101, in a Phase 1 study. In that study the maximum tolerated dose of DN-101 that did not cause high blood calcium levels when given weekly for several months was determined. That dose is within the range that is potentially therapeutic for MDS patients and will be used in this MDS study.

The purposes of this study are to determine if HDPA DN-101 treatment:

  • increases the number of red blood cells, white blood cells, and platelets in the blood
  • reduces the number of blood transfusions
  • reduces the number of serious infections requiring antibiotics
  • reduces the number of serious bleeding events
  • improves fatigue
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Diagnosis of low or intermediate-1 risk MDS
  • Dependent on monthly blood transfusions
  • No cancer within the last 5 years (cured skin cancer is allowed)
  • No heart attack or stroke within the last 6 months
  • No kidney stones within the last 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057031

Locations
United States, Alabama
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33612
United States, Illinois
Rush Cancer Institute MDS Center
Chicago, Illinois, United States, 60612
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Tennessee
Boston Baskin Cancer Group
Memphis, Tennessee, United States, 38104
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Novacea
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00057031     History of Changes
Other Study ID Numbers: DN101-003
Study First Received: March 26, 2003
Last Updated: October 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
myelodysplastic syndrome
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014