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Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) Clinical research trials and Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS). Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS) condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS)  Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS)
Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS)
For Condition: Myelodysplastic Syndrome
Status: No longer recruiting
Sponsor(s): Novacea ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 46
Location and Contact Information:
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Rush Cancer Institute MDS Center
Chicago, Illinois, 60612
United States
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216
United States
Boston Baskin Cancer Group
Memphis, Tennessee, 38104
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
James A. Haley Veterans Hospital
Tampa, Florida, 33612
United States
Oregon Health Sciences University
Portland, Oregon, 97201
United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: DN101-003;
Study Start Date: November 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057031
Other Myelodysplastic SyndromeStudies:
1. Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
2. Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia
3. Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia
4. Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS
5. Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
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Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS)
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