Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)
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
1 other identifier
interventional
46
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2002
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 26, 2003
CompletedFirst Posted
Study publicly available on registry
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedNovember 1, 2006
February 1, 2005
March 26, 2003
October 31, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Novacealead
Study Sites (10)
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216, United States
University of California, San Francisco
San Francisco, California, 94143, United States
James A. Haley Veterans Hospital
Tampa, Florida, 33612, United States
Rush Cancer Institute MDS Center
Chicago, Illinois, 60612, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Boston Baskin Cancer Group
Memphis, Tennessee, 38104, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (3)
Mellibovsky L, Diez A, Perez-Vila E, Serrano S, Nacher M, Aubia J, Supervia A, Recker RR. Vitamin D treatment in myelodysplastic syndromes. Br J Haematol. 1998 Mar;100(3):516-20. doi: 10.1046/j.1365-2141.1998.00598.x.
PMID: 9504634BACKGROUNDBeer TM, Munar M, Henner WD. A Phase I trial of pulse calcitriol in patients with refractory malignancies: pulse dosing permits substantial dose escalation. Cancer. 2001 Jun 15;91(12):2431-9.
PMID: 11413535BACKGROUNDBeer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003 Jan 1;21(1):123-8. doi: 10.1200/jco.2003.05.117.
PMID: 12506180BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2003
First Posted
April 1, 2003
Study Start
November 1, 2002
Study Completion
March 1, 2004
Last Updated
November 1, 2006
Record last verified: 2005-02