Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes - Tabular View

Tracking Information
First Received Date ^ICMJE	January 30, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00030069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Official Title ^ICMJE	Calcitriol and Dexamethasone for Myelodysplastic Syndromes
Brief Summary	This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
Detailed Description	Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results. This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Safety/Efficacy Study
Condition ^ICMJE	Myelodysplastic Syndromes
Intervention ^ICMJE	Drug: Calcitriol Drug: Dexamethasone
Study Arms / Comparison Groups
Publications *
* 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	Recruiting
Enrollment ^ICMJE	60
Completion Date	September 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria: Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS) Evidence of cytopenia affecting at least 1 hematological cell lineage Adequate liver and renal function ECOG 0-2 Expected survival of at least 12 weeks Exclusion criteria: Symptomatic coronary artery disease Uncontrolled diabetes mellitus Uncontrolled and symptomatic glaucoma History of dangerous reactions to steroid therapy Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks History of nephrolithiasis Children Chronic myelomonocytic leukemia (CMML)
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00030069
Responsible Party
Study ID Numbers ^ICMJE	FD-R-2025-01, FD-R-002025-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP