Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00030069|
Recruitment Status : Completed
First Posted : January 31, 2002
Last Update Posted : January 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: Calcitriol Drug: Dexamethasone||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Masking:||None (Open Label)|
|Official Title:||Calcitriol and Dexamethasone for Myelodysplastic Syndromes|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||May 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030069
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|