Myelodysplastic Syndromes Clinical Trial
Official title:
Calcitriol and Dexamethasone for Myelodysplastic Syndromes
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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