Myelodysplastic Syndrome Clinical Trial
Official title:
Phase I Study of the Combination of 5-azacytidine With Valproic Acid and All-trans Retinoic Acid in Patients With High Risk Myelodysplastic Syndrome and Acute Myelogenous Leukemia
5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied.
Participants receive 5-aza as an injection under the skin once a day for 7 days. This will
be repeated every 3-8 weeks depending on blood counts and how well bone marrow is
recovering. This is defined as 1 treatment cycle. Also during each cycle, participant will
take VPA by mouth for 7 days and ATRA by mouth for 5 days. VPA will be given on the same
days as 5-aza. ATRA will start on Day 3.
In the Phase I portion of the study, the dose of VPA will be increased in each new group of
participants until the highest safe dose is found. A minimum of 3 participants and a maximum
of 10 will be treated at each dose level.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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