Phase I-II Study of Vorinostat Combined with Azacitidine
ID Number 11-1773Principal Investigator(s)
Lewis R. Silverman
Department(s) or Division(s)
Hematology and Medical Oncology
There are two drugs that will be used in this study. One is called vorinostat, which belongs to a group of drugs known as histone deacetylase inhibitors (HDAC). HDAC inhibitors are drugs that prevent the removal of certain molecules attached to important proteins surrounding a cell's DNA. These proteins help control how genes are turned on and off much like a switch on an electric light outlet. Genes that are turned off or on incorrectly (on when they should be off or off when they should be on) can lead to the development of certain blood diseases such as leukemia or a myelodysplastic syndrome (MDS). In these diseases the switch controlling the genes is broken, but can be repaired and reversed. By using HDAC inhibitors we can prevent the removal of these important molecules from these regulating proteins and thus reverse the abnormality and repair the switch controlling the genes so that they are returned to the correct state, on or off, as is appropriate. Vorinostat is an investigational drug, not approved by the Food and Drug Administration (FDA) for commercial use for treatment of MDS or AML. However, Vorinostat is approved by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL). The other drug, azacitidine (AzaC), is approved by the FDA for the treatment of MDS. The use of azacitidine in combination with vorinostat in this study is considered experimental; this combination is not FDA approved.
Recruiting Patients: Yes