A Phase I/II Study of Vorinostat [Suberoylanilide Hydroxamic Acid (SAHA)] in Combination With Azacitidine in Patients With the Myelodysplastic Syndrome (MDS)

Study Status

Open to Enrollment

Study Description

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 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 it 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 appropriate.

Vorinostat is an investigational drug, not approved by the Food & Drug Administration (FDA) for the treatment of myelodysplastic syndrome. However, vorinostat is approved by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL).

The other drug in this study, azacitidine (AzaC) is approved by the FDA for the treatment of MDS. However, the use of azacitidine in combination with vorinostat in this study is considered experimental.

Disease Status and/or Stage

Myelodysplastic Syndromes (MDS); Acute Myeloid Leukemia

Sponsor

New York Cancer Consortium; National Cancer Institute

Key Eligibility

  • Men and women age 18 and older
    • Diagnosis of Myelodysplastic Syndrome (MDS)
  • Detailed eligibility discussed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (212) 746-9498
roh2026@med.cornell.edu

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