Trial Information

Summary: A Phase I Clinical Trial of Vorinostat in Combination with Decitabine in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome

You have been asked to participate in this research study because you fit into one of the following groups:

·        You are 18 years of age or older and have acute myelogenous leukemia (AML) that has relapsed (returned after initially responding to chemotherapy) or is refractory (has failed to respond to standard therapy)

·        You are 18 years of age or older and have myelodysplastic syndrome

·        You are 60 years of age or older and have untreated AML that would not be effectively treated by standard chemotherapy or Myelodysplastic Syndrome (MDS). 

The purposes of this study are to (1) determine the highest dose of vorinostat that can be taken in combination with decitabine without causing unmanageable side effects to treat AML or MDS, (2) to test the safety and tolerability of this combination treatment, and (3) to do laboratory studies to evaluate the effects of this combination treatment on AML and MDS. 

Your treatment on this study is expected to last for at least one 28-day (four-week) cycle of treatment.  If you are tolerating treatment and your medical condition is not getting worse, you will be able to receive additional cycles of treatment for a total of 24 months.  After you discontinue treatment, your medical condition will continue to be followed for about two years.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: June 2, 2008 at 2:51:04 PM