Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• •Histologically confirmed acute myeloid leukemia (AML) defined by the WHO classification
• •Initial diagnosis with either of the following:
• •* Bone marrow or peripheral blood myeloblasts of at least 20%,
• •* Recurring genetic abnormalities (e.g., t\[8;21\], inv 16, or t\[16;16\]) and
• •* Bone marrow blast percentage less than 20%
• •Relapsed or refractory disease defined by 1 of the following:
• •* Under 60 years of age and in second relapse or greater,
• •* Over 60 years of age and in first relapse,
• •* Acute promyelocytic leukemia that has relapsed despite prior tretinoin and arsenic therapy,
• •* Primary refractory AML for which no standard therapy exists
• •Patients who are over 60 years of age with previously untreated disease and who refuse conventional chemotherapy are eligible
• •Patients who are over 60 years of age and in first relapse and poor medical candidates for reinduction chemotherapy or who refuse conventional chemotherapy are eligible
• •Not medically appropriate for OR refused curative bone marrow or stem cell transplantation
• •No CNS leukemia
• •ECOG 0-2 OR Karnofsky 60-100%
• •LVEF at least 40% by MUGA
• •QTc interval less than 500 msec by EKG
• •No myocardial infarction within the past 3 months
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reactions attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide)
• •No concurrent uncontrolled illness
• •No psychiatric illness or social situation that would preclude study compliance
• •No ongoing or active infection
• •At least 4 weeks since prior autologous stem cell or bone marrow transplantation
• •No prior allogeneic stem cell or bone marrow transplantation
• •No concurrent biologic agents
• •At least 2 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas)
• •No concurrent chemotherapy, concurrent hydroxyurea allowed during the first course of study therapy to control hyperleukocytosis
• •No concurrent radiotherapy
• •Recovered from prior therapy
• •At least 4 weeks since prior investigational agents
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent investigational agents
• •No concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
• •No other concurrent antineoplastic agents
• •No prior FR901228 (depsipeptide)
• •At least 2 weeks since prior radiotherapy