Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

You may be eligible if

• 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