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