Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Inclusion Criteria: Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies: Gastrointestinal stromal tumors (GIST) Refractory to imatinib mesylate Desmoplastic small round cell tumors Clear cell sarcoma Extraskeletal osteosarcoma* Extraskeletal Ewing's sarcoma* Extraskeletal (myxoid) chondrosarcoma* Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis) allowed Metastatic or unresectable disease No standard curative therapy exists Patients with GIST must have received and progressed on imatinib mesylate Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known brain metastases Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 Performance status - Karnofsky 50-100% More than 3 months White blood cells (WBC) ⥠3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ⤠2.5 times upper limit of normal (ULN) Bilirubin normal Creatinine < 1.5 times ULN Creatinine clearance ≥ 60 mL/min QTc ≤ 480 msec Exclusion Criteria: No cardiac abnormalities (e.g., congenital long QT syndrome) No myocardial infarction within the past year No history of coronary artery disease (e.g., angina Canadian Class II-IV or positive stress imaging study) No cardiac ischemia (ST depression >2 mm) by electrocardiogram (ECG) No New York Heart Association Class II-IV congestive heart failure Ejection fraction > 50% by multi gated acquisition scan (MUGA) scan or echocardiogram No history of sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, or cardiac arrest unless controlled by an automatic implantable cardioverter defibrillator No hypertrophic or restrictive cardiomyopathy from prior treatment or other causes No significant left ventricular hypertrophy No uncontrolled hypertension (i.e., blood pressure ≥ 160/95 mm Hg) No cardiac arrhythmia requiring anti-arrhythmic medication Beta blocker or calcium channel blocker allowed Patients on digitalis that cannot be discontinued not allowed No Mobitz II second degree block without a pacemaker (first degree or Mobitz I second degree block, bradyarrhythmias, or sick sinus syndrome require Holter monitoring and evaluation by cardiology) No uncontrolled dysrhythmia No poorly controlled angina No other cardiac disease No history of allergic reaction attributed to compounds of similar chemical or biological composition to FR901228 No ongoing or active infection No iatrogenic immune deficiency or immune deficiency secondary to an underlying disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Potassium ≥ 4.0 mmol/L Magnesium ≥ 2.0 mg/dL No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No concurrent anticancer biologic agents No more than 1 prior chemotherapy regimen for sarcoma Adjuvant chemotherapy preceding disease relapse is considered 1 prior chemotherapy regimen Patients with GIST may have received up to 3 prior chemotherapy regimens comprising imatinib mesylate and/or sunitinib malate provided no other chemotherapy agents were used No prior FR901228 (depsipeptide) At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior cumulative doxorubicin dose > 500 mg/m^2 No other concurrent anticancer chemotherapy At least 4 weeks since prior radiotherapy No concurrent anticancer radiotherapy At least 4 weeks since prior surgery No prior organ transplantation Recovered from all prior therapy No concurrent medications that cause QTc prolongation No concurrent combination highly active anti-retroviral therapy for HIV-positive patients No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate) No other concurrent investigational agents No other concurrent anticancer agents