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

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