romidepsin in treating patients with steroid-refractory graft-versus-host disease

Conditions: Graft Versus Host Disease

Summary: this pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (gvhd) that has not responded to treatment with steroids. romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

primary objectives: i. to determine if romidepsin should be developed as a therapy for patients with steroid-refractory gvhd. outline: patients receive romidepsin intravenously (iv) over 4 hours on days 1, 8, and 15. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * patients with steroid (or immunosuppressive therapy \[ist\]) refractory acute gvhd (agvhd) or chronic gvhd (cgvhd) * absolute neutrophil count \>= 750/mm\^3 * platelet count \>= 50,000/mm\^3 * corrected qt interval (qtc) =\< 480 msec * bilirubin =\< 1.5 x upper limit of normal (uln) * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]) and alanine aminotransferase (alt) (serum glutamate pyruvate transaminase \[sgpt\]) =\< 3 x uln * serum potassium \>= 3.8 mmol/l * serum magnesium \>= 1.8 mg/dl * serum creatinine =\< 2.0 mg/dl * eastern cooperative oncology group (ecog) performance status (ps) 0-3 * patients may undergo electrolyte repletion therapy to meet eligibility requirements * patients must be scheduled for tapering doses of (or no longer treated with): * cyclosporine; * tacrolimus; * sirolimus; * steroids (patients may be on physiologic doses of steroids) * patients receiving extracorporeal photopheresis must discontinue extracorporeal photopheresis or placed on a tapering schedule; * any prior therapy for gvhd must be completed and discontinued with the exception of the above; * patients with breakpoint cluster region (bcr)-abl proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxis * there must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy * the patient must be aware of the high risk and experimental nature of the treatment and provide informed consent * negative serum pregnancy test at the time of enrollment for females of childbearing potential * for males and females of child-producing potential, use of effective contraceptive methods during the study and for at least 6 months after the last dose of romidepsin exclusion criteria: * active/uncontrolled infection * evidence of relapsed disease * life expectancy \< 12 weeks * pregnant or breast feeding females * prior therapy with romidepsin * known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv); patients who are seropositive because of hepatitis b virus vaccine are eligible * any known cardiac abnormalities such as: * congenital long qt syndrome * qtc interval \>= 480 milliseconds; * myocardial infarction within 6 months of course 1, day 1 (c1d1); subjects with a history of myocardial infarction between 6 and 12 months prior to c1d1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate; * other significant electrocardiogram (ecg) abnormalities including 2nd degree atrio-ventricular (av) block type ii, 3rd degree av block, or bradycardia (ventricular rate less than 50 beats/min); * symptomatic coronary artery disease (cad), e.g., angina canadian class ii-iv; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present; * an ecg recorded at screening showing evidence of cardiac ischemia (st depression of \>= 2 mm, measured from isoelectric line to the st segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present; * congestive heart failure (chf) that meets new york heart association (nyha) class ii to iv definitions and/or ejection fraction \< 40% by multi gated acquisition (muga) scan or \< 50% by echocardiogram and/or magnetic resonance imaging (mri); * a known history of sustained ventricular tachycardia (vt), ventricular fibrillation (vf), torsade de pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (aicd); * hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other cause; * any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers) * uncontrolled hypertension, i.e., blood pressure (bp) of \>= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or * patients taking drugs leading to significant qt prolongation must have an ecg prior to each treatment * concomitant use of cytochrome p450, family 3, subfamily a, polypeptide 4 (cyp3a4) inhibitors * concomitant use of medications known to induce a disulfiram-like reaction to alcohol