FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Malignant Melanoma, Melanoma
About this trial
This is an interventional treatment trial for Malignant Melanoma focused on measuring stage III melanoma, stage IV melanoma, Depsipeptide
Eligibility Criteria
Inclusion Criteria: Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies. Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees. Normal electrocardiogram (EKG) Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA) Corrected QT (QTc) < 500 msec Age greater than or equal to 18 Negative pregnancy test Fertile patients must use effective contraception Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Normal organ and marrow function Patients on hydrochorthiazide should be switched to a potassium-sparing diuretic or another antihypertensive At least 4 weeks since prior radiotherapy Patients with cardiac hypertrophy may be enrolled but should be carefully monitored. Exclusion Criteria: Prior FR901228 (depsipeptide) Prior chemotherapy Other concurrent chemotherapy Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI) History of coronary atherosclerotic heart disease History of myocardial infarction History of congestive heart failure Non-melanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer Pregnant or nursing women Conditions that in the opinion of the investigator would interfere with the ability of the patient to complete this protocol History of allergic reactions attributed to compounds of similar chemical or biologic composition to Depsipeptide Co-medication with an agent that causes QTc prolongation Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements Concurrent radiotherapy Left ventricular hypertrophy (LVH) on their baseline EKG tracing
Sites / Locations
Arms of the Study
Arm 1
Experimental
Depsipeptide
Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.