fr901228 in treating patients with unresectable stage iii or stage iv malignant melanoma

Conditions: Malignant Melanoma; Melanoma

Summary: rationale: drugs used in chemotherapy, such as fr901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well fr901228 works in treating patients with unresectable stage iii or stage iv malignant melanoma.

objectives: primary * determine the response rate in patients with unresectable stage iii or stage iv malignant melanoma treated with fr901228 (depsipeptide). secondary * determine the progression-free and overall survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. outline: this is a multicenter study. patients receive fr901228 (depsipeptide) intravenously (iv) over 4 hours on days 1, 8, and 15. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year. projected accrual: a total of 22-40 patients will be accrued for this study within 18 months.

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

Keywords: stage iii melanoma stage iv melanoma depsipeptide