FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Phase 2TerminatedNCT00104884

ECOG-ACRIN Cancer Research Group4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Melanoma Melanoma

Interventions

DepsipeptideDRUG

Given IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of Patients With Response to Depsipeptide

Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR). Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.

Time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years

Data from ClinicalTrials.gov

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