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

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Romidepsin

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