FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Condition: Malignant Melanoma; Melanoma
MeSH terms: Melanoma
Intervention: Depsipeptide
Intervention description: Given IV
Intervention MeSH terms: Romidepsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III melanoma; stage IV melanoma; Depsipeptide

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.
    

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