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

Primary Purpose

Malignant Melanoma, Melanoma

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Depsipeptide
Sponsored by
ECOG-ACRIN Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring stage III melanoma, stage IV melanoma, Depsipeptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Arm Label

    Depsipeptide

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2005
    Last Updated
    June 13, 2023
    Sponsor
    ECOG-ACRIN Cancer Research Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00104884
    Brief Title
    FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
    Official Title
    Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study was terminated on May 17, 2006 due to slow accrual.
    Study Start Date
    October 4, 2005 (Actual)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ECOG-ACRIN Cancer Research Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Melanoma, Melanoma
    Keywords
    stage III melanoma, stage IV melanoma, Depsipeptide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Depsipeptide
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Depsipeptide
    Other Intervention Name(s)
    FR901228, FK228
    Intervention Description
    Given IV
    Primary Outcome Measure Information:
    Title
    Proportion of Patients With Response to Depsipeptide
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David H. Lawson, MD
    Organizational Affiliation
    Emory University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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