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

NCT ID: NCT00104884

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-04
• Study Completion Date: 2009-03-31

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.

Conditions

Malignant Melanoma; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Depsipeptide

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.

Group Type: EXPERIMENTAL

Depsipeptide

Intervention Type: DRUG

Given IV

Interventions

Depsipeptide

Given IV

Intervention Type: DRUG

Other Intervention Names

FR901228; FK228

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H. Lawson, MD

Role: STUDY_CHAIR

Emory University

Other Identifiers

U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

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E1603

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000415355

Identifier Type: -

Identifier Source: org_study_id