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

June 13, 2023 updated by: ECOG-ACRIN Cancer Research Group

Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Depsipeptide
Given IV
Other Names:
  • FK228
  • FR901228

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Response to Depsipeptide
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

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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David H. Lawson, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimated)

March 4, 2005

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000415355
  • U10CA021115 (U.S. NIH Grant/Contract)
  • E1603 (Other Identifier: ECOG-ACRIN Cancer Research Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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