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

This study has been terminated.
(The study was terminated on May 17, 2006 due to slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00104884
First received: March 3, 2005
Last updated: February 1, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Melanoma
Drug: Depsipeptide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 4
Study Start Date: January 2005
Study Completion Date: March 2009
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • FR901228
  • FK228

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104884

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: David H. Lawson, MD Emory University
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00104884     History of Changes
Other Study ID Numbers: CDR0000415355  U10CA021115  E1603 
Study First Received: March 3, 2005
Results First Received: December 15, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Eastern Cooperative Oncology Group:
stage III melanoma
stage IV melanoma
Depsipeptide

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2016