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

March 3, 2005
February 1, 2016
January 2005
May 2006   (final data collection date for primary outcome measure)
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.

Not Provided
Complete list of historical versions of study NCT00104884 on ClinicalTrials.gov Archive Site
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FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Melanoma
  • Melanoma
Drug: Depsipeptide
Given IV
Other Names:
  • FR901228
  • FK228
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.
Intervention: Drug: Depsipeptide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2009
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00104884
CDR0000415355, U10CA021115, E1603
No
No
Not Provided
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study Chair: David H. Lawson, MD Winship Cancer Institute of Emory University
Eastern Cooperative Oncology Group
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP