Clinical trial NCT00104884: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Melanoma
Melanoma
Keywords: stage III melanoma
stage IV melanoma
Depsipeptide
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-03-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Patients With Response to Depsipeptide
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: David H. Lawson, MD
role: STUDY_CHAIR
References: