Status:
TERMINATED
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Melanoma
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 I...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00104884
Start Date
October 4 2005
End Date
March 1 2009
Last Update
June 28 2023
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