Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 主要终点
- Proportion of Patients With Response to Depsipeptide
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Depsipeptide (Drug)
结局指标
主要结局
Proportion of Patients With Response to Depsipeptide
时间窗: 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.
次要结局
未报告次要终点