Phase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (romidepsin).
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients. II. To measure serum tumor markers (pancreastatin, gastrin, pancreatic polypeptide, glucagon, substance-P, neurotensin, calcitonin, somatostatin, vasoactive intestinal peptide, gastrin releasing polypeptide, ACTH) depending on the tumor type pre-, during-, and post-treatment.
III. To perform a nuclear medicine functional imaging scan (octreoscan) to evaluate the disease status pre-, during-, and post-treatment.
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
- •Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor
- •Well- or moderately-differentiated tumor
- •Metastatic and/or locally advanced disease
- •Measurable disease
- •Unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Lesions in a previously irradiated area are not considered measurable
- •No truly non-measurable lesions, including the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural or pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging
- •Cystic lesions
- •Ineligible for standard treatment
- •Performance status - ECOG 0-1
- •At least 6 months
- •WBC >= 3,000/mm^3
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •Bilirubin =< 1.5 mg/dL
- •AST and ALT =< 2.5 times upper limit of normal
- •Creatinine =< 1.5 mg/dL
- •No New York Heart Association class III or IV congestive heart failure
- •No myocardial infarction within the past year
- •No uncontrolled dysrhythmias
- •No poorly controlled angina
- •No serious ventricular arrhythmia, defined as ventricular tachycardia or ventricular fibrillation >= 3 beats in a row
- •No left ventricular hypertrophy by EKG
- •No other significant cardiac disease
- •QTc < 500 msec
- •LVEF > 40% by resting MUGA
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 4 weeks since prior immunotherapy (e.g., interferon alfa)
- •More than 4 weeks since prior chemotherapy
- •More than 12 weeks since prior hepatic artery chemoembolization unless liver lesions are not the only indicator lesions
- •No prior FR901228 (depsipeptide)
- •No more than 1 prior systemic chemotherapy regimen for carcinoid or islet cell tumor (other than hepatic artery chemoembolization)
- •More than 4 weeks since prior oral or IV steroids (first 16 patients only)
- •Concurrent long-acting octreotide allowed at standard doses if dose has been stable for the past 12 weeks
- •Concurrent subcutaneous octreotide for breakthrough use for symptomatic relief allowed
- •No concurrent systemic steroids (first 16 patients only)
- •More than 4 weeks since prior radiotherapy
- •More than 4 weeks since prior investigational tumor-specific therapy
- •No other prior histone deacetylase inhibitors (e.g., valproic acid)
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses beyond CR.
干预措施: romidepsin (Drug)
Treatment (romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses beyond CR.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response rate
时间窗: Up to 4 weeks
Frequency of response will be estimated with a 95% confidence interval.
次要结局
- Incidence of toxicity(Up to 4 weeks)