NCT00022464已完成2 期
A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma
City of Hope Medical Center41 个研究点 分布在 2 个国家开始时间: 2001年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 41
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
- Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in patients with metastatic melanoma.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion
- •Measurable disease
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •The following are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Progressive disease
- •No prior or concurrent CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 4 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed)
- •Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No prior allergic reactions to compounds of similar chemical or biological composition to study drug
- •No ongoing or active infection
- •No seizure disorder
- •No autoimmune disease
- •No psychiatric illness or social situation that would preclude study
- •No other concurrent uncontrolled illness that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than 1 prior adjuvant biological therapy regimen
- •No more than 1 prior biological therapy regimen for advanced disease
- •At least 6 months since prior biological therapy or biochemotherapy and recovered
- •Prior isolated limb perfusion with biological agent allowed if not to sole site of disease
- 另有 18 项未显示
排除标准
- 未提供
研究者
研究点 (41)
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