NCT00098943已完成1 期
Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
European Organisation for Research and Treatment of Cancer - EORTC4 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
研究概览
简要总结
RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of tumor vasculature-targeted tumor necrosis factor alpha (NGR-TNF) in patients with advanced solid tumors.
- Determine the recommended phase II dose of this drug in these patients.
Secondary
- Determine the mechanism of action of this drug in these patients.
- Determine response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of advanced solid tumor not amenable to any clinical improvement by current standard treatments
- •Preferably tumors well known to be very angiogenic (e.g., renal, colon, thyroid, and head and neck cancers)
- •No clinical signs of CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •AST and/or ALT < 2.5 times ULN (5 times ULN in the presence of liver metastases)
- •Creatinine < 1.5 times ULN
- •Cardiovascular
- •Cardiac function normal
- •No uncontrolled hypertension
- •No condition in which hypovolemia and its consequences (e.g., increased stroke volume, elevated blood pressure) or hemodilution could represent a risk to the patient
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No active or uncontrolled systemic infection
- •No other uncontrolled disease, serious illness, or medical condition that would preclude study participation
- •No known hypersensitivity/allergic reaction to human albumin preparations or any of the excipients
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 28 days since prior immunotherapy
- •Chemotherapy
- •At least 28 days since prior chemotherapy and recovered
- •Endocrine therapy
- •At least 28 days since prior hormonal therapy
- •Radiotherapy
- •At least 28 days since prior radiotherapy and recovered
- •No prior radiotherapy to > 25% of bone marrow reserve
- •More than 2 weeks since prior surgery
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
次要结局
- Clinical response as measured by RECIST criteria
- Mechanism of action as measured by Dynamic Imaging
研究者
研究点 (4)
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