NCT00471562已完成1 期
Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of therapeutic angiotensin-(1-7) in patients with metastatic or unresectable solid tumors.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine tumor response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed advanced solid tumor meeting 1 of the following criteria:
- •Metastatic disease
- •Unresectable disease
- •Standard curative or palliative measures do not exist or are no longer effective
- •Measurable or nonmeasurable disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •Nonmeasurable disease, defined as all other lesions, including small lesions (i.e., ≥ 1 unidimensionally measurable lesion < 20 mm by conventional techniques or < 10 mm by spiral CT scan) and truly nonmeasurable lesions, including any of the following:
- •Bone lesions
- •Pleural or pericardial effusion
- •Lymphangitis cutis or pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No lung cancer with recent hemoptysis
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 4 weeks
- •No evidence of bleeding diathesis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine clearance > 30 mL/min
- •Bilirubin < 2 mg/dL
- •AST and ALT < 3 times upper limit of normal
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Uncontrolled hypertension or hypotension
- •No psychiatric illness or social situation that would preclude informed consent or study compliance
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior major surgery
- •At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for melphalan, nitrosoureas, or mitomycin C)
- •No concurrent therapeutic anticoagulation
- •No other concurrent investigational agents
- •No concurrent angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
结局指标
主要结局
Toxicity
时间窗: 105 days
Maximum tolerated dose
时间窗: 21 days
次要结局
- Response rate (complete or partial response) as measured by RECIST criteria(105 days)
研究者
研究点 (1)
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