NCT00086723已完成1 期
Phase I/II Trial of In Vivo Angiostatin Generation With Tissue Plasminogen Activator (tPA) and Captopril in Patients With Progressive, Metastatic Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Angiostatin production
研究概览
简要总结
RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin. Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they work in treating patients with progressive metastatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity of captopril and tissue plasminogen activator (tPA) in patients with progressive metastatic cancer.
- Determine the in vivo generation of angiostatin by western analysis in patients treated with this regimen.
Secondary
- Determine the antitumor effect of this regimen in these patients.
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:
- •Diagnosis of progressive metastatic cancer, excluding hematologic malignancies (i.e., leukemia or lymphoma)
- •Measurable disease not required
- •Must have received at least 1 prior systemic treatment for metastatic disease
- •No known CNS involvement
- •CNS involvement allowed provided it is successfully controlled by prior surgery or radiotherapy and there is no current requirement for corticosteroids
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding diathesis
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 3 times upper limit of normal
- •Albumin normal
- •PT and aPTT normal
- •Fibrinogen > lower limit of normal
- •Creatinine no greater than 1.8 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No history of stroke, transient ischemic attack, or symptoms of cerebral ischemia
- •No history of angioedema with captopril
- •No severe or uncontrolled hypertension (i.e., systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg)
- •No congestive heart failure requiring therapy
- •No chronic hypotension (e.g., systolic blood pressure less than 100 mm Hg)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •Potassium no greater than 5.2 mmol/L
- •No active internal bleeding
- •No history of seizures
- •No psychiatric disorder that would preclude the giving of informed consent or study follow-up
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No uncontrolled or active bacterial, viral, or invasive fungal infection
- •No recent trauma
- •No medical indication for anticoagulation
- •No contraindication to captopril
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior biologic therapy
- •No concurrent immunomodulator therapy
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •At least 4 weeks since prior endocrine therapy
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Angiostatin production
次要结局
未报告次要终点
研究者
研究点 (1)
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