NCT00072098终止1 期
Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
Max Sung1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2003年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- safety measure
研究概览
简要总结
RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.
详细描述
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer .
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed* colorectal adenocarcinoma metastatic to the liver
- •Solitary or multiple metastatic tumors in the liver
- •Metastatic involvement of the liver no greater than 40% of estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection
- •Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI
- •At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (US) and accessible for US-guided percutaneous injection
- •Extrahepatic metastases allowed
- •No prior or current ascites
- •Ineligible for hepatic resection
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 16 weeks
- •Hematopoietic
- •Granulocyte count at least 1,500/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Platelet count at least 100,000/mm^3
- •No clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy)
- •PT no greater than 14 seconds
- •Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 45 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation
- •HIV negative
- •No active infection
- •No other concurrent serious medical illness
- •No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer
- •Oriented and rational
- •Weight at least 30 kg
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy
- •At least 2 months since prior corticosteroids
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 2 months since prior systemic immunosuppressive drugs
- •No concurrent immunosuppressive drugs
- •No concurrent anticoagulant therapy with heparin or warfarin
排除标准
- 未提供
研究组 & 干预措施
Experimental Group
Experimental
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
干预措施: adenovirus vector (Biological)
Experimental Group
Experimental
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
干预措施: interleukin-12 gene (Biological)
结局指标
主要结局
safety measure
时间窗: up to day 57
adverse event reporting
toxicity grading
时间窗: up to day 57
toxicity will assessed from grades 0 to 4 as per common toxicity criteria
次要结局
- tumor response compared at four weeks to baseline(baseline and four weeks)
研究者
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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