NCT00107861已完成1 期
A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- - Evaluate the safety of a single IV administration of Ad.hIFN-β.
研究概览
简要总结
This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are:
- to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;
- help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.
详细描述
This trial is a clinical research study of Ad.hIFN-β, an investigational, replication-defective, recombinant adenovirus containing the human interferon beta gene, for people that have refractory colorectal carcinoma with liver metastases. Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases; a disease for which current treatment provides only limited relief, so there is a need for new medications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma.
- •Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI).
- •Tumor progression after prior therapy for colorectal carcinoma, including fluoropyrimidine (5 FU or capecitabine), irinotecan, oxaliplatin, or cetuximab.
- •One or more metastatic hepatic tumors that is measurable on CT scan. In addition, subjects may have nonhepatic metastatic tumors.
- •ECOG performance status of ≤
- •Age ≥ 18 years.
- •Signed, written IRB-approved informed consent.
- •Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after completion of treatment.
- •Acceptable liver function:
- •Bilirubin ≤ 1.5 x upper limit of normal;
- •AST, ALT ≤ 2.0 x upper limit of normal;
- •Albumin ≤ 3.0 g/dL.
- •Acceptable hematologic status:
- •Granulocyte ≥ 1000 cells/mm3;
- •Platelet count ≥ 150,000 plts/mm3;
- •Hemoglobin > 9 g/dL.
- •Acceptable coagulation status: INR within normal limits.
- •Acceptable kidney function: Serum creatinine within normal limits.
排除标准
- •New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Day
- •Seizure disorders requiring anticonvulsant therapy.
- •Severe chronic obstructive pulmonary disease with hypoxemia.
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to Day
- •Active uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •Pregnant or nursing women.
- •Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 1 month prior to study entry.
- •Unwillingness or inability to comply with procedures required in this protocol.
- •Known infection with HIV, hepatitis B, or hepatitis C.
- •Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
- •Clinically significant bleeding event within the last 3 months, unrelated to trauma.
- •More than 50% of liver replaced by tumor (estimated by the PI from CT scan within 14 days of Day 1).
- •Previous treatment with Ad.hIFN-β.
- •Any prior treatment with a gene delivery vector or an adenovirus therapeutic agent.
结局指标
主要结局
- Evaluate the safety of a single IV administration of Ad.hIFN-β.
次要结局
- Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
- Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
- Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
- Explore preliminary clinical activity.
研究者
研究点 (4)
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