NCT00473954已完成1 期
A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- EGEN, Inc.
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
研究概览
简要总结
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD
详细描述
This study has two purposes:
- To determine what different strengths and number of doses of EGEN-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
- To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation);
- •Histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria:
- •measurable disease by computed tomography (CT) scan or
- •malignant ascites, or
- •Serum CA-125 levels; or
- •Clinically evaluable recurrent disease by other criteria.
- •Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6 months since last exposure to platinum based therapy).
- •Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;
- •Recovered from prior chemotherapy, having adequate bone marrow function:
- •Adequate renal function;
- •Adequate liver function;
- •If of childbearing potential, have a negative pregnancy test and agree to follow an acceptable method of birth control;
- •Agree to be compliant with the study's requirements;
- •Understand and sign a written Informed Consent prior to the performance of any study-related procedures.
排除标准
- •Ovarian cancer other than documented epithelial cancer;
- •Intra-abdominal disease > 5 cm in diameter;
- •Any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to:
- •Autoimmune disorders
- •Cardiac Disorders
- •Intrahepatic disease/cancer as documented by CT-scan
- •An active infection within 4 weeks of study entry;
- •Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
- •Prior treatment with whole abdominal irradiation;
- •Currently receiving or have received any investigational agents within 28 days of study entry;
- •Received prior chemotherapy for ovarian cancer administered by the IP route;
- •Received any chemotherapy between completion of primary chemotherapy for ovarian cancer and study entry (e.g. consolidation therapy);
- •Receipt of immunotherapy and/or any medications with the potential to affect the activity of EGEN 001;
- •Known history of HIV infection, hepatitis B, or hepatitis C;
- •Known hypersensitivity to any of the components of carboplatin or docetaxel;
- •Life expectancy of less than 3 months;
- •Known, current, recreational drug or alcohol abuse;
- •Breast feeding an infant;
- •Psychiatric illness/social situations which would limit compliance with study requirements;
- •Any other known condition which in the Investigator's opinion would make the patient a poor candidate for the study.
研究组 & 干预措施
EGEN-001
Experimental
干预措施: EGEN-001 (phIL-12-005/PPC) (Genetic)
结局指标
主要结局
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
时间窗: 12-14 months
次要结局
- Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity.(10 months)
研究者
研究点 (8)
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