NCT00562003已完成1 期
A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD
研究概览
简要总结
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.
Secondary objectives :
- To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
- To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
- To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
- •Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
- •Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
- •Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
- •Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
- •WBC> 3,000 ul
- •Granulocytes> 1,500 ul
- •Platelets> 100,000
- •Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0
- •Serum transaminases <2.5x upper limits of normal
- •Normal serum bilirubin
- •PT/PTT/INR < 1.5 x institutional ULN
- •Ejection fraction on echocardiogram > 55%
- •O2 saturation > 92%
- •Patients must be 19 years or older (as mandated by Alabama state law) and must have signed informed consent
排除标准
- •Patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study
- •Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study
- •Patients who are pregnant or lactating are ineligible to participate in the study
- •Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study
- •Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF < 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)
结局指标
主要结局
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD
时间窗: 1 month
次要结局
- To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD(1 month)
研究者
研究点 (2)
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