NCT00964756已完成1 期
A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Evaluation for toxicity
研究概览
简要总结
In spite of surgical and chemotherapeutic advances, long term survival for advanced and recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease exists. Novel treatment strategies are needed. This is a study to determine the maximally tolerated dose of and toxicities associated with intraperitoneal delivery of an infectivity enhanced adenovirus that expresses a suicide gene and an gene that allows imaging of gene transfer. This vector will be given in combination with intravenous ganciclovir in patients with recurrent ovarian and other gynecological cancers.
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
- 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, extraovarian, fallopian tube or endometrial carcinoma.
- •Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy.
- •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, and hepatic function defined as:
- •WBC > 3,000 ul
- •Granulocytes > 1,500 ul
- •Platelets > 100,000
- •Creatinine clearance > 80 mg/dl or serum creatinine > 2.0
- •Serum transaminases < 2.5 x upper limits of normal
- •Normal serum bilirubin
- •PT/PTT/INR < 1.5 x institutional ULN
- •O2 saturation > or = 92 %
- •Patients must be 19 years or older and must have signed informed consent
排除标准
- •Patients with epithelial tumors of low malignant potential, stromal tumors and 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 hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)
研究组 & 干预措施
Gene therapy
Experimental
干预措施: Ad5.SSTR/TK.RGD (Genetic)
Gene therapy
Experimental
干预措施: Ganciclovir (GCV) (Drug)
结局指标
主要结局
Evaluation for toxicity
时间窗: 2 years
次要结局
- Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy(30 days)
研究者
Ronald D. Alvarez
Professor
University of Alabama at Birmingham
研究点 (1)
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