Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Ovarian Spore)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
研究概览
简要总结
The purpose of this research study is to collect tumor samples at the time of surgery and store them for possible use as part of an experimental vaccine study for the participants cancer in the future.
详细描述
- Even if tumor sample is collected, the participant is under no obligation to participate in the vaccine study.
- Participants will have their regularly planned surgery as described by their surgeon. During the surgery, tumor samples will be collected. We will only collect tumor that is not needed and could otherwise be thrown away.
- The tumor samples will be frozen and placed in storage for up to two years.
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
- Other
- 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
- •Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist
- •Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease
- •Estimated life expectancy of 6 months or greater
- •18 years of age or older
排除标准
- •More than one prior chemotherapy regimen
- •Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
- •Known HIV infection
- •Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin
- •Significant autoimmune disease, including psoriasis
- •History of clinically significant venous thromboembolism
研究组 & 干预措施
Cohort 1
Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF
干预措施: Tumor collection (Procedure)
Cohort 2
Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF and topical Imiquimod at site of vaccination
干预措施: Tumor collection (Procedure)
结局指标
主要结局
To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
时间窗: 2 years
To gain experience in appropriate clinical processing of tumor samples and determining cell yield.
时间窗: 2 years
次要结局
- Based on feasibility of collection of blood samples of subjects, quantification of T cell subsets, regulatory T cells, activated memory effector cells, and DC phenotype at pre-surgery and post-surgery time points.(2 years)
研究者
David Avigan, MD
Principal Investigator
Dana-Farber Cancer Institute