SBRT With Immunotherapy for Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor
研究概览
简要总结
This phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving stereotactic body radiation therapy and immunotherapy may improve the tumors response to the treatment and decrease side-effects.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of focal stereotactic body radiation therapy (SBRT) with immune check inhibitors (ICI) for treatment of mesothelioma.
SECONDARY OBJECTIVES:
I. To determine progression free survival in patients treated with SBRT and ICI.
II. To assess acute and late toxicities overall in patients treated with SBRT and ICI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Histological confirmation of pleural mesothelioma
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
- •Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only. NOTE: male/female: Must be willing to use birth control for the entire study and must agree to use one of the following birth control methods listed:
- •Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- •Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- •Intrauterine device (IUD)
- •Abstinence (no sex)
- •Provide written informed consent
- •Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- •Willing to provide blood samples for correlative research purposes
- •Patient has received or is planning to receive ICI for mesothelioma
- •Patient is planning to receive SBRT (stereotactic body radiation therapy) for mesothelioma
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women
研究组 & 干预措施
Treatment (SBRT, immunotherapy)
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
干预措施: Immunotherapy (Other)
Treatment (SBRT, immunotherapy)
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
干预措施: Quality-of-Life Assessment (Other)
Treatment (SBRT, immunotherapy)
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor
时间窗: Up to 2 years
Feasibility of treating patients with SBRT and ICI will be determined by ability to treat all enrolled patients without meeting stopping rules (maintaining \<30%toxicity).
次要结局
- Progression-free survival (PFS)(Up to 2 years)
- Incidence of acute toxicity(Up to 90 days post-SBRT)
- Incidence of late toxicity(Up to 90 days post-SBRT)