Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Renal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday before the Monday on which IL-2 starts.
详细描述
All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intraveneous bolus (IVB) every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles. Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gray (Gy) on the Wednesday and Friday before the Monday on which IL-2 starts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histological confirmation of predominant conventional (clear cell) renal cancer
- •Patients must be ≥ 18 years of age
- •Tumors amenable to SBRT in lungs (central locations preferred), mediastinum, chest wall, bones with a soft tissue component (other than long bones), or liver, liver hilum and associated lymph nodes (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of protocol treatment. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy
- •Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry)
- •Patients must sign a study-specific consent form
排除标准
- •No metastatic site amenable to SBRT
- •Patients with brain metastases not candidates for radiosurgery alone
- •Previous radiation to sites proposed for SBRT
- •Patients with active systemic, pulmonary, or pericardial infection
- •Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
- •Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG
- •Clinically significant underlying pulmonary disease as measured by pulmonary function tests
- •Blood tests within protocol-specified range
- •Need for chronic steroids
研究组 & 干预措施
High Dose IL-2 and SBRT
Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
干预措施: High Dose IL-2 (Biological)
High Dose IL-2
Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for 14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
Patients assigned to the IL-2 arm who have disease progression after the first two IL-2 cycles have the option to receive SBRT followed by 2 additional cycles of IL-2.
干预措施: High Dose IL-2 (Biological)
High Dose IL-2 and SBRT
Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before IL-2 starts (the following Monday). Patients will receive IL-2 at 600,000 international units per kg IVB every 8 hours for14 planned doses with an additional cycle 14 days after the first. Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.
干预措施: SBRT (Radiation)
结局指标
主要结局
Response Rate
时间窗: 5 years
The objective of this study is to compare the response rate among renal cell cancer (RCC) patients of high dose IL-2 to SBRT + IL-2 in patients with metastatic renal cancer
次要结局
- Response Rate in Patients Who Receive SBRT following Progression on IL-2(5 years)