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 Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
研究概览
简要总结
The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.
详细描述
All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.
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 melanoma will be required by previous biopsy or cytology.
- •Patients must be ≥ 18 years of age.
- •Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones (other than long bones), or liver (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.
- •ECOG performance status of 0-
- •Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
- •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.
- •Previous radiation to sites proposed for radiation as part of this study.
- •Patients with active systemic, pulmonary, or pericardial infection.
- •Pregnant or lactating women.
- •Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG.
- •DLCO, FEV1 or FEV1/FVC less than 70% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high dose IL-2 therapy.
- •WBC < 3.0 x 109/L
- •Hgb < 9.0 g/dL
- •AST/ALT > 3 times the upper limit of the normal range
- •total bilirubin > 1.9 g/dL
- •creatinine > 1.9 g/dL
- •Patient requires chronic steroids.
研究组 & 干预措施
Arm A: IL-2 Monotherapy
Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.
干预措施: High-dose IL-2 (Drug)
Arm B: SBRT + IL-2
Patients will receive two doses of radiation before receiving high-dose IL-2.
干预措施: Radiation therapy and high-dose IL-2 (Other)
结局指标
主要结局
Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
时间窗: At the end of Cycle 2 (Week 14).
Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective. Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions treated by SBRT, which were assessed separately. Both CT and positron emission tomography imaging were employed to assess response. Complete Response: disappearance of all target/non-target lesions and no abnormalities on PET; Partial Response: ≥30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease: ≥20% increase in sum of LD recorded since tx start or appearance of ≥1 new lesions; Stable Disease: Neither qualifying for PR nor PD since tx started.
次要结局
- Response Rate in Crossover Patients(7 weeks following Cycle 2 (Week 21).)