The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population
研究概览
简要总结
The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.
详细描述
Original tumor slides will be collected to identify tumor markers that may predict responses to treatment. Blood samples will be obtained prior to treatment with IL-2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Malignant melanoma that is metastatic or unresectable
- •Eligible to receive high-dose IL-2
- •Tissue block available with adequate tumor to perform RNA extraction and DASL analysis
排除标准
- •Prior immunotherapy for unresectable or metastatic disease
- •Untreated brain metastases, leptomeningeal disease, or seizure disorder
研究组 & 干预措施
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
干预措施: IL-2 (Drug)
结局指标
主要结局
To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population
时间窗: 2 years
次要结局
- To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response(2 years)
- To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most(2 years)
- To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2(2 years)
- To explore the predictive value of several genetic polymorphisms associated with immune function(2 years)
- To explore the relationship of serum fibronectin and VEGF levels with the molecular signature of immune responsiveness in patients with advanced melanoma receiving high-dose IL-2 in order to identify specific cohorts with dramatic differences in response(2 years)
研究者
David McDermott
Principal Investigator
Beth Israel Deaconess Medical Center