A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
研究概览
简要总结
Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years of age or older
- •Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease
- •Patients with recurrent sarcoma at relapse
- •Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor)
- •If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing
- •Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development.
- •No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX
- •Fresh tumor tissue available for PDX development
- •Eastern Cooperative Oncology Group performance status of 0-1
- •Life expectancy exceeds 6 months
- •Plan to receive systemic therapy
- •Informed consent
排除标准
- 未提供
研究组 & 干预措施
PDX drug sensitivity testing
Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician.
干预措施: PDX drug sensitivity testing (Other)
结局指标
主要结局
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
时间窗: 3 years
Overall accuracy as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in PDX model for same drug treatment.
次要结局
- Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.(3 years)
- Factors that impact on engraftment success.(2 years)
- Factors that impact time to drug sensitivity testing.(2 years)