PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Metabolic activity at metastatic sites
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well positron emission tomography and computed tomography scan predicts response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.
详细描述
OBJECTIVES:
Primary
- Measure changes in metabolic activity at visceral sites during the acute treatment phase of adoptive cell transfer (ACT) using positron emission tomography (PET)/CT fusion imaging in patients with metastatic melanoma or renal cell cancer.
- Measure changes in metabolic activity at metastatic sites during the acute treatment phase of ACT using PET/CT fusion imaging.
- Compare the changes in metabolic activity at visceral and metastatic sites in patients treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions.
Secondary
- Correlate response of individual metastases with these metabolic alterations.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Renal cell cancer
- •Metastatic disease
- •Measurable disease by CT scan or MRI
- •Enrolled in a Surgery Branch protocol utilizing 1 of the following variations of adoptive cell transfer of tumor-infiltrating lymphocytes (TIL):
- •Intravenous (IV) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158)
- •Intra-arterial (IA) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158)
- •IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation (e.g., NCI-04-C-0288)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •No history of or treatment for diabetes mellitus
- •No hypersensitivity or allergy to fludeoxyglucose F 18
- •Weight ≤ 350 lbs (136 kg)
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No treatment with both IV and IA TIL
排除标准
- 未提供
结局指标
主要结局
Metabolic activity at metastatic sites
Metabolic activity at visceral sites
Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions
次要结局
- Response of individual metastases in comparison with metabolic alterations