Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells.
详细描述
To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
- •Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:
- •Not candidates for known curative intent therapy.
- •Progressed following at least one prior systemic therapy.
- •Have advanced melanoma unresectable stage III or stage IV
- •Have advanced head and neck recurrent or metastatic disease
- •Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
- •Life expectancy of greater than 3 months.
- •ECOG Performance Status of 0 or
- •Adequate organ and marrow function
- •Seronegative for HIV antibody.
- •Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
- •More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
- •Patient has stable or progressing disease after at least one prior treatment.
- •Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy
排除标准
- •Currently using investigational agents.
- •Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
- •Patient is a female of child-bearing potential who is pregnant or breastfeeding
- •Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
- •Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- •Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- •Patient has opportunistic infections.
- •Patient has a history of coronary revascularization or ischemic symptoms.
- •Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
研究组 & 干预措施
Solid Tumor
Solid Tumor
干预措施: Autologous Tumor Infiltrating Lymphocytes (Biological)
Solid Tumor
Solid Tumor
干预措施: High-Dose Interleukin 2 (Biological)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 2 months
Dose Limiting Toxicity (DLT)
次要结局
未报告次要终点
研究者
Gregory Daniels
Professor of Medicine
University of California, San Diego