A Pilot Trial of NY-ESO-1-Specific T Cells in Patients With Metastatic NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
研究概览
简要总结
This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that have spread to other places in the body and are receiving palliative (relief of symptoms and suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into white blood cells may help the body build an immune response to kill tumor cells that express NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a better treatment for patients with sarcomas.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and toxicity of NY-ESO-1-specific T cells when given following high-dose, hypo-fractionated palliative radiation to patients with advanced NY-ESO-1 expressing sarcomas.
SECONDARY OBJECTIVES:
I. To look for preliminary evidence of systemic efficacy of NY-ESO-1-specific T-cell therapy following radiation on non-radiated tumors.
II. To determine whether radiation increases trafficking of adoptively transferred NY-ESO-1-specific T cells by comparing tumor biopsy specimens from radiated and non-radiated tumors.
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
- •INCLUSION CRITERIA FOR SCREENING:
- •Histopathological documentation of sarcoma
- •Patients must express NY-ESO-1 in their tumor by immunohistochemistry (IHC) (> 5%) prior to leukapheresis
- •For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator [PI]):
- •Pulse > 45 or < 120
- •Weight >= 45 kg
- •Temperature =< 38° Celsius (C) (=< 100.4° Fahrenheit [F])
- •White blood cell count (WBC) >= 2,000
- •Hematocrit (HCT) >= 30%
- •Platelets >= 75,000
- •INCLUSION CRITERIA FOR TREATMENT:
- •A diagnosis of a metastatic or unresectable sarcoma
- •Patient must have a biopsy-accessible tumor to be radiated
- •Patient must have consulted with a radiation oncologist who is planning radiation; their radiation oncologist should have documented plans to administer a dose of at least 30 Gy in 5 or fewer fractions
- •Human leukocyte antigen (HLA) type A0201 or A2402
- •Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of '0-2'
- •All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning
- •All patients must have an echo or multigated acquisition (MUGA) scan showing ejection fraction (EF) > 50% and normal troponin and creatine kinase MB (CK MB) performed within 90 days of starting treatment
排除标准
- •EXCLUSION CRITERIA FOR SCREENING:
- •Patients who do not meet the above inclusion criteria will not receive leukapheresis
- •EXCLUSION CRITERIA FOR TREATMENT:
- •Patients with a history of proven myocarditis, pericarditis, or endocarditis
- •Pregnant women, nursing women, men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
- •Inadequate renal function as indicated by serum creatinine >= 1.5 times the upper limit of normal
- •Inadequate liver function as indicated by total bilirubin >= 1.5 times the upper limit of normal
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >= 2.5 times the upper limit of normal
- •Active symptomatic congestive heart failure
- •Clinically significant hypotension
- •Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 3 months will be allowed to participate
- •Known untreated central nervous system (CNS) metastasis
- •Patients with systemic infections requiring antibiotics or chronic maintenance/suppressive therapy
- •Patients receiving systemic anticancer therapy (chemotherapy, "biologics", immunotherapy) less than 2 weeks prior to starting radiation
- •Clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
- •Patients with acquired immunodeficiency syndrome (AIDS) or who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study; testing may have been done up to 3 months prior to treatment
- •Current treatment with steroids
- •Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); testing may have been done up to 3 months prior to treatment
结局指标
主要结局
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
时间窗: Up to 12 weeks post-treatment
CTCAE v4.03
次要结局
- Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers(Up to 6 weeks post-treatment)
- T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1(At 6 weeks post-treatment)
研究者
Seth Pollack
Responsible Party
Fred Hutchinson Cancer Center