NCT00690872Unknown2 期
Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal Carcinoma
National Cancer Centre, Singapore2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Median progression-free survival (PFS 1), defined as the time from study enrollment to the time of radiological disease progression or death from any cause
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together with laboratory-treated T lymphocytes works in treating patients with metastatic or locally recurrent Epstein-Barr virus-positive nasopharyngeal cancer.
详细描述
OBJECTIVES:
Primary
- To determine progression-free survival (PFS 1) of patients with metastatic or locally recurrent Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma treated with gemcitabine hydrochloride and carboplatin followed EBV-specific cytotoxic T-lymphocytes (CTL).
Secondary
- To determine progression-free survival (PFS 2) of these patients during the immunotherapy portion of this study.
- To determine the clinical benefit rate of EBV-specific CTL in these patients.
- To determine the tolerability of EBV-specific CTL therapy in these patients.
- To demonstrate persistence of EBV-specific immune response in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-proven nasopharyngeal carcinoma (NPC)
- •WHO type 2/3 disease
- •Metastatic or locally recurrent disease
- •Epstein-Barr virus (EBV)-positive disease as confirmed by in situ hybridization assay or PCR amplification for EBV-encoded RNA expression
- •Radiologically measurable disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •ANC > 1,200/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8 g/dL
- •Bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 3 times ULN
- •Creatinine clearance ≥ 40 mL/min
- •Corrected calcium normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent severe illness, including any of the following:
- •Chronic obstructive pulmonary disease
- •Ischemic heart disease
- •Active congestive cardiac failure
- •Active angina pectoris
- •Uncontrolled arrhythmia
- •Uncontrolled hypertension
- •No concurrent severe infections
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •No more than one line of prior chemotherapy for metastatic disease
- •No prior gemcitabine hydrochloride
- •Prior platinum agents allowed
- •At least 1 month since prior investigational therapy
排除标准
- 未提供
结局指标
主要结局
Median progression-free survival (PFS 1), defined as the time from study enrollment to the time of radiological disease progression or death from any cause
次要结局
- Median PFS 2, defined as the time from the start of induction immunotherapy to radiological disease progression or death from any cause
- Response rate, defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) after 4 courses of chemotherapy and the proportion of patients who achieve a further response after immunotherapy
- Clinical benefit rate of immunotherapy, defined as the proportion of patients who achieve CR, PR, or stable disease
研究者
研究点 (2)
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