NCT00589186Unknown2 期
Phase II Clinical Trial of Tumour Vaccination By Intradermal Delivery of Autologous Dendritic Cells Transduced With Adenoviral Vector (AD5F35) Expressing Latent Membrane Protein-1 (LMP-1) and Latent Membrane Protein-2 (LMP-2) Genes in Combination With Celecoxib in Patient With Metastatic 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: 2007年11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
- Clinical benefit rate (CBR) (complete response [CR], partial response [PR], and stable disease [SD] for ≥ 14 weeks) as defined by RECIST criteria
研究概览
简要总结
RATIONALE: Vaccines made from a gene-modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with celecoxib works in treating patients with metastatic nasopharyngeal cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the clinical benefit rate (complete response, partial response, and stable disease for ≥ 14 weeks) in patients with metastatic nasopharyngeal carcinoma treated with autologous dendritic cells (DC) transduced with AD5F35 expressing LMP-1 and LMP-2 when administered in combination with celecoxib.
Secondary
- To evaluate the toxicities of this regimen in these patients.
- To evaluate the specific T-cell response against LMP-1 and LMP-2 as measured by HLA tetramer technology, ELISPOT assay, and delayed-type hypersensitivity in patients treated with this regimen.
- To evaluate the surrogate tumor marker response plasma EBV DNA by real-time PCR in these patients.
- To evaluate and characterize immunological cell types and tumor characteristics in biopsy specimens of patients treated with this DC vaccine and compare it with pre-vaccine biopsy specimens.
- To evaluate progression-free survival and overall survival of patients who show initial clinical benefit to DC vaccine.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed nasopharyngeal carcinoma (NPC)
- •Metastatic disease
- •WHO type II/III disease
- •Measurable disease
- •Meets 1 of the following criteria:
- •Progression on one or more lines of polychemotherapy for treatment of metastatic disease
- •Failed non-myeloablative hematopoietic stem cell transplant
- •No active CNS metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Hemoglobin ≥ 8.5 g/dL
- •Serum bilirubin ≤ 1.5 times upper limit of normal
- •ALT or AST ≤ 5 times normal
- •Creatinine clearance ≥ 40 mL/min
- •Left ventricular ejection fraction ≥ 45% by MUGA
- •Corrected DLCO > 50% of predicted
- •No active or prior gastrointestinal bleeding
- •No history of adverse reaction to NSAIDs or sensitivity to celecoxib
- •No cardiac disease, including any of the following:
- •Symptomatic congestive heart failure
- •Active angina pectoris
- •High-risk uncontrolled arrhythmia
- •Uncontrolled hypertension
- •No pulmonary disease, including any of the following:
- •Severe chronic obstructive lung disease
- •Uncontrolled large pleural effusion
- •Severe restrictive lung disease
- •No cerebrovascular accident
- •No transient ischemic attack
- •No HIV positivity
- •No active uncontrolled infection
- •No symptomatic leukoencephalopathy or other neuropsychiatric abnormalities
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior celecoxib allowed
- •At least 28 days since prior chemotherapy
- •At least 100 days since prior non-myeloablative hematopoietic stem cell transplant
- •At least 2 months since prior donor lymphocyte infusions
- •More than 28 days since prior participation in another clinical trial with any investigational drugs
- •No other concurrent experimental drugs
- •No other concurrent anticancer therapy
- •No concurrent anticoagulation with warfarin or low molecular weight heparin
- •No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin
排除标准
- 未提供
结局指标
主要结局
Clinical benefit rate (CBR) (complete response [CR], partial response [PR], and stable disease [SD] for ≥ 14 weeks) as defined by RECIST criteria
次要结局
- Response rate (CR and PR)
- Overall survival
- Progression-free survival
- Toxicity profile
研究者
研究点 (2)
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