NCT01094405已完成2 期
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical Benefit Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (clinical benefit rate) of MVA EBNA1/LMP2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal carcinoma, and its impact on disease progression.
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
- •Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- •NPC associated with EBV infection, determined as:
- •NPC occurred in association with a raised serum titre of IgA to EBV viral capsid antigen (VCA) in a patient living in an area of high incidence of EBV+ undifferentiated NPC, or
- •The presence of EBV has been confirmed in the tumour by immunohistochemistry for EBV antigens or in situ hybridization for EBV early RNA (EBER), or
- •NPC with persistent or recurrent disease occurs in the context of an elevated circulating EBV genome level
- •Patients with persistent, recurrent or metastatic NPC that have residual EBV DNA following completion of conventional therapy (chemotherapy or radiotherapy).
- •Patients with residual masses at the site(s) of previous disease that are not progressing and for whom no standard therapy is currently appropriate.
- •Patients with residual or recurrent disease that is low volume, that is causing minimal or no symptoms and for whom no standard therapy is currently appropriate.
- •Disease must be not amenable to potentially curative radiotherapy or surgery.
- •Completion of standard therapy for malignancy at least 4 weeks before trial entry.
- •Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.
- •Age greater than 18 years.
- •World Health Organisation (WHO) performance status of 0 or 1
- •Life expectancy of at least 4 months.
- •Female patients of child-bearing potential are eligible, provided they have a negative pregnancy test prior to enrolment and agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
- •Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
排除标准
- •Chemotherapy, radiotherapy, or major surgery received within 4 weeks of trial entry.
- •Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •Current active autoimmune disease.
- •Current active skin diseases requiring therapy (psoriasis, eczema etc).
- •Ongoing active infection.
- •History of anaphylaxis or severe allergy to vaccination.
- •Allergy to eggs or egg products.
- •Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant.
- •Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction.
- •Receiving current immunosuppressive medication, including corticosteroids (inhaled steroids are acceptable).
- •Pregnant and lactating women.
- •Ongoing toxic manifestations of previous treatment. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator should not exclude the patient.
- •Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
结局指标
主要结局
Clinical Benefit Rate
时间窗: 2 Years
Clinical benefit rate (CBR, percent of patients experiencing complete response \[CR\], partial response \[PR\] or stable disease \[SD\] for at least 12 weeks from post cycle 2 to cycle 6 measurements) determined according to the Response Evaluation Criteria in Solid Tumours (RECIST), or by immune-related Response criteria (irRC) in the absence of measurable disease.
次要结局
- Objective Response Rate (ORR)(2 Years)
- Overall survival (OS)(3 Years)
- Progression-free survival (PFS)(3 Years)
- Duration of Response (DR)(2 Years)
研究者
CCTU
Prof. Anthony TC Chan
Chinese University of Hong Kong
研究点 (1)
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