NCT01256853已完成1 期
A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine
研究概览
简要总结
This is a phase I, dose escalation trial of MVA-EBNA1/LMP2 vaccine across a pre-defined range of doses in patients in remission having had an EBV+ nasopharyngeal carcinoma (NPC).
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 NPC, in which the presence of EBV within the malignant cells has been demonstrated by (1) EBER (EBV early RNA) in situ hybridisation in more than 50% of the malignant cells, or (2) undifferentiated or poorly differentiated carcinoma histology in association with a raised serum titer of IgA to EBV VCA.
- •Patients in remission from disease, ie complete response (CR) or unconfirmed complete response (CRu).
- •Completion of standard therapy for malignancy at least 12 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.
- •Haematological and biochemical indices (these measurements must be performed within 28 days prior to the patient going on study):
- •Haemoglobin (Hb) > 10.0 g/dl
- •Lymphocytes > 1.0 x 109/L (or above the lower limit of normal range of institutional laboratory)
- •Neutrophils ≥ 1.5 x 109/L
- •Platelets (Plts) ≥ 100 x 109/L
- •baseline liver function tests :
- •Serum bilirubin ≤ 1.5 x upper normal limit
- •Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN.
- •baseline renal function test:
- •calculated creatinine clearance > 50ml/min 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
- •Receiving current chemotherapy or radiotherapy, or received within 12 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.
- •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 and Cancer Research UK should not exclude the patient.
- •Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
- •Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- •Concurrent congestive heart failure or prior history of class III/ IV cardiac disease
研究组 & 干预措施
MVA Vaccine
Experimental
干预措施: MVA Vaccine (Drug)
结局指标
主要结局
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine
时间窗: 4 years
次要结局
- To describe changes in the frequency of functional T-cell responses to MHC class I and II-restricted epitopes within EBNA1 and LMP2 in peripheral blood at sequential time-points before, during and up to nine months after the vaccination course.(4 years)
- To assess changes in levels of EBV genome levels in plasma(4 Years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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