NCT01147991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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI CTCAE version 3.0)
研究概览
简要总结
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with Epstein-Barr virus and cancer.
详细描述
OBJECTIVES:
Primary
- To determine safety and to characterize the toxicity profile of EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine in patients in remission having been treated conventionally for Epstein-Barr virus (EBV) and malignancy.
- To describe changes in the frequency of functional T-cell responses to major histocompatibility complex (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 in these patients.
Secondary
- To assess changes in levels of EBV genome in plasma in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 malignancy of a type typically associated with Epstein-Barr virus (EBV) latent infection meeting the following criteria:
- •The presence of EBV within the malignant cells has been demonstrated by immunohistochemistry for viral antigens or by EBER (EBV early RNA) in situ hybridization
- •Patients in remission from disease or with disease for which no standard treatment is appropriate, as defined by 1 of the following groups:
- •Have achieved a continuing complete response (CR) or unconfirmed CR
- •Residual masses at the site of treated disease that are not progressing (i.e., stable disease) and for which no standard therapy is recognized
- •Residual or recurrent disease that is low-volume and causing minimal or no symptoms and for which no standard therapy is recognized
- •Completed standard therapy for malignancy ≥ 12 weeks before trial entry
- •No more than 1 course of chemotherapy as treatment for EBV+ malignancy
- •No ongoing toxic manifestations of prior treatment, except alopecia or certain grade 1 toxicities at the discretion of the investigator and Cancer Research UK
- •No patients with active EBV+ cancer for whom evidence-based active treatment is available and likely to be offered to prolong life or relieve symptoms within 14 weeks of the first vaccination
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0 or 1
- •Life expectancy ≥ 4 months
- •Lymphocyte count must satisfy 1 of the following criteria:
- •Greater than lower limit of the reference range in the investigator site
- •Greater than or equal to 0.5 x 10^9/L AND recovery from nadir of lymphocyte numbers following primary treatment for EBV+ malignancy, judged by no successive rises in lymphocyte count measured up to 3 successive occasions 3 weeks apart
- •Hemoglobin > 10.0 g/dL
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Serum alkaline phosphatase < 1.5 times ULN
- •ALT and/or AST < 1.5 times ULN
- •Calculated creatinine clearance > 50 mL/min (uncorrected value) OR isotope clearance measurement > 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during study and for 6 months after completion of study treatment
- •No known chronic active infection with hepatitis B, hepatitis C, or HIV
- •No history of anaphylaxis or severe allergy to vaccinations
- •No allergy to eggs or egg products
- •No ongoing active infection
- •No known splenic dysfunction
- •No concurrent active autoimmune disease
- •No prior NYHA class III or IV cardiac disease or concurrent congestive heart failure
- •No concurrent active skin diseases requiring therapy (i.e., psoriasis, eczema)
- •No other condition that, in the Investigator's opinion, would make the patient not a good candidate for this clinical trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior myeloablative therapy followed by an autologous or allogeneic hematopoietic stem cell transplant
- •More than 12 weeks since prior and no concurrent chemotherapy or radiotherapy
- •No splenectomy or splenic irradiation
- •No concurrent immunosuppressive medication, including corticosteroids
- •Long-term prophylactic use of inhaled corticosteroids allowed
- •No major thoracic and/or abdominal surgery within the past 4 weeks from which the patient has not yet recovered
- •No other concurrent anticancer or investigational drugs
排除标准
- 未提供
结局指标
主要结局
Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI CTCAE version 3.0)
Occurrence of local skin reactions considered related to the vaccination
Occurrence of drug-related systemic reactions (e.g., transient fever)
Demonstration by ELIspot assays of the frequency of T-lymphocytes recognizing major histocompatibility complex (MHC) class I and II-restricted epitopes within EBNA1 and LMP2 in peripheral blood at sequential time-points before, during, and up to 9 mo ...
次要结局
- Measurement of EBV-genome levels in plasma
研究者
研究点 (6)
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