A Phase II Study of Phenylbutyrate and Valganciclovir in Epstein-Barr Virus Positive Tumors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evidence of Epstein-Barr virus (EBV) lytic phase activation (expression of EBV antigens BZLF1 and LMP2) as assessed by biopsy on day 3 of course 1
研究概览
简要总结
RATIONALE: The Epstein-Barr virus can cause cancer and lymphoproliferative disorders. Valganciclovir is an antiviral drug that acts against the Epstein-Barr virus. Phenylbutyrate may make cells infected with Epstein-Barr virus more sensitive to valganciclovir. Giving phenylbutyrate together with valganciclovir may block the growth of Epstein-Barr virus-infected cells and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving phenylbutyrate together with valganciclovir works in treating patients with relapsed or refractory Epstein-Barr virus-positive cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of Epstein-Barr virus (EBV) lytic phase activation by BZLF1 expression in patients with relapsed or refractory, EBV-positive malignancies treated with phenylbutyrate.
Secondary
- Determine tumor responses in patients treated with phenylbutyrate followed by valganciclovir.
- Track serum EBV load by quantitative polymerase chain reaction and correlate changes with EBV lytic phase activation/tumor response.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm Study of Biopsy
干预措施: oral sodium phenylbutyrate (Drug)
Single Arm Study of Biopsy
干预措施: valganciclovir (Drug)
Single Arm Study of Biopsy
干预措施: polymerase chain reaction (Genetic)
Single Arm Study of Biopsy
干预措施: protein expression analysis (Genetic)
Single Arm Study of Biopsy
干预措施: biopsy (Procedure)
结局指标
主要结局
Evidence of Epstein-Barr virus (EBV) lytic phase activation (expression of EBV antigens BZLF1 and LMP2) as assessed by biopsy on day 3 of course 1
次要结局
- Tumor response in patients with measurable disease as assessed by RECIST criteria