ACTRN12607000191493已完成1 期
Phase I trial to assess the safety of adoptive transfer of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) in patients with Stage III and IV nasopharyngeal carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 15 Years 至 ot stated(—)
- 性别
- All
入选标准
- •1.Stage III or IV nasopharyngeal carcinoma as defined by the 6th edition of the UICC TNM staging. 2. Geographically accessible for follow up 3.Informed consent (from patient, or patient and parent/guardian if aged < 16 years) 4.ECOG performance status 1, 2 or 3 (see Appendix G). 5.Life expectancy of at least three months.
排除标准
- •1.EBV negative tumour, as found in project P4902.Inability to identify a LMP peptide to stimulate CTL cultures3.Positive serology for HIV, 4.Serology indicating active HBV infection or carrier status for HBV 5.Serology indicating active HCV infection6.Significant non –malignant disease 7.Psychiatric, addictive or any condition which may compromise the ability to participate in this trial8.Prior cancers, except those diagnosed > five years ago with no evidence of disease recurrence and clinical expectation of recurrence <5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix.9.Currently receiving immunosuppressive therapy, including corticosteroids.10.Pregnancy, or unwilling to use adequate contraception.
研究者
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