Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
研究概览
简要总结
TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
详细描述
TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.
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
- •Age > 18
- •Informed consent
- •Diagnosis of grade IV glioma with progression following standard treatment.
- •Must be able to tolerate surgery to provide tumor tissue for vaccine.
- •Must be able to produce viable vaccine from tumor tissue.
- •Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or Karnofsky Performance Status must be 70 or greater.
- •Negative HIV test.
- •Negative for hepatitis B and C virus.
- •Respiratory reserve must be reasonable.
- •Sufficient renal function.
- •Satisfactory blood counts.
- •Negative pregnancy test for women of childbearing potential.
排除标准
- •Surgically removed cancer reveals that it is not grade IV glioma.
- •Concomitant life-threatening disease.
- •Active autoimmune disease.
- •Currently receiving chemotherapy or biological therapy for the treatment of cancer.
- •Currently receiving immunosuppressive drugs for any reason.
- •Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.
- •Prior treatment with Gliadel wafers.
- •Corticosteroids beyond peri-operative period.
- •Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
结局指标
主要结局
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
时间窗: 8 weeks
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
时间窗: 48 hours
The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.
次要结局
- Overall Survival(12 months)