Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- blood count
研究概览
简要总结
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and understand the informed consent document; must sign the informed consent.
- •Aged 18 to 75 years old , sex is not limited
- •Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection
- •Availability of at least 1 g tumor sample.
- •Karnofsky functional status rating > or equal to
- •Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)
- •Agree to Surgical indications of Heart & lung and without the coagulation system disease
- •Negative pregnancy test for female patients of childbearing potential
- •Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration
排除标准
- •Inability to comply with study-related procedures
- •patient not suitable for Neurosurgery.
- •Unavailability of at least 6 doses of vaccine
- •Progression prior to vaccination as determined by the Principal Investigator
- •Patient with allergic constitution
- •Unstable or severe intercurrent medical conditions
- •Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
- •patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
- •any other clinical trials within 30 days pre-vaccination.
- •Female patients who are pregnant or breastfeeding
研究组 & 干预措施
gp96 group
autologous gp96 vaccination + basal treatment
干预措施: gp96 (Biological)
结局指标
主要结局
blood count
时间窗: within 3 days after the 6th injection
blood count within 3 days after the 6th injection
blood chemistries
时间窗: within 3 days after the 6th injection
blood chemistries test within 3 days after the 6th injection
electrocardiogram
时间窗: within 3 days after the 6th injection
electrocardiogram test within 3 days after the 6th injection
progression-free survival rate of six month
时间窗: six month after surgery
progression-free survival rate of six month
次要结局
- progress free survive(up to 3 years)
- overall survive(up to 3 years)
- quality of life(up to 3 years)
- tumor control rate(six month after surgery)
- changes in antigen specific T cells(baseline and within 3 days before the 6th injection)