A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1-year survival rate
研究概览
简要总结
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
详细描述
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.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 4 g tumor sample;
- •Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy).
- •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
- •Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received.
排除标准
- •Inability to comply with study-related procedures
- •Unavailability of at least 6 doses of vaccine
- •Severe allergies
- •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
- •Carmustine extended release implant surgery within 6 months
- •Steroidal drugs are currently being used systemically.
研究组 & 干预措施
control group
Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
干预措施: radiotherapy (Radiation)
gp96 group
Patients receive standard treatment with radiation and temozolomide after surgery.
Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy.
( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. )
The first adjunctive temozolomide startes on the day of the fifth gp96 injection.
(150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)
干预措施: gp96 (Biological)
gp96 group
Patients receive standard treatment with radiation and temozolomide after surgery.
Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy.
( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. )
The first adjunctive temozolomide startes on the day of the fifth gp96 injection.
(150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)
干预措施: Temozolomide (Drug)
gp96 group
Patients receive standard treatment with radiation and temozolomide after surgery.
Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy.
( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. )
The first adjunctive temozolomide startes on the day of the fifth gp96 injection.
(150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)
干预措施: radiotherapy (Radiation)
control group
Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
干预措施: Temozolomide (Drug)
结局指标
主要结局
1-year survival rate
时间窗: 1 years
次要结局
- Overall survival(5 years)
- changes in antigen specific T cells(within 3 days before the first vaccination and within 10 days after the last vaccination)
- Number of participants with adverse events related to gp96 immunotherapy(up to 3 months after vaccine completion)
- Progression-free survival rate(1 year)
- Progression-free survival(5 years)