NCT00323115已完成2 期
A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tumor-specific Cytotoxic T-cell Response
研究概览
简要总结
Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.
详细描述
Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.
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
- •Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC)
- •Tumor specimen obtained at the time of surgery adequate for vaccination
- •18 years of age or older
- •Karnofsky Performance Status 60% or greater
- •Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L
- •Platelets greater than or equal to 100 x 10 9th/L
- •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal to 5 times the upper limits of normal (ULN)
- •Total bilirubin less than or equal to 1.5 times ULN
- •Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min
- •No known immunosuppression other than chemo-related
- •Negative HIV serologies
- •No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests
- •No chemotherapy within four weeks prior to leukapheresis
- •Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol
- •Off steroids for at least two weeks before leukapheresis
- •No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS
- •Negative serum or urine pregnancy test for women of childbearing potential
- •No serious uncontrolled medical disorder or active infection
- •All patients must give informed consent
- •No history of clinical evidence of active autoimmune disease
排除标准
- •Invasive cancers in the past 5 years
- •Rheumatologic/autoimmune disease
- •Pregnancy or unwillingness to remain on acceptable form of birth control during study
- •Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection
研究组 & 干预措施
Vaccine
Experimental
干预措施: Autologous Dendritic Cell (Biological)
Vaccine
Experimental
干预措施: Temozolomide (Drug)
Vaccine
Experimental
干预措施: Radiotherapy (Procedure)
Vaccine
Experimental
干预措施: Dendritic Cell Vaccine (Biological)
结局指标
主要结局
Tumor-specific Cytotoxic T-cell Response
时间窗: Day 42
MRI \& pheresis post vaccine
次要结局
- Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Mean(Day 7 (pre-vaccination) and Day 42 (post-vaccination))
- Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Mean(Day 7 (pre-vaccination) and Day 42 (post-vaccination))
- Evaluation of T Cell Characteristics(Before starting radiation/Temozolomide and at Day 7 and Day 42.)
- Immunohistochemistry(Approximately 42 months)
- Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination(Until death or approximately 24 months after diagnosis)
- Number of Participants With Evaluable Data: Feasibility of Vaccination(Through enrollment, approximately 2 years)
- Progression Free Survival (PFS)(Approximately 42 months)
- Number of Participants With Significant Difference in Tumor Volume Size Pre- and Postvaccination: Neuroimaging and Tumor Assessment(baseline and 4 weeks)
- Overall Survival Duration: Efficacy Parameters(Approximately 42 months)
- Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Median(Day 7 (pre-vaccination) and Day 42 (post-vaccination).)
- Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Median(Day 7 (pre-vaccination) and Day 42 (post-vaccination))
- Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Median(Day 7 (pre-vaccination) and Day 42 (post-vaccination))
- Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Mean(Day 7 (pre-vaccination) and Day 42 (post-vaccination))
研究者
研究点 (1)
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