Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy (DEN-STEM)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months.
研究概览
简要总结
To identify the therapeutic effect of the product on progression free survival in glioblastoma patients.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years and less than 70 years of age.
- •Must be ambulatory with a ECOG performance status 0 or 1
- •Must have histologically confirmed glioblastoma IDH wild type, with non-methylated MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy ("Stupps Regimen").
- •Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA).
- •Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume.
- •Normal organ function defined by laboratory values.
- •Serology indicating contagious HIV, HBV, HCV and Treponema pallidum must be negative.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
排除标准
- •Tumor in a localization where a modest increase in size due to reactive edema may have a large impact on the patient's neurological condition, i.e. brain stem.
- •Positive pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose. Reliable methods of contraception are defined in section
- •Any reason why, in the opinion of the investigator, the patient should not participate.
- •History of prior malignancy other than glioblastoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.
- •Active infection requiring antibiotic therapy.
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •Prior splenectomy.
- •Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
- •Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- •Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination.
结局指标
主要结局
Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months.
Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months.
As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.
As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.
次要结局
未报告次要终点
研究者
Einar Vik-Mo
Scientific
Oslo University Hospital HF