EUCTR2015-002198-40-NO进行中（未招募）1 期
Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy (DEN-STEM)
Oslo University Hospital0 个研究点目标入组 60 人开始时间: 2016年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following conditions must apply:
- •1.Must be at least 18 years and less than 70 years of age.
- •2.Must be ambulatory with a ECOG performance status 0 or 1
- •3.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”).
- •4.Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA).
- •5.Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume.
- •6.Normal organ function defined by laboratory values.
- •7.Glucocorticosteroids should be minimized or stopped before starting given vaccination.
- •8.Negative 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 8.8.
- •9.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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on the patient’s neurological condition, i.e. brain stem.
- •2.Large tumor remnant.
- •3.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.
- •4.Active infection requiring antibiotic therapy.
- •5.Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •6.Prior splenectomy.
- •7.Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
- •8.Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- •9.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.
- •10.Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination.
- •11.Any reason why, in the opinion of the investigator, the patient should not participate.
研究者
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