2024-514820-18-00招募中2 期
Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma
Heinrich-Heine-Universitaet Duesseldorf, Heinrich-Heine-Universitaet Duesseldorf5 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年8月26日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- The primary efficacy endpoint is OS measured from the day of surgery until death.
研究概览
简要总结
The primary objective of the study is to determine whether overall survival of newly diagnosed GBM patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV), including the histological variants of gliosarcoma and giant cell glioblastoma, confirmed by central neuropathologist according to the WHO classification of central nervous system tumors
- •Tumors may cross into, but not beyond the corpus callosum.
- •Near-complete resection (≤ 5 ml residual contrast enhancing tumor volume) confirmed by central neuroradiologist on MRI scan within 72 h postoperative; awake surgery and second look surgery are possible, if medically indicated.
- •Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production.
排除标准
- •Severe acute or chronic medical conditions that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of trial results and, in the opinion of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to the following: Immunosuppressive disease / immunodeficiency, Chronic renal disease / failure, Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia, Severe poorly controlled diabetes, Planned other major surgery.
结局指标
主要结局
The primary efficacy endpoint is OS measured from the day of surgery until death.
The primary efficacy endpoint is OS measured from the day of surgery until death.
次要结局
- PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause.
- OS and PFS rates at 6, 12 and 24 months after the day of surgery.
- Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03.
- Overall and neurological performance as determined by the KPS and the MMSE-2.
- Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.
研究者
Prof. Dr. Michael Sabel
Scientific
Heinrich-Heine-Universitaet Duesseldorf
研究点 (5)
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