EUCTR2006-002881-20-BE进行中（未招募）1 期
HGG-2006: a phase I/II clinical trial for the treatment of newly diagnosed high grade glioma with tumor vaccination as add-on therapy to standard primary treatment
niversity Hospital Gasthuisberg0 个研究点目标入组 60 人开始时间: 2006年6月2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
- •* Age: > 18 years and < 70 years; * First diagnosis of high grade glioma (glioblastoma multiforme WHO grade IV), histologically proven; * Diagnosis confirmed by the reference pathology; * Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon ( 3 months; * Informed consent by patient.
- •The final and definitive inclusion in the trial can only be done at the trial center in Leuven after considering all the necessary information on the clinical, pathological and radiological data.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Pregnancy; * Patients with postoperative Karnofsky index < 70; * Simultaneous treatment according to other clinical trials; * Virus serology positive for Hepatitis, syphilis or HIV; * Blood counts: Leukocytes < 3000/µl, lymphocytes < 500/µl, neutrophils < 1000/µl, hemoglobin < 9 g/100 ml, thrombocytes < 100000/µl at day 10, about 2 days prior to leukapheresis; * Documented immune deficiency; * Documented autoimmune disease; * Mandatory treatment with corticosteroids or salicylates in inflammatory dose; * Other active malignancy.
研究者
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