Imune therapy of High Grade Glioma with dendritic cell vaccination. A phase II study.

Department of Neurology, Karolinska University Hospital0 个研究点开始时间: 2008年5月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Age: >3y and preferably <40y
•first diagnosis: glioblastoma (WHO grade IV) or recurrent high grade glioma (WHO grade III and IV)
•macroscopically total or subtotal (>90%) resection of tumor mass, confirmed by neurosurgeon and postoperative MRI scan with gadolinium within 3 days post op.
•sufficient tumor tissue (>1cm*3) sterile and immediatly frozen for tumor lysate preparation
•life expectancy >3 months
•informed consent by patient or parents for children.
•Are the trial subjects under 18? yes
•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) no
•F.1.3.1 Number of subjects for this age range

•patient with neurologic status according to WHO >2 (equivalent to Karnovsky index <70, patient can care for some daily activities with effort and must rest <50% of the time)
•simultaneous treatment in other clinical trial
•virus serology positive for hepatitis, lues or HIV
•low blood counts: WBC <3x10*9/L , lymph <0.5 x10*9/L, neutrophils <1x10*9/L, hemoglobin <90 g/L, platelets <100 x10*9/L at day 10 post op and/or 2 days before leukapheresis.
•documented immune defiiency or autoimmune disease
•other active malignancy

发起方

Department of Neurology, Karolinska University Hospital