Imune therapy of High Grade Glioma with dendritic cell vaccination. A phase II study.
- Conditions
- High grade glioma
- Registration Number
- EUCTR2007-003513-14-SE
- Lead Sponsor
- Department of Neurology, Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
pregnancy
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method