High grade glioma
Conditions
Interventions
Product Name: DC
Product Code: 0
Pharmaceutical Form: Suspension for injection
Sponsors
Department of Neurology, Karolinska University Hospital
Dept. of Pediatric hematology and oncology, Astrid Lindgren Children´s Hosp,Karolinska Univ Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: >3y and preferably 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the feasability and confirm the safety of tumor vaccination with autologous dendritic cells;Secondary Objective: To investigate the immune response in the individual patient, measured by tumor response (serial MRI´s and clinical status) and by following biological parameters of immune response in the blood. To determine the effect on the overall survival and influence on progression-free survival;Primary end point(s): To improve the overall and progression free survival of patients with high grade glioma, both at initial presentation and at first recurrence with immune therapy based on dendritic cells loaded with tumor derived lysates (antigens). The current standard treatment of surgery, radiation therapy and chemotherapy cannot cure most patients with high grade glioma; an ongoing study in Belgium has shown significant improvement of survival of young patients with relapsed high grade glioma when this treatment is used. It has found to be safe andwell tolerated in contrast to many other heavy chemotherapy protocols used in these patients. Another goal is to show the feasability and confirm the safety of this approach at our hospital especially since the availability to the treatment is restricted to Belgium with limited capacity to treat patients who could benefit from the treatment. | — |
Countries
Sweden
Outcome results
None listed