E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To prove the feasability and confirm the safety of tumor vaccination with autologous dendritic cells |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |