E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adults with newly diagnosed glioblastoma multiforme |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The first aim of this study is to assess the feasibility/toxicity to integrate tumor vaccination within the global treatment plan for a patient with newly diagnosed HGG. The major primary aim will be the event-free survival at 6 months (PFS) after diagnosis. |
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E.2.2 | Secondary objectives of the trial |
The secondary end-point will be the OS of the patients. A further secondary question is to assess the efficacy to generate an immune response in combination with non-immunosuppressive chemotherapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
* 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 (<S2) and by postoperative MRI scan within 72 hours (<R2) (see full protocol for definitions of S and R); * Availibility of enough tumor tissue, kept dry in a sterile vial at -80°C; * Postoperative radiological assessment by the reference radiology; * Perioperative administration of corticosteroids tapered within 5 days postoperatively; * Life expectancy > 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.
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E.4 | Principal exclusion criteria |
* 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |