E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients older than 3 years of age with newly diagnosed Glioblastoma Multiforme (GBM) undergoing brain surgery for removal of at least 70% of tumour mass and receiving subsequently standard radiation therapy and standard chemotherapy with temozolomide. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
E.1.2 | Term | Glioblastoma multiforme |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 12 months after a post-operative MRI scan treated according to the current standard (surgical resection, irradiation, oral chemo-therapy with Temozolomide), and Trivax, an autologous DC cancer vaccine charged with autologous tumour protein, as add-on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B). |
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E.2.2 | Secondary objectives of the trial |
Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 18 and 24 months after a post-operative MRI scan receiving standard treatment and Trivax as add-on therapy (group A), in com-parison to patients receiving standard treatment without Trivax (group B).
Extension of overall survival of patients with newly diagnosed GBM receiving standard treatment and Trivax as add-on therapy, in comparison to patients receiving standard treatment without Trivax.
Quality of life in patients treated with Trivax as an add-on therapy using ECOG (Eastern Cooperative Oncology Group) performance status compared to quality of life of patients receiving standard therapy (for study patients older 18 years).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female or male, paediatric or adult patients older than 3 years of age at time of diagnosis
that qualify for standard treatment including surgery, Temozolomide and radiotherapy.
• Primary GBM (WHO IV), confirmed by histology.
• Resection of at least 70% of tumour mass defined by brain MRI scan.
• Supratentorial tumour localisation.
• Life expectancy of at least 12 weeks by assessment of the attending physician.
• ECOG performance status 0, 1, or 2 (for study patients older 18 years).
• Written informed consent of patient and/or legal guardian in case of children and
adolescents.
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E.4 | Principal exclusion criteria |
• Less than 100 µg of tumour protein obtained from the resected tissue for Tri-vax production.
• Anti-neoplastic chemotherapy or radiotherapy at least 4 weeks before entering the study, e.g. in another therapeutic clinical trial.
• Positive pregnancy test or breast-feeding.
• Patients unwilling to perform a save method of birth control.
• Known hypersensitivity to temozolomide.
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival measured as percentage of non-progressive patients at 12 months post initiation of treat-ment. |
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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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
plus/minus add-on to standard therapy |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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
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Last visit of last subject. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |