E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paediatric High grade glioma, excluding brain stem gliomas |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065443 |
E.1.2 | Term | Malignant glioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 primary objective is to assess the feasibility and safety of delivering dendritic cells vaccines to patients in the context of conventional primary treatment (radiotherapy and temozolomide chemotherapy). |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is the characterisation of immune responses
against high grade glioma tumours in patients undergoing dendritic cell
vaccinations.
• To characterise in detail the cellular and humoral components of the
specific anti-tumour immune response in patients with high grade glioma
following administration of tumour lysate primed dendritic cell vaccines
• To demonstrate that effective T cell immunity is achievable and
sustainable in the context of moderate lymphodepletion
• To compare the efficacy of different in vitro dendritic cell maturation
strategies in producing an immune response; specifically, this trial will
examine the role of PGE2
• To determine (in those patients who have a second biopsy or resection)
the numbers and function of tumour infiltrating lymphocytes including
regulatory T cells and CD8+ T cells
A further secondary endpoint is clinical responsiveness.
• To accrue clinical data on the safety of the strategy
• To collect clinical dat |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically confirmed high-grade glioma (including anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma and anaplastic variants of ganglioglioma and pleomorphic xanthoastrocytoma)
• Substantial debulking surgery (primary treatment or relapse group) or small volume recurrence (relapse group).
• Available tumour lysate for DC pulsing
• Informed consent
|
|
E.4 | Principal exclusion criteria |
• Brain stem glioma
• Metastatic spinal disease
• Uncorrected hydrocephalus
• Other ongoing chemotherapy
• Positive serology for HIV, Hepatitis B or C, or positive TPHA test (syphilis)
• Auto-immune disease (presence of autoantibodies in standard screen plus clinical features consistent with presence of antibodies)
• Lansky/Karnovsky score less than 40 unless lower due to surgery
• Pregnancy
• Grade 4 CTC toxicity in any of the following categories
o Cardiac
o Infection
o Dermatology/skin
o Renal
o Gastrointestinal (excluding anorexia)
o Pain
o Neurological (excluding sensory and audiological)
|
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E.5 End points |
E.5.1 | Primary end point(s) |
feasibility and safety of delivering dendritic cells vaccines to patients in the context of conventional primary treatment (radiotherapy and temozolomide chemotherapy). |
|
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 | No |
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 |
Immunological response evaluation |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
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) | No |
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) | 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
| 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 | 7 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of trial is defined as the date of the last visit of the last subject |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 29 |