E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tumores infantiles del sistema nervioso central refractarios o recurrentes |
|
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 |
Determinar la dosis máxima tolerada de la infusiñon del adenovirus oncolítico de replicación condicionada ICOVIR5 en pacientes con tumores cerebrales refractarios o recurrentes al tratamiento estándar. Proponer una dosis segura para estudios subsiguientes (dosis recomendada) |
|
E.2.2 | Secondary objectives of the trial |
Determinar la seguridad y perfil de toxicidad. Evaluar la biodistribución del adenovirus oncolítico de replicación condicionada ICOVIR5 en suero y líquido cefalorraquídeo. Evaluar la respuesta clínica objetiva y la respuesta inmune provocada por la infusión del adenovirus oncolítico de replicación condicionada ICOVIR5 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Niños con tumores malignos del SNC (gliomas malignos, meduloblastomas, ependimomas y tumores rabdoides) que sean retractarios o recurrentes a la 1ª línea de tto con diagnóstico histológico. Presencia de una masa tumoral única mensurable. Edad entre 6 meses y 18 años. Deben haber recibido una 1ª línea de tto estándar y no haber presentado respuesta favorable. Esperanza de vida<12 meses. Indice de Lansky>60%. Alternación funcional leve de órganos. Serología HIV negativa |
|
E.4 | Principal exclusion criteria |
Pacientes con proceso infeccioso activo u otro estado médico subyacente grave. Pacientes con más de una masa tumoral en el sistema nervioso. Afectación sensorial o motora preexistente grado 2 según los criterios del National Cancer Institute (NCI) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Dosis Máxima Tolerada (DMT). Dosis del nivel inmediatamente inferior que produce la toxicidad limitante de dosis |
|
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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 | Information not present in EudraCT |
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) | 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
|
Ultima visita del último sujeto incluido en el ensayo |
|
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 |