409
Participants
Start Date
September 29, 2022
Primary Completion Date
September 30, 2028
Study Completion Date
September 30, 2031
Everolimus
Tablets of 2.5 mg or 10 mg. The prescribed dose is 5 mg/m²/day, orally, once daily. Dose will be capped at 10 mg once daily.
ONC201
Capsules of 125mg. The prescribed dose is 375mg/m², once daily at Day 1 and Day 2 of each week. Dose will be capped at 625 mg per dose.
Radiotherapy
"All patients will be treated with 30 conventional single daily fractions of 1.8 Gy to a total of 54 Gy over a planned period of 6 weeks. Dose may be increased up to 60 Gy for adult patients with supratentorial ND-DMG. The clinical target volume will include all the areas of abnormality on T2/FLAIR sequences with a 1-cm margin.~Radiotherapy will have to start within a maximum of 4 weeks for DIPG, up to 6 weeks for other DMG H3K28-altered (ND-DMG), after the biopsy or last surgery. The study medication will be started at Day 1 (+3 days max) of radiotherapy. Reirradiation is permitted only at disease progression according to local practice.~In case of metastatic disease or intramedullary tumors, patients can be included in the study. In this situation, radiotherapy will have to start within a maximum of 4 weeks for DIPG, up to 6 weeks for other DMG H3K28-altered (ND-DMG), after the biopsy or last surgery while targeted treatment will start at the end of the irradiation."
RECRUITING
Rigshospitalet, Copenhagen
RECRUITING
H.C. Andersen Children's Hospital, Odense Universitetshospital, Odense
RECRUITING
Hospital Vall D´Hebron, Barcelona
RECRUITING
Aarhus Universitetshospital Skejby, Aarhus
RECRUITING
Hôpital de La Timone, Marseille
RECRUITING
CHU de Caen - Hôpital Côte de Nacre, Caen
RECRUITING
Karolinska University Hospital, Stockholm
RECRUITING
CHU François Mitterrand, Dijon
RECRUITING
CHU Besançon - Hôpital Jean Minjoz, Besançon
RECRUITING
Hospital Universitario Niño Jesus, Madrid
RECRUITING
CHRU de Brest - Hôpital Morvan, Brest
RECRUITING
Hôpital des enfants, Toulouse
RECRUITING
CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André, Bordeaux
RECRUITING
CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants, Bordeaux
RECRUITING
Hôpital Arnaud de Villeneuve, Montpellier
RECRUITING
Centre Eugène Marquis, Rennes
RECRUITING
CHU Rennes - Hôpital Sud, Rennes
RECRUITING
CHRU Tours - Hôpital Clocheville, Tours
RECRUITING
CHRU Tours - Hôpital Bretonneau, Tours
RECRUITING
CHU Grenoble Alpes - Hôpital Couple-Enfant, Grenoble
RECRUITING
CHU de Saint-Etienne - Hôpital Nord, Saint-Etienne
RECRUITING
Hospital Universitario y Politécnico de La Fe, Valencia
RECRUITING
Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin, Angers
RECRUITING
CHU d'Angers - Bâtiment Robert Debré, Angers
RECRUITING
CHU de Reims - American Memorial Hospital 2, Reims
RECRUITING
CHRU Nancy - Hôpital central, Nancy
RECRUITING
CHRU Nancy Brabois - Hôpital d'enfants, Nancy
RECRUITING
Centre Oscar Lambret, Lille
RECRUITING
CHU Estaing, Clermont-Ferrand
RECRUITING
Centre Jean Perrin, Clermont-Ferrand
RECRUITING
Institut de cancérologie Strasbourg Europe (ICANS) - Centre Paul Strauss, Strasbourg
RECRUITING
Hôpital de Hautepierre, Strasbourg
RECRUITING
Centre Léon Bérard, Lyon
RECRUITING
Hôpital Saint Louis, Paris
RECRUITING
Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Paris
RECRUITING
Institut Curie, Paris
RECRUITING
CHU Rouen Normandie - Hôpital Charles-Nicolle, Rouen
RECRUITING
CHU d'Amiens-Picardie Site Sud, Amiens
RECRUITING
CHU Poitiers, Poitiers
RECRUITING
Hôpital de la mère et de l'enfant, Limoges
RECRUITING
Gustave Roussy, Villejuif
RECRUITING
CHU de Nice - Hôpital L'Archet 2, Nice
Collaborators (1)
Jazz Pharmaceuticals
INDUSTRY
Innovative Therapies For Children with Cancer Consortium
OTHER
Ministry of Health, France
OTHER_GOV
Gustave Roussy, Cancer Campus, Grand Paris
OTHER