AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

March 31, 2027

Conditions
Glioblastoma
Interventions
DRUG

Polysiloxane Gd-Chelates based nanoparticles (AGuIX)

Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose

RADIATION

radiotherapy

60 Gy in 6 weeks

DRUG

Temozolomide

"Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.~After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days ."

Trial Locations (9)

63011

Centre Jean Perrin, Clermont-Ferrand

Unknown

CHU de Brest, Brest

CHU de Grenoble, Grenoble

Centre Léon Berard, Lyon

Hospices Civils de Lyon, Lyon

Hôpital La Pitié Salpetrière, Paris

Institut de Cancérologie de l'Ouest, Saint-Herblain

Institut de Cancérologie Strasbourg Europe, Strasbourg

Institut Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

Ministry for Health and Solidarity, France

OTHER_GOV

lead

Centre Jean Perrin

OTHER