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ACTIVE NOT RECRUITING
NCT04881032
PHASE1/PHASE2

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

Sponsor: Centre Jean Perrin

View on ClinicalTrials.gov

Summary

This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma. The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II) Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.

Official title: Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-03-07

Completion Date

2027-03

Last Updated

2025-02-13

Healthy Volunteers

No

Conditions

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 .

Locations (9)

CHU de Brest

Brest, France

Centre Jean Perrin

Clermont-Ferrand, France

CHU de Grenoble

Grenoble, France

Centre Léon Berard

Lyon, France

Hospices Civils de Lyon

Lyon, France

Hôpital La Pitié Salpetrière

Paris, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

Institut Gustave Roussy

Villejuif, France