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AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma
Sponsor: Centre Jean Perrin
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
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
radiotherapy
60 Gy in 6 weeks
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