Informations générales (source: ClinicalTrials.gov)
Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma (NANO-GBM)
Interventional
Phase 1/Phase 2
Centre Jean Perrin (Voir sur ClinicalTrials)
mars 2022
mars 2027
24 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sophie BOCKEL | 29/04/2024 10:50:50 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU de Brest - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU de Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Pitié Salpetrière - Paris - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie Strasbourg Europe - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)
- Patient not operated or partial resection
- KPS superior to 70%
- Age between 18 years old and 75 years old
- Life expectancy superior to 6 months
- Platelets superior to 100,000 / mm3
- PNN superior to 1500 / mm3
- Hb superior to 10 g / dL
- Creatinine superior to 1.5 times the upper normal limit or clearance according to
Cockcroft-Gault superior to 50 mL / min
- Liver function (GGT, PAL, ASAT, ALAT, bilirubin) superior to 1.5 times the upper
normal limit
- For patients receiving treatment with corticosteroids, treatment with
corticosteroids must be at a stable or decreasing dose for at least 14 days before
inclusion
- Patient able to swallow and retain oral medication
- Negative serum pregnancy test within 7 days before the first administration of
treatment for women
- Women of childbearing potential and men whose partners are of childbearing potential
must agree to use, themselves or their partners, an approved method of contraception
throughout the treatment and at least 6 months after the last administration of
study treatment.
- Obtaining signed informed consent from the patient
- Patient affiliated to a social security regimen
- Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)
- Patient not operated or partial resection
- KPS superior to 70%
- Age between 18 years old and 75 years old
- Life expectancy superior to 6 months
- Platelets superior to 100,000 / mm3
- PNN superior to 1500 / mm3
- Hb superior to 10 g / dL
- Creatinine superior to 1.5 times the upper normal limit or clearance according to
Cockcroft-Gault superior to 50 mL / min
- Liver function (GGT, PAL, ASAT, ALAT, bilirubin) superior to 1.5 times the upper
normal limit
- For patients receiving treatment with corticosteroids, treatment with
corticosteroids must be at a stable or decreasing dose for at least 14 days before
inclusion
- Patient able to swallow and retain oral medication
- Negative serum pregnancy test within 7 days before the first administration of
treatment for women
- Women of childbearing potential and men whose partners are of childbearing potential
must agree to use, themselves or their partners, an approved method of contraception
throughout the treatment and at least 6 months after the last administration of
study treatment.
- Obtaining signed informed consent from the patient
- Patient affiliated to a social security regimen
- prior brain radiotherapy
- prior chemotherapy (including implants containing carmustine (Gliadel®) or
immunotherapy (vaccination included)
- Any contraindication to TMZ listed in the SPCs
- History of major intestinal resection which may modify the absorption of oral drugs
according to the judgment of the investigator
- Diagnosed inflammatory bowel disease (Crohn disease or ulcerative colitis)
- Diarrhea superior to grade 2 CTCAE (whatever the cause)
- Current or recent treatment with another investigational drug or participation in
another therapeutic clinical trial (within 30 days of inclusion).
- History of other cancer in the 5 years preceding inclusion, except for basal cell
carcinomas of the skin and in situ carcinomas of the cervix
- Pregnant or breastfeeding women
- Contraindication to MRI or gadolinium injection
- History of severe anaphylactic reactions due to the injection of gadolinium-based
contrast product (dotarem, etc.)
- Patient under guardianship or curatorship
- History of nephropathy
- Psychological disorder or social or geographic reasons that may compromise medical
monitoring of the trial or compliance with treatment