Status:
ACTIVE_NOT_RECRUITING
AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma
Lead Sponsor:
Centre Jean Perrin
Collaborating Sponsors:
Ministry for Health and Solidarity, France
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 obj...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04881032
Start Date
March 7 2022
End Date
March 1 2027
Last Update
February 13 2025
Active Locations (9)
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1
CHU de Brest
Brest, France
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
CHU de Grenoble
Grenoble, France
4
Centre Léon Berard
Lyon, France