Phase I/II study of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma

Centre Jean Perrin0 个研究点目标入组 66 人开始时间: 2020年12月2日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•- Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)
•- Patient not operated on or partial resection
•- KPS = 70%
•- Age = 18 years old and <75 years old
•- Life expectancy = 6 months
•- Platelets = 100,000 / mm3
•- PNN = 2000 / mm3
•- Hb = 10 g / L
•- Creatinine <1.5 times the upper normal limit or clearance according to Cockcroft-Gault = 50 mL / min
•- Liver function (GGT, PAL, ASAT, ALAT, bilirubin) <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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•-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's disease or ulcerative colitis)
•-Diarrhea = 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
•-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

发起方

Centre Jean Perrin