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

Phase 1

• Conditions: glioblastoma; MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004552-15-FR
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-02
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

- 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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified