Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. AGuIX particles may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation.

PURPOSE: This first-in-man Phase I trial will study the side effects and best dose of AGuIX when injected together with whole brain radiation therapy in treating patients with multiple brain metastases. The effectiveness of the combination of AGuIX and radiation therapy will be also assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: NH TherAguix SAS

Criteria

Inclusion criteria:

• Patients with brain metastasis ineligible for local treatment by surgery or stereotactic radiation

• At least 18 years old

• Secondary brain metastases from a histologically confirmed solid tumor

• Patient competent to give informed consent (ou Signed informed consent after informing the patient)

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

• No prior brain irradiation

• No renal insufficiency (glomerular filtration rate > 60 mL/min/1.73m²)

• Normal liver function (bilirubin < 30 µmol/L; Alkaline phosphatase < 400 UI/L; Aspartate aminotransferase (AST) < 75 UI/L; Alanine aminotransferase (ALT) < 175 UI/L)

• For both male and female patients, effective methods of contraception must be used throughout the study. Acceptable methods of contraception are oral or implantable contraceptives, intrauterine device, condoms, spermicidal gels, or surgical sterilization.

• Affiliated to a social security scheme or assimilated

Exclusion criteria:

• Meningeal carcinomatosis

• Progressive and threatening extracranial disease

• Previous cranial irradiation (whether whole or partial brain radiation therapy, except stereotactic irradiation) or total body irradiation

• Known contra-indication, sensitivity or allergy to gadolinium

• Patients unable to undergo or tolerate Magnetic Resonance Imaging

• Patients participating in another clinical investigation at the time

• Protected persons under articles L1121-5 to L1121-8, Code of Public Health