Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles
NANO-RAD
Etude Clinique de Phase I de Radiosensibilisation de métastases cérébrales Par Nanoparticules de Gadolinium
2 other identifiers
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJune 7, 2019
April 1, 2019
2.9 years
June 2, 2016
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum-tolerated dose (MTD) of polysiloxane gadolinium-chelates based nanoparticles (AGuIX) given concurrently to the whole brain radiation therapy for the treatment of multiple brain metastases
To determine Maximum-tolerated dose (MTD) of polysiloxane gadolinium-chelates based nanoparticles (AGuIX) given concurrently to the whole brain radiation therapy, according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
18 months
Secondary Outcomes (6)
Pharmacokinetic characteristics of AGuIX particles after intravenous injection
18 months
Pharmacokinetic characteristics of AGuIX particles after intravenous injection
18 months
Pharmacokinetic characteristics of AGuIX particles after intravenous injection
18 months
Distribution of AGuIX particles in brain metastases and surrounding healthy tissue evaluated by MRI
30 months
Intracranial progression-free survival
12 months after radiation
- +1 more secondary outcomes
Study Arms (1)
AGuIX and radiotherapy
EXPERIMENTALPatients receive a single intravenous injection of AGuIX on day 1. Then patients undergo a whole brain radiation therapy, 5 days a week in weeks 1-2. The first radiotherapy session will be performed 4 hours after AGuIX injection. Five dose escalation cohorts : 15 mg/kg, 30mg/kg, 50mg/kg, 75mg/kg and 100 mg/kg
Interventions
A single intravenous injection on day 1. Dose level 1: 15mg/kg; Dose level 2: 30mg/kg, Dose level 3: 50mg/kg; Dose level 4: 75mg/kg; Dose level 5: 100mg/kg
30Gy in 10 sessions of 3Gy (5 days a week in weeks 1-2); first session 4 hours after AGuIX injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- NH TherAguix SAScollaborator
Study Sites (1)
University Hospital Grenoble
Grenoble, 38100, France
Related Publications (1)
Verry C, Sancey L, Dufort S, Le Duc G, Mendoza C, Lux F, Grand S, Arnaud J, Quesada JL, Villa J, Tillement O, Balosso J. Treatment of multiple brain metastases using gadolinium nanoparticles and radiotherapy: NANO-RAD, a phase I study protocol. BMJ Open. 2019 Feb 11;9(2):e023591. doi: 10.1136/bmjopen-2018-023591.
PMID: 30755445DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camille VERRY, MD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
July 1, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
June 7, 2019
Record last verified: 2019-04