Overview

Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases

Status:
Terminated
Trial end date:
2021-02-24
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Leon Berard
Criteria
Inclusion Criteria:

- Male or female patients aged of at least 18 years on day of signing informed consent.

- Histologically-confirmed diagnosis of any histological type of solid tumors, excluding
primary central nervous system (CNS) tumors.

- Radiological evidence by MRI : At least one and a maximum of 5 brain metastases, and
at least one brain lesion with a longest diameter ≥ 2 cm and eligible for FSRT.

- Patient without progression on extracranial disease documented by radiological
assessment as per RECIST v1.1 within 4 weeks before inclusion.

- For patients treated with a systemic anti-cancer therapy: a minimal 2-week washout
period is required from the date of last systemic treatment administration to Day 1,
except for hormonal agents.

- ECOG Performance Status (PS) ≤2.

- Absolute neutrophil count (ANC) ≥ 1.0 G/L, Platelets ≥ 75 G/L, Hemoglobin ≥ 8 g/dL,
Serum creatinine OR Creatinine clearance according to CKD-EPI ≤ 1.5 x Upper Limit of
Normal (ULN) OR ≥ 50 mL/min/1.73m2, ASAT and ALAT ≤ 3 x ULN (or ≤ 5.0 ULN in case of
liver metastasis or hepatic infiltration),INR and Activated Partial Thromboplastin
Time (aPTT) ≤1.5 x ULN.

- Women of child-bearing potential must have a negative serum pregnancy test at
screening and must agree to use 2 effective forms of contraception from the time of
the negative pregnancy test up to 3 months after the last dose of the study drug.

- Fertile men must agree to use contraceptive measures up to 3 months after the last
dose of study drug.

- Patients who understand, sign, and date the written voluntary informed consent form at
the screening visit prior to any protocol-specific procedures. Patient should be able
and willing to comply with study visits and procedures as per protocol.

- Patients must be covered by a medical insurance.

Exclusion Criteria:

- Prior local treatment with radiotherapy (whole / partial brain or stereotactic
radiosurgery) or surgical resection of brain lesions.

- Patient participating to another clinical trial with an investigational agent.

- Patients who have not recovered from significant adverse events (i.e. Grade > 2 AE
according to NCI CTCAE v5.0) due to prior treatment with anti-cancer agents with
exception of any Grade alopecia or lab values presented in inclusion criteria.

- Contra-indication for MRI enhanced with gadolinium (e.g. cardiac pacemaker, implanted
defibrillator, certain cardiac valve replacements, certain metal implants).

- Patients who are pregnant or breastfeeding.