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

NCT04094077 | Terminated Phase 2 DMC

• 1 other identifier: ET18-270 NANOSTEREO
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.

Conditions

Brain Metastases

Keywords

Stereotactic Radiation; Nanoparticles

Outcome Measures

Primary Outcomes (1)

• Rate of local control

  The primary endpoint is the rate of local control defined as the proportion of patients with a complete response, a partial response or a stable disease. Response of Brain lesion will be evaluated using the RECIST classifications with partial response (PR, \> 30% decrease in longest diameter), stable disease (SD \<30% decrease and \<20% increase in longest diameter), progressive disease (PD \> 20% increase in longest diameter) and Complete response (CR) (complete disappearance of the brain lesion).

  1 year

Secondary Outcomes (7)

• Distant Brain failure

  6 month and at 1 year

• Time to brain relapse

  6 month and 1 year

• Tumor target volume

  4 days

• Brain lesion 3-D volume variation

  45 days and 3 month

• Adverse events

  From Day 1 to Day 45

Study Arms (1)

Aguix + Stereotactic Radiation

EXPERIMENTAL

Drug: AGuIX

Interventions

AGuIX DRUG

2 IV injections (100 mg/Kg/injection) at day 4 and day 8 + Strereotactic Radiation from day 8 to day 15 as per standard practice.

Aguix + Stereotactic Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

Centre Léon Bérard

Lyon, 69008, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

AGuIX

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a paucicentric, single arm Phase II trial conducted according to a single stage Fleming-A'Hern design and aiming to evaluate the efficacy of AGuIX® during FSRT of brain metastasis.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: January 17, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

FR (2)