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AGuIX Nanoparticles + Stereotactic Radiation for Brain Metastases

Phase 2
Recruiting
Led By Ayal Aizer, MD, MHS
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Melanoma with intracranial growth consistent with tumor progression despite immunotherapy
Karnofsky performance status of at least 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 12 months
Awards & highlights

Study Summary

This trial will test whether AGuIX can help radiation work better in treating brain metastases that are difficult to control.

Who is the study for?
This trial is for adults with brain metastases from solid tumors like lung, breast, or gastrointestinal cancer. They must have a Karnofsky performance status of at least 70 and a lesion ≥2cm. Patients should not be pregnant or breastfeeding, able to undergo MRI and gadolinium use, and expected to live at least 3 more months.Check my eligibility
What is being tested?
The study tests if AGuIX nanoparticles can make stereotactic radiation more effective in treating brain metastases that are hard to control with radiation alone. Participants will either receive the nanoparticles with radiation or a placebo with radiation.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of nanoparticles, issues due to MRI contrast agent gadolinium such as kidney problems, and typical risks associated with stereotactic radiation like headaches or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma has spread to my brain and is growing despite having immunotherapy.
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I am able to care for myself but cannot do normal activities or work.
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My cancer started in my digestive system.
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My cancer has spread, and the largest area is at least 2cm big.
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My cancer came back in the same area after targeted radiation.
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My cancer has returned in the brain after full brain radiation treatment.
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My cancer has spread and formed cyst-like growths.
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I have a confirmed solid cancer with a brain lesion larger than 5mm.
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My breast cancer is HER2 positive, as determined by my doctor.
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I was 18 or older when my brain cancer was diagnosed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local Recurrence
Secondary outcome measures
Ability to complete activities of daily living
Death due to neurologic causes
Incidence and time to additional radiotherapeutic treatments
+16 more

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648
67%
Nausea
67%
Hypotension
67%
Cough
67%
Constipation
33%
Hyperchloraemia
33%
Seizure
33%
Pyrexia
33%
Rectal haemorrhage
33%
Abdominal pain
33%
Proctitis
33%
Hypokalaemia
33%
Fatigue
33%
Pain
33%
Hyperglycaemia
33%
Pain in extremity
33%
Dyspnoea
33%
Vision blurred
33%
Mood altered
33%
Sepsis
33%
Nocturia
33%
Pollakiuria
33%
Urinary incontinence
33%
Traumatic haematoma
33%
Vomiting
33%
Haemorrhoids
33%
Decreased appetite
33%
Micturition urgency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Dose Level 1
Phase 1 Dose Level 2
Phase 1 Dose Level 3
Phase 2 Cohort 2a
Phase 2 Cohort 2b
Phase 2 Cohort 2c

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stereotactic Radiation plus placeboExperimental Treatment2 Interventions
Randomly assigned participants will receive: Placebo 3-5 days before radiation is initiated Placebo up to 2x during radiation, depending on standard of care radiation treatment. If standard of care radiation treatment involves only one day of radiation participant will receive Placebo on the day of radiation. If standard of care radiation treatment involves 5 or 6 days of radiation participant will receive Placebo two-times (2x) in total, on the first and third day of radiation.
Group II: Stereotactic Radiation plus AGuIX gadolinium-based nanoparticlesExperimental Treatment2 Interventions
Randomly assigned participants will receive: AGuIX gadolinium-based nanoparticles 3-5 days before radiation is initiated AGuIX gadolinium-based up to 2x during radiation, depending on standard of care radiation treatment. If standard of care radiation treatment involves only one day of radiation, participant will receive AGuIX gadolinium-based nanoparticles on the day of radiation. If standard of care radiation treatment involves 5 or 6 days of radiation, participant will receive AGuIX gadolinium-based nanoparticles two-times (2x) in total, on the first and third day of radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiation
2014
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,739 Total Patients Enrolled
NH TherAguix SASOTHER
3 Previous Clinical Trials
215 Total Patients Enrolled
Ayal Aizer, MD, MHSPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
214 Total Patients Enrolled

Media Library

Stereotactic Radiation Clinical Trial Eligibility Overview. Trial Name: NCT04899908 — Phase 2
Gastrointestinal Cancer Research Study Groups: Stereotactic Radiation plus placebo, Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles
Gastrointestinal Cancer Clinical Trial 2023: Stereotactic Radiation Highlights & Side Effects. Trial Name: NCT04899908 — Phase 2
Stereotactic Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899908 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current stance of the FDA on Stereotactic Radiation?

"Even though there is no data affirming its efficacy, stereotactic radiation received a safety score of 2."

Answered by AI

Are researchers still looking for test subjects?

"Yes, as of right now this study is still recruiting patients. The initial posting was on September 15th, 2021 with the most recent update being October 19th, 2021."

Answered by AI

How many patients are included in the current iteration of this research?

"Yes, this study is still enrolling patients according to the latest information available on clinicaltrials.gov. The trial was created on September 15th, 2021 and updated October 19th, 2021. They are looking for 112 individuals total from 2 different locations."

Answered by AI

What is the medical research history of Stereotactic Radiation?

"There are 11 Stereotactic Radiation trials currently underway. Of these active studies, 0 are in Phase 3 testing. Most of the research is taking place in Portland, Oregon; however, there are 28 clinical trial sites for this treatment across the United States."

Answered by AI
~33 spots leftby Feb 2025