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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

Must not have

Patients with active brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk has previously received either >6.0 Gy in a single fraction or a cumulative dose in 2.0 Gy equivalents, using an alpha/beta ratio of 2, of >40.0 Gy

Participants with widespread, definitive leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 12 months

Awards & highlights

All Individual Drugs Already Approved

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.

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.

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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I was 18 or older when my brain cancer was diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases near critical areas and they've been heavily treated with radiation.

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My cancer has spread to the lining of my brain and spinal cord.

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I cannot receive gadolinium.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local Recurrence

Secondary study objectives

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%

Constipation

67%

Hypotension

67%

Cough

67%

Nausea

33%

Proctitis

33%

Seizure

33%

Pain in extremity

33%

Abdominal pain

33%

Urinary incontinence

33%

Vomiting

33%

Vision blurred

33%

Dyspnoea

33%

Hypokalaemia

33%

Pollakiuria

33%

Micturition urgency

33%

Decreased appetite

33%

Hyperglycaemia

33%

Traumatic haematoma

33%

Haemorrhoids

33%

Rectal haemorrhage

33%

Pyrexia

33%

Hyperchloraemia

33%

Fatigue

33%

Pain

33%

Mood altered

33%

Sepsis

33%

Nocturia

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 Dose Level 1

Phase 2 Cohort 2b

Phase 2 Cohort 2a

Phase 1 Dose Level 2

Phase 1 Dose Level 3

Phase 2 Cohort 2c

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 12Eligibility criteria met