Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases

Launched by DANA-FARBER CANCER INSTITUTE · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with brain metastases, which are cancerous growths that have spread to the brain from other parts of the body. Researchers want to see if a special type of nanoparticles called AGuIX can make radiation therapy more effective when treating these brain tumors. The trial is open to adults aged 18 and older who have been diagnosed with certain types of cancer, such as melanoma, breast cancer, or colorectal cancer, and have specific measurable lesions in their brain.

To participate, patients need to have at least one brain tumor that is at least 5mm in size and meet other health criteria. Those who join the study can expect to receive either the standard radiation treatment or the radiation treatment combined with AGuIX nanoparticles. The goal is to find out if the nanoparticles help improve the effectiveness of radiation therapy. It’s also important for potential participants to know that women who are pregnant or breastfeeding cannot take part in this study due to possible risks to the fetus or nursing infant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:
• • Melanoma with intracranial growth consistent with tumor progression despite immunotherapy
• • Gastrointestinal primary
• • HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and/or study PI)
• • Cystic metastases
• • Metastases ≥2cm in maximal unidimensional size
• • Locally recurrent metastases after prior stereotactic radiation
• • Locally recurrent metastases after prior whole brain radiation \*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)
• • Age ≥18 years at diagnosis of brain metastases
• • Estimated glomerular filtration rate of ≥ 60 mL/min/1.73m2
• • Karnofsky performance status of at least 70 (i.e. at minimum, "cares for self" but "unable to carry on normal activity or do active work")
• • Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and/or study PI
• • Ability to understand and the willingness to sign a written informed consent document
• • The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation
• Exclusion Criteria:
• • Participants who cannot undergo a brain MRI
• • Participants who cannot receive gadolinium
• • Participants with widespread, definitive leptomeningeal disease
• • Patients requiring radiation to either \>10 targets (if naïve to whole brain radiation) or \>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and/or study PI
• • Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study
• • In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) 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 (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha/beta ratio of 2, of \>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique/dose/fractionation, are not eligible for the study until written approval is provided by the study/site PI