This is a phase 2, open-label clinical trial determining feasibility, safety, and tolerability of GammaTile® in elderly or frail subjects with newly diagnosed or recurrent malignant gliomas.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States
Percentage of Participants who were able to receive the GammaTile Implant
Feasibility is defined by proportion of participants who were able to be treated with GammaTile
Time frame: 28 days
Number of Participants with Treatment-related Adverse Events
Safety and tolerability will be determined by the proportion, nature, and severity of treatment-related adverse events in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments.
Time frame: 24 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast.
Time frame: 24 months
Overall Survival (OS)
Overall Survival (OS) as measured by time from registration to death of any cause as documented dates of registration and death within the electronic medical system.
Time frame: 24 months
Chao Family Comprehensive Cancer Center University of California, Irvine
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University of California Irvine Medical
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