Astrocytoma, Elderly GBM, Elderly Glioblastoma, GBM, Glioblastoma, Glioma, Glioma, Malignant, Oligodendroglioma
Conditions
Keywords
Glioma, Glioblastoma, GBM, Astrocytoma, Oligodendroglioma, GammaTile, GammaTile®, ENDURANCE, Elderly Glioblastoma, Elderly GBM
Brief summary
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.
Interventions
DEVICEGammaTile®
GammaTile is a bioabsorbable collagen tile embedded with cesium-131 radioactive seeds.
Sponsors
University of California, Irvine
GT Medical Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Supratentorial * A bi-dimensionally measurable lesion of at least 10 mm, visible on two or more axial slices 5 mm apart. * The pre-operative tumor planned for resection is ≤ 7 cm in maximal dimension. * Tumor, which in the opinion of the enrolling neurosurgeon, is amenable to attempted gross total resection (GTR) or near total resection (NTR). * Anticipated GT placement (i.e., closest aspect of post resection tumor bed anticipated to receive GT placement) that is \> 15mm from the optic chiasm or brainstem. * If multifocal, must be fully resectable in one operative bed. Surgical protocol will follow current institutional standards. * Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR or NTR of enhancing tumor. * Karnofsky Performance Scale (KPS) 1. Elderly GBM: baseline KPS score of ≥ 60. 2. Frail GBM: baseline (pre-GBM diagnosis) is \<70 and surgical management is expected to improve KPS to ≥ 60.
Exclusion criteria
* Staged surgery planned (prior biopsy allowed). * Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field. * Spinal tumors are excluded. * Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR or NTR. * Leptomeningeal disease not expected to be encompassed by the surgical resection. * Evidence of diffuse leptomeningeal disease that requires whole brain irradiation are excluded from this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who were able to receive the GammaTile Implant | 28 days | Feasibility is defined by proportion of participants who were able to be treated with GammaTile |
| Number of Participants with Treatment-related Adverse Events | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 24 months | Progression-Free Survival (PFS) as measured by Response Assessment in Neuro-Oncology (RANO) 2.0 on brain MRI with and without contrast. |
| Overall Survival (OS) | 24 months | 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. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORCarlen Yuen, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed