← Back to all trials
Not Yet Recruiting
NCT07821112
Phase II Elderly/Frail Pts With Newly Diagnosed or Recurrent Malignant Glioma Treated With Cesium-131 GammaTile®
Conditions: Glioma, Glioblastoma, GBM, Glioma, Malignant, Astrocytoma, Oligodendroglioma, Elderly Glioblastoma, Elderly GBM
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: University of California, Irvine
Location: Chao Family Comprehensive Cancer Center, University of California, Irvine Orange California
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07821112). StuddyBuddy aggregates publicly available trial information.