Phase II Elderly/Frail Pts With Newly Diagnosed or Recurrent Malignant Glioma Tx Treated With Cesium-131 GammaTile® (ENDURANCE)

University of California Irvine (UCI)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Oligodendroglioma; Glioblastoma; Glioma; Astrocytoma; Elderly Glioblastoma; Elderly GBM; Glioma, Malignant; GBM

Treatments: Device: GammaTile®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07821112

UCI-25-151 (Other Identifier)

STUDY00001050

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 4 patient groups

Newly Diagnosed Elderly or Frail Glioblastoma

Experimental group

Description:

GammaTile®

Treatment:

Device: GammaTile®

Recurrent Elderly or Frail Glioblastoma

Experimental group

Description:

GammaTile®

Treatment:

Device: GammaTile®

Newly Diagnosed Frail (Non-GBM) Malignant Glioma

Experimental group

Description:

GammaTile®

Treatment:

Device: GammaTile®

Recurrent Frail (Non-GBM) Malignant Glioma

Experimental group

Description:

GammaTile®

Treatment:

Device: GammaTile®