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

Korábbi kezelés

• Staged surgery planned (prior biopsy allowed).

Más betegség

• 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.

Egyéb

• 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.

• 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)
  • Elderly GBM: baseline KPS score of ≥ 60.
  • Frail GBM: baseline (pre-GBM diagnosis) is <70 and surgical management is expected to improve KPS to ≥ 60.