A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma (Defined for the Purposes of the Protocol as Anaplastic Astrocytoma [AA] or Glioblastoma Multiforme [GBM]) Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
Light Infusion Technology (Litx™) is a locoregional cancer treatment in which a systemically
administered light-activated drug (LS11) is activated locally by illuminating the diseased
tissue using light-emitting diodes (LEDs) of a specific wavelength. The activated
photosensitizer reacts with endogenous oxygen to yield highly reactive species of oxygen
that cause destruction of cellular structures such as mitochondria, lysosomes and cell walls
leading to irreversible cell damage and tissue death.
Either twenty-four or twelve hours prior to surgery, the patient will receive an intravenous
dose of 1 mg/kg of LS11, given IV by slow push over 3-5 minutes.
Following craniotomy, patients will undergo intraoperative placement of a single Light
Source, centrally placed within the tumor, under direct visualization prior to tumor
resection. Following placement of the light source (with the depth of the end of the light
bar from the cortical surface to be calculated from the pre-operative MRI and spiral CT
scan, so as to be centralized within the main tumor bulk), light will be delivered following
a predetermined escalation schedule (either 100 J/cm or 200 J/cm) at 20 mW/cm light energy
for a treatment time of 1 hour 24 minutes (100J/cm) or 2 hours 46 minutes (200 J/cm). The
Light Source will then be manually removed and the tumor maximally resected.
The resected tumor and marginal tissue will be submitted for pathology to determine depth of
cell death, extent of tumor tissue containing closed vessels, any evidence of vessel closure
or other damage to tissues outside of the projected kill zone.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma
Sy-Shi Wang, PhD
Light Sciences Oncology
Serbia: Serbian Drug Agency