Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
The pupose of this study is 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.
Drug: LS11 (talaporfin sodium)
Device: Light source (interstitial light emitting diodes)
Procedure: Intraoperative placement of device in glioma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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
|Study Start Date:||November 2006|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
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.