Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409214
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2006-12-07
Brief Title:
Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or RecurrentHigh-grade Glioma Using the Litx System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
Sponsor:
Light Sciences Oncology
Organization:
Light Sciences Oncology
Study Overview
Official Title:
A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or RecurrentHigh-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
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgkg 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 Jcm or 200 Jcm at 20 mWcm light energy for a treatment time of 1 hour 24 minutes 100Jcm or 2 hours 46 minutes 200 Jcm 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
Either twenty-four or twelve hours prior to surgery the patient will receive an intravenous dose of 1 mgkg 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 Jcm or 200 Jcm at 20 mWcm light energy for a treatment time of 1 hour 24 minutes 100Jcm or 2 hours 46 minutes 200 Jcm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None