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
NCT00409214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2012-11-16
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.
Conditions
- Glioma
- Glioblastoma Multiforme
- Anaplastic Astrocytoma
Interventions
- DRUG
-
LS11 (talaporfin sodium)
- DEVICE
-
Light source (interstitial light emitting diodes)
- PROCEDURE
-
Intraoperative placement of device in glioma
Sponsors & Collaborators
-
Light Sciences Oncology
lead INDUSTRY
Principal Investigators
-
Sy-Shi Wang, PhD · Light Sciences Oncology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2008-02-29
Countries
- Serbia
Study Locations
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