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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409214 on ClinicalTrials.gov