Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether the Litx™ treatment is safe and effective in treating inoperable hepatocellular carcinoma (HCC).
Litx™ is an integrated treatment system comprising an intravenously administered photosensitizing agent, Talaporfin Sodium (LS11), that is activated by non-coherent light generated inside the tumor by an implanted light emitting diode (LED) array light source.
Procedure: Photodynamic therapy
Drug: Talaporfin Sodium
|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 1/2 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LEDs) in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma (HCC)|
- Tumor Response
|Study Start Date:||April 2005|
|Study Completion Date:||October 2006|
Subjects that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions. Depending on lesion size, one or more Light Sources may be used to treat a single lesion.
Following ultrasound or CT confirmation of the Light Sources, patients will receive an intravenous dose of LS11 at 1 mg/kg. 15 minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm light energy at 20 mW/cm will begin. Upon completion of light treatment, the Light Sources will then be manually removed and the patients will be observed for acute complications.
Subjects will be evaluated for treatment-related adverse events at every scheduled clinical visit. Restaging by contrast enhanced spiral CT and tumor evaluation, using the RECIST criteria, are performed at Week 4 and Week 8.
Subjects may receive a second Litx™ treatment at Week 4 or Week 8, as recommended by the study investigator. Subjects who receive the second Litx™ treatment will be evaluated for treatment-related adverse events at every scheduled clinical visit. Restaging by contrast enhanced spiral CT and tumor evaluation, using the RECIST criteria, are performed. The active phase of the protocol ends 8 weeks after the last treatment received.
Following completion of the active phase of the protocol, subjects will be monitored for survival for one year (at 6, 9 and 12 month time points) from the date of study entry or until death, whichever occurs first.
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|National Cancer Centre Singapore|
|Singapore General Hospital|
|Kaohsiung Medical University Hospital|
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung Hsien, Taiwan|
|Taipei Veterans General Hospital|
|National Taiwan University Hospital|
|Mackay Memorial Hospital|
|Chang Gung Memorial Hospital - Linkou|
|Taoyuan Hsien, Taiwan|
|Study Director:||Sy-Shi Wang, PhD||Light Sciences Oncology|