Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by:
Light Sciences LLC
ClinicalTrials.gov Identifier:
NCT00122876
First received: July 19, 2005
Last updated: December 5, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Liver Neoplasms
Procedure: Photodynamic therapy
Drug: Talaporfin Sodium
Phase 1
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Light Sciences LLC:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Tumor Response
  • Survival

Estimated Enrollment: 25
Study Start Date: April 2005
Study Completion Date: October 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC;
  • Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Life expectancy of at least 16 weeks;
  • Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects;
  • Understanding and ability to sign written informed consent;
  • 18 years of age or more;
  • Adequate hematologic, liver and renal functions as evidenced by the following: *WBC > 2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5 Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine < 2.5 mg/dL (SI: 221 mmol/L)

Exclusion Criteria:

  • Subjects who are candidates for surgery with curative intent;
  • Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement;
  • Known sensitivity to porphyrin type drugs;
  • Known history of porphyria;
  • Known presence of extrahepatic metastases;
  • Anticipated need for systemic chemotherapy during the first 8 weeks of the study;
  • Child-Pugh C cirrhosis;
  • Diffuse HCC;
  • Concurrent participation in another clinical trial involving experimental treatment;
  • Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122876

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Singapore
National Cancer Centre Singapore
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung Hsien, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien, Taiwan
Sponsors and Collaborators
Light Sciences Oncology
Investigators
Study Director: Sy-Shi Wang, PhD Light Sciences Oncology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00122876     History of Changes
Other Study ID Numbers: LSC-OL004
Study First Received: July 19, 2005
Last Updated: December 5, 2007
Health Authority: Hong Kong: Department of Health
United States: Food and Drug Administration

Keywords provided by Light Sciences LLC:
Hepatocellular Carcinoma
HCC
Photodynamic therapy
Talaporfin Sodium (LS11)
Light emitting diodes (LEDs)
Litx
Light Infusion Technology

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Talaporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014