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

NCT00122876 | Completed Phase 1

• 1 other identifier: LSC-OL004
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 9

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Keywords

Hepatocellular Carcinoma; HCC; Photodynamic therapy; Talaporfin Sodium (LS11); Light emitting diodes (LEDs); Litx; Light Infusion Technology

Outcome Measures

Primary Outcomes (1)

• Safety

Secondary Outcomes (2)

• Tumor Response

• Survival

Interventions

Photodynamic therapy PROCEDURE

Talaporfin Sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Light Sciences Oncology: lead

Study Sites (9)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

National Cancer Centre Singapore

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung Hsien, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan Hsien, Taiwan

Location

Related Publications (2)

• Lustig RA, Vogl TJ, Fromm D, Cuenca R, Alex Hsi R, D'Cruz AK, Krajina Z, Turic M, Singhal A, Chen JC. A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors. Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708.

  PMID: 14534895 BACKGROUND

• Chen J, Keltner L, Christophersen J, Zheng F, Krouse M, Singhal A, Wang SS. New technology for deep light distribution in tissue for phototherapy. Cancer J. 2002 Mar-Apr;8(2):154-63. doi: 10.1097/00130404-200203000-00009.

  PMID: 11999949 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Photochemotherapy; Talaporfin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Sy-Shi Wang, PhD

  Light Sciences Oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: April 1, 2005
• Study Completion: October 1, 2006
• Last Updated: December 7, 2007

Record last verified: 2007-12

Locations

SG (2); TW (6); HK (1)