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

Sponsor

Light Sciences Oncology (Industry)

Overall Status

Completed

CT.gov ID

NCT00122876

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Apr 1, 2005

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Safety []

Secondary Outcome Measures

Tumor Response []
Survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Queen Mary Hospital	Hong Kong	Hong Kong
2	National Cancer Centre Singapore	Singapore	Singapore
3	Singapore General Hospital	Singapore	Singapore
4	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung Hsien	Taiwan
5	Kaohsiung Medical University Hospital	Kaohsiung	Taiwan
6	Mackay Memorial Hospital	Taipei	Taiwan
7	National Taiwan University Hospital	Taipei	Taiwan
8	Taipei Veterans General Hospital	Taipei	Taiwan
9	Chang Gung Memorial Hospital - Linkou	Taoyuan Hsien	Taiwan