Clinical trial NCT00122876: Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Hepatocellular
Liver Neoplasms
Keywords: Hepatocellular Carcinoma
HCC
Photodynamic therapy
Talaporfin Sodium (LS11)
Light emitting diodes (LEDs)
Litx
Light Infusion Technology
Lead sponsor: Light Sciences LLC
Sponsor class: INDUSTRY
First posted: 2005-07-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Tumor Response
measure: Survival
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Kaohsiung Hsien
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan Hsien
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
Study officials:
affiliation: Light Sciences Oncology
name: Sy-Shi Wang, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.