A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

January 22, 2015 updated by: Light Sciences Oncology

A Phase 3 Randomized Study to Evaluate Survival of Patients Treated With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.

Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who provide Informed Consent and satisfy the Eligibility Criteria will be placed in an eligibility pool for randomization for either the Litx™ treatment arm or the standard of care arm.

A Patient assigned to the Litx™ treatment group may receive up to three Litx™ treatments. Regardless of which group the patient is assigned the treatment planning should anticipate ablation of all lesions with three Litx™ treatments using up to 4 Light Sources per treatment (a single Light Source may kill 2 cm x 4 cm of tissue).

The Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions. Following imaging confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 1 mg/kg. Fifteen minutes to one hour following completion of LS11 administration, delivery of 200 J/cm per Light Source at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for any complication after Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and maintained for up to two weeks.

Patients designated for the standard of care group, will receive current standard of care treatment recommended by the investigating physician. Should the elected treatment fail, a patient may switch to another standard of care treatment.

A patient designated for the Litx™ treatment group may receive up to two additional Litx™ treatments. A second and third treatment with Litx™ may be considered if any residual tumor or new tumor exists. The third treatment must take place within six months after the first treatment. A patient may switch to receiving standard of care after the third Litx™ treatment or as recommended by the investigator as necessary.

For either the Litx™ group or standard of care group once all treatment therapies have been exhausted the patient will be followed for survival. No protocol-directed office visits are required during this period and the patient may be followed by phone and/or e-mail at four week intervals. All patients will be monitored for survival from the time of randomization to the time of death from any cause or until at least 142 deaths have been observed, whichever occurs first.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia
        • University Hospital Dubrava
  • Hong Kong
      • New Territories, Hong Kong
        • Prince of Wales Hospital, Dept. of Clincal Oncology
    • New Territories
      • Tuen Mun, New Territories, Hong Kong
        • Tuen Mun Hospital
  • India
      • Chennai, India
        • Dr. Kamakshi Memorial Hospital
      • Jaipur, India
        • SMS Medical College
      • Lucknow, India
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Nagpur, India, 440012
        • Cancer Clinic
      • Nasik, India
        • Shatabdi Super Specialty Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Medical Center Anam hospital
      • Seoul, Korea, Republic of
        • Kyunghee Univeristy Medical Center
      • Seoul, Korea, Republic of
        • Sinchon Severance Hospital, Yonsei University
  • Malaysia
      • Kuala Lumpur, Malaysia
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia
        • Hospital Universiti Kebangsaan Malaysia
      • Penang, Malaysia
        • Island Hospital
      • Penang, Malaysia
        • Lam Wah Ee Hospital
  • Philippines
      • Cebu City, Philippines
        • Cebu Doctors University Hospital
      • Cebu City, Philippines
        • Vicente Sotto Memorial Medical Center
      • Manila, Philippines
        • Santo Tomas University Hospital
      • Pasig City, Philippines
        • The Medical City
      • Quezon City, Philippines
        • St. Luke's Medical Center
      • Quezon City, Philippines
        • National Kidney and Transplant Institute
  • Poland
      • Krakow, Poland
        • Szpital Uniwersytecki CMUJ
      • Warsaw, Poland
        • Centralny Szpital Kliniczny Mswia
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Military Medical Academy
      • Belgrade, Serbia
        • Clinical Center of Serbia, Institute for Gastroenterology and Hepatology
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • Thailand
      • Bangkok, Thailand
        • Mahidol University, siriraj hospital
      • Chiang Mai, Thailand
        • Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level >400 ng/mL; C. Histological evidence of HCC
  • ECOG Performance Status 0-2
  • Life expectancy of at least 16 weeks
  • Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient 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/mm³ ; Platelet Count >= 75,000/µl ; Hemoglobin >= 9.4 gm/dL ; PT and PTT <= 1.5 Control ; SGOT, SGPT <= 5 × ULN ; Bilirubin <= 2.5 × ULN ; Alk Phos <= 3 × ULN ; Creatinine <= 2.5 mg/dL (SI: 221 mmol/L) ; Albumin >= 2 g/dL

Exclusion Criteria:

  • Patients who are candidates for surgery with curative intent are not eligible
  • Patients with 6 or more lesions are not eligible
  • Patients with greater than 50% of parenchyma disease involvement are excluded
  • Patients with Child-Pugh C cirrhosis are excluded
  • Patients with diffuse HCC are excluded
  • Patients with grade 3 ascites are excluded
  • Evidence of major vessel invasion or extrahepatic disease is excluded. Lymph node involvement in the hilum region of the liver is eligible if the nodes do not exceed 2 cm.
  • Known sensitivity to porphyrin-type drugs or known history of porphyria are exclusionary
  • Pregnancy or breast-feeding patients are excluded. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
  • Concurrent participation in another clinical trial involving experimental treatment is excluded
  • Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as 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 are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Litx
Drug: Talaporfin Sodium (1 mg/kg iv), Device: Interstitial Light Emitting Diodes (200 J/cm) 3 treatments within 6 months
Drug: Talaporfin sodium
LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.
Device: Interstitial Light Emitting Diodes
200 J/cm per Light Source at 20 mW/cm light energy
Procedure: Percutaneous placement of device in the liver
Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions.
Active Comparator: Standard Care
The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.
Procedure: Standard Care
The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 130 weeks
130 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Sciences Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSO-OL005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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