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Sponsored by: |
Light Sciences Oncology |
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Information provided by: | Light Sciences Oncology |
ClinicalTrials.gov Identifier: | NCT00355355 |
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.
Condition | Intervention | Phase |
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Carcinoma, Hepatocellular Liver Neoplasms |
Drug: Talaporfin sodium Device: Interstitial Light Emitting Diodes Procedure: Percutaneous placement of device in the liver Procedure: Standard Care |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 200 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Litx: Experimental |
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.
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Standard Care: Active Comparator |
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.
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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. The patient will be followed for survival for a maximum of 30 months after randomization or until death.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sy-Shi Wang, PhD | Light Sciences Oncology |
Responsible Party: | Light Sciences Oncology, Inc. ( Sy-Shi Wang, PhD ) |
Study ID Numbers: | LSO-OL005 |
Study First Received: | July 19, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00355355 |
Health Authority: | United States: Food and Drug Administration; Singapore: Health Sciences Authority; India: Drugs Controller General of India; Philippines: Bureau of Food and Drugs; Italy: The Italian Medicines Agency; South Korea: Korea Food and Drug Administration (KFDA); Malaysia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; Croatia: Ministry of Health and Social Care; Sweden: Medical Products Agency |
Hepatocellular carcinoma HCC Liver Neoplasms |
Talaporfin Sodium (LS11) Light emitting diodes (LEDs) Light activation |
Liver Diseases Digestive System Neoplasms Talaporfin Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma Ethanol |
Photosensitizing Agents Neoplasms Neoplasms by Site Neoplasms by Histologic Type Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |