Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Neoplasm Metastasis

Liver Neoplasms

Neoplasms, Second Primary

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Liver Extracts

Talaporfin

Photosensitizing Agents

Talaporfin sodium (LS11)

LED-based light infusion device

Light emitting diodes (LED)

Photodynamic therapy

Phototherapy

Chemotherapy

The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.

Patients 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 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions.

Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.

Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases

Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer

Light Sciences LLC

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Talaporfin Sodium

Sy-Shi Wang, PhD

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.

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.

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

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)

Light Sciences Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases	NCT00083785	Liver Metastasi... Colorectal Neop... Liver Neoplasms Neoplasm Metast...	Talaporfin sodi... LED-based light... Light emitting ... Photodynamic th... Phototherapy Chemotherapy	18 Years -	Light Sciences LLC
Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)	NCT00122876	Carcinoma, Hepa... Liver Neoplasms	Photodynamic th... Talaporfin Sodi...	18 Years -	Light Sciences LLC

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