Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma, Capillary

Port-Wine Stain

Hemangioma

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Talaporfin

Photosensitizing Agents

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Talaporfin sodium

Kristen Kelly, MD

Port wine stains Birthmark are congenital, progressive vascular malformations of the skin that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of these malformations occur on the face. Personality development of virtually all patients is adversely affected as a result of the negative reaction of others to a "marked" person. Detailed studies have documented lower self-esteem and difficulties with interpersonal interactions in Port wine stains patients. Port wine stains are initially flat and red, but with time, they tend to darken to purple and become thickened as vascular nodules develop. This thickening occurs in approximately two-thirds of lesions and further disfigures the facial features of many patients.

Pulsed dye laser is currently the standard of care treatment for Port wine stains. Researchers at University of California Irvine at Beckman Laser Institute Medical Clinic can use Photodynamic therapy, another treatment option for Port wine stains. Photodynamic therapy involves light activation of a photosensitizer (a drug that is responsive to light or radiant energy). Because the photosensitizer can be localized to a desired portion of the Port wine stain, Photodynamic therapy creates an opportunity for targeted destruction of Port wine stains.

Researchers will use a photosensitizer medication called Talaporfin sodium, an intravenously administered investigational photosensitizer, being evaluated for multiple clinical indications. Photodynamic therapy with talaporfin sodium has been investigated for many different conditions, and can be used for treatment for Port wine stains. Photosensitivity precaution instructions will be provided, including appropriate photo protective clothing, protective hat and sunglasses that wrap around the temples to help minimize lateral sun light exposure when traveling home following discharge from the study site.

For efficacy, evaluated study variable will be Port wine stain blanching, and the researchers can use diffuse reflectance imaging chromametry, Laser Speckle Imaging and Spatial Frequency Domain Imaging to measure the change of Port wine stain blanching. The maximum power of the Laser Speckle Imaging and Spatial Frequency Domain Imaging light source is 10-50 mW, which is comparable to halogen-bulb household flashlights. Efficacy will be evaluated based on comparison of pre-treatment visit and post treatment day 1, week 1, week 4, and week 12 measurements.

Novel Treatment for Port Wine Stain Birthmarks

The outcome measure will be PWS blanching as assessed by Diffuse Reflectance Imaging/Laser Speckle Imaging/Spatial Frequency Domain Imaging.

Beckman Laser Institute University of California Irvine

University of California, Irvine

Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Photodynamic therapy

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
Novel Treatment for Port Wine Stain Birthmarks	NCT01924273	Port-Wine Stain	Talaporfin sodi...	18 Years -	University of California, Irvine
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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