Photodynamic Therapy Using Blue Light or Red Light in Treating Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Basal Cell Carcinoma of the Skin Clinical Trial

Official title: Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During LevulanTM-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Status Active, not recruiting

Clinical Trial Summary

This pilot randomized phase II trial studies how well photodynamic therapy using blue light or red light works in treating basal cell cancer (carcinoma) in patients with a genetic condition that causes unusual facial features and disorders of the skin, bones, nervous system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor cells and when exposed to an intensive light source (blue light or red light) become active and may kill the cells. It is not yet known whether photodynamic therapy is more effective with blue light or red light in treating basal cell carcinoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether cyclic photodynamic therapy (PDT) treatment is effective in curing existing basal cell carcinoma (BCC) tumors in patients with basal cell nevus syndrome (BCNS), and whether red light or blue light is more effective in this regard.

SECONDARY OBJECTIVES:

I. To assess the tolerability (pain during treatment) of red light versus blue light in this patient population.

II. To assess patient satisfaction with the technique.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the left side of the body and red light on the right side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive aminolevulinic acid hydrochloride topically. Beginning 4 hours later, patients undergo photodynamic therapy using blue light on the right side of the body and red light on the left side of the body on days 1 and 8. Treatment repeats every 2 months for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma of the Skin
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Nevoid Basal Cell Carcinoma Syndrome
• Syndrome

• NCT number: NCT02258243
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2015
• Completion date: December 2017