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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 S

Brief 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.

Detailed Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome:

  • Tumor diameter as a function of time [ Time Frame: Up to 6 months ]
  • Mean reduction in tumor diameter measured via digital imaging software [ Time Frame: Up to 6 months ]
  • Mean reduction in number of tumors [ Time Frame: Up to 6 months ]
  • Number of lesions with complete response (CR) measured via digital imaging software [ Time Frame: Up to 6 months ]
    Generalized linear mixed-effects models will be applied to categorical endpoints.
  • Number of lesions with partial response measured via digital imaging software [ Time Frame: Up to 6 months ]
  • Number of lesions with no response measured via digital imaging software [ Time Frame: Up to 6 months ]
  • Average time to clearance for lesions with a CR [ Time Frame: Up to 6 months ]
    Recorded photographically. The analysis for time to clearance will be based on a random-frailty survival model, where lesions without CR will be considered to have clearance times censored at the end of study.
  • Percent of lesions with a CR, as a function of initial tumor size [ Time Frame: Up to 6 months ]
    Recorded photographically.
  • Time to recurrence, following CR, in a given PDT-treated field [ Time Frame: Up to 2 years ]
  • Protoporphyrin IX levels in tumors via noninvasive fluorescence dosimetry [ Time Frame: Up to 6 months post-treatment 

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Pain during treatment using patient's symptom score sheets [ Time Frame: Up to 4 months ]
      The absence/presence of pain will be recorded on a 0-to-10 visual/analog scale.
    • Patient satisfaction using a short questionnaire [ Time Frame: Up to 6 months ]


    Original Secondary Outcome: Same as current

    Information By: Case Comprehensive Cancer Center

    Dates:
    Date Received: October 3, 2014
    Date Started: December 2015
    Date Completion: December 2017
    Last Updated: November 4, 2016
    Last Verified: November 2016