Clinical Trials /

Photodynamic Therapy for Benign Dermal Neurofibromas

NCT02728388

Description:

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Related Conditions:
  • Neurofibroma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Photodynamic Therapy for Benign Dermal Neurofibromas
  • Official Title: Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II

Clinical Trial IDs

  • ORG STUDY ID: PRO00026795
  • NCT ID: NCT02728388

Conditions

  • NEUROFIBROMATOSIS 1

Purpose

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Detailed Description

      Neurofibromas contain a large quantity of fibrous matter, and it is not anticipated that
      significant reductions in tumor size can be achieved in large, long established, tumors.
      Cutaneous neurofibromas, which do not usually become apparent until puberty, continue to
      increase in size and number throughout adulthood. The psychosocial burden of these
      disfiguring tumors is significant, and the targeted age group (14-30) is at a life period
      associated with an acceleration in tumor growth. It is for these reasons that the
      investigators hope to affect the growth rate of less established tumors, in order to prevent
      or lessen this burden as the patient progresses further into adulthood.

      Therefore, the investigators wish to determine the time to disease progression (defined as
      50% growth in size over baseline) for benign neurofibromas treated with PDT in patients with
      neurofibromatosis type 1 (NF1) in subjects aged 14-30.

      The treatment will consist of choosing several neurofibromas of similar size, and applying a
      topical drug called Levulan, or just the topical application alone (a placebo). After 1 day,
      the neurofibromas will be illuminated with red light (both Levulan and placebo). The Levulan
      is what is known as a photosensitizer, and will be activated by the red light to potentially
      kill some of the tumor cells. Every 4 months after, for three years, the tumors will be
      measured to see if they are growing more slowly than the ones with the placebo application
      alone.
    

Trial Arms

NameTypeDescriptionInterventions
PDT TreatmentExperimentalEach subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his/her own control subject. After 24 hours, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW/cm2 for 1000 seconds (16.7 minutes).

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Patient is 14 years or older.
    
              2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis
                 section).
    
              3. Tumor Location: cutaneous, trunk, or limbs only.
    
              4. Tumor Type: superficial dermal neurofibromas ≤4mm deep.
    
              5. Patient has provided written informed consent.
    
              6. Patient is willing to and can comply with study follow-up requirements.
    
              7. Absence of any other malignancy.
    
            Exclusion Criteria:
    
              1. Life expectancy less than 3 years.
    
              2. Pregnancy.
    
              3. Cutaneous photosensitivity to the wavelengths used to active PDT.
    
              4. A diagnosis of porphyria.
    
              5. Allergy to aminolevulinic acid or any of the topical solution vehicle components.
    
              6. Previous chemotherapy within 6 weeks of proposed PDT.
    
              7. Other concurrent tumor therapy.
          
    Maximum Eligible Age:30 Years
    Minimum Eligible Age:14 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Time to disease progression
    Time Frame:3 years
    Safety Issue:
    Description:The time it takes for 50% growth in tumor size over baseline measurements.

    Secondary Outcome Measures

    Measure:Tumor growth rate
    Time Frame:3 years
    Safety Issue:
    Description:Measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Harry T Whelan, MD

    Trial Keywords

    • NF1
    • Neurofibroma
    • Neurofibromatosis Type 1

    Last Updated