Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harry T Whelan, MD
• Treatments: Aminolevulinic Acid

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.