Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT01682811
• Date of registration: 05/09/2012
• Prospective Registration: No
• Primary sponsor: Harry T Whelan, MD
• Public title: Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)
• Scientific title: Photodynamic Therapy for Benign Dermal Neurofibromas Using Levulan Kerastick For Topical Solution, Plus Illumination With Red Light
• Date of first enrolment: March 12, 2012
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01682811
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Harry T Whelan, MD
• Affiliation: Medical College of Wisconsin

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects with NF1 will be selected for photodynamic therapy on the following criteria.

1. Age: 18 years or older.

2. NF1 will be diagnosed by American Academy of Neurology guidelines.

3. Location of tumor: cutaneous, trunk or limbs only.

4. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.

5. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and
photo-volumetric method.

6. Informed consent of subject.

7. Absence of any other malignancy.

8. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying

Exclusion Criteria:

Subjects will be excluded from participation in the study on the basis of the following:

1. Life expectancy less than 1 year.

2. Pregnancy.

3. Inability to consent.

4. Cutaneous photosensitivity to the wavelengths used to activate PDT.

5. A diagnosis of porphyria.

6. Allergy to aminolevulinic acid or any of the Topical Solution Vehicle components.

7. Previous chemotherapy within 6 weeks of proposed PDT.

8. Other concurrent tumor therapy. -



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neurofibromatoses

Intervention(s)

Drug: Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2

Drug: Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3

Drug: Part 1 Levulan injection

Drug: Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1

Drug: Part 1 Levulan surface application twice

Drug: Part 1 Levulan surface application

Drug: Part 1 Levulan surface application twice with microneedling

Primary Outcome(s)

Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX [Time Frame: 24 hours]

Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light [Time Frame: 48 hours]

Secondary Outcome(s)

Part 2: Efficacy - Lesion Area Growth Rate [Time Frame: 12 weeks]

Part 2: Cosmetic Improvement [Time Frame: 1 year]

Part 1: Optimal Occlusion Time [Time Frame: 24 hours]

Part 2: Pain Reduction [Time Frame: 1 year]

Secondary ID(s)

PRO 14555

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01682811