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Photodynamic Therapy for Benign Dermal Neurofibromas Using Levulan Kerastick For Topical Solution, Plus Illumination With Red Light

Phase 1
18 Years
90 Years
Open (Enrolling)

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Trial Information

Photodynamic Therapy for Benign Dermal Neurofibromas Using Levulan Kerastick For Topical Solution, Plus Illumination With Red Light

STUDY DESIGN This protocol is a Phase I light dose escalation pilot study to determine the
safety and, secondarily, the efficacy of PDT using Levulan and 630 nm light in the treatment
of benign dermal neurofibromas. This protocol represents the first two parts of a planned
three part study including both pediatric and adult subjects. Part 1 will consist of
studying the penetration and uptake of the PS in neurofibromas that are scheduled for
excision. These tumors will be excised for therapeutic reasons unrelated to this study, and
so this study will place no further burden on the subject other than a 3-24 hr incubation of
the Levulan on the tumor prior to excision. The primary hypothesis to be tested is whether
Levulan will accumulate, and be converted to PpIX, by the tumor tissue more than by the
surrounding normal tissue. Secondary hypotheses are that tumors incubated with Levulan will
show greater fluorescence than untreated tumors and tumors incubated with vehicle only
(placebo application).

As the Institutional Review Boards involved generally desire pilot data on adult populations
first, we will with then proceed with the adult clinical trial portion of this protocol as
part 2. Part 2 will use the optimum incubation time, if one has been identified in part 1,
and add a dose escalation study of the amount of red light used to activate the Levulan.
Part 3, with pediatric subjects, will commence at a future date, pending review of the
initial adult study results.

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. -

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1: Photosensitizer uptake

Outcome Description:

Measurement of the ratio of the mean fluorescence intensity in excised, sectioned tumors, to the fluorescence in immediately adjacent tissue, as determined by fluorescence microscopy

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Harry T Whelan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Institutional Review Board

Study ID:

PRO 14555



Start Date:

November 2011

Completion Date:

November 2017

Related Keywords:

  • Neurofibromatoses
  • Neurofibroma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica



The Medical College of Wisconsin Milwaukee, Wisconsin  53226