Overview

Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Edward Maytin
Edward Maytin, MD, PhD
Collaborator:
DUSA Pharmaceuticals, Inc.
Treatments:
Aminolevulinic Acid
Criteria
Inclusion Criteria:

- Men, women, and children of any age or ethnic group who meet eligibility

- Patients under 18 years of age must be accompanied and co-consented, by a parent or
legal guardian.

- Patients must have a diagnosis of Basal Cell Nevus Syndrome (BCNS)

- For diagnosis of BCNS, the patient must have either 2 major criteria, one major and
two minor criteria, or one major criterion plus molecular confirmation of a PTCH1 gene
mutation

- Major criteria are:

- (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to
prior sun exposure and skin type

- (2) keratocyst of the jaw prior to age 20

- (3) palmar or plantar pitting

- (4) lamellar calcification of the falx cerebri

- (5) medulloblastoma

- (6) first degree relative with BCNS

- Minor criteria are:

- (1) rib anomalies, or other specific skeletal malformations including
kyphoscoliosis and short 4th metacarpals

- (2) macrocephaly

- (3) cleft/lip or palate;

- (4) fibroma of the heart or ovary

- (5) ocular abnormalities

- (6) other rare abnormalities

- At least two BCC tumors, preferably more, located in different body regions or located
greater than 10 cm apart in locations that can be reproducibly separated into red and
blue illumination fields

- Female subjects are not pregnant or nursing or planning to become pregnant during the
study

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Pregnant, planning on getting pregnant or nursing

- Currently participating in another clinical trial

- Using any topical treatment for their BCC tumors, unless discontinued at least 1 month
prior

- Currently being treated for other cancers with medical or radiation therapy

- Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of
the study material

- Patients with a history of a photosensitivity disease, including porphyria cutanea
tarda