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

Edward Maytin, MD, PhD

Status

Completed

Conditions

Basal Cell Nevus Syndrome

Treatments

Other: Blue Light PDT

Drug: Levulan

Other: Red Light PDT

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02157623

CASE 2614

Details and patient eligibility

About

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.

Full description

This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).

Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.

Enrollment

3 patients

Sex

All

Volunteers

No Healthy Volunteers

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