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

NCT ID: NCT02157623

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2016-12-01

Brief 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.

Detailed 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.

Conditions

Basal Cell Nevus Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Red Light PDT and Blue Light PDT

The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.

Group Type: EXPERIMENTAL

Levulan

Intervention Type: DRUG

Levulan application followed by Red or Blue light PDT

Red Light PDT

Intervention Type: OTHER

Aktilite™ (red lamp) after Levulan application on lesions

Blue Light PDT

Intervention Type: OTHER

Blu-U® (blue lamp) after Levulan application on lesions

Interventions

Levulan

Levulan application followed by Red or Blue light PDT

Intervention Type: DRUG

Red Light PDT

Aktilite™ (red lamp) after Levulan application on lesions

Intervention Type: OTHER

Blue Light PDT

Blu-U® (blue lamp) after Levulan application on lesions

Intervention Type: OTHER

Other Intervention Names

Levulan™; Levulan® Kerastick® for Topical Solution; 5-aminolevulinic acid; aminolevulinic acid HCL; ALA; Aktilite™; Red Lamp; Red Light; PDT; Blu-U; Blue Lamp; Blue Light; PDT

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Edward Maytin, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Edward Maytin, MD, PhD

Staff

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edward V. Maytin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE 2614

Identifier Type: -

Identifier Source: org_study_id

NCT02258243

Identifier Type: -

Identifier Source: nct_alias