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

NCT02157623 | Completed Results DMC

• 1 other identifier: CASE 2614
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Nevus Syndrome

Keywords

Basal Cell Nevus Syndrome; Gorlin's Syndrome

Outcome Measures

Primary Outcomes (1)

• Tumor Clearance Rate Following Red or Blue Light PDT

  The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).

  6 months

Secondary Outcomes (2)

• Pain During Illumination

  Maximum value reported during the illumination period

• Patient Satisfaction Survey

  6 months

Study Arms (1)

Red Light PDT and Blue Light PDT

EXPERIMENTAL

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

Drug: Levulan; Other: Red Light PDT; Other: Blue Light PDT

Interventions

Levulan DRUG

Levulan application followed by Red or Blue light PDT

Also known as: Levulan™, Levulan® Kerastick® for Topical Solution, 5-aminolevulinic acid, aminolevulinic acid HCL, ALA

Red Light PDT and Blue Light PDT

Red Light PDT OTHER

Aktilite™ (red lamp) after Levulan application on lesions

Also known as: Aktilite™, Red Lamp, Red Light, PDT

Red Light PDT and Blue Light PDT

Blue Light PDT OTHER

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

Also known as: Blu-U, Blue Lamp, Blue Light, PDT

Red Light PDT and Blue Light PDT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Maytin, MD, PhD: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Basal Cell Nevus Syndrome

Interventions

Aminolevulinic Acid; Solutions; Photochemotherapy; Red Light; 1-phenyl-3,3-dimethyltriazene; Blue Light

Condition Hierarchy (Ancestors)

Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Carcinoma, Basal Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Results Point of Contact

• Title: Edward Maytin, MD, PhD
• Organization: Cleveland Clinic

maytine@ccf.org

216-445-6676

Study Officials

• Edward V. Maytin, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Model Details: All patients received a different treatment to each half of their body. First Levulan with red light PDT (to tumors on one side of the body), and then Levulan with blue light PDT (to tumors on the other side of the body), at six treatment visits.

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 6, 2014
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 30, 2020
• Results First Posted: June 2, 2017

Record last verified: 2020-07

Locations

US (1)