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

Primary Purpose

Basal Cell Nevus Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levulan
Red Light PDT
Blue Light PDT
Sponsored by
Edward Maytin, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Nevus Syndrome focused on measuring Basal Cell Nevus Syndrome, Gorlin's Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Red Light PDT and Blue Light PDT

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain During Illumination
Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
Patient Satisfaction Survey
Overall patient satisfaction with the technique will be assessed using a simple survey: 6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.

Full Information

First Posted
June 2, 2014
Last Updated
July 15, 2020
Sponsor
Edward Maytin, MD, PhD
Collaborators
DUSA Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02157623
Brief Title
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
Official Title
Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Maytin, MD, PhD
Collaborators
DUSA Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Nevus Syndrome
Keywords
Basal Cell Nevus Syndrome, Gorlin's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red Light PDT and Blue Light PDT
Arm Type
Experimental
Arm Description
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
Intervention Type
Drug
Intervention Name(s)
Levulan
Other Intervention Name(s)
Levulan™, Levulan® Kerastick® for Topical Solution, 5-aminolevulinic acid, aminolevulinic acid HCL, ALA
Intervention Description
Levulan application followed by Red or Blue light PDT
Intervention Type
Other
Intervention Name(s)
Red Light PDT
Other Intervention Name(s)
Aktilite™, Red Lamp, Red Light, PDT
Intervention Description
Aktilite™ (red lamp) after Levulan application on lesions
Intervention Type
Other
Intervention Name(s)
Blue Light PDT
Other Intervention Name(s)
Blu-U, Blue Lamp, Blue Light, PDT
Intervention Description
Blu-U® (blue lamp) after Levulan application on lesions
Primary Outcome Measure Information:
Title
Tumor Clearance Rate Following Red or Blue Light PDT
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain During Illumination
Description
Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
Time Frame
Maximum value reported during the illumination period
Title
Patient Satisfaction Survey
Description
Overall patient satisfaction with the technique will be assessed using a simple survey: 6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward V. Maytin, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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