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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02157623
Other study ID # CASE 2614
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date December 1, 2016

Study information

Verified date July 2020
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT02258243

Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date December 1, 2016
Est. primary completion date September 1, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levulan
Levulan application followed by Red or Blue light PDT
Other:
Red Light PDT
Aktilite™ (red lamp) after Levulan application on lesions
Blue Light PDT
Blu-U® (blue lamp) after Levulan application on lesions

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Edward Maytin, MD, PhD DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Maximum value reported during the illumination period
Secondary 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.
6 months
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Recruiting NCT03483441 - Vitamin D and Photodynamic Therapy for Treatment of BCC in BCNS Phase 1
Active, not recruiting NCT03467789 - Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma Phase 1
Recruiting NCT05463757 - Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study
Completed NCT02762084 - Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients Phase 2
Terminated NCT04308395 - Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome) Phase 3
Withdrawn NCT03767439 - Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome Phase 2
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Recruiting NCT06330350 - Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
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Terminated NCT02303041 - Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma Phase 2
Completed NCT02100371 - Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome N/A
Completed NCT03703310 - Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome) Phase 3
Completed NCT00957229 - To Determine The Efficacy and Safety of GDC-0449 in Patients With Basal Cell Nevus Syndrome (BCNS) Phase 2
Completed NCT01556009 - Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas Phase 2