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Aminolevulinic Acid

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

Levulan application followed by Red or Blue light PDT

Levulan

Aktilite™ (red lamp) after Levulan application on lesions

Red Light PDT

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

Blue Light PDT

Edward V. Maytin, MD, PhD

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.

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.

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.

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

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

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).

Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.

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.

DUSA Pharmaceuticals, Inc.

Edward Maytin, MD, PhD

Staff

Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field

Red Light Photodynamic Therapy

Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field

Blue Light Photodynamic Therapy

Subject will be receive red light PDT on one side of the body, and blue light PDT to the contralateral side after Levulan application

Red Light / Blue Light Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

One side of patient received red light PDT

The other side of the patient received blue light PDT

Three (3) patients with BCNS were enrolled.

Tumor Clearance Rate Following Red or Blue Light PDT

Pain during red light illumination (on a 0-10 visual analog scale)

Pain During Red Light

Pain during blue light illumination (on a 0-10 visual analog scale)

Pain During Blue Light

Pain During Illumination

RATING SCALE: 6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.

Red Light Treatment

Blue Light Treatment

Patient Satisfaction Survey

Subjects will receive Red Light PDT on one side of the body, and Blue Light PDT to the contralateral side.

Red Light/Blue Light Participants

Overall Study

Basal Cell Carcinoma, Multiple

Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

Vismodegib

20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Aminolevulinic acid %20 topical solution

Ervin Epstein, MD

The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

This is a Phase II, 28 month, randomized, two arm multicenter clinical study design. During the initial 7 months of the study, all 24 subjects will receive vismodegib, 150mg/day. They then will be randomized in a 1:1 ratio to receive intermittent vismodegib, 150 mg/day, during months 10-13, 16-19, and 22-25 or to receive treatment with PDT at month 10 and at three month intervals thereafter. The safety and efficacy of intermittent vismodegib and of PDT will be assessed at the time of the subjects' visits to the Study Center and at the time of telephone contacts. A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months. The DSMB review will focus on adverse events and efficacy results. Subjects will be monitored for the presence of surrogate endpoint biomarkers (SEBs) at each Study visit.

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

A Phase II Randomized, Open Label Trial Comparing the Effects of Intermittent Vismodegib Versus PDT on the Maintenance of Benefit Following 7 Months of Continuous Vismodegib Treatment in Patients With Multiple Basal Cell Carcinomas

Primary:

i. To compare the efficacy of (i) intermittent vismodegib vs. (ii) the efficacy of photodynamic therapy (PDT) in preventing the return of the burden of surgically eligible BCCs (SEBs) to baseline level following 7 months of continuous vismodegib therapy.

ii. To compare the cumulative diameter (burden) of SEBs in patients treated intermittently with vismodegib vs. with photodynamic therapy (PDT).

i. To assess the safety of intermittent vismodegib in patients with multiple BCCs (BCNS and non-BCNS) during months 8-28.

ii. To assess resistance of SEBs to treatments in patients with multiple BCCs (BCNS and non-BCNS) treated intermittently during months 8-28.

iii. To assess the degree of reduction of SEBs after 7 months of continuous daily vismodegib therapy.

iv. To conduct an exploratory evaluation in non-BCNS patients with multiple BCCs (high burden of disease) of the efficacy and tolerability of intermittent vismodegib vs PDT

Genentech, Inc.

UCSF Benioff Children's Hospital Oakland

The PI has left the institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.

Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

Drug (Vismodegib)

Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome	NCT02157623	Basal Cell Nevu...	Levulan Red Light PDT Blue Light PDT	-	The Cleveland Clinic
Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas	NCT01556009	Basal Cell Nevu... Gorlin's Syndro...	Vismodegib Aminolevulinic ...	18 Years - 75 Years	UCSF Benioff Children's Hospital Oakland
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome	NCT02157623	Basal Cell Nevu...	Levulan Red Light PDT Blue Light PDT	-	The Cleveland Clinic

Spots Global Cancer Trial Database for gorlin's syndrome