Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients (PDT)

The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.

Study Overview

• Status: Completed
• Conditions: Nonmelanoma Skin Cancers
• Intervention / Treatment: Other: have Levulan Kerastick (aminolevulinic acid) solution

Detailed Description

Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (PDT) administration.

Primary endpoints include:

1. development of non melanoma skin cancers (NMSC) lesions and
2. assessment of actinic damage score.

The primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. The patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment.

Additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score will be reassessed. The investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Melanoma Na Skin Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient has been the recipient of any solid organ transplant.
2. Active immunosuppression for at least 5 years
3. History of at least one NMSC
4. Subject is willing to sign an informed consent to participate in this study.

Exclusion Criteria:

1. Patient is not appropriate candidate for treatment or research trial per treating physician
2. Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.
3. Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered	Other: have Levulan Kerastick (aminolevulinic acid) solution; Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of non melanoma skin cancers in organ transplant recipients	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of actinic keratosis damage/epidermal dysplasia in organ transplant recipients as assessed by physician and graded per actinic damage scale	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: DUSA Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Jennifer DeSimone, MD, Physician

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 15-1845