This pilot phase II trial studies the side effects of aminolevulinic acid hydrochloride and photodynamic therapy and to see how well they work in preventing actinic keratosis and non-melanoma skin cancer in patients who have undergone a solid organ transplant. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03110159.
PRIMARY OBJECTIVES:
I. To examine the safety and efficacy of cyclic aminolevulinic acid hydrochloride-photodynamic therapy (Levulan-PDT) on primary prevention of actinic keratosis/non-melanoma skin cancer (AKs/NMSC) in recently transplanted solid organ recipients.
SECONDARY OBJECTIVES:
I. To investigate pain control with Levulan-PDT in solid organ transplant recipient (SOTR).
OUTLINE:
Patients receive aminolevulinic acid hydrochloride topically. After 1 hour, patients undergo BLU-U blue light PDT over 16 minutes 40 seconds on day 1. Treatment repeats on day 30 and 180, and months 12, 18, 24, 30, and 36 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months.
Lead OrganizationArizona Cancer Center-Phoenix Campus
Principal InvestigatorNathalie Zeitouni