This phase II trial studies the effect of jet-injection assisted photodynamic therapy (PDT) in treating patients with a common form of skin cancer called basal cell carcinoma. PDT uses a drug that increases the skin cells’ sensitivity to light (a photosensitizer called aminolevulinic acid [ALA]) and a particular type (wavelength) of light to kill cancer and other abnormal cells. When the ALA is exposed to the light, the drug is activated (turned on) to destroy the cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04552990.
PRIMARY OBJECTIVE:
I. To assess tolerability of jet-injection assisted photodynamic therapy (PDT) for nodular basal cell carcinomas (BCCs) by following acute local skin responses (local skin response [LSR]; erythema, edema, flaking/scaling, crusting, pustulation, erosion/ulceration) in the treatment area up to 3 months after treatment.
SECONDARY OBJECTIVES:
I. Assessing pain during jet-injection.
II. Assessing pain during PDT illumination.
III. Assessing long term skin changes (scarring, hyperpigmentation, hypopigmentation, skin texture).
IV. Assessing pain and pruritus up to 3 months following treatment.
V. Assessing biodistribution of aminolevulinic acid (ALA) inside the tumor.
VI. Assessing tumor clearance.
VII. Assessing patient satisfaction.
EXPLORATORY OBJECTIVE:
I. To evaluate the feasibility of using standard and novel tele-assessments to evaluate LSR’s.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (PATIENTS 1-4): Patients undergo PDT with jet injection of ALA followed by 3 hour (h) incubation. After 3h incubation, patients undergo standard of care surgical excision on day 0.
ARM II (PATIENTS 5-16): Patients undergo PDT with jet injection of ALA followed by 3h incubation and illumination with red light on days 0 and 14 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnthony Rossi
