This phase I trial studies how well vitamin D works when given before photodynamic therapy when treating patients with basal cell cancer in basal cell nevus syndrome. Giving vitamin D before photodynamic therapy may help improve the effectiveness of treatment. Photodynamic therapy is a noninvasive treatment in which a topical agent called Levulan or ALA is applied to the skin and then exposed to blue light, which targets and kills tumor cells. It is not yet known how well vitamin D works when given before photodynamic therapy in patients with basal cell cancer in basal cell nevus syndrome.
Additional locations may be listed on ClinicalTrials.gov for NCT03467789.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine tumor clinical clearance rates after neoadjuvant cholecalciferol (D3)/photodynamic therapy (PDT), and after PDT alone.
SECONDARY OBJECTIVES:
I. To assess the level of protoporphyrin IX (PpIX) accumulation in basal cell carcinoma (BCC) lesions at various treatment visits, in the absence or presence of neoadjuvant D3. (Fluorescence dosimetry measurements)
II. To assess tolerability of the technique. (Pain scale measurements)
III. To assess patient satisfaction with the technique. (Cosmetic result, and questionnaire)
IV. To assess D3 serum levels, serum vitamin D1 25-dihydroxy levels, vitamin D receptor (VDR) status (in leukocyte deoxyribonucleic acid [DNA]), and correlate these results to clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients receive cholecalciferol orally (PO) daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo photodynamic therapy with topical aminolevulinic acid hydrochloride (Levulan) on day 0. Patients then receive placebo PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo a second photodynamic therapy session on at month 2. Patients undergo a third photodynamic therapy session at month 4.
GROUP B: Patients receive placebo PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo photodynamic therapy with topical Levulan on day 0. Patients then receive cholecalciferol PO daily on days 1-5 or 1-14 (depending on serum vitamin D3 levels) and undergo a second photodynamic therapy session at month 2. Patients undergo a third photodynamic therapy session at month 4.
After completion of each study treatment, patients are followed up in 24-48 hours and followed for up to 6 months.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorEdward Maytin
