Phase 1 Study of Intralesional 5-Fluorouracil Alone or with Topical Calcipotriene Cream for Treating Squamous Cell Carcinoma on the Lower Legs

What this Trial Is About

Researchers are evaluating a new approach to treat squamous cell carcinoma SCC on the lower legs, focusing on delivering medicine directly to the tumor. This trial is a Phase I study aimed at assessing the safety and tolerability of direct injections of 5-fluorouracil 5FU, a chemotherapy drug, with or without a topical vitamin D analogue cream called calcipotriene. The study also measures how well these treatments reduce tumor size compared to untreated lesions three weeks after treatment. Participants will be randomly assigned to one of three groups a control group receiving standard surgical removal of the tumor, a group receiving monthly intralesional injections of 5FU for three months, or a group receiving the same 5FU injections plus applying calcipotriene cream twice daily for four days after each injection. Biopsies will be taken before, during, and after treatment to assess tumor response and tissue changes. Throughout the study, participants will have lesion photographs, biopsies, and clinical evaluations to monitor treatment effects and safety. After treatment, patients with no remaining tumor cells will be followed every six months for two years. Those with persistent tumor cells may undergo further surgery. The total participation lasts about three months with additional follow-up for responders to monitor long-term outcomes and safety.

Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC