Intralesional 5-Fluorouracil (5FU), Topical Imiquimod Treatment for SCC
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
This clinical trial proposes to evaluate a relatively unexplored approach to treatment of
squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and
specifically deliver drug to the tumor. For the proposed phase I clinical trial, the
investigators will perform intralesional injections of a well characterized, potent
chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 5%
imiquimod to kill topically accessible SCC cells. The goal of the study is to evaluate the
safety profile and tolerability of intralesional-5FU with and without a concomitant topical
imiquimod and measure the clinical objective response rate (ORR) in treated lesions compared
to untreated lesions 3 weeks after treatment.