Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities
Melissa Pugliano-Mauro
30 participants
Aug 3, 2018
INTERVENTIONAL
Conditions
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 0.005% calcipotriene cream 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 calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.
Eligibility
Plain Language Summary
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Interventions
Intralesional injections of 50mg/ml over a 3 week period.
Topical application of .005% cream two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections..
Locations(1)
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NCT03370406