RecruitingPhase 1NCT03370406

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


Sponsor

Melissa Pugliano-Mauro

Enrollment

30 participants

Start Date

Aug 3, 2018

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment — injections of a chemotherapy drug (5-fluorouracil, or 5-FU) directly into the tumor alongside a topical vitamin D cream (calcipotriene) applied to the skin — for treating squamous cell carcinoma (a common type of skin cancer) on the lower legs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed by biopsy with squamous cell skin cancer on your knee or below, measuring between 1.0 cm and 2.0 cm in diameter - Your expected survival is at least 12 months - You are not currently on any other experimental treatment - You are willing to follow the study instructions and sign an informed consent form - Your overall health is good (performance status 0 or 1) **You may NOT be eligible if...** - Your skin cancer is smaller than 1 cm or larger than 2 cm - The cancer is located above the knee - You are currently participating in another clinical trial - Your health is too poor to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5-fluorouracil

Intralesional injections of 50mg/ml over a 3 week period.

DRUGCalcipotriene

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)

St. Margaret Hospital Dermatology

Pittsburgh, Pennsylvania, United States

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NCT03370406


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