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
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.
Description
Squamous cell carcinoma of the skin is a common form of keratinocyte skin cancer. The majority of cutaneous SCCs occur on the head and neck, more so in men than women, but can occur anywhere squamous cells are found. Squamous cell carcinoma of the skin is usually not life-threatening, though it can be aggressive in some cases, and is normally treated with minor surgery. Squamous cell carcinoma (SCC) of the lower extremity is a distinct subset of cutaneous squamous cell carcinomas which tend to occur multiply in elderly women. Histopathological studies of lower extremity SCCs reveals that they…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lower extremities, defined as the knees and below. * Subjects must have an expected survival of greater than or equal to12 months. * Subjects must not be on any other investigational device/drug treatment. * Subjects must to be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study. * Patient is ≥ 18 years of age on day of signing informed consent. * Patient must have a performance status of 0 or 1 on the E…
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..
Location
- St. Margaret Hospital DermatologyPittsburgh, Pennsylvania