About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patients with any evidence of nodal (Nx) and/or metastatic disease including distant subcutaneous and/or lymph node metastases.
Patients with primary non-cutaneous SCC - such as nasopharyngeal SCC.
Patient with history of receiving organ transplantation.
Patients with history of iatrogenic systemic immunosuppression.
Trial design
Treatments tested in this trial
- 5-fluorouracil
- Calcipotriene
Treatment groups
Sponsors and collaborators
Melissa Pugliano-Mauro
Lead sponsor
University of Pittsburgh
Sponsor institution
National Cancer Institute (NCI)
Collaborator