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Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

NCT03370406 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Carcinoma, Squamous Cell

Interventions

DRUG

5-fluorouracil

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

DRUG

Calcipotriene

Topical application of .005% cream two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections..

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Melissa Pugliano-Mauro

    lead OTHER

Principal Investigators

  • Melissa Pugliano-Mauro, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2026-09-30
Completion
2026-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370406 on ClinicalTrials.gov