OncoMatch/Clinical Trials/NCT03370406
Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
Is NCT03370406 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including 5-fluorouracil and Calcipotriene for carcinoma, squamous cell.
Treatment: 5-fluorouracil · Calcipotriene — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Excluded: Stage NODAL (NX), METASTATIC DISEASE
Patients with any evidence of nodal (Nx) and/or metastatic disease including distant subcutaneous and/or lymph node metastases.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Patients who have had chemotherapy, radioactive or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse effects (AEs) due to cancer therapeutics administered more than four weeks earlier.
Cannot have received: radioactive or biological cancer therapy
Exception: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Patients who have had chemotherapy, radioactive or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse effects (AEs) due to cancer therapeutics administered more than four weeks earlier.
Cannot have received: investigational agent or device
Patients currently participating or who have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study drug.
Lab requirements
Cardiac function
No baseline known prolongation of QT/QTc interval (>500 msec); no heart failure (clinical or LV EF <50%); no uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, or severe cardiac arrhythmia.
Patients with the following cardiac co-morbidities including: Baseline known prolongation of QT/QTc interval (QTc interval >500 msec). Heart failure either on clinical examination ... or based on known decreased left ventricular ejection fraction (LV EF) <50%. Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Margaret Hospital Dermatology · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify