Actively Recruiting
Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
Led by Melissa Pugliano-Mauro · Updated on 2025-06-15
30
Participants Needed
1
Research Sites
430 weeks
Total Duration
On this page
Sponsors
M
Melissa Pugliano-Mauro
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed squamous cell carcinoma on lower extremities between 1.0 and 2.0 cm in diameter
- Expected survival of 12 months or more
- No use of other investigational drugs or devices
- Willingness to follow study instructions and sign informed consent
- Age 18 years or older at consent
- Performance status of 0 or 1 on ECOG scale
- Negative pregnancy test for females of childbearing potential within 7 days before first dose
- Use of effective contraception or abstinence for females not free from menses and male participants during the study and for 120 days after last dose
You will not qualify if you...
- Evidence of nodal or distant metastatic disease
- Primary squamous cell carcinoma outside the skin (e.g., nasopharyngeal)
- History of organ transplantation
- History of systemic immunosuppression
- Skin conditions requiring topical steroids or other creams
- Active infections needing systemic therapy such as hepatitis B/C or HIV
- Known autoimmune diseases
- Certain heart conditions including prolonged QT/QTc interval over 500 msec or heart failure with ejection fraction less than 50%
- Recent chemotherapy, radiation, or biological cancer therapy within 4 weeks unless neuropathy is grade 2 or less
- Incomplete recovery from major surgery before therapy
- Participation in investigational studies within 4 weeks of first dose
- Need for other systemic or localized antineoplastic therapies during study
- History of hematologic malignancies, brain tumors, sarcomas, or other solid tumors unless disease-free for 5 years
- Severe hypersensitivity to 5-fluorouracil or imiquimod
- Serious illnesses such as uncontrolled cardiovascular disease, bleeding disorders, autoimmune diseases, severe lung diseases, active systemic infections, or inflammatory bowel disease
- Conditions or therapies interfering with study participation or safety
- Current or recent illicit drug or alcohol abuse within last year
- Pregnancy, breastfeeding, or planning to conceive or father children during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Margaret Hospital Dermatology
Pittsburgh, Pennsylvania, United States, 15238
Actively Recruiting
Research Team
M
Melissa Pugliano-Mauro, MD
CONTACT
J
Jeff Plowey, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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