Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID03370406

Phase I Open-Label Trial of Intralesional 5-Fluorouracil with or without Topical Calcipotriene in Patients with Lower Extremity Squamous Cell Carcinoma

Led by Melissa Pugliano-Mauro · Updated on 2026-06-01

30

Participants Needed

1

Research Sites

4 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

Researchers are evaluating a new approach to treat squamous cell carcinoma (SCC) on the lower legs, focusing on delivering medicine directly to the tumor. This trial is a Phase I study aimed at assessing the safety and tolerability of direct injections of 5-fluorouracil (5FU), a chemotherapy drug, with or without a topical vitamin D analogue cream called calcipotriene. The study also measures how well these treatments reduce tumor size compared to untreated lesions three weeks after treatment. Participants will be randomly assigned to one of three groups: a control group receiving standard surgical removal of the tumor, a group receiving monthly intralesional injections of 5FU for three months, or a group receiving the same 5FU injections plus applying calcipotriene cream twice daily for four days after each injection. Biopsies will be taken before, during, and after treatment to assess tumor response and tissue changes. Throughout the study, participants will have lesion photographs, biopsies, and clinical evaluations to monitor treatment effects and safety. After treatment, patients with no remaining tumor cells will be followed every six months for two years. Those with persistent tumor cells may undergo further surgery. The total participation lasts about three months with additional follow-up for responders to monitor long-term outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-confirmed squamous cell carcinoma lesion on the lower extremities between 1.0 cm and 2.0 cm in diameter
  • Expected survival of at least 12 months
  • Not currently receiving any other investigational drug or device treatment
  • Willing to follow study instructions and sign informed consent
  • Age 18 years or older at time of consent
  • Performance status of 0 or 1 on the ECOG scale
  • For women of childbearing potential, negative pregnancy test within 7 days before first study medication dose
  • Willingness to use effective contraception or abstain from heterosexual activity during the study and 120 days after last dose (for applicable participants)
Not Eligible

You will not qualify if you...

  • Evidence of lymph node involvement or metastatic disease
  • Non-cutaneous squamous cell carcinoma (e.g., nasopharyngeal SCC)
  • History of organ transplantation
  • History of systemic immunosuppression
  • Skin or other disorders requiring topical steroids or creams
  • Active infections requiring systemic therapy (e.g., hepatitis B/C, HIV)
  • Known autoimmune diseases
  • Certain heart conditions including prolonged QT interval or heart failure with reduced ejection fraction
  • Recent chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to study
  • Unrecovered side effects from prior cancer therapies except mild neuropathy
  • Recent major surgery without adequate recovery
  • Participation in other investigational studies within 4 weeks prior to study
  • Need for other systemic or localized anti-cancer treatment during study
  • History of certain cancers unless disease-free for 5 years or successfully treated in situ cancers
  • Severe hypersensitivity to 5-fluorouracil or imiquimod
  • Serious illnesses like uncontrolled cardiovascular disease, bleeding disorders, autoimmune diseases, severe lung diseases, active systemic infections, or inflammatory bowel disorders
  • Conditions or treatments that might interfere with study participation or results
  • Current or recent (within 1 year) illicit drug or alcohol abuse
  • Pregnancy, breastfeeding, or planning to conceive or father children during study period and follow-up timeframe after last dose of study drug (120 days)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 3 months

Participants receive intralesional injections of 5-fluorouracil once a month for 3 months. Participants in one group also apply topical calcipotriene cream to the lesion twice daily for four days after each injection. Control participants receive standard care without these treatments.

3 monthly injections visits and 1 biopsy visit after last injection

Follow-up

Duration - 2 years

Participants with negative biopsy results have clinical follow-up visits every 6 months for 2 years to monitor health. Participants with positive biopsy results undergo Mohs surgery 2 to 4 weeks after biopsy.

Clinical follow-up visits every 6 months

Trial Site Locations

Total: 1 location

1

St. Margaret Hospital Dermatology

Pittsburgh, Pennsylvania, United States, 15238

Actively Recruiting

Loading map...

Research Team

M

Melissa Pugliano-Mauro, MD

J

Jeff Plowey, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

A Randomized, Multicenter, Prospective, Controlled Clinical ...

Carcinoma, Squamous Cell

Actively Recruiting

1 location

An Open, Single Arm, Multicenter, Exploratory Phase II Clini...

Esophageal Squamous Cell Carcinoma

Actively Recruiting

1 location

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and N...

Head and Neck Neoplasm

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Eruptive postoperative squamous cell carcinomas exhibiting a pathergy-like reaction around surgical wound sites.

Suleman J Bangash, W Harris Green, David J Dolson...

https://pubmed.ncbi.nlm.nih.gov/19766351

Intratumoral chemotherapy with fluorouracil/epinephrine injectable gel: a nonsurgical treatment of cutaneous squamous cell carcinoma.

S Kraus, B H Miller, J M Swinehart...

https://pubmed.ncbi.nlm.nih.gov/9520026