5-Fluorouracil + Imiquimod for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drug treatment or require systemic or localized cancer therapy while participating in the study.
Is the combination of 5-fluorouracil and imiquimod safe for treating skin conditions?
How is the drug 5-Fluorouracil + Imiquimod unique for treating skin cancer?
What data supports the effectiveness of the drug 5-Fluorouracil + Imiquimod for skin cancer?
Research shows that 5-fluorouracil and imiquimod are effective in treating early skin cancers like actinic keratosis and basal cell carcinoma. They are also used together to treat actinic damage and have shown potential in treating complex skin conditions, suggesting their combined use may be beneficial for skin cancer.2671011
Who Is on the Research Team?
Melissa Pugliano-Mauro, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults with biopsy-confirmed squamous cell carcinoma (SCC) on the lower legs, who are expected to live more than a year and have good performance status. They must not be on other investigational treatments or have had cancer therapy within four weeks. Women of childbearing potential must test negative for pregnancy and use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly intralesional injections of 5-fluorouracil (5FU) for 3 weeks, with a subset also receiving topical imiquimod
Surgical Resection
Lesions are surgically resected to render patients disease-free
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 5-fluorouracil
- Imiquimod 5% cream
5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:
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Who Is Running the Clinical Trial?
Melissa Pugliano-Mauro
Lead Sponsor
National Cancer Institute (NCI)
Collaborator