30 Participants Needed

5-Fluorouracil + Imiquimod for Skin Cancer

MP
JP
Overseen ByJeff Plowey, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

5-fluorouracil (5-FU) and imiquimod creams are generally safe but can cause skin reactions like redness, pain, and crusting. These treatments often lead to an inflammatory response, which is a normal part of the process, but can be uncomfortable.12345

How is the drug 5-Fluorouracil + Imiquimod unique for treating skin cancer?

The combination of 5-fluorouracil and imiquimod is unique because it uses two topical creams that work together to enhance their antitumor effects, potentially offering a more effective treatment for skin cancer compared to using each drug alone.26789

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?

MP

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

I have a skin cancer spot between 1.0 and 2.0 cm on my leg below the knee.
Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study
I am fully active or restricted in physically strenuous activity but can do light work.
See 4 more

Exclusion Criteria

I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.
I have fully recovered from any major surgery before starting treatment.
I use topical steroids or creams for a skin condition as advised by my doctor.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly intralesional injections of 5-fluorouracil (5FU) for 3 weeks, with a subset also receiving topical imiquimod

3 weeks
3 visits (in-person)

Surgical Resection

Lesions are surgically resected to render patients disease-free

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 5-fluorouracil
  • Imiquimod 5% cream
Trial Overview The study tests injecting a chemotherapy drug called 5-fluorouracil (5FU) directly into SCC tumors in the lower extremities, with or without an additional topical cream called imiquimod. The aim is to assess safety, tolerability, and how well the tumor responds three weeks post-treatment.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: 5FU GroupExperimental Treatment1 Intervention
Group II: 5FU + 0.005% Calcipotriene cream GroupExperimental Treatment2 Interventions
Group III: Control GroupActive Control1 Intervention

5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as 5-FU for:
🇪🇺
Approved in European Union as 5-FU for:
🇨🇦
Approved in Canada as 5-FU for:
🇯🇵
Approved in Japan as 5-FU for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Melissa Pugliano-Mauro

Lead Sponsor

Trials
3
Recruited
90+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Topical 5-fluorouracil (5-FU) is effective for treating actinic keratosis and early skin cancers, as demonstrated in a patient with diffuse actinic damage who showed no inflammatory response in previously treated basal cell carcinoma (BCC) areas.
Imiquimod, used 10 years prior for the BCC, not only targets atypical keratinocytes but may also provide photoprotective effects, suggesting a long-term benefit in preventing inflammation and further skin damage.
Imiquimod induces sustained remission of actinic damage: a case report spanning one decade of observation.Knackstedt, TJ., Quitadamo, M.[2018]
In a study of 30 elderly patients with complex eyelid basal cell carcinomas (BCCs) who were unfit for surgery, both imiquimod 5% and fluorouracil 1% creams showed promising long-term efficacy, with complete tumor resolution in 10 patients using imiquimod and 8 patients using fluorouracil after 12 to 16.5 weeks.
While imiquimod was associated with more side effects like skin erythema and chemical conjunctivitis, fluorouracil had a more tolerable side-effect profile, suggesting that both treatments can be effective alternatives to surgery for patients with significant co-morbidities.
Long-term efficacy and safety of imiquimod 5% and fluorouracil 1% creams in medical monotherapy of complex eyelid basal cell carcinomas.Singh, M., Mehta Grewal, A., Singh, H., et al.[2022]
In a study involving 5700 subjects, 5-fluorouracil was found to significantly reduce the overall risk of developing keratinocyte carcinoma compared to imiquimod, with an adjusted hazard ratio of 0.86.
Despite the overall effectiveness of 5-fluorouracil, there were no significant differences in the risk of specific types of keratinocyte carcinoma (squamous or basal cell) or in the cumulative risk over 2 and 5 years between the two treatments.
Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: A cohort study.Neugebauer, R., Su, KA., Zhu, Z., et al.[2020]

Citations

Imiquimod induces sustained remission of actinic damage: a case report spanning one decade of observation. [2018]
Long-term efficacy and safety of imiquimod 5% and fluorouracil 1% creams in medical monotherapy of complex eyelid basal cell carcinomas. [2022]
Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: A cohort study. [2020]
Topical treatment of cutaneous metastases of malignant melanoma using combined imiquimod and 5-fluorouracil. [2022]
The treatment of actinic keratoses with a combination of 5-fluorouracil and imiquimod creams. [2018]
Measuring the severity of topical 5-fluorouracil toxicity. [2017]
Inflammation of solar keratoses following systemic 5-fluorouracil. [2013]
Topical Application of 5-Fluorouracil Associated with Distant Seborrheic Dermatitis-like Eruption: Case Report and Review of Seborrheic Dermatitis Cutaneous Reactions after Systemic or Topical Treatment with 5-Fluorouracil. [2020]
Topical 5-fluorouracil in dermatologic disease. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
A real-world, community-based cohort study comparing the effectiveness of topical fluorouracil versus topical imiquimod for the treatment of actinic keratosis. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Cisplatin and 5-fluorouracil for advanced locoregional and metastatic squamous cell carcinoma of the skin. [2022]
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