What side effects are associated with this type of intervention?

The most common side effects of 5-Fluorouracil when used for treating Basal Cell Carcinoma include local skin reactions such as redness, irritation, burning sensation, and inflammation at the application site. Prolonged use can lead to more severe skin reactions like ulceration and scarring. Calcipotriene, when used in combination, can cause similar local skin reactions, including itching, dryness, and erythema. Systemic side effects are rare due to the topical application of these treatments.

What prior FDA approvals exist?

5-Fluorouracil (5-FU) cream is FDA-approved for the treatment of superficial basal cell carcinoma (sBCC). It works by inhibiting DNA synthesis in cancer cells, leading to cell death. The combination of 5-Fluorouracil with Calcipotriene, which modulates cell differentiation and proliferation, is being studied for its potential to treat low-risk skin cancers, including sBCC. This combination has shown promise in clearing pre-cancerous lesions and preventing future skin cancers, offering a potentially shorter treatment course compared to 5-FU alone.

What other types of research exist?

Promising novel alternatives to 5-Fluorouracil and Calcipotriene Cream for Basal Cell Carcinoma patients include: 1) PAC-14028 cream, a TRPV1 antagonist, which has shown safety and efficacy in preclinical studies without increasing the risk of tumorigenesis. 2) Peldesine (BCX-34) cream, a purine nucleoside phosphorylase inhibitor, which is being evaluated for its efficacy in treating cutaneous T-cell lymphoma and may have potential applications in BCC. These alternatives are in various stages of research and may offer new therapeutic options for BCC patients by 2024.

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Anti-metabolites

5-Fluorouracil + Calcipotriene Cream for Skin Cancer

Q: What is the mechanism of action of this treatment?

5-Fluorouracil (5-FU) works by inhibiting DNA synthesis in cancer cells, leading to cell death, which is particularly effective in rapidly dividing cells like those in Basal Cell Carcinoma (BCC). Calcipotriene, a synthetic vitamin D derivative, modulates cell differentiation and proliferation, normalizing skin cell growth and enhancing the effectiveness of 5-FU. These mechanisms are crucial for BCC patients as they target cancerous cells specifically, aiming to minimize damage to healthy tissue.

Phase 2 & 3

Recruiting

Led By Bilal Fawaz, MD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates

Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia

Must not have

Periorbital lesions

Genetic disorders associated with high skin cancer risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial compares a standard cancer-killing cream with a new, potentially more effective cream. It targets patients with less aggressive skin cancers. The new cream might work better by combining two ingredients to kill cancer cells and prevent new ones from forming.

Who is the study for?

This trial is for English-speaking adults with low-risk skin cancers (sBCC or SCCis) on certain body parts, who haven't had treatment yet and aren't good candidates for surgery. They must be willing to follow the study plan and attend follow-ups. Women of childbearing age need a negative pregnancy test before starting and must use birth control during the study.

What is being tested?

The trial compares two creams: one with just 5-fluorouracil, an FDA-approved treatment, against a mix of 5-fluorouracil and calcipotriene. The goal is to see if the combo cream can clear cancer in a shorter time (7-14 days). Participants will be checked over three years to see if their skin cancer has been treated successfully.

What are the potential side effects?

Possible side effects include skin irritation, redness, burning sensation where the cream is applied, increased sensitivity to sunlight leading to sunburns more easily than usual, changes in skin color at the application site, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a skin cancer diagnosis on sensitive areas and cannot or do not wish to undergo surgery.

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I have a skin cancer diagnosis that hasn't been treated and is smaller than 2 cm, not on my hands, feet, or private areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lesions around my eye area.

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I have a genetic condition that increases my risk for skin cancer.

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I have been diagnosed with cutaneous T-cell lymphoma.

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I have had treatments on my lesions before.

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I am not pregnant or breastfeeding.

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I have a deficiency in the DPD enzyme.

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My condition affects the mouth, nose, or genital areas.

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I have been exposed to arsenic.

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I have had an organ transplant or am currently on immunosuppressants.

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I have had radiation therapy on the skin cancer area.

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I have had PUVA therapy at the affected site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clearance rate of cancer lesions at 3 months

Clearance rate of cancer lesions at 3 years

Secondary study objectives

Day of worst redness

Participant compliance with treatment

Participant satisfaction with treatment

+9 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Combination cream of 5-fluorouracil and calcipotrieneExperimental Treatment1 Intervention

Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

Group II: 5-fluorouracil creamActive Control1 Intervention

Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

5-Fluorouracil (5-FU) works by inhibiting DNA synthesis in cancer cells, leading to cell death, which is particularly effective in rapidly dividing cells like those in Basal Cell Carcinoma (BCC). Calcipotriene, a synthetic vitamin D derivative, modulates cell differentiation and proliferation, normalizing skin cell growth and enhancing the effectiveness of 5-FU. These mechanisms are crucial for BCC patients as they target cancerous cells specifically, aiming to minimize damage to healthy tissue.

Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy.