RECRUITING

Combination 5-FU / Calcipotriene Cream for SCCIS/SCC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will determine if calcipotriene and 5-fluorouracil (5-FU) creams when combined can treat SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC). 30 Patients will be divided into a 7 day treatment group (n=10), a 14 day treatment group (n=10), and a placebo group (n=10, divided into 7 and 14 days evenly). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives.

Official Title

Combination Topical 5-fluorouracil 5% / Calcipotriene 0.005% Cream for Treatment of in Situ and Superficially Invasive Squamous Cell Carcinoma of the Skin

Quick Facts

Study Start:2021-04-14
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04839731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recruited patients will be limited to those with a biopsy-proven in situ or superficially invasive (does not invade past the papillary dermis) squamous cell carcinoma of the skin of the low risk or "L" areas. The tumor must measure 1.0-2.0cm in longest diameter dimension. Tumors must lack induration and/or nodularity. The tumor must also demonstrate positive margins on review of the original biopsy pathology (biopsy must be partial; there must be residual tumor that requires further treatment).
  2. * Patient has capacity to provide consent
  1. * Immunocompromise or immunosuppression.
  2. * Contraindication to surgical excision.
  3. * Contraindication to use of topical medication(s) (e.g., history of allergic contact dermatitis to topical 5-fluorouracil)
  4. * Currently pregant, concerned could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by birth control method (5-Fluorouracil is pregnancy category X)
  5. * Tumor is recurrent

Contacts and Locations

Study Contact

Kiley K Fagan, MD
CONTACT
5402245170
kkfagan@carilionclinic.org
Mariana Phillips, MD
CONTACT
5405810170
maphillips@carilionclinic.org

Principal Investigator

Mariana Phillips, MD
PRINCIPAL_INVESTIGATOR
Carilion Clinic Dermatology

Study Locations (Sites)

Carilion Clinic Dermatology and Mohs Surgery
Roanoke, Virginia, 24016
United States

Collaborators and Investigators

Sponsor: Carilion Clinic

  • Mariana Phillips, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic Dermatology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-14
Study Completion Date2023-12

Study Record Updates

Study Start Date2021-04-14
Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

  • Calcipotriene
  • Fluorouracil
  • Squamous cell carcinoma

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma