RECRUITING

5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

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 investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.

Official Title

Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ

Quick Facts

Study Start:2022-10-15
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05381597

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking
  2. * 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
  3. * 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
  4. * Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
  5. * Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
  6. * If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.
  1. * Current or prior field treatment within 2 cm of the target BCC or SCCis
  2. * Periorbital lesions
  3. * Lesions that have been previously treated
  4. * Known allergy to any of the study medication ingredients
  5. * History of solid organ transplant or current immunosuppression
  6. * Genetic disorders associated with high skin cancer risk
  7. * Arsenic exposure
  8. * Cutaneous T-cell lymphoma
  9. * Current or prior radiation therapy at the site of the sBCC or SCCis
  10. * Women who are pregnant or currently breastfeeding
  11. * Prior psoralen plus Ultraviolet light (UVA) treatment at the site
  12. * Very high mortality risk at the start of the study
  13. * Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  14. * Demonstrated hypercalcemia or evidence of vitamin D toxicity
  15. * Lesions that extend into the oral, nasal or genital mucosa

Contacts and Locations

Study Contact

Frederick Gibson, MD
CONTACT
(617) 358-9700
frederick.gibson@bmc.org
Alexandria Riopelle, MD
CONTACT
(617) 358-9700
alexandria.riopelle@bmc.org

Principal Investigator

Bilal Fawaz, MD
PRINCIPAL_INVESTIGATOR
Dermatology, Boston University School of Medicine

Study Locations (Sites)

Boston Medical Center Dermatology Clinic
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Bilal Fawaz, MD, PRINCIPAL_INVESTIGATOR, Dermatology, Boston University School of Medicine

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 Date2022-10-15
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-10-15
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • 5-fluorouracil cream
  • fluorouracil with calcipotriene

Additional Relevant MeSH Terms

  • Superficial Basal Cell Carcinoma
  • Squamous Cell Carcinoma in Situ