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

Launched by BOSTON UNIVERSITY · May 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different creams to treat low-risk skin cancers, specifically superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). One cream is a well-known treatment called 5-fluorouracil, while the other is a new combination cream that mixes 5-fluorouracil with calcipotriene. Researchers want to see if this new cream, applied for a shorter time of 7 to 14 days, is just as effective as the standard treatment, which lasts for four weeks. Participants will be monitored for three years to check if the cancer has cleared and to ensure their safety.

To join the study, participants must be English-speaking adults aged 65 to 74 with untreated skin cancers that are less than 2 cm in size. They can have multiple lesions, but they need to be spaced apart. Those who are pregnant or breastfeeding, or have had recent treatments near the cancer site, are not eligible. Throughout the study, participants will attend regular follow-up visits to track their progress. This trial aims to find a potentially quicker and effective treatment option for these types of skin cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • English-speaking
• • 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
• • 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
• • Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
• • Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
• • 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.
• Exclusion Criteria:
• • Current or prior field treatment within 2 cm of the target BCC or SCCis
• • Periorbital lesions
• • Lesions that have been previously treated
• • Known allergy to any of the study medication ingredients
• • History of solid organ transplant or current immunosuppression
• • Genetic disorders associated with high skin cancer risk
• • Arsenic exposure
• • Cutaneous T-cell lymphoma
• • Current or prior radiation therapy at the site of the sBCC or SCCis
• • Women who are pregnant or currently breastfeeding
• • Prior psoralen plus Ultraviolet light (UVA) treatment at the site
• • Very high mortality risk at the start of the study
• • Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
• • Demonstrated hypercalcemia or evidence of vitamin D toxicity
• • Lesions that extend into the oral, nasal or genital mucosa