Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• Adults, 18 years of age or older

• Any gender, race, or ethnicity

• Clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade)

• Oral leukoplakia at least 1 cm in largest diameter

• Ability to understand and willingness to sign a written informed consent document

• Willingness to provide blood and tissue from diagnostic biopsies

• Any smoking history is permitted

Exclusion Criteria:

• Pregnant or lactating women

• Men and women unwilling to use contraception while on study

• History of malignancy that required cytotoxic chemotherapy within the previous 3 months

• Use of 5-FU (systemic or topical) within 3 months prior to study enrollment

• History of allergic reaction or severe hypersensitivity to 5-FU and/or lidocaine

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data