Principal Investigator no longer with university.

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).

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of intralesional 5-fluorouracil (5-FU) injection for the treatment of oral leukoplakia

SECONDARY OBJECTIVE:

I. Evaluate the safety profile and side effects of the study drug.

OUTLINE:

Participants diagnosed with OL will receive multiple intralesional injections of 5-FU solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.

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