Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Francisco
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
