Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia (OL_5FU)

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 1

Conditions: Oral Leukoplakia

Treatments: Drug: 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT05505539

OL_5FU

22-36039 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

5-fluorouracil

Experimental group

Description:

Participants will receive up to 3 intralesional 5-fluorouracil injections (0.25 mL of a 50mg/mL solution) once every 2 weeks into an oral leukoplakia lesion.

Treatment:

Drug: 5-fluorouracil