ClinicalTrials.Veeva

Menu

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

University of California San Francisco (UCSF) logo

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Withdrawn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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems