Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia

Oral Leukoplakia Clinical Trial

— OL_5FU  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05505539
• Other study ID #: OL_5FU
• Secondary ID: 22-36039
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukoplakia
• Leukoplakia, Oral
• Oral Leukoplakia

Intervention

Drug:
• 5-fluorouracil
Given intralesionally by injection

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants s who complete 5-FU injections	The number of participants who completed the full course of 3 intralesional injections will be compared to the overall total of participants. If the the mucosa becomes ulcerated or participants are unable/unwilling to continue with therapy, 5FU injections will be stopped.	Up to 6 weeks
Primary	Number of participants with treatment-related adverse events	The number of participants with documented treatment-related adverse events classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported	Up to 3 months
Secondary	Change in area of clinically visible oral leukoplakia lesions	The total change in area (measured to nearest millimeter (mm) of clinically visible oral leukoplakia lesion will be defined by the product of the two largest perpendicular measurements. The two largest perpendicular measurements of the treated oral leukoplakia lesion will be measured and multiplied to calculate the lesion area at baseline and again at 3 months.	Up to 3 months
Secondary	Proportion of participants with a change in histologic grade	A board-certified oral and maxillofacial pathologist will review biopsy specimens obtained from the treated oral leukoplakia before and after treatment with 5FU and determine change in histologic grade from baseline.	Up to 3 months
Secondary	Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)	The oral mucosal diseases quality of life questionnaire (COMD-QLQ) is a validated instrument that will assesses the effect that oral leukoplakia has on participants' daily life activities before and after 5-FU intralesional therapy. The survey consists of 24 questions with five response options per item. The response for each item is coded from 0 to 4 with "not at all=0" and "extremely=4" (at time of scoring, for 3 questions, the Likert scale is reversed). The summary of the overall score ranges from 0 to 104, with a higher score indicating a poorer patient-assessed quality of life score.	Up to 3 months