Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia
NCT ID: NCT05505539
Last Updated: 2022-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2022-09-30
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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5-fluorouracil
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.
5-fluorouracil
Given intralesionally by injection
Interventions
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5-fluorouracil
Given intralesionally by injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kyle Jones, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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22-36039
Identifier Type: OTHER
Identifier Source: secondary_id
OL_5FU
Identifier Type: -
Identifier Source: org_study_id
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