Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of participants s who complete 5-FU injections
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Proportion of participants s who complete 5-FU injections
时间窗: Up to 6 weeks
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.
Number of participants with treatment-related adverse events
时间窗: Up to 3 months
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
次要结局
- Proportion of participants with a change in histologic grade(Up to 3 months)
- Change in area of clinically visible oral leukoplakia lesions(Up to 3 months)
- Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)(Up to 3 months)