NCT03196180

Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia

A Feasibility Trial of Alternating Intravaginal Application of 5-Fluorouracil and Imiquimod for Treatment of High-Grade Cervical Squamous Intraepithelial Lesions

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This early phase I clinical trial studies the side effects of topical fluorouracil and imiquimod ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system. Applying topical fluorouracil and imiquimod ointment may cause fewer side effects and may be a better way to treat patients with precancerous cervical lesions.

Detailed description

PRIMARY OBJECTIVE: I. Assess feasibility, evaluated based on safety and tolerability, of a combination agent intervention (once-weekly self-administered intravaginal application of 5-fluorouracil alternating with once-weekly provider-applied imiquimod) for treatment of high-grade cervical squamous intraepithelial lesions. SECONDARY OBJECTIVES: I. Assess efficacy of the combination agent intervention on cervical disease regression (endpoint based on histologic regression from high-grade lesions to low-grade or no lesions and clearance of high risk-human papillomavirus \[HPV\] detection) between baseline and study exit visits. II. Assess efficacy of the combination agent intervention on genotype-specific HPV clearance between baseline and study exit visits. III. Assess efficacy of the combination agent intervention on biomarkers of local immune activation (measurement of changes in expression of Toll-like receptors (TLR) and T-regulatory cells and the levels of innate, immune mediating and proinflammatory cytokines with intravaginal 5-fluorouracil \[FU\] and imiquimod) between baseline and study exit visits. OUTLINE: This is a phase I, dose escalation study of imiquimod. Patients receive topical fluorouracil intravaginally via applicator at weeks 1, 3, 5, 7, 9, 11, 13, and 15 and imiquimod intravaginally via applicator at weeks 2, 4, 6, 8, 10, 12, 14, and 16. Patients who are menstruating will delay application until the end of the menstrual cycle. After completion of study treatment, patients are followed up within 8 months.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3
• Cervical Squamous Cell Carcinoma In Situ
• Cervical Squamous Intraepithelial Neoplasia 2
• High Grade Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Imiquimod	Given intravaginally
DRUG	Topical Fluorouracil	Given intravaginally

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-11-04
• Completion: 2024-08-02
• First posted: 2017-06-22
• Last updated: 2025-04-08
• Results posted: 2022-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study