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Immunomodulator

Topical Fluorouracil + Imiquimod for Cervical Dysplasia

Phase < 1

Waitlist Available

Led By Lisa Rahangdale

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky >= 70%

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to up to end of study visit (4-6 weeks after last agent application)

Awards & highlights

Study Summary

This trial is testing a new way to treat precancerous cervical lesions with two drugs. The drugs are applied topically, and this may cause fewer side effects than other treatments.

Who is the study for?

This trial is for women with high-grade cervical lesions confirmed by biopsy, who are not HIV positive and do not have other infections. They must be able to understand the consent form and agree to use effective contraception. Women who've had a hysterectomy, previous treatments for these lesions, or are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The trial tests topical Fluorouracil and Imiquimod ointments on patients with precancerous cervical lesions. It aims to see if this treatment has fewer side effects compared to others while being an effective way of treating these high-grade cervical intraepithelial neoplasias.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the application site, immune system reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders such as low white cell counts which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of study visit (4-6 weeks after the last agent application)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of study visit (4-6 weeks after the last agent application)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of study visit (4-6 weeks after the last agent application) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions.

Secondary outcome measures

Change in Expression of Biomarkers of Local Immune Activation After Treatment With Self-administered Intravaginal Topical Fluorouracil and Imiquimod

Response to Intravaginal 5-FU and Imiquimod Defined as Histologic Regression and Clearance of High-risk Human Papilloma Virus (HR-HPV)

Type Specific Human Papillomavirus (HPV) Clearance

Side effects data

From 2014 Phase 3 trial • 467 Patients • NCT02120898

Nasopharyngitis

Sinusitis

Squamous cell carcinoma of skin

Upper respiratory tract infection

Hip fracture

Orthostatic hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Vehicle Cream

Generic Imiquimod Cream 2.5%

Zyclara® (Imiquimod) Cream 2.5%

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (topical fluorouracil, imiquimod)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imiquimod

2005

Completed Phase 4

~2260

0 / 1Eligibility criteria met