Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

NCT02130323 | Completed Phase 2 FDA Drug

• 1 other identifier: NMCSD.2014.0040
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical intraepithelial neoplasia, Imiquimod

Outcome Measures

Primary Outcomes (1)

• Human Papillomavirus(HPV) Clearance

  HPV clearance will be determined by pathology and HPV testing, followed by colposcopy. Descriptive statistics will include numbers and rates of occurrence with confidence intervals of regression, pre and post-treatment HPV including Human Papillomavirus type 16 (HPV16) and HPV 18/45 typing, and adverse effects. A non-inferiority type design is used in which the difference between treatments is defined as medical treatment being preferable if the regression rate is not more than 10% below that of the excisional treatment. Comparison of the regression rates of the two treatments will be made by a non-inferiority Fisher's exact test.

  6 months from treatment initiation

Secondary Outcomes (3)

• Evidence of local or systemic side effects of Imiquimod cream

  Every 4 weeks after initiation of Imiquimod Arm for 16 weeks

• Evidence of local or systemic side effects of Imiquimod cream

  Daily after initiation of Imiquimod treatment Arm, up to 6 months after study initiation

• Number of Participants with Serious and Non-Serious Adverse Events

  Up to 6 months after study initiation

Study Arms (2)

Loop Electrosurgical Excision Procedure

ACTIVE COMPARATOR

Excision of the cervical transformation zone by way of the loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC).

Procedure: Loop Electrosurgical Excision Procedure

Imiquimod

EXPERIMENTAL

Imiquimod 12.5mg intravaginally once weekly for 16 weeks

Drug: Imiquimod

Interventions

Imiquimod DRUG

12.5mg (5%) once a week vaginally for 16 weeks

Also known as: Aldara

Imiquimod

Loop Electrosurgical Excision Procedure PROCEDURE

Patients with CIN 2-3 will be randomized to receive intervention, CKC or LEEP versus medical therapy with Imiquimod.

Also known as: LEEP

Loop Electrosurgical Excision Procedure

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women older than age 21, military or civilian
• Negative pregnancy test results
• Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix.
• The patient will be available and in the San Diego area for 6 months after enrollment to complete the clinic visits and follow up.

You may not qualify if:

• Positive CIN 2-3 on ECC
• Presence of cancer
• Pregnancy or lactation
• Immuno-compromised (systemic lupus erythematosus, kidney transplant)
• Hepatitis
• Hypersensitivity to Imiquimod
• Ulcerative colitis
• Crohn's disease
• Human Immunodeficiency virus

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134-5000, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Addie N Alkhas, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 5, 2014
• Study Start: February 1, 2015
• Primary Completion: December 21, 2016
• Study Completion: May 9, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)