Trial Information

Phase II Topical Immunomodulatory Therapy With Imiquimod for the Chemoprevention of Recurrent and High-Grade Cervical Intraepithelial Neoplasia (CIN)

OBJECTIVES:

- Compare the chemopreventive efficacy of topical imiquimod followed by local ablative or
excisional therapy vs ablative/excisional therapy alone in patients with recurrent or
high-grade cervical intraepithelial neoplasia.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

- Determine the safety and tolerability of imiquimod in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, disease (primary vs recurrent or persistent), severity of dysplasia
(grade I vs grade II vs grade III), current tobacco use (yes vs no), planned surgical
procedure (excisional vs laser vs cryotherapy vs other), and time since first abnormal Pap
smear, including pathology of ascus favor dysplasia (less than 1 year vs 1-3 years vs more
than 3 years). Patients are randomized to one of two treatment arms.

- Arm I: Patients undergo ablative or excisional therapy.

- Arm II: Patients have topical imiquimod applied to the cervix for 6-10 hours twice
weekly for a total of 5 doses. Within 3-4 weeks after the final application, patients
undergo ablative or excisional therapy.

Quality of life is assessed at baseline, after last dose of study drug (arm II only), 3-5
days after ablation or excisional therapy, at 3 months, and then annually thereafter.

Patients are followed every 3-4 months until 2 consecutive normal Pap smears or colposcopic
exams, every 6 months for 2 years, and then annually until 5 years after completion of study
therapy.

PROJECTED ACCRUAL: A total of 66-152 (33-76 per treatment arm) will be accrued for this
study within 18 months.