Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

Overview

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.

Full Title of Study: “Phase II Topical Immunomodulatory Therapy With Imiquimod for the Chemoprevention of Recurrent and High-Grade Cervical Intraepithelial Neoplasia (CIN)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2004

Detailed Description

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.

Interventions

  • Drug: imiquimod
  • Procedure: Ablative or excisional therapy

Arms, Groups and Cohorts

  • Other: Ablative or excisional therapy
    • Patients undergo ablative or excisional therapy. Quality of life is assessed at baseline, 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.
  • Experimental: Ablative or excisional therapy + imiquimod
    • 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, 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: Up to 7.5 years

Secondary Measures

  • Compare the quality of life of patients treated with these regimens
    • Time Frame: Up to 7.5 years

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary grade II or III cervical intraepithelial neoplasia (CIN) or persistent grade I-III CIN (dysplasia that is not new and requires treatment)
  • Squamous cell lesions not involving endocervix by colposcopy OR colposcopy with negative cytobrush or endocervical curettage
  • No untreated cervical or vaginal infection other than human papilloma virus
  • No desire for hysterectomy as ablative therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Life expectancy:

  • At least 5 years

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study
  • HIV negative
  • No AIDS
  • No known hypersensitivity to imiquimod
  • No latex allergy

PRIOR CONCURRENT THERAPY:

Other:

  • No concurrent immunosuppressive therapy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alliance for Clinical Trials in Oncology
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bobbie S. Gostout, MD, Study Chair, Mayo Clinic

Citations Reporting on Results

Pachman DR, Barton DL, Clayton AC, McGovern RM, Jefferies JA, Novotny PJ, Sloan JA, Loprinzi CL, Gostout BS. Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia. Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.

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