Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031759
• Other study ID #: NCCTG-989251
• Secondary ID: CDR0000069223NCI
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2002
• Last updated: July 12, 2016
• Start date: June 1999
• Est. completion date: February 2010

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2010
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Drug:
• imiquimod

Procedure:
• Ablative or excisional therapy

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.aj — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 7.5 years	No
Secondary	Compare the quality of life of patients treated with these regimens		Up to 7.5 years	No