Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	18 and over	NCI	NCCTG-989251 NCI-P02-0208, NCT00031759

Objectives

1. 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.
2. Compare the toxicity of these regimens in these patients.
3. Compare the quality of life of patients treated with these regimens.
4. Determine the safety and tolerability of imiquimod in these patients.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• No concurrent immunosuppressive therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• At least 5 years

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Bobbie Gostout, MD, Protocol chair		Ph: 507-266-8685

Registry Information
Official Title		Phase II Topical Immunomodulatory Therapy with Imiquimod for the Chemoprevention of Recurrent and High-Grade Cervical Intraepithelial Neoplasia (CIN)
Trial Start Date		1999-06-22
Trial Completion Date		2004-07-02
Registered in ClinicalTrials.gov		NCT00031759
Date Submitted to PDQ		2002-01-14
Information Last Verified		2004-04-29
NCI Grant/Contract Number		CA31946

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