Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imiquimod

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

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