RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may be an effective treatment for recurrent Paget's disease.

PURPOSE: This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Paget's disease of the vulva.

OBJECTIVES:

• To assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease.

OUTLINE: This is a pilot, prospective, multicenter study.

Patients apply topical imiquimod cream to a target vulvar lesion 3 times weekly. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. If the lesion is still present after completion of 12 weeks of imiquimod therapy, the patient undergoes surgical excision of the target lesion (and any other progressive lesions suspicious for evolving adenocarcinoma) at week 16.

Patients undergo punch biopsy and photographic assessment of a target vulvar lesion at baseline and again at 12 weeks.

After completion of imiquimod therapy or after surgical excision, patients are followed at 6 weeks and then every 3 months for at least 2 years.

Inclusion Criteria:

All patients presenting to the Gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. The eligibility requirements are as follows:

• Age ≥18.
• Ability to give informed consent.
• Patients must have biopsy proven recurrent extramammary Paget's disease confirmed at the participating site.

Exclusion Criteria:

• Patients with known hypersensitivity to imiquimod.
• Pregnant and nursing women are not eligible
• Patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.

2 years