Topical Imiquimod 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.