Trial Information

A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease

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.