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

18 Years
Open (Enrolling)
Vulvar Cancer

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Trial Information

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


- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical and histologic effects

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dennis S. Chi, MD, FACOG, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

April 2014

Related Keywords:

  • Vulvar Cancer
  • Paget disease of the vulva
  • recurrent vulvar cancer
  • stage 0 vulvar cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • imiquimod
  • 07-029
  • Paget Disease, Extramammary
  • Vulvar Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240