Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Vulvar Cancer

Treatments: Procedure: biopsy; Procedure: therapeutic conventional surgery; Drug: imiquimod

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00504023

MSKCC-07029

07-029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

imiquimod

Experimental group

Description:

This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).

Treatment:

Procedure: biopsy

Procedure: therapeutic conventional surgery

Drug: imiquimod