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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vulvar Cancer

Intervention / Treatment
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* Drug: imiquimod
* Procedure: biopsy
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imiquimod<br>This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD). | Drug: imiquimod<br>* The patient will be seen in clinic every six weeks during treatment for examination. Imiquimod cream is to be applied 3 times per week for 12 weeks.<br>Procedure: biopsy<br>* Punch biopsy and photography will be performed at the baseline and 12 week time points.<br>Procedure: therapeutic conventional surgery<br>* If the lesion is still present after 12 weeks of therapy, the treating physician will recommend excision of the lesion four weeks after completion of therapy (week 16).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical and Histologic Remission | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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imiquimod, Paget disease of the vulva, recurrent vulvar cancer, stage 0 vulvar cancer, stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, 07-029