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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2018-01-31

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.

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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.

Conditions

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Vulvar Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imiquimod

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

Group Type EXPERIMENTAL

imiquimod

Intervention Type DRUG

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.

biopsy

Intervention Type PROCEDURE

Punch biopsy and photography will be performed at the baseline and 12 week time points.

therapeutic conventional surgery

Intervention Type PROCEDURE

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).

Interventions

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imiquimod

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.

Intervention Type DRUG

biopsy

Punch biopsy and photography will be performed at the baseline and 12 week time points.

Intervention Type PROCEDURE

therapeutic conventional surgery

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).

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No