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

May 7, 2018 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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.
Procedure: biopsy
Punch biopsy and photography will be performed at the baseline and 12 week time points.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical and Histologic Remission
Time Frame: 12 weeks post treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
Ohio State University

Investigators

  • Principal Investigator: Dennis S. Chi, MD, FACOG, FACS, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Robert Soslow, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2007

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-029
  • MSKCC-07029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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