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

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Brief Title

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

Official Title

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

Brief Summary

      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

      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


Primary Outcome

Percentage of Participants With Clinical and Histologic Remission


Condition

Vulvar Cancer

Intervention

imiquimod

Study Arms / Comparison Groups

 imiquimod
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

April 2007

Completion Date

January 2018

Primary Completion Date

January 2018

Eligibility Criteria

        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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dennis S. Chi, MD, FACOG, FACS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00504023

Organization ID

07-029

Secondary IDs

MSKCC-07029

Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Dennis S. Chi, MD, FACOG, FACS, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

February 2018