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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504023
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : May 8, 2018
Last Update Posted : June 6, 2018
National Cancer Institute (NCI)
Ohio State University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Vulvar Cancer Drug: imiquimod Procedure: biopsy Procedure: therapeutic conventional surgery Not Applicable

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease
Actual Study Start Date : April 2007
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

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).

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504023

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Ohio State University
Principal Investigator: Dennis S. Chi, MD, FACOG, FACS Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert Soslow, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00504023     History of Changes
Other Study ID Numbers: 07-029
First Posted: July 19, 2007    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: June 6, 2018
Last Verified: February 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Paget disease of the vulva
recurrent vulvar cancer
stage 0 vulvar cancer
stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers