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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ohio State University College of Medicine
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00504023
First received: July 17, 2007
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 Intervention
Vulvar Cancer
Drug: imiquimod
Procedure: biopsy
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Clinical and histologic effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504023

Locations
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
Ohio State University College of Medicine
Investigators
Principal Investigator: Dennis S. Chi, MD, FACOG, FACS Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert Soslow, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00504023     History of Changes
Other Study ID Numbers: 07-029, MSKCC-07029
Study First Received: July 17, 2007
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

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
imiquimod
07-029

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

ClinicalTrials.gov processed this record on October 23, 2014