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