Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
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|ClinicalTrials.gov Identifier: NCT00504023|
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : May 8, 2018
Last Update Posted : June 6, 2018
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|
- 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)|
|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|
This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
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.
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).
- 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
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 ClinicalTrials.gov 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|
|Principal Investigator:||Dennis S. Chi, MD, FACOG, FACS||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Robert Soslow, MD||Memorial Sloan Kettering Cancer Center|