Clinical Trial: Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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 Summary:
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.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Clinical and histologic effects [ Time Frame: 2 years ]
Original Primary Outcome: Clinical and histologic effects
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: July 17, 2007
Date Started: April 2007
Date Completion: April 2018
Last Updated: March 29, 2017
Last Verified: March 2017
