NCT00504023

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

A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2007-04-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2007-07-19
• Last updated: 2018-06-06
• Results posted: 2018-05-08

Locations

2 sites across 1 country: United States