This trial is active, not recruiting.

Condition vulvar cancer
Treatments imiquimod, biopsy, therapeutic conventional surgery
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date April 2007
End date April 2017
Trial size 8 participants
Trial identifier NCT00504023, 07-029, MSKCC-07029


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
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).

Primary Outcomes

Clinical and histologic effects
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease
Principal investigator Dennis S. Chi, MD, FACOG, FACS
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.