Official Title: “A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease”

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.

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: April 2010

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.

Intervention(s) in this Clinical Trial

• Drug: imiquimod
• Procedure: biopsy
• Procedure: conventional surgery

Primary Measures

• Clinical and histologic effects
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Patients who present to the Gynecology outpatient clinic of Memorial Sloan-Kettering

Cancer Center (MSKCC) meeting the following criteria:

• Biopsy-proven extramammary Paget's disease of the vulva with histological confirmation performed at MSKCC
• No underlying adenocarcinoma on biopsy of lesion
• Recurrent disease

PATIENT CHARACTERISTICS:

• No known hypersensitivity to imiquimod
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• Not specified

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Dennis S. Chi, MD, FACOG, FACS Principal Investigator Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00504023

Study ID Number: CDR0000556722

ClinicalTrials.gov Identifier: NCT00504023

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database