Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Patients who present to the Gynecology outpatient clinic at a participating institution meeting the following criteria:

• Biopsy-proven extramammary Paget's disease of the vulva with histological confirmation performed at the participating site

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Dennis S. Chi

Principal Investigator

Robert Soslow

Principal Investigator

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Dennis S. Chi	Ph: 212-639-5016
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph: 866-627-7616
			Email: osu@emergingmed.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00504023
Information obtained from ClinicalTrials.gov on February 06, 2012

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