Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic, Treatment Active 18 and over NCI MSKCC-07029 07-029, NCT00504023

Objectives

1. To assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget’s disease.

Entry Criteria

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

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• No known hypersensitivity to imiquimod
• Not pregnant or nursing

Expected Enrollment

Outcomes

Clinical and histologic effects

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 Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dennis Chi, MD, FACOG, FACS, Principal investigator		Ph: 212-639-5016; 800-525-2225
Robert Soslow, MD, Principal investigator		Ph: 212-639-5905; 800-525-2225 Email: soslowr@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Dennis Chi, MD, FACOG, FACS	Ph:  212-639-5016 800-525-2225

Registry Information
Official Title		A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease
Trial Start Date		2007-04-24
Trial Completion Date		2010-04-26 (estimated)
Registered in ClinicalTrials.gov		NCT00504023
Date Submitted to PDQ		2007-06-14
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748

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