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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00504023 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Vulvar Cancer |
Drug: imiquimod Procedure: biopsy Procedure: conventional surgery |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | 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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Recruiting |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Contact: Clinical Trials Office - Feist-Weiller Cancer Center at Louisi 318-813-1412 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Dennis S. Chi, MD, FACOG, FACS 212-639-5016 | |
| Principal Investigator: | Dennis S. Chi, MD, FACOG, FACS | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Robert Soslow, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000556722, MSKCC-07029 |
| Study First Received: | July 17, 2007 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00504023 History of Changes |
| Health Authority: | Unspecified |
|
Paget disease of the vulva recurrent vulvar cancer stage 0 vulvar cancer |
stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer |
|
Immunologic Factors Interferons Vulvar Cancer Adjuvants, Immunologic Genital Neoplasms, Female Imiquimod Urogenital Neoplasms Bone Diseases Recurrence Paget's Disease, Extramammary |
Carcinoma Genital Diseases, Female Musculoskeletal Diseases Vulvar Neoplasms Osteitis Deformans Paget Disease Adenocarcinoma Osteitis Vulvar Diseases Neoplasms, Glandular and Epithelial |
|
Interferon Inducers Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Genital Neoplasms, Female Imiquimod Urogenital Neoplasms Bone Diseases Pharmacologic Actions Paget's Disease, Extramammary |
Carcinoma Genital Diseases, Female Neoplasms Neoplasms by Site Musculoskeletal Diseases Vulvar Neoplasms Therapeutic Uses Osteitis Deformans Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Vulvar Diseases Neoplasms, Glandular and Epithelial |
