Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
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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: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease |
- Clinical and histologic effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: imiquimod
This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
|
Drug: imiquimod
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.
Procedure: biopsy
Punch biopsy and photography will be performed at the baseline and 12 week time points.
Procedure: 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).
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| 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
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504023 History of Changes |
| Other Study ID Numbers: | 07-029, MSKCC-07029 |
| Study First Received: | July 17, 2007 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Paget disease of the vulva recurrent vulvar cancer stage 0 vulvar cancer stage I vulvar cancer |
stage II vulvar cancer stage III vulvar cancer imiquimod 07-029 |
Additional relevant MeSH terms:
|
Paget Disease, Extramammary Vulvar Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Ductal, Lobular, and Medullary Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Vulvar Diseases Genital Diseases, Female Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on June 18, 2013