Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvar Cancer
Intervention: imiquimod (Drug); biopsy (Procedure); therapeutic conventional surgery (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Dennis S. Chi, MD, FACOG, FACS, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center Robert Soslow, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
Official title: A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical and histologic effects
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database Memorial Sloan Kettering Cancer Center
Starting date: April 2007
Last updated: March 24, 2015
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