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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

Page last updated: August 23, 2015

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