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

NCT00504023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-06-06

Study results available
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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.

Conditions

  • Vulvar Cancer

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Dennis S. Chi, MD, FACOG, FACS · Memorial Sloan Kettering Cancer Center

  • Robert Soslow, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504023 on ClinicalTrials.gov