NCT00504023 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2018-06-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Clinical and Histologic Remission

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
intervention Names
Drug: imiquimod
Procedure: biopsy
Procedure: therapeutic conventional surgery
label
imiquimod
type
EXPERIMENTAL

interventions

arm Group Labels
imiquimod
description
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.
name
imiquimod
type
DRUG
arm Group Labels
imiquimod
description
Punch biopsy and photography will be performed at the baseline and 12 week time points.
name
biopsy
type
PROCEDURE
arm Group Labels
imiquimod
description
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).
name
therapeutic conventional surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
measure
Percentage of Participants With Clinical and Histologic Remission
time Frame
12 weeks post treatment

Full study description

brief 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.
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.

Source references