NCT00504023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 8, 2018

Completed
Last Updated

June 6, 2018

Status Verified

February 1, 2018

Enrollment Period

10.8 years

First QC Date

July 17, 2007

Results QC Date

April 5, 2018

Last Update Submit

May 7, 2018

Conditions

Vulvar Cancer

Keywords

Paget disease of the vulvarecurrent vulvar cancerstage 0 vulvar cancerstage I vulvar cancerstage II vulvar cancerstage III vulvar cancerimiquimod07-029

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Clinical and Histologic Remission

    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

    12 weeks post treatment

Study Arms (1)

imiquimod

EXPERIMENTAL

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: imiquimodProcedure: biopsyProcedure: therapeutic conventional surgery

Interventions

imiquimodDRUG

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.

imiquimod
biopsyPROCEDURE

Punch biopsy and photography will be performed at the baseline and 12 week time points.

imiquimod
therapeutic conventional surgeryPROCEDURE

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).

imiquimod

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Related Links

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

ImiquimodBiopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Dr. Dennis Chi, MD
Organization
Memorial Sloan Kettering Cancer Center
chid@mskcc.org
212-639-5016

Study Officials

  • Dennis S. Chi, MD, FACOG, FACS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Robert Soslow, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

April 1, 2007

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 6, 2018

Results First Posted

May 8, 2018

Record last verified: 2018-02

Locations

US(2)