Clinical trial · Interventional
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Paget's Disease
NCT00504023CI-TRIAL-00033185completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| imiquimod | Drug | Imiquimod | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imiquimod
- 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).
- interventionNames
- Drug: imiquimod
- Procedure: biopsy
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Percentage of Participants With Clinical and Histologic Remission
- timeFrame
- 12 weeks post treatment
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.