Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504023
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2007-07-17
Brief Title:
Topical Imiquimod in Treating Patients With Recurrent Pagets Disease of the Vulva
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of Topical Imiquimod Therapy for the Treatment of Recurrent Extramammary Pagets Disease
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Pagets disease
PURPOSE This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Pagets disease of the vulva
PURPOSE This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Pagets disease of the vulva
Detailed Description:
OBJECTIVES
To assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Pagets 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
To assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Pagets 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-07029 | None | None | None |