Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079300
Status:
COMPLETED
Last Update Posted:
2013-04-26
First Post:
2004-03-08
Brief Title:
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
Sponsor:
National Naval Medical Center
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Double-Blind Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara Imiquimod Cream 5 Applied Once or Twice a Day
Status:
COMPLETED
Status Verified Date:
2013-04
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 cream work in different ways to stimulate the immune system and stop tumor cells from growing
PURPOSE This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer
PURPOSE This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer
Detailed Description:
OBJECTIVES
Primary
Compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5 cream
Secondary
Compare levels of apoptosis in patients treated with this drug on two different administration schedules
OUTLINE This is a randomized double-blind placebo-controlled parallel-group study
Patients undergo fine needle aspiration and punch biopsies of the target lesion Patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy
Arm I Patients apply topical imiquimod to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses
Arm II Patients apply topical placebo to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses
Arm III Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-4 for a total of 4 doses
Arm IV Patients apply topical placebo to the target lesion once every 24 hours on days 1-4 for a total of 4 doses
Arm V Patients apply topical imiquimod to the target lesion once every 12 hours on days 1-4 for a total of 8 doses
Arm VI Patients apply topical placebo to the target lesion once every 12 hours on days 1-4 for a total of 8 doses
Arm VII Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-8 for a total of 8 doses
Arm VIII Patients apply topical placebo to the target lesion every 24 hours on days 1-8 for a total of 8 doses
All patients undergo excision of the target tumor within 18-30 hours after the last topical treatment
Patients are followed at 7-14 days
PROJECTED ACCRUAL A total of 48 patients 8 per treatment arm and 4 per placebo arm will be accrued for this study
Primary
Compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5 cream
Secondary
Compare levels of apoptosis in patients treated with this drug on two different administration schedules
OUTLINE This is a randomized double-blind placebo-controlled parallel-group study
Patients undergo fine needle aspiration and punch biopsies of the target lesion Patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy
Arm I Patients apply topical imiquimod to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses
Arm II Patients apply topical placebo to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses
Arm III Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-4 for a total of 4 doses
Arm IV Patients apply topical placebo to the target lesion once every 24 hours on days 1-4 for a total of 4 doses
Arm V Patients apply topical imiquimod to the target lesion once every 12 hours on days 1-4 for a total of 8 doses
Arm VI Patients apply topical placebo to the target lesion once every 12 hours on days 1-4 for a total of 8 doses
Arm VII Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-8 for a total of 8 doses
Arm VIII Patients apply topical placebo to the target lesion every 24 hours on days 1-8 for a total of 8 doses
All patients undergo excision of the target tumor within 18-30 hours after the last topical treatment
Patients are followed at 7-14 days
PROJECTED ACCRUAL A total of 48 patients 8 per treatment arm and 4 per placebo arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3M-1454-IMIQ | None | None | None |
| NCI-02-CC-0289 | None | None | None |