Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Phase 1

Completed

• Conditions: Non-melanomatous Skin Cancer

• Registration Number: NCT00079300
• Lead Sponsor: National Naval Medical Center

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.

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-03-08
• Study First Submitted QC: 2004-03-09
• Study First Posted: 2004-03-10
• Study Completion: 2005-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

NIH - Warren Grant Magnuson Clinical Center; 🇺🇸 Bethesda, Maryland, United States