NCT00079300

Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Naval Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-melanomatous Skin Cancer

Interventions

Type	Name	Description
DRUG	imiquimod
PROCEDURE	conventional surgery

Timeline

• Start date: 2004-01-01
• Completion: 2005-08-01
• First posted: 2004-03-10
• Last updated: 2013-04-26

Locations

1 site across 1 country: United States