Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Non-melanomatous Skin Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Non-melanomatous Skin Cancer
• Skin Neoplasms

• NCT number: NCT00079300
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 1
• Start date: January 2004
• Completion date: August 2005