Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

April 25, 2013 updated by: National Naval Medical Center

Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • NIH - Warren Grant Magnuson Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed basal cell skin cancer

    • Superficial or nodular disease
    • No aggressive disease

  • At least 1 lesion at least 7 mm in diameter that meets the following criteria:

    • Primary tumor (no recurrent or previously treated disease)
    • Located on the scalp, face (including ears), trunk, or proximal extremities
    • Qualifies for surgical excision as primary therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No evidence of a clinically significant or unstable medical condition that would adversely affect blood circulation

Other

  • No dermatological disease (e.g., psoriasis or eczema) at the treatment site that may be exacerbated by treatment with imiquimod or interfere with examination
  • No febrile viral infection within the past 4 weeks
  • No evidence of a clinically significant or unstable medical condition that would adversely affect immune function

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior interferon, interferon inducers, or immunomodulators
  • No concurrent interferon, interferon inducers, or immunomodulators

Chemotherapy

  • More than 6 months since prior anticancer chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • More than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone or equivalent) corticosteroids
  • More than 4 weeks since prior topical steroids to the target tumor
  • Concurrent topical steroids in non-target areas are allowed provided amount used is ≤ 2 g of fluorinated steroids daily for > 1 week or 6 g of beclomethasone for > 1 week
  • No concurrent oral or inhaled corticosteroids

Radiotherapy

  • Not specified

Surgery

  • More than 4 months since prior biopsy

Other

  • More than 4 weeks since prior immunosuppressive therapies
  • More than 4 weeks since prior cytotoxic or investigational drugs
  • No concurrent immunosuppressive therapies
  • No other concurrent cytotoxic or investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Naval Medical Center

Investigators

  • Principal Investigator: Francesco M. Marincola, MD, NIH - Warren Grant Magnuson Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 9, 2004

First Posted (Estimate)

March 10, 2004

Study Record Updates

Last Update Posted (Estimate)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000355151
  • NCI-02-CC-0289
  • 3M-1454-IMIQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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