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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: imiquimod
• Procedure: conventional surgery

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Naval Medical Center

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00079300

Study ID Number: CDR0000355151

ClinicalTrials.gov Identifier: NCT00079300

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database