Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: imiquimod
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imiquimod|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma of the skin