Expired Study
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Bethesda, Maryland 20892


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00079300


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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