Other Clinical Trial - Cetuximab Before Surgery in Treating Patients With

Status Completed

Clinical Trial Summary

This pilot clinical trial studies the side effects and how well cetuximab before surgery works in treating patients with skin cancer that forms, grows, and spreads quickly and has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways be targeting certain cells. Giving cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the response rate of cetuximab by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with advanced squamous cell carcinoma of skin (SCCS). II. To assess whether neoadjuvant cetuximab given in this patient population is both safe and feasible. SECONDARY OBJECTIVES: I. To measure the progression free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab. II. To determine the conversion to resectability of patients treated with neoadjuvant cetuximab and capture changes in reconstructive options rendered possible by neoadjuvant treatment. III. Analyze the relationship of known deoxyribonucleic acid (DNA) mutations in tumor per the FoundationOneTM genomic profile, and correlate to clinical endpoints such as clinical benefit and conversion to resectability to discover potential markers of response and/or resistance. IV. Measure the downstream activation of signaling pathways without a known driver, including the epidermal growth factor receptor (EGFR) pathway. V. Determine if tumor shrinkage with cetuximab is associated with increased apoptosis as evidenced by activated caspase-3, in pre- and post- treatment tumor tissues. VI. Determine whether cetuximab results in increased antibody-dependent cell cytotoxicity (ADCC) in post-, compared with pre-treatment tumor tissues. OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once weekly for 8 weeks. After completion of study treatment, patients are followed up every 3 months for 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02324608
Study type	Interventional
Source	Rutgers, The State University of New Jersey
Contact
Status	Completed
Phase	N/A
Start date	January 30, 2015
Completion date	May 30, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms