Cetuximab and Lenalidomide in Head and Neck
The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cetuximab and Lenalidomide in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck|
- Correlate the presence of specific Fc RIIIa polymorphisms with progression-free survival in subjects receiving cetuximab and lenalidomide for SCCHN. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Incidence of toxicities associated with the combination of cetuximab and lenalidomide given to treat subjects with SCCHN. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Sub Group 1
All Subjects Enrolled in the Trial
Drug: Cetuximab and Lenalidomide
The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide
To study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. There is evidence with cetuximab in CRC, trastuzumab in breast cancer and rituximab with follicular lymphoma, that FcRIIIa polymorphisms correlate with clinical response to antibody therapy and clinical outcome. It is our hypothesis that patients with SCCHN will have clinical outcomes to cetuximab and lenalidomide that correlate with patient FcRIIIa genotype.
To evaluate the safety and toxicity profile of the combination of cetuximab and lenalidomide given to treat subjects with SCCHN.
To study FcRIIIa polymorphisms and the correlation with the ability of NK cells to mediate ADCC against SCCHN. It is our hypothesis that NK cells from patients with advanced SCCHN can mediate ADCC against SCCHN cell lines in the presence of cetuximab and lenalidomide and that the efficiency of ADCC correlates with FcRIIIa polymorphisms.
To evaluate the ability of NK cells to induce ADCC expression of specific activation markers on the NK cell surface. It is our hypothesis that NK cells that induce ADCC will express specific activation markers that are predictive of efficiency of ADCC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133665
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Study Chair:||Everett Vokes, M.D.||University of Chicago|