Cetuximab and Lenalidomide in Head and Neck

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.

Secondary:

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.