Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer

Inclusion Criteria

• •Histologically documented squamous cell carcinoma of the head and neck (irrespective of site of primary - nasopharyngeal, oral cavity, oropharyngeal, laryngeal or unknown primary) that is metastatic/incurable and has progressed on a first line chemotherapy regimen.
• •Progression of measurable disease within the last 6 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• •If the patient has received prior treatment with anti-epidermal growth factor receptor (EGFR) therapy as a part of definitive therapy concurrent with radiation, the time from the last cetuximab exposure must be \> 180 days.
• •Must be at least 30 days from prior treatment and have recovered from the reversible effects of previous anti-cancer treatment
• •Age ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
• •Adequate bone marrow, renal and hepatic function within 14 days of study enrollment defined as:
• •* Bone marrow: White blood cells (WBC) \> 3,000/uL; absolute neutrophil count \> 1,500/uL; platelets \> 100,000/uL
• •* Renal: creatinine ≤ 2.5 times the institutional upper limit of normal (ULN)
• •* Hepatic: total bilirubin \< 1.5 X institutional ULN; aspartate aminotransferase/alanine aminotransferase (AST\[SGOT\] and ALT\[SGPT\]) \< 2.5 X institutional ULN
• •* Albumin \> 3.0 gm/dL
• •Women of childbearing potential and fertile men must be willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 60 days after the last dose of study drug.
• •Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care