Spots Global Cancer Trial Database for Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer

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Trial Identification

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

Official Title: Potentiation of Cetuximab by Tregs Depletion With Metronomic Cyclophosphamide in Metastatic Squamous Cell Cancers of Head and Neck

Study ID: NCT01581970

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Interventions

Cyclophosphamide

Cetuximab

Study Description

Brief Summary: This is a feasibility study to assess the effectiveness of cetuximab when administered with low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and neck who have progressed on first line chemotherapy other than a cetuximab containing regimen will be treated with standard of care weekly cetuximab and twice daily low dose oral cyclophosphamide for 12 weeks.

Detailed Description: In this study, patients with head and neck squamous cell carcinoma (HNSCC) will be given low-dose cyclophosphamide in combination with standard of care cetuximab. Tumor biopsies will be collected before and six weeks after treatment for measurement of tumor infiltration by effector cells, including CD8+ T cells, natural killer (NK) cells, and monocytes. In addition, the proportion of Regulatory T Cells (Tregs) to effector cells will be measured in peripheral blood at the same time points.