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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Progression
The number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions.
Time frame: At 2 Years
Aggregate Ratio of Tregs to Effector Cells for All Participants
The ratio of Tregs to effector cells (NK cells, CD 8+ lymphocytes, macrophages/monocytes) in tumor tissue as measured by immune-histochemistry (IHC) of tumor tissue for all Participants. Measure of central tendency was collected but the data is not accessible anymore because PI left institution and did not respond to requests for data.
Time frame: 6 Weeks Post Treatment with Cyclophosphamide
Aggregate Ratio of Tregs to Natural Killer (NK) Cells for All Participants
the Ratio of Tregs to NK cells in peripheral blood as measured by flow cytometry for all Participants. Measure of central tendency was collected but the data is not accessible anymore because the PI left institution and did not respond to requests for data.
Time frame: 6 Weeks Post Treatment with Cyclophosphamide
Myeloid-derived Suppressor Cells in Tumor Tissue
Myeloid-derived suppressor cells in tumor tissue as measured by immune-histochemistry (IHC)
Time frame: Week 6
Quality of Life Scores
Comparison of health related quality of life scores as measured by FACT-G: Functional Assessment of Cancer Therapy - General (constitutes the core of all subscales; the FACT-G can be used with patients of any tumor type)questionnaire. At this point, the data is not able to be analyzed because the PI left the institution and did not respond to requests for data.
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Time frame: Comparison from Baseline to Week 6 and Week 12
Overall Survival
Defined as the number of patients alive two years out from study enrollment.
Time frame: 2 years