Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer
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.
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Potentiation of Cetuximab by Tregs Depletion With Metronomic Cyclophosphamide in Metastatic Squamous Cell Cancers of Head and Neck|
- Progression Free Survival [ Time Frame: At 2 Years ] [ Designated as safety issue: No ]Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Ratio of Tregs to Effector Cells [ Time Frame: 6 Weeks Post Treatment with Cyclophosphamide ] [ Designated as safety issue: No ]the ratio of Tregs to effector cells (NK cells, CD8+ lymphocytes, macrophages/monocytes) in tumor tissue as measured by immune-histochemistry (IHC) of tumor tissue
- Ratio of Tregs to Natural Killer (NK) Cells [ Time Frame: 6 Weeks Post Treatment with Cyclophosphamide ] [ Designated as safety issue: No ]the Ratio of Tregs to NK cells in peripheral blood as measured by flow cytometry
- Myeloid-derived suppressor cells in Tumor Tissue [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Myeloid-derived suppressor cells in tumor tissue as measured by immune-histochemistry (IHC)
- Quality of Life Scores [ Time Frame: Comparison from Baseline to Week 6 and Week 12 ] [ Designated as safety issue: No ]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.
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Defined as patient alive at this time period.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab/low dose Cyclophosphamide
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
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.
Other Name: CytoxanDrug: Cetuximab
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.
Other Name: Erbitux
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 Tregs to effector cells will be measured in peripheral blood at the same time points.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581970
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Gautam Jha, M.D.||Masonic Cancer Center, University of Minnesota|