Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer
|ClinicalTrials.gov Identifier: NCT01581970|
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Head and Neck Squamous Cell Carcinoma||Drug: Cyclophosphamide Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Potentiation of Cetuximab by Tregs Depletion With Metronomic Cyclophosphamide in Metastatic Squamous Cell Cancers of Head and Neck|
|Study Start Date :||June 2012|
|Primary Completion Date :||February 2015|
|Study Completion Date :||July 2015|
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
- Progression Free Survival [ Time Frame: At 2 Years ]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 ]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 ]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 ]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 ]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 ]Defined as patient alive at this time period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|