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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.
- Determine the response rate, in terms of prostaglandin E2 expression, in patients with oral leukoplakia and/or dysplasia treated with celecoxib.
- Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF, and CD31, in patients treated with this drug.
- Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia lesions and presence of dysplasia, in these patients.
- Correlate change in biomarker expression with response of oral leukoplakia lesions and/or dysplasia in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.
Patients are followed every 3-6 months for 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.
Allocation: Non-Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Prevention
Head and Neck Cancer
Brigham and Women's Hospital
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:34-0400
The purpose of this study is to better understand how to use celecoxib, a popular drug widely used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib may...
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer. PURPOSE: This ...
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurr...
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before surgery may ...
This is a phase I/II study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
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This study investigates cutoff scores for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions (EORTC QLQ-C30) and head and neck cancer-specif...
The purpose of this study was to determine whether outcomes in head and neck cancer would vary based on geographic location of patients.
Head and neck cancer is morbid with a poor prognosis that has not significantly improved in the past several decades. The purpose of this study was to identify biological pathways underlying progressi...
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A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)
A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.
Large veins on either side of the root of the neck formed by the junction of the internal jugular and subclavian veins. They drain blood from the head, neck, and upper extremities, and unite to form the superior vena cava.
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Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...