Spots Global Cancer Trial Database for PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery

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Trial Identification

Brief Title: PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery

Official Title: A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck

Study ID: NCT00276523

Conditions

Head and Neck Cancer

Interventions

PEG-interferon alfa-2b

Conventional surgery

Neoadjuvant therapy

Study Description

Brief Summary: RATIONALE: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells and slow the growth of head and neck cancer. It may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well different doses of PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head and neck cancer that can be removed by surgery.

Detailed Description: OBJECTIVES: Primary * Determine the antiangiogenic effects of PEG-interferon alfa-2b, in terms of pre- and post-treatment levels of microvessel density (MVD), endothelial cell apoptosis, vascular endothelial growth factor (VEGF), interleukin-8, basic fibroblast growth factor (bFGF), Nuclear Factor-KappaB (NF-KB), matrix metalloproteinase/MMP-9, and NF-KB in biopsy specimens, from patients with resectable stage II-IV squamous cell carcinoma of the head and neck. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the clinical response in patients treated with this drug. OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients undergo surgery within 3 weeks after randomization. * Arm II: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, and 15. * Arm III: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose. * Arm IV: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose than in arm III. In arms II, III, and IV, patients undergo surgery within 1 week after completion of PEG-interferon alfa-2b. After completion of study treatment, patients are followed for up to 30 days. PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study.