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

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

• Stage II, III, or IV disease
• One of the following primary tumor sites:

• Oral cavity
• Oropharynx
• Hypopharynx
• Larynx
• Resectable disease

• Scheduled to undergo surgery as primary treatment

• Distant metastases or a second primary tumor allowed provided tumor deemed resectable by the surgeon
• No squamous cell carcinoma of the nasopharynx or skin

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• White Blood Cells (WBC) > 3,000/mm^3
• Platelet count ≥ 150,000/mm^3
• Hemoglobin ≥ 10 g/dL

• Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week before study entry AND the patient is stable
• Bilirubin < 1.5 times upper limit of normal (ULN)
• serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN
• Creatinine < 1.5 times ULN
• No hemolytic anemia
• No hemoglobinopathies (e.g., thalassemia)
• No prior or current ascites
• No bleeding varices
• No other evidence of decompensated liver disease
• No symptomatic ischemic heart disease
• No symptomatic congestive heart failure
• No other uncontrolled heart condition
• No chronic obstructive pulmonary disease
• No documented pulmonary hypertension
• No other chronic pulmonary disease
• No known HIV positivity
• No AIDS-related illness
• No active uncontrolled infection
• No immunologically mediated disease, including any of the following:

• Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• Rheumatoid arthritis
• Idiopathic thrombocytopenia purpura
• Systemic lupus erythematosus
• Autoimmune hemolytic anemia
• Scleroderma
• Severe psoriasis
• No Central Nervous System (CNS) trauma
• No confusion or disorientation
• No active seizure disorders requiring medication
• No spontaneous encephalopathy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing uncontrolled thyroid abnormality
• No poorly controlled diabetes mellitus
• No history of major psychiatric illness that would prelude giving informed consent
• No nonmalignant systemic disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior biologic therapy and recovered
• More than 4 weeks since prior chemotherapy and recovered
• More than 4 weeks since prior radiotherapy and recovered
• More than 4 weeks since prior surgery
• No prior interferon
• No other concurrent immunotherapy
• No concurrent chemotherapy
• No concurrent hormonal antineoplastic therapy
• No concurrent systemic corticosteroids
• No concurrent radiotherapy