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
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx
Eligibility Criteria
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
Sites / Locations
- M.D. Anderson Cancer Center at University of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Control
PEG-Intron 0.5 mg/kg
PEG-Intron 2.5 mg/kg
PEG-Intron 5.0 mg/kg
Control (no treatment), conventional surgery.
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.