Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx

Date de début de l'étude : 1 septembre 1992

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity or oropharynx Operable, primary, unilateral, stage T2-4, N0-3, M0 disease No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection) No tumor involvement of the following sites: Pterygopalatine fossa Carotid artery Maxillary sinus Facial skin Anterior floor of the mouth Base of the tongue infiltrating more than 1 cm Measurable or evaluable disease by physical exam and/or noninvasive imaging PATIENT CHARACTERISTICS: Age: 75 and under Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 60,000/mm3 Hematocrit at least 30% Hepatic: Bilirubin normal Hepatitis B surface antigen negative Renal: Creatinine normal Cardiovascular: No congestive heart failure No uncontrolled hypertension No coronary artery disease No serious arrhythmia No evidence of prior myocardial infarction on ECG (stress test required if in doubt) Other: HIV negative No autoimmune disease No contraindications to pressor agents No serious infection requiring antibiotics No other concurrent primary malignancy Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or other concurrent immunotherapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: No prior or concurrent hormonal therapy No concurrent corticosteroids Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No prior major organ allografts Other: No other prior therapy No other concurrent investigational drugs, agents, or devices No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin