Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists
• * Metastatic disease OR incurable with surgery or radiation
• Measurable disease by CT scan or MRI
• * Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas
• PATIENT CHARACTERISTICS:
• Age:
• 16 and over
• Performance status:
• Karnofsky 60-100%
• Life expectancy:
• At least 2 months
• Hematopoietic:
• WBC at least 2,000/mm\^3
• Platelet count at least 50,000/mm\^3
• Hepatic:
• No hepatic insufficiency
• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 2.5 mg/dL
• Renal:
• No renal insufficiency
• Creatinine no greater than 2.5 mg/dL
• No renal conditions that contraindicate high dosages of sodium
• Cardiovascular:
• No chronic heart failure
• No uncontrolled hypertension
• No history of congestive heart failure
• No other cardiovascular conditions that contraindicate high dosages of sodium
• Pulmonary:
• No serious lung disease (e.g., severe chronic obstructive pulmonary disease)
• Other:
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No other serious medical or psychiatric conditions
• No active infection
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulatory agents
• Chemotherapy:
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic therapy
• Endocrine therapy:
• Concurrent corticosteroids allowed
• Radiotherapy:
• See Disease Characteristics
• At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered
• Surgery:
• See Disease Characteristics
• Other:
• Prior cytodifferentiating agents allowed