Antineoplaston Therapy for Advanced Primary Liver Cancer

Study start date: March 21, 1977

DISEASE CHARACTERISTICS: Histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists Measurable disease by CT scan or MRI Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: 14 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin less than 3 mg/dL SGOT/SGPT no greater than 10 times upper limit of normal No hepatic failure Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high doses of sodium Cardiovascular: No uncontrolled hypertension No known chronic heart failure No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high doses of sodium Pulmonary: No serious lung disease (e.g., chronic obstructive pulmonary disease) Other: Not pregnant or nursing Fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study No serious medical or psychiatric disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent steroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: No prior antineoplaston therapy Prior cytodifferentiating agents allowed