Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Inclusion Criteria

• •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