RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have primary liver cancer.

OBJECTIVES:

• Determine the response, tolerance to, and side effects of antineoplaston A10 in patients with incurable primary liver cancer.

OUTLINE: This is an open label study.

Patients receive gradually increasing doses of antineoplaston A10 by arterial infusion daily until the final dose level is reached.

Therapy continues for at least 2 months in the absence of unacceptable toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 2 months after reaching CR.

Tumors are measured every month for the first 2 months, every 2 months for the first year, and every 3 months for the second year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Ages Eligible for Study:  14 Years and above,  Genders Eligible for Study:  Both

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