Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Primary Liver Cancer patients receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to 12 months in the absence of disease progression or unacceptable
toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with advanced Primary
Liver Cancer, as measured by an objective response to therapy (complete response,
partial response or stable disease).

- To determine the safety and tolerance of Antineoplaston therapy in patients with
advanced Primary Liver Cancer.

- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.

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