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.
- 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.
- 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
- 14 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm3
- Platelet count at least 50,000/mm3
- Bilirubin less than 3 mg/dL
- SGOT/SGPT no greater than 10 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high doses of sodium
- 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
- No serious lung disease (e.g., chronic obstructive pulmonary disease)
- 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:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agents
- Concurrent steroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- No prior antineoplaston therapy
- Prior cytodifferentiating agents allowed