Phase II Testing of ADI-PEG in Hepatocellular Carcinoma

Inclusion Criteria

- Histologically confirmed diagnosis of hepatocellular carcinoma.

- Non-resectable disease.

- Progressive disease after chemotherapy, radiotherapy, surgery or immuno-therapy, and
be no longer responding to such therapy, or have refused such therapy.

- Been off previous treatment for at least 4 weeks.

- Been fully recovered from all prior surgery.

- Age of > 18 years.

- Karnofsky performance status of > 70.

- Expected survival of > 12 weeks.

- Total bilirubin < 3.0 mg/dl.

- Serum albumin > 3.0 g/dl.

- Serum SGOT < 5 x upper limit of normal.

- Serum alkaline phosphatase < 5 x upper limit of normal.

- Serum ammonia < 55 mg/dl.

- Serum glucose > 60 mg/dl.

- Serum amylase < 1.5 x upper limit of normal.

- ANC > 1,500 / ml.

- Platelets > 100,000 / ml.

- Female subjects of childbearing age and male subjects must be asked to use
appropriate contraception for both the male and female for the duration of the study.
Subjects must agree to use two forms of contraception or agree to refrain from
intercourse for the duration of the study. Females must not be pregnant at the start
of the study, and a serum HCG pregnancy test must be negative before entry into the
study.

- Informed consent.

- Not be enrolled in other IND studies.

- Disease must be measurable or evaluable.