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Phase II Testing of ADI-PEG in Hepatocellular Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

2206

NCT ID:

NCT00056992

Start Date:

September 2002

Completion Date:

October 2003

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096