Phase I/II Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma
- This study will enroll HLA-A 0201 adults over the age of 18 with history of
biopsy-proven HCC and AFP positive by immunohistochemistry or serum AFP levels > 2
times above the upper limit of normality. Any stage of disease will be eligible.
- Both male and female patients may be enrolled. Females of childbearing potential must
have a negative pregnancy test prior to treatment.
- Patients must be ambulatory with a Karnofsky Performance Status greater than or equal
to 70 percent.
- No previous evidence of class 3 or greater New York Heart Association cardiac
insufficiency or coronary artery disease.
- No evidence of opportunistic infection.
- A minimum of 4 weeks must have elapsed since the completion of prior chemotherapy or
- Adequate baseline hematological function as assessed by the following laboratory
values within 30 days prior to study entry (day -30 to 0):
- Hemoglobin > 8.5 g/dl (patients cannot be transfusion dependent).
- Platelets > 30,000/mm3
- WBC > 2,000/mm3
- Absolute Neutrophil Count (ANC) > 1,000/mm3
- Positive skin test to common antigens (tetanus and/or candida).
- Ability to give informed consent and signed informed consent.
Patients who meet any one of the following criteria will be excluded from study entry:
- Any congenital or acquired condition leading to inability to generate an immune
response, including concomitant immune suppressive therapy. The ability to adequately
respond to antigens will be tested before trial entry by requiring a positive
response to skin allergens (tetanus and candida).
- Lactating females: All patients must practice adequate birth control and females of
child-bearing potential must have a negative serum HCG pregnancy test (within day -7
to day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires
specific therapy. Acute therapy must have been completed within 14 days prior to
- HIV-infected patients, due to concerns in the ability to stimulate an effective
- Acute medical problems such as ischemic heart or lung disease that may be considered
an unacceptable anesthetic or operative risk.
- Patients with any underlying conditions that would contraindicate therapy with study
treatment (or allergies to reagents used in this study).
- Patients with organ allografts.
- Uncontrolled hepatic insufficiency and cirrhosis, Class C in the Child's
classification, with bilirubin > 3 mg/dl, albumin < 3.0 g/dl, poorly controlled
ascites, advanced encephalopathy and poor nutritional status.
- Uncontrolled CNS metastasis. Patients with previously known CNS metastasis will be
eligible if they have received CNS irradiation to control local tumor growth.
- Concomitant Medication and Treatment:
All allowed medications or treatments should be kept to a minimum and recorded.
- Concomitant Medications and Treatments Not Allowed: Corticosteroids, Cyclosporin A,