Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00022334
Eligibility Criteria:
Inclusion Criteria:
* HLA-A\*0201 positive adults over the age of 18.
* Have HCC with a serum AFP determination \>30ng/ml.
* Both male and female patients may be enrolled.
* 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 previous evidence of opportunistic infection.
* Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
1. Hemoglobin \>9.0g/dl
2. Platelets \>50000/mm3
3. Absolute Neutrophil Count \>1,000/mm3
* Child-Pugh Class A or B for chronic liver disease.
* Ability to give informed consent.
Exclusion Criteria:
* Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
* Concomitant steroid therapy or chemotherapy, or any of these other treatments \< 30 days before the first vaccination.
* Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 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 study treatment.
* HIV-infected patients.
* Patients with any underlying conditions which would contraindicate therapy with study treatment.
* Patients with organ allografts.
* O2 sat \<91% on room air; dyspnea at rest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00022334
Study Brief:
Protocol Section:
NCT00022334