Vaccine Therapy in Treating Patients With Liver Cancer (NCT00005629) | Clinical Trial Compass
CompletedPhase 1/2
Vaccine Therapy in Treating Patients With Liver Cancer
United States6 participantsStarted 1999-07
Plain-language summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* 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 radiation therapy.
* 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.
Exclusion Criteria
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 respon…