Vaccine Therapy in Treating Patients With Liver Cancer
Completed · Phase 1/Phase 2
Conditions studied: Liver Cancer
In brief
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins 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.
Key facts
- Study ID
- NCT00022334
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 33
- Starts
- 2001-01-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Hemoglobin >9.0g/dl
- Platelets >50000/mm3
- Absolute Neutrophil Count >1,000/mm3
- Child-Pugh Class A or B for chronic liver disease.
- Ability to give informed consent.
You may not qualify if…
- 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.
Where it is running
- Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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