Vaccine Therapy in Treating Patients With Liver Cancer
- Conditions
- Liver Cancer
- Interventions
- Biological: AFP
- Registration Number
- NCT00022334
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A\*0201-positive patients with hepatocellular carcinoma.
* Determine the safety and toxicity of this regimen in these patients.
* Determine the immunological effects of this regimen in these patients.
* Determine the progression-free survival and clinical responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.
Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
-
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.
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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.
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No previous evidence of opportunistic infection.
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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.
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Ability to give informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment AFP See intervention description.
- Primary Outcome Measures
Name Time Method Dose limiting toxicity and maximum tolerable dose. 1 year
- Secondary Outcome Measures
Name Time Method Generation of AFP specific immunity. 3 years Progression-free survival. 3 years clinical response in patients with measurable disease. 3 years
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States