Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II, Phase I | Treatment | Completed | Over 18 | NCI, Other | CDR0000068806 P30CA016042, UCLA-0001026, NCI-G01-1997, NCT00022334 |
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.
Further Study Information
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.
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.
Trial Lead Organizations/Sponsors
Jonsson Comprehensive Cancer Center at UCLA
National Cancer Institute| James S. Economou |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00022334
Information obtained from ClinicalTrials.gov on December 14, 2011
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