Vaccine Therapy in Treating Patients With Liver Cancer

This study has been completed.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center Identifier:
First received: August 10, 2001
Last updated: July 27, 2012
Last verified: July 2012

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.

Condition Intervention Phase
Liver Cancer
Biological: AFP
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Dose limiting toxicity and maximum tolerable dose. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Generation of AFP specific immunity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • clinical response in patients with measurable disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2001
Study Completion Date: October 2008
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
See intervention description.
Biological: AFP
Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
Other Name: AFP peptide-pulsed autologous DC

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00022334

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Principal Investigator: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00022334     History of Changes
Other Study ID Numbers: CDR0000068806, P30CA016042, UCLA-0001026, NCI-G01-1997
Study First Received: August 10, 2001
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site processed this record on March 30, 2015