Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Vaccine Therapy in Treating Patients With Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022334
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 3, 2020
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Cancer Biological: AFP Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2001
Actual Primary Completion Date : December 2004
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Dose limiting toxicity and maximum tolerable dose. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Generation of AFP specific immunity. [ Time Frame: 3 years ]
  2. Progression-free survival. [ Time Frame: 3 years ]
  3. clinical response in patients with measurable disease. [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022334

Layout table for location information
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Institutes of Health (NIH)
Layout table for investigator information
Principal Investigator: James S. Economou, MD Jonsson Comprehensive Cancer Center
Layout table for additonal information
Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00022334    
Other Study ID Numbers: CDR0000068806
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2012
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:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases