A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity and maximum tolerable dose.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

James S. Economou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068806

NCT ID:

NCT00022334

Start Date:

January 2001

Completion Date:

October 2008

Related Keywords:

  • Liver Cancer
  • 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
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781