Vaccine Therapy in Treating Patients With Liver Cancer

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022334
• Other study ID #: CDR0000068806
• Secondary ID: UCLA-0001026NCI-
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2001
• Est. completion date: October 2008

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2008
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity and maximum tolerable dose.		1 year
Secondary	Generation of AFP specific immunity.		3 years
Secondary	Progression-free survival.		3 years
Secondary	clinical response in patients with measurable disease.		3 years