NCT00022334

Vaccine Therapy in Treating Patients With Liver Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Cancer

Interventions

Type	Name	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.

Timeline

• Start date: 2001-01-01
• Primary completion: 2004-12-01
• Completion: 2008-10-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States