NCT00093548

Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer

A Phase I/II Trial Testing Immunization With AFP + GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma (AFP Prime-Boost Protocol)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from DNA and a gene-modified virus may make the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of liver cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or stage IVA liver cancer.

Detailed description

OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination comprising alpha fetoprotein (AFP) plasmid DNA and sargramostim (GM-CSF) plasmid DNA followed by AFP adenoviral vector boost in patients with HLA-A\*0201-expressing stage II-IVA hepatocellular carcinoma. Secondary * Determine the optimal biological dose of this regimen, as defined by the generation of AFP-specific immunity, in these patients. * Determine disease-free survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of alpha fetoprotein (AFP) adenoviral vector boost. Patients receive vaccination comprising AFP plasmid DNA and sargramostim (GM-CSF) plasmid DNA intramuscularly (IM) on days 1, 30, and 60 in the absence of unacceptable toxicity. Patients then receive boost immunization comprising AFP adenoviral vector IM and intradermally on day 90. Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 3 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	alpha fetoprotein adenoviral vector vaccine
BIOLOGICAL	alpha fetoprotein plasmid DNA vaccine
BIOLOGICAL	sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant

Timeline

• First posted: 2004-10-08
• Last updated: 2012-10-04