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)

Jonsson Comprehensive Cancer Center0 个研究点开始时间: 2004年10月8日最近更新: 2012年10月4日

适应症

试验速览

阶段: 1 期
状态: 撤回
发起方: Jonsson Comprehensive Cancer Center

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究者

发起方

Jonsson Comprehensive Cancer Center

申办方类型

Other

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