NCT00093548撤回1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatocellular carcinoma
- •Stage II-IVA disease
- •No active disease after local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)
- •Serum alpha fetoprotein > upper limit of normal
- •HLA-A*0201 positive by DNA subtyping
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin > 9.0 g/dL (transfusion independent)
- •Platelet count > 50,000/mm^3
- •Absolute neutrophil count > 1,000/mm^3
- •Child Pugh class A or B liver function
- •Hepatitis B or C viral infection allowed
- •Not specified
- •Cardiovascular
- •No New York Heart Association class III or IV cardiac insufficiency
- •No coronary artery disease
- •Immunologic
- •HIV negative
- •No other acute viral, bacterial, or fungal infection requiring therapy
- •No allergy to study agents
- •No history of opportunistic infection
- •No high serum titer of neutralizing anti-adenoviral antibodies
- •No congenital or acquired condition resulting in an inability to generate an immune response
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective double-method (including a barrier method) contraception
- •No other condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 30 days since prior chemotherapy
- •No concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •At least 30 days since prior steroid therapy
- •No concurrent steroid therapy, including corticosteroids
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •No prior organ allograft
- •At least 2 weeks since prior therapy for acute infection
- •No concurrent immunosuppressive therapy
- •No concurrent cyclosporine
排除标准
- 未提供
研究者
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