Injection of AJCC Stage IIB, IIC, III, and IV Melanoma Patients With Human and Mouse gp100 DNA: A Phase I Trial to Assess Safety and Immune Response
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- safety and feasibility
研究概览
简要总结
RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma.
- Determine the maximum tolerated dose of this regimen in these patients.
- Compare the antibody and T-cell response in patients treated with two different vaccination schedules.
Secondary
- Assess antitumor response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant melanoma
- •Stage IIB, IIC, III, or IV disease
- •Patients with stage III or IV disease who are free of disease after surgical resection* are eligible
- •Patients free of disease after surgical resection* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: *Patients who underwent surgical resection must have had the surgery within the past year
- •HLA-A0201 positive
- •No detectable brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •No active bleeding
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Albumin ≥ 3.5 g/dL
- •AST and ALT ≤ 2.5 times ULN
- •Lactate dehydrogenase ≤ 2 times ULN
- •No clinical history of hepatitis B or C
- •Creatinine ≤ 2.0 mg/dL
- •Immunologic
- •No clinical history of HIV
- •No clinical history of HTLV-1
- •No active infection requiring antibiotics within the past 72 hours
- •No history of collagen vascular, rheumatologic, or other autoimmune disorder
- •No grade 1 fever within the past 72 hours
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Weight ≥ 25 kg
- •No serious underlying medical condition that would preclude study participation
- •No preexisting uveal or choroidal eye disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •More than 4 weeks since prior immunotherapy
- •No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy
- •No concurrent corticosteroids that would preclude study participation
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •Recovered from all prior therapy
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
human gp100 DNA vaccine
Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
干预措施: human gp100 plasmid DNA vaccine (Biological)
human gp100 DNA vaccine
Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
干预措施: mouse gp100 plasmid DNA vaccine (Biological)
mouse gp100 DNA vaccine
Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16
干预措施: human gp100 plasmid DNA vaccine (Biological)
mouse gp100 DNA vaccine
Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16
干预措施: mouse gp100 plasmid DNA vaccine (Biological)
结局指标
主要结局
safety and feasibility
时间窗: 2 years
次要结局
- maximum tolerated dose(2 years)
- antibody and T-cell response(2 years)