NCT00458601已完成2 期
A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Progression-free survival status
研究概览
简要总结
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
- •Gross total resection followed by conventional chemoradiation therapy without progression of disease.
排除标准
- •Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
- •Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
- •Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
- •Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
研究组 & 干预措施
CDX-110 with GM-CSF
Experimental
干预措施: CDX-110 with GM-CSF (Drug)
CDX-110 with GM-CSF
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression-free survival status
时间窗: 5.5mo
次要结局
- Immune response; T-cell response to vaccine.(2 years)
- Safety and tolerability characterized by adverse events (term, grade, frequency).(2 years)
- Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).(2 years)
- Safety and tolerability characterized by physical examinations.(2 years)
- Immune response; antibody response to vaccine.(2 years)
- Immune response; HLA typing.(2 years)
- Safety and tolerability characterized by urinalysis.(2 years)
- Safety and tolerability characterized by vital signs.(2 years)
- Overall survival.(indeterminate)
研究者
研究点 (1)
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