An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 主要终点
- Prevention of disease progression
研究概览
简要总结
The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 Years or Older
- •Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
- •Karnofsky performance status > 70%
- •Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL
- •Signed informed consent
- •Pathologic confirmation of GBM or AAF
- •A negative beta hCG test for women of childbearing potential
- •Negative HAMA test
排除标准
- •Metastases or Second Primary Cancer
- •Iodine allergy
- •Inability to tolerate oral intake of Lugol's solution
- •HIV Infection
- •Positive HAMA test
- •Pregnancy
- •Uncontrolled Seizures
研究组 & 干预措施
Treated with MAB-425
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
干预措施: MAB-425 radiolabeled with I-125 (Drug)
结局指标
主要结局
Prevention of disease progression
时间窗: 3 months after first course with follow-up
For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline
次要结局
未报告次要终点