A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Binding of 89Zr-J591
研究概览
简要总结
The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for humanized antibody called J591, that is attached to a radioactive material called Zirconium-89) in patients with glioblastoma multiforme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age > 25 years old and < 80 years old
- •Patients with reoccurrence of brain tumor
- •The principal investigator or co-PI must review MRI and CT findings based on the radiologic assessment provided they meet the following imaging criteria (as established in the clinical trial 09-177):
- •Patients with newly diagnosed GBM and one of the following options:
- •Eligible for surgery after the last research scan.
- •Significant residual disease after initial surgery
- •The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease
- •Treatment (non-surgical) naïve
- •Karnofsky Performance Score ≥ 70
排除标准
- •Laboratory values:
- •Serum creatinine >2.5 mg/dL.
- •AST (SGOT) >2.5x ULN.
- •Bilirubin (total) >1.5x ULN.
- •Serum calcium >11 mg/dL.
- •Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done).
- •If an initial biopsy demonstrates neoplasm other than GBM
- •Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.
- •Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements
- •Prior treatment.
- •Other serious illness (es), which might preclude completion of this, study or interfere with determination of causality of any adverse effects experienced in this study.
研究组 & 干预措施
89Zr-J591
Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
干预措施: 89Zr-J591 (Drug)
89Zr-J591
Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
干预措施: PET/CT Scan (Device)
89Zr-J591
Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
干预措施: MRI (Device)
89Zr-J591
Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
干预措施: Blood draw (Other)
结局指标
主要结局
Binding of 89Zr-J591
时间窗: 1 year
This will be measured by J591 uptake in PET scan.
次要结局
未报告次要终点