NCT01898273终止2 期
Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 9
- 主要终点
- Optimal Imaging Parameters - Dose
研究概览
简要总结
The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma
- •scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
- •ECOG performance status of 0 to 2 (Appendix C)
- •18 years of age or older
- •has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
- •has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative)
- •if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment
- •Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug.
排除标准
- •ongoing grade 2 or greater toxicities due to previous therapies. However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
- •has following laboratory abnormalities
- •Platelets < 100,000/μL
- •WBC < 3000/μL
- •Hematocrit < 22%
- •Serum creatinine > 2.5 mg/dL
- •ALT > 1.5 x ULN
- •Bilirubin > 1.5 x ULN
- •ongoing chronic immunosuppressive therapy
- •history of hypersensitivity to iodine
- •any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
- •women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
- •pregnancy or breast-feeding
- •inability to comply with the protocol
- •use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)
研究组 & 干预措施
Single
Experimental
I-124-CLR1404, open-label
干预措施: I-124-CLR1404 (Drug)
结局指标
主要结局
Optimal Imaging Parameters - Dose
时间窗: 8 days
Up to two dose levels (5 mCi and 7.5 mCi) will be evaluated in conjunction with multiple imaging time points to determine the optimal parameters for PET/CT brain imaging. Dosing will begin at 5 mCi and if the images are deemed inadequate, as assessed by count statistics and image quality, the 7.5 mCi dose level will be evaluated.
次要结局
- Optimal Imaging Parameters - Imaging Time Point(8 days)
研究者
研究点 (9)
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