A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Terminal Phase Half-life (t½)
研究概览
简要总结
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the post-treatment period, and for response and safety at 3,6,and 12 months during the first year, annually thereafter up to five years, and annually for additional safety and outcomes information up to 10 years.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Terminal Phase Half-life (t½)
时间窗: 0 to 7 days from dosimetric dose (given only once on Day 0)
The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.
Clearance (CL) Values
时间窗: 0 to 7 days from dosimetric dose given only once on Day 0
Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.
Volume of Distribution at Steady State (Vss)
时间窗: 0 to 7 days from dosimetric dose given only once on Day 0
Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.
Maximum Concentration (Cmax) Values
时间窗: 0 to 7 days from dosimetric dose (given only once on Day 0)
Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours
时间窗: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)
Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.
次要结局
- Area Under the Curve (AUC) at 0 to 120 Hours(0-120 hours from dosimetric dose (given only once on Day 0))
- Area Under the Curve (AUC) at 0 to 168 Hours(0-168 h from dosimetric dose (given only once on Day 0))
- Maximum Concentration (Cmax) Values(0 to 7 days from dosimetric dose (given only once on Day 0))
- Mean Residence Times From Day 0 to Day 7(0 to 7 days from dosimetric dose (given only once on Day 0))
- Overall Survival(Week 7 to Week 260 post treatment)
- Mean Absorbed Dose in the Source Organs and the Target Organs(0 to 7 days from dosimetric dose)
- Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)(From Baseline up to 99 Months)
- Duration of Response(Week 7 to Week 260 post treatment)
- Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)(0 to infinity h from dosimetric dose (given only once on Day 0))
- Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.(0 to 7 days from dosimetric dose (given only once on Day 0))
- Progression-free Survival(Week 7 to Week 260 post treatment)