Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
研究概览
简要总结
RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.
PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM
- To characterize the biodistribution and radiation dosimetry of Cotara®
OUTLINE:
This is an open-label, dose escalation study of Cotara®.
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
- •Patients with recurrent GBM
- •Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
- •Patients of 18 years of age or older
- •Karnofsky Performance Status ≥ 60 at screening
- •Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry
排除标准
- •Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
- •Patients with diffuse disease
- •Patients with known or suspected allergy to study medication or iodine
- •Patients who received investigational agents within 30 days prior to baseline
- •Patients who received surgical resection within 4 weeks from baseline
- •Patients with known HIV or evidence of active hepatitis
- •Patients who cannot undergo MRI
研究组 & 干预措施
1
1.5 mCi/cc
干预措施: 131-I-chTNT-1/B MAB (Drug)
2
2.0 mCi/cc
干预措施: 131-I-chTNT-1/B MAB (Drug)
3
2.5 mCi/cc
干预措施: 131-I-chTNT-1/B MAB (Drug)
结局指标
主要结局
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
次要结局
未报告次要终点