Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- To confirm the safety and tolerability of the maximum tolerated dose
研究概览
简要总结
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.
详细描述
To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed GBM
- •Clinical Target Volume between 5 and 60 cc (inclusive)
- •18 to 75 years old (inclusive)
- •Karnofsky Performance Status ≥ 70 percent
- •If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
- •Adequate hematology
- •Adequate renal function
- •Adequate liver function
排除标准
- •Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
- •Bilateral non-contiguous gadolinium enhancing tumor
- •Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
- •Known or suspected allergy to study medication or iodine
- •Surgical procedure within four weeks of baseline
- •More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
- •Radiation therapy within four weeks of baseline
- •Investigational agent within last 30 days
- •Previous treatment with any chimeric monoclonal antibody
- •HIV positive
- •Evidence of active hepatitis
研究组 & 干预措施
131I-chTNT-1/B MAb (Cotara)
干预措施: 131I-chTNT-1/B MAb (Cotara) (Drug)
结局指标
主要结局
To confirm the safety and tolerability of the maximum tolerated dose
次要结局
- To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.