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临床试验/NCT01884740
NCT01884740终止1 期

Phase I/II Trial Of Super-Selective Intraarterial Infusion Of Erbitux (Cetuximab) And Avastin (Bevacizumab)For Treatment Of Relapsed/Refractory Intracranial Glioma In Patients Under 22 Years Of Age

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
13
试验地点
1
主要终点
Median Overall Survival (OS)

研究概览

简要总结

Central nervous system (CNS) malignancies are the second most common malignancy and the most common solid tumor of childhood, including adolescence. Annually in the United States, approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be increasing. CNS tumors are the leading cause of death from solid tumors in children. Survival duration after diagnosis in children is highly variable depending in part on age at diagnosis, location of tumor, and extent of resection; however, most children with high grade glioma die within 3 years of diagnosis. All patients with high grade glioma experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in previous phase I trials that a single Superselective Intra-arterial Cerebral Infusion (SIACI) of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent glioblastoma multiforme (GBM) in adults, and we are currently evaluating the efficacy of this treatment. Therefore, this phase I/II clinical research trial is an extension of that trial in that we seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab is safe and effective in the treatment of relapsed/refractory glioma in patients <22 years of age. We expect that this project will provide important information regarding the utility of SIACI Cetuximab and Bevacizumab therapy for malignant glioma in patients <22 years of age and may alter the way these drugs are delivered to our patients in the near future.

详细描述

The experimental aspects of this treatment plan will include:

  1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol 25%; 10 mL over 2 minutes) in order to disrupt the blood brain barrier. This technique has been used in several thousand patients in previous studies for the IA delivery of chemotherapy for malignant glioma. We have used this without complication in our patients from our Phase I protocols as well.
  2. To treat patients <22 years of age with recurring or relapsing glioma with a single intraarterial delivery (SIACI) of Cetuximab and Bevacizumab. Our Phase I trials have demonstrated the safety of SIACI delivery of these drugs in adults. This trial will focus on the safety and efficacy in patients <22 years of age.

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
1 Year 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

SIACI of Erbitux and Bevacizumab

Experimental

Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m^2) and Bevacizumab (15 mg/kg)

干预措施: SIACI of Erbitux and Bevacizumab (Drug)

结局指标

主要结局

Median Overall Survival (OS)

时间窗: 2 Years

Overall Survival (OS) will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of death.

Composite Overall Response Rate (CORR)

时间窗: 6 Months

The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions. The investigator will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.

次要结局

  • Number of Treatment Emergent Adverse Events(28 days)
  • Median Progression-free Survival (PFS)(2 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Intraarterial Infusion Of Erbitux and Bevacizumab... | 临床试验