Phase I/II Trial of Repeat Dosing 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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Treatment Related Adverse Events
研究概览
简要总结
This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab 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
- 是
入选标准
- •Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)
- •Must have at least one confirmed and evaluable tumor site
- •Must have a Karnofsky or Lansky performance status ≥60%.
- •No chemotherapy for three weeks prior to treatment
- •Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3 and platelets ≥100,000/ mm3
- •Pre-enrollment chemistry parameters must show: bilirubin<1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)<2.5x IUNL and creatinine<1.5x IUNL
- •Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL
- •Growth factor(s): Must not have received within 1 week of entry onto this study
- •Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
- •Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study
- •Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening
- •Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks
排除标准
- •Females who are pregnant or lactating
- •Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study
- •Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
研究组 & 干预措施
SIACI of cetuximab and bevacizumab
Participants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year.
干预措施: SIACI of cetuximab and bevacizumab (Drug)
结局指标
主要结局
Number of Treatment Related Adverse Events
时间窗: 1 month post injection
The number of treatment-related adverse events will be assessed and graded according to the NCI Common Toxicity Criteria, version 5.0.
Progression-free survival (PFS)
时间窗: 1 year
PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.
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. We will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.
Overall Survival (OS)
时间窗: 1 year
OS will be measured from the date of diagnosis to the date of death
次要结局
未报告次要终点
研究者
Heather McCrea, MD
Assistant Professor
University of Miami