Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT
研究概览
简要总结
Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma.
II. Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients.
III. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs).
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
- •Histologically confirmed progressive or recurrent malignant glioma
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Prior low-grade gliomas that have progressed to high-grade after therapy allowed
- •Measurable disease by MRI or CT scan
- •Performance status - Karnofsky 60-100%
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Transaminases no greater than 4 times upper limit of normal
- •Creatinine no greater than 1.7 mg/dL
- •Mini mental score at least 15
- •No concurrent serious infection or other medical illness that would preclude study participation
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No more than 1 prior chemotherapy regimen
- •At least 3 months since prior radiotherapy and recovered
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
结局指标
主要结局
Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT
时间窗: 3 weeks
Graded using the CTC version 2.0.
次要结局
- Biological effectiveness estimated using 20S proteosome activity(Up to 6 years)
- Frequency of toxicity, graded using the CTC version 2.0(Up to 6 years)