A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Progression at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well talampanel works in treating patients with recurrent, progressive high-grade glioma.
详细描述
OBJECTIVES:
- Determine the efficacy of talampanel, in terms of 6-month progression-free survival, in patients with recurrent high-grade gliomas.
- Determine, preliminarily, the toxic effects of this drug in these patients.
- Determine, preliminarily, the quality of life of patients treated with this drug.
- Determine the pharmacokinetics of this drug in patients who are and who are not receiving enzyme-inducing antiepileptic drugs.
OUTLINE: Patients are stratified according to type of glioma (anaplastic astrocytoma vs glioblastoma multiforme). Patients in each stratum are assigned to 1 of 3 treatment groups according to concurrent enzyme-inducing antiepileptic drug use (yes, no, or valproic acid).
Patients in each group receive different doses of oral talampanel 3 times daily on days 1-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 3 weeks during the first course, every 6 weeks before all subsequent courses, and then within 2 weeks of study completion.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed high-grade glioma, including any of the following:
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant astrocytoma not otherwise specified
- •Patients with clinical and radiographic diagnosis of brain stem glioma are also eligible
- •Evidence of tumor progression by MRI or CT scan
- •Scan must be performed while patient is on a stable steroid dose for at least 5 days
- •Must have failed prior radiotherapy
- •Residual disease after prior resection of recurrent or progressive tumor is allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •More than 8 weeks
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3 (transfusion independent)
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •SGOT less than 2 times ULN
- •No significant active hepatic disease
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No significant active renal disease
- •No significant active cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 effective methods of contraception during and for 2 months after study participation
- •Able to swallow whole capsules
- •No active infection requiring IV antibiotics
- •No significant active psychiatric disease that would preclude use of the study drug
- •No other significant uncontrolled medical illness that would preclude study participation
- •No other active life-threatening malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 1 week since prior interferon or thalidomide
- •No concurrent anticancer immunotherapy
- •Chemotherapy
- •At least 2 weeks since prior vincristine
- •At least 3 weeks since prior procarbazine
- •At least 6 weeks since prior nitrosoureas
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •At least 1 week since prior tamoxifen
- •Concurrent steroids for the control of increased intracranial pressure allowed
- 另有 11 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression at 6 months
次要结局
未报告次要终点