NCT00036894已完成1 期
A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antiangiogenic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •One of the following:
- •Histologically confirmed high-grade glioma
- •Glioblastoma multiforme
- •Gliosarcoma
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant glioma/astrocytoma, not otherwise specified
- •Meningioma
- •Hemangioblastoma
- •Ependymoma
- •Primitive neuroectodermal tumors
- •Hemangiopericytoma
- •Progressive glioma
- •Clinically and radiographically diagnosed brain stem glioma
- •Progressive or recurrent disease as determined by CT scan or MRI
- •Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor
- •Must have failed prior radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •WBC at least 2,300/mm^3
- •Platelet count at least 90,000/mm^3
- •Hemoglobin at least 8 g/dL (transfusions allowed)
- •Bilirubin less than 3 times upper limit of normal (ULN)
- •SGOT less than 3 times ULN
- •No significant active hepatic disease
- •Creatinine less than 2.0 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No significant active renal disease
- •Cardiovascular:
- •No significant active cardiac disease
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No significant active psychiatric disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 2 weeks since prior interferon
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 6 weeks since prior nitrosoureas
- •At least 4 weeks since prior temozolomide or carboplatin
- •At least 3 weeks since prior procarbazine
- 另有 17 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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