NCT00017264已完成1 期
A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant 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
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma.
- Describe the pharmacokinetics of this drug in these patients.
- Assess preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral atrasentan once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 patient experiences 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:
- •Histologically confirmed malignant glioma
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Progressive or recurrent after prior radiotherapy with or without chemotherapy
- •Prior low-grade glioma that has progressed to high-grade after therapy allowed
- •Measurable disease by MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •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
- •Hepatitis A, B, and C negative
- •Creatinine no greater than 1.7 mg/dL
- •Cardiovascular:
- •No New York Heart Association class II, III, or IV cardiac disease
- •HIV negative
- •Mini mental score at least 15
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- •No serious concurrent infection
- •No other concurrent medical illness that would preclude study entry
- •No alcoholism or drug addiction within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No more than 1 prior chemotherapy regimen
- •No prior or concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)
- •No prior atrasentan
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy and recovered
- •No concurrent anticancer radiotherapy
- •No concurrent anticancer surgery
- •Recovered from prior therapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (10)
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