Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%.
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 anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
- •Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy
- •Prior low-grade disease that 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/mm3
- •Hemoglobin at least 8.5 g/dL
- •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
- •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
- •No serious concurrent infection
- •No other medical illness that would preclude study
- •Negative pregnancy test
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No more than 1 prior chemotherapy regimen
- •Endocrine therapy:
- •Must be on stable dose of steroids for at least 5 days
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy and recovered
- •No more than 1 prior course of radiotherapy
- •Not specified
- •No other concurrent investigational agents
- •At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
排除标准
- 未提供