NCT00004004已完成1 期
A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
New Approaches to Brain Tumor Therapy Consortium20 个研究点 分布在 1 个国家开始时间: 1999年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 20
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/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of oral procarbazine when administered to patients with recurrent glioma receiving or not receiving anticonvulsants metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic enzyme inducing drugs, in these patients.
- Assess the response rate to procarbazine in these patients.
- Evaluate this regimen in terms of overall survival and duration of disease free survival in these patients.
- Evaluate the toxicity of this regimen in these patients.
OUTLINE: Phase I of this study is a dose escalation study. Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or modest-induction drugs).
- Phase I: Patients receive oral procarbazine once daily for 5 days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of oral procarbazine until the maximum tolerated dose (MTD) is determined.
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 proven malignant glioma of one of the following types:
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Progressive or recurrent disease after radiotherapy with or without chemotherapy
- •Measurable disease by serial MR or CT
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Greater than 2 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGPT/SGOT no greater than 4 times upper limit of normal
- •Creatinine no greater than 1.7 mg/dL
- •No serious concurrent infection
- •No other illness that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent filgrastim (G-CSF) during the first course
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 1 prior chemotherapy regimen
- •At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas)
- •No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively
- •No prior procarbazine
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy
- •Prior surgery allowed
- •Recovered from toxicity of prior therapy
- •At least 10 days since prior anticonvulsants for patients in Arm II
- •No concurrent investigational agents
- •No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates
- •At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor)
- •Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)
排除标准
- 未提供
研究者
研究点 (20)
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