NCT00015899已完成1 期
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
Pediatric Brain Tumor Consortium18 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2002年1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
- 入组人数
- 53
- 试验地点
- 18
- 主要终点
- Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
研究概览
简要总结
RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.
详细描述
OBJECTIVES:
- Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors.
- Estimate the maximum tolerated dose of this drug in these patients.
- Describe the pharmacokinetics of this drug with and without dexamethasone in these patients.
- Investigate the efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent or progressive (refractory) brain tumors
- •Histologic confirmation waived for brainstem gliomas
- •Bone marrow involvement allowed if transfusion independent
- •PATIENT CHARACTERISTICS:
- •21 and under
- •Performance status:
- •Lansky 60-100% OR
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •See Disease Characteristics
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 75,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •Bilirubin no greater than upper limit of normal
- •SGPT and SGOT less than 2.5 times normal
- •Albumin greater than 3 g/dL
- •PT/PTT no greater than 120% upper limit of normal
- •No overt hepatic disease
- •Creatinine no greater than 1.5 times normal OR
- •Glomerular filtration rate greater than 70 mL/min
- •No overt renal disease
- •Cardiovascular:
- •No overt cardiac disease
- •No overt pulmonary disease
- •Neurologic deficits allowed if stable for at least 1 week prior to study
- •More than 3rd percentile weight for height
- •Able to swallow pills
- •No uncontrolled infection
- •No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 10 weeks after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •More than 6 months since prior bone marrow transplantation
- •More than 1 week since prior growth factors
- •Chemotherapy:
- •At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- •Endocrine therapy:
- •Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study
- •Concurrent oral contraceptives or other hormonal contraceptive methods allowed
- •Radiotherapy:
- •More than 6 weeks since prior substantial bone marrow radiotherapy
- •More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation
- •More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites
- •Not specified
- •No concurrent enzyme-inducing anticonvulsant drugs
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
Maximum tolerated dose of SCH 66336
时间窗: Four weeks
Pharmacokinetics of SCH 66336
次要结局
- Tumor response to SCH 66336
研究者
研究点 (18)
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