A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 20
- 主要终点
- Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression
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 II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.
详细描述
OBJECTIVES:
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression.
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse.
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
- Describe the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (medulloblastoma [measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression] vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor
- •Recurrent or refractory disease
- •Measurable disease by radiography
- •Patients with positive cerebrospinal fluid cytology or linear leptomeningeal disease are eligible
- •PATIENT CHARACTERISTICS:
- •21 and under
- •Performance status
- •Karnofsky 50-100% OR
- •Lansky 50-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3 (transfusion independent)
- •Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)
- •Bilirubin no greater than 1.5 times normal
- •ALT less than 2.5 times normal
- •Creatinine no greater than 1.5 times normal OR
- •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- •Cardiovascular
- •Shortening fraction at least 27% by echocardiogram OR
- •Ejection fraction at least 50% by MUGA
- •No dyspnea at rest
- •No exercise intolerance
- •Pulse oximetry greater than 94%
- •No uncontrolled infection
- •No active graft-versus-host disease
- •No uncontrolled seizure disorders
- •Seizure disorders well controlled with anticonvulsants allowed
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 2 weeks since prior growth factors
- •At least 6 months since prior allogeneic stem cell transplantation
- •No concurrent colony-stimulating factors during the first course of study
- •No concurrent immunomodulating agents
- •Chemotherapy
- •At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas) and recovered
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •If concurrent corticosteroids necessary for intracranial pressure, must be on stable or decreasing dose for at least 1 week prior to study
- •No other concurrent corticosteroids
- •Radiotherapy
- •At least 2 weeks since prior local palliative radiotherapy (small port) to symptomatic metastatic sites
- •At least 3 months since prior craniospinal radiotherapy
- •No concurrent palliative radiotherapy
- •Recovered from prior radiotherapy
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression
Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse
次要结局
- Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)
- Pharmacokinetics of oxaliplatin in the serum and CSF