此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors

2013年8月22日 更新者：Children's Oncology Group

An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors

RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed, high-risk CNS embryonal tumors (Phase I completed as of 11-25-03).
  • Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin after concurrent carboplatin, vincristine, and radiotherapy in these patients.
  • Determine the overall and individual toxicity rates of this regimen in these patients.
  • Determine the complete response rate in patients treated with this regimen.
  • Obtain preliminary estimates of event-free survival of patients treated with this regimen.
  • Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event-free survival of these patients.

OUTLINE: This is a pilot, dose-escalation study of carboplatin. (Phase I completed as of 11-25-03.)

Within 31 days of definitive surgery, all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes (after completion of vincristine infusion) 5 days a week for 6 weeks. Patients undergo radiotherapy (1-4 hours after carboplatin infusion) 5 days a week for 6 weeks.

Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 12 patients experience dose-limiting toxicity. (Phase I completed as of 11-25-03.)

At 6 weeks after completion of radiotherapy, patients are assigned to arm II for adjuvant/maintenance chemotherapy. (Arm I closed to accrual as of 11-25-03.)

  • Arm I (closed to accrual as of 11-25-03): Patients receive cyclophosphamide IV over 1 hour on days 0 and 1, vincristine IV on days 0 and 7, and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 2 and continuing for at least 10 days until blood counts recover.
  • Arm II: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2, vincristine IV on days 0 and 7, cisplatin IV over 6 hours on day 0, and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover.

In both arms, adjuvant/maintenance chemotherapy repeats every 4 weeks for 6 courses.

Patients are followed every 3 months for 8 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

168

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6H 3V4
        • British Columbia Children's Hospital
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3J 3G9
        • IWK Grace Health Centre
  • 澳大利亚
    • Western Australia
      • Perth、Western Australia、澳大利亚、6001
        • Princess Margaret Hospital for Children
  • 美国
    • California
      • Long Beach、California、美国、90806
        • Long Beach Memorial Medical Center
      • Los Angeles、California、美国、90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles、California、美国、90027-0700
        • Children's Hospital Los Angeles
      • Orange、California、美国、92668
        • Children's Hospital of Orange County
      • San Francisco、California、美国、94115-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Colorado
      • Denver、Colorado、美国、80218
        • Children's Hospital of Denver
    • District of Columbia
      • Washington、District of Columbia、美国、20010-2970
        • Children's National Medical Center
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis、Indiana、美国、46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0752
        • University Of Michigan Comprehensive Cancer Center
      • Kalamazoo、Michigan、美国、49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota Cancer Center
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City、Missouri、美国、64108
        • Children's Mercy Hospital
    • Nebraska
      • Omaha、Nebraska、美国、68198-3330
        • University of Nebraska Medical Center
    • New Jersey
      • Paterson、New Jersey、美国、07503
        • St. Joseph's Hospital and Medical Center
    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • New York、New York、美国、10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York、New York、美国、10032
        • Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
    • North Dakota
      • Fargo、North Dakota、美国、58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cincinnati、Ohio、美国、45229-3039
        • Children's Hospital Medical Center - Cincinnati
      • Cleveland、Ohio、美国、44106-5065
        • Ireland Cancer Center
      • Columbus、Ohio、美国、43205-2696
        • Children's Hospital of Columbus
    • Oregon
      • Portland、Oregon、美国、97201-3098
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania Cancer Center
      • Pittsburgh、Pennsylvania、美国、15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville、Tennessee、美国、37232-6838
        • Vanderbilt Cancer Center
    • Texas
      • Houston、Texas、美国、77030
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City、Utah、美国、84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle、Washington、美国、98109
        • Fred Hutchinson Cancer Research Center
      • Seattle、Washington、美国、98105
        • Children's Hospital and Regional Medical Center - Seattle
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • University of Wisconsin Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 21年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically proven high-risk CNS embryonal tumors, including:

    • Primitive neuroectodermal tumors
    • Atypical teratoid/rhabdoid tumor
    • Medulloblastoma
    • Desmoplastic medulloblastoma
    • Ependymoblastoma
    • Medullomyoblastoma
    • Spongioblastoma
    • Spongioblastoma polare
    • Primitive polar spongioblastoma
    • Neuroepitheliomatous neoplasms
    • Medulloepithelioma
    • Neuroblastoma
    • Pineoblastoma
  • No bone marrow involvement or bone metastases
  • No M4 disease
  • M3 disease must have evidence of tumor on spinal MRI

PATIENT CHARACTERISTICS:

Age:

  • 3 to 21 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed)

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT/SGPT less than 2.5 times normal

Renal:

  • Creatinine less than 1.5 times upper limit of normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Prior definitive surgery allowed

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Newly diagnosed cerebral PNET with histologic verification
Begin therapy within 31 days of surgery. Radiation therapy will be given in standard fractions along with filgrastim. The craniospinal axis will be treated first. Patients will receive carboplatin at 35 mg/m2/day IV over 15-20 minutes Monday through Friday, 1-4 hours prior to radiation for 6 weeks (total of 30 doses). Vincristine sulfate 1.5 mg/m2 IV will be given weekly x 6. Following radiation, patients will receive Maintenance chemotherapy. Patients enrolled prior to Amendment #5 will receive six cycles of cyclophosphamide and vincristine (Regimen A). Patients enrolled after Amendment #5 will receive six cycles of cyclophosphamide, vincristine sulfate and cisplatin (Regimen B).
程序：辅助治疗
药品：环磷酰胺
鉴于IV
其他名称：
  • 胞毒素
  • NSC-26271
药品：硫酸长春新碱
鉴于IV
其他名称：
  • 致癌素
  • NSC-67574
药品：顺铂
鉴于IV
其他名称：
  • 铂金-AQ
  • NSC-119875
药品：卡铂
鉴于IV
其他名称：
  • 副铂
  • NSC-241240
生物：非格司亭
鉴于IV
其他名称：
  • 脑脊液
  • 纽普生
  • NSC-614629
辐射：radiation therapy
1.8 Gy/fx x 20fx=36Gy Craniospinal XRT*
其他名称：
  • 放疗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Event Free Survival
大体时间：Length of study
Minimum time to disease progression or recurrence, time to death for any reason, or time to occurrence of a second malignant neoplasm (SMN).
Length of study

次要结果测量

结果测量
措施说明
大体时间
Survival
大体时间：Length of study
Time to death from any cause
Length of study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Regina Jakacki, MD、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1998年3月1日

初级完成 (实际的)

2007年10月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2003年5月16日

首次发布 (估计)

2003年5月19日

研究记录更新

最后更新发布 (估计)

2013年8月23日

上次提交的符合 QC 标准的更新

2013年8月22日

最后验证

2013年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A9971
  • COG-A9971 (其他标识符：Children's Oncology Group)
  • CCG-99701 (其他标识符：Children's Cancer Group)
  • CDR0000066055 (其他标识符：Clinical Trials.gov)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅