CLINICAL TRIAL: A PHASE I TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS

临床试验:卡培他滨快速崩解片的 I 期试验

基本信息

  • 批准号:
    8356676
  • 负责人:
  • 金额:
    $ 0.24万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2010
  • 资助国家:
    美国
  • 起止时间:
    2010-12-01 至 2011-11-30
  • 项目状态:
    已结题

项目摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT HYPOTHESIS Oral capecitabine will be well tolerated by pediatric patients with newly diagnosed nondisseminated, intrinsic brainstem gliomas and non-disseminated high-grade gliomas. ISPECIFIC AIMS Primary Objectives: 1. To estimate the maximum tolerated dose (MTD) of capecitabine administered concurrently with radiation therapy (RT) to children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. 2. To describe the dose-limiting toxicity (ies) of capecitabine administered concurrently with radiation therapy to children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. Secondary Objectives: 1. To characterize the pharmacokinetics of capecitabine as delivered by Capecitabine Rapidly Disintegrating Tablets in this pediatric patient population. 2. To describe in the context of this phase 1 investigation, the anti-tumor activity of capecitabine and radiation that is observed in children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. 3. To characterize radiographic changes in non-disseminated, newly diagnosed intrinsic brainstem gliomas and high-grade gliomas treated with radiation and capecitabine using MRI, MRS, perfusion and diffusion imaging and PET scans. III. BACKGROUND AND SIGNIFICANCE Brainstem gliomas are astrocytic neoplasms that occur in the pons, midbrain or medulla of children and adolescents. High-grade astrocytomas of childhood are clinically aggressive, regionally invasive tumors, and children with intrinsic brainstem malignant gliomas have a 1- and 5-year progression-free survival (PFS) of less than 25 and 10%, respectively. Other than radiation therapy, no therapy has demonstrated benefit for these patients. The role of chemotherapy in the treatment of this disease is not clear. Previous studies suggest that the benefit from addition of chemotherapy, when compared to surgery and radiotherapy alone, is modest at best. Clearly, new agents and new approaches to therapy are needed for children with high-grade glial tumors. Capecitabine is converted to 5-fluorouracil (5-FU), with thymidine phosphorylase (TP) as the final and rate limiting enzyme for intra-tumoral activation. Previous studies have correlated capecitabine efficacy with the level of TP expression in both cell culture and human xenograft models. Radiation therapy, a standard component of brain tumor management, has been shown to substantially induce TP in glioblastoma xenografts. Additionally, capecitabine has been shown to be a radiosensitizer as well as an active single agent against metastatic brain lesions. Thus there is a strong rationale for evaluating the combination of capecitabine and radiation in the treatment of primary brain tumors. A favorable therapeutic index may also be achieved, since TP appears to be expressed in far greater amounts in brain tumors compared to normal brain tissue. Initial experience with combination treatment in adults indicates that treatment is well tolerated with no unexpected or additive toxicities seen.
这个子项目是利用这些资源的众多研究子项目之一

项目成果

期刊论文数量(0)
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SUSAN M. BLANEY其他文献

SUSAN M. BLANEY的其他文献

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{{ truncateString('SUSAN M. BLANEY', 18)}}的其他基金

PROTOCOL SPECIFIC RESEARCH SUPPORT
特定于协议的研究支持
  • 批准号:
    8181022
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
CLINICAL TRIAL: A PHASE I STUDY OF MK-0752 IN PEDIATRIC PATIENTS WITH RECURREN
临床试验:MK-0752 在复发性儿科患者中的 I 期研究
  • 批准号:
    8356709
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
CLINICAL TRIAL: PBTC-019: A PHASE I PHARMACOKINETIC OPTIMAL DOSING STUDY OF INT
临床试验:PBTC-019:INT 的 I 期药代动力学最佳剂量研究
  • 批准号:
    8356671
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
CLINICAL TRIAL: A PHASE I TRIAL OF ESCALATING DOSES OF KARENITECIN PLUS CYCLOPH
临床试验:Karenitecin 加 CYCLOPH 剂量递增的 I 期试验
  • 批准号:
    8356684
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
PBTC-025-A PHASE I PHARMACOPKINETIC AND SAFETY STUDY IN CHILDREN
PBTC-025-A 儿童 I 期药代动力学和安全性研究
  • 批准号:
    8356726
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
A PHASE I STUDY OF ABT-888, AN ORAL INHIBITOR OF POLY
ABT-888(一种口服 POLY 抑制剂)的 I 期研究
  • 批准号:
    8356743
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
CLINICAL TRIAL: PBTC-022 PHASE II STUDY OF BEVACIZUMAB PLUS IRINOTECAN (CAMPTOS
临床试验:贝伐珠单抗加伊立替康 (CAMPTOS) 的 PBTC-022 II 期研究
  • 批准号:
    8356679
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
NANT 2007-02 - A PHASE I STUDY OF BEVACIZUMAB WITH BOLUS
NANT 2007-02 - 贝伐珠单抗推注的 I 期研究
  • 批准号:
    8356742
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
CLINICAL TRIAL: A PHASE II TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS
临床试验:卡培他滨快速崩解片的 II 期试验
  • 批准号:
    8356747
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:
DATA SAFETY AND MONITORING BOARD
数据安全和监控委员会
  • 批准号:
    8181025
  • 财政年份:
    2010
  • 资助金额:
    $ 0.24万
  • 项目类别:

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