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Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors

2014年7月23日 更新者：Children's Oncology Group

A Phase I Study of Thrombopoietin (rhTPO) Plus G-CSF in Children Receiving Ifosfamide, Carboplatin, and Etoposide (I.C.E.) Chemotherapy for Recurrent or Refractory Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide, carboplatin, and etoposide (ICE).
  • Determine a safe dose of recombinant human thrombopoietin with filgrastim (G-CSF) in this patient population.
  • Evaluate the time to platelet count recovery following chemotherapy in this patient population.
  • Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population.

OUTLINE: This is a dose escalation study of recombinant human thrombopoietin.

All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days.

Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33.

PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

16

阶段

  • 阶段1

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

  • 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、91010
        • Beckman Research Institute, City of Hope
      • 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
    • District of Columbia
      • Washington、District of Columbia、美国、20010-2970
        • Children's National Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46202-5265
        • Indiana University Cancer Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0752
        • University Of Michigan Comprehensive Cancer Center
    • 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 - Kansas City
    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • New York、New York、美国、10016
        • Kaplan Cancer Center
      • New York、New York、美国、10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati、Ohio、美国、45229-3039
        • Children's Hospital Medical Center - Cincinnati
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia
      • 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、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

1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 (except for brain stem tumors) malignancy that has

failed or relapsed after standard first-line antineoplastic therapy

  • Sarcoma (soft tissue and bone)
  • Kidney tumors
  • Brain tumors
  • Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
  • retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks

No bone marrow involvement

No prior or concurrent myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

  • 1 to 21

Performance status:

  • Lansky or Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1000/mm3
  • Platelet count greater than 100,000/mm3
  • No grade III or IV thrombosis

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN

Renal:

  • Creatinine clearance or glomerular filtration rate at least 70 mL/min

Cardiovascular:

  • Ejection fraction normal
  • No evidence of arrhythmias requiring therapy
  • Fractional shortening greater than 28%

Other:

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 10 days since prior colony-stimulating factor therapy and recovered
  • At least 30 days since prior epoetin alfa
  • No other concurrent cytokines, including epoetin alfa

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and
  • recovered
  • At least 3 months since therapy with etoposide, carboplatin, or ifosfamide
  • that is identical to study treatment

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Concurrent radiotherapy allowed after third course of therapy
  • No prior cranial/spinal radiotherapy
  • No prior radiotherapy to greater than 50% of bone marrow

Surgery:

  • Concurrent surgery allowed after the second course of therapy

Other:

  • No concurrent investigational agents
  • No concurrent lithium, aspirin, coumadin, or heparin

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：支持治疗
  • 分配：非随机化
  • 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：Cohort 1
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). rhTPO began on the last day of ICE (Ifosfamide, Carboplatin and Etoposide) chemotherapy (Day 4) and subsequent doses will be administered on Days 6, 8, 10 and 12 (5 doses total). The initial dose of rhTPO was 1.2 μg/kg/dose and was subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one only).
药品：卡铂
其他名称：
  • CBDCA
  • 副铂
  • 国家安全委员会#241240
药品：依托泊甙
其他名称：
  • VP-16
  • 维佩斯
  • 国家安全委员会#141540
药品：异环磷酰胺
其他名称：
  • 国际外汇
  • 国家安全委员会#109724
  • IFOS
  • IND #7887
生物：重组人血小板生成素
其他名称：
  • RhTPO
  • BB-IND # 7431)
生物：G-CSF
其他名称：
  • 非格司亭
  • r-metHuG-CSF
  • 国家安全委员会#614629
  • 纽普生®
  • 粒细胞集落刺激因子
实验性的：Cohort 2

Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). The dose of rhTPO 1.2 μg/kg/dose and subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Patients assigned to Cohort II will receive pre-chemotherapy rhTPO at 3.6 μg/kg/dose on Days -5, -3, -1, and post-chemotherapy rhTPO on Days +4, +6, and +8 (6 doses total. Subsequent courses of chemotherapy will begin as soon as the ANC recovers to

≥ 1,000/μL and the platelet count to ≥ 100,000/μL between days 21 and 35. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one nly). For the second cohort, full data collection will occur for cycles one and two and limited data collection for cycles 3, 4, 5, and 6.
药品：卡铂
其他名称：
  • CBDCA
  • 副铂
  • 国家安全委员会#241240
药品：依托泊甙
其他名称：
  • VP-16
  • 维佩斯
  • 国家安全委员会#141540
药品：异环磷酰胺
其他名称：
  • 国际外汇
  • 国家安全委员会#109724
  • IFOS
  • IND #7887
生物：重组人血小板生成素
其他名称：
  • RhTPO
  • BB-IND # 7431)
生物：G-CSF
其他名称：
  • 非格司亭
  • r-metHuG-CSF
  • 国家安全委员会#614629
  • 纽普生®
  • 粒细胞集落刺激因子

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
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)
大体时间：length of study
To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E. myelosuppressive chemotherapy.
length of study

次要结果测量

结果测量
措施说明
大体时间
Evaluate the time for patients to demonstrate platelet recovery
大体时间：Length of study
To evaluate the time for patients to demonstrate platelet recovery following I.C.E. chemotherapy with rhTPO + G-CSF.
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：Mitchell S. Cairo, MD、Herbert Irving Comprehensive Cancer Center

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11月1日

初级完成 (实际的)

2004年10月1日

研究完成 (实际的)

2005年9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4月17日

首次发布 (估计)

2003年4月18日

研究记录更新

最后更新发布 (估计)

2014年7月24日

上次提交的符合 QC 标准的更新

2014年7月23日

最后验证

2014年7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

  • 09717
  • CCG-09717
  • CDR0000066668

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.

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