INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWING'S TUMOR METASTATIC AT DIAGNOSIS: A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 49
研究概览
简要总结
Phase II trial to study the effectiveness of combination chemotherapy in treating patients with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
详细描述
OBJECTIVES:
I. Evaluate the response rate and duration of response of patients with newly diagnosed, metastatic Ewing's sarcoma or primitive neuroectodermal tumor treated with maximally intensified VAdrC (vincristine, doxorubicin, cyclophosphamide) alternating with IE (ifosfamide, etoposide).
II. Evaluate the response to new agents (first topotecan, then topotecan with cyclophosphamide) utilized in an upfront treatment window.
III. Assess the role of surgery with regard to local control of primary and metastatic sites and disease course.
IV. Evaluate whether individual variability in ifosfamide and cyclophosphamide metabolism correlates with toxicity and/or response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
See detailed description.
干预措施: filgrastim (Biological)
Arm I
See detailed description.
干预措施: amifostine trihydrate (Drug)
Arm I
See detailed description.
干预措施: cyclophosphamide (Drug)
Arm I
See detailed description.
干预措施: doxorubicin hydrochloride (Drug)
Arm I
See detailed description.
干预措施: etoposide (Drug)
Arm I
See detailed description.
干预措施: ifosfamide (Drug)
Arm I
See detailed description.
干预措施: topotecan hydrochloride (Drug)
Arm I
See detailed description.
干预措施: vincristine sulfate (Drug)
Arm I
See detailed description.
干预措施: conventional surgery (Procedure)
Arm I
See detailed description.
干预措施: low-LET cobalt-60 gamma ray therapy (Radiation)
Arm I
See detailed description.
干预措施: low-LET electron therapy (Radiation)
Arm I
See detailed description.
干预措施: low-LET photon therapy (Radiation)
