European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 22
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. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
详细描述
OBJECTIVES:
- Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide, etoposide and carboplatin, and cyclophosphamide, doxorubicin, and vincristine followed by surgery.
- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
- Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to symptomatic spinal cord involvement (yes vs no).
Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5. Treatment repeats every 14 days for 2 courses. Patients eligible for surgery undergo surgical resection and then are removed from the study.
Patients ineligible for surgery after 2 courses of initial chemotherapy, but with at least 25% response to initial chemotherapy, receive 2 additional courses of vincristine and cyclophosphamide. Patients eligible for surgery undergo surgical resection and then are removed from the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed newly diagnosed stage II or III neuroblastoma or ganglioneuroblastoma
- •Unresectable disease
- •No MYCN amplification (i.e., fewer than 10 copies)
- •No metastases to bone marrow
- •No radiological bone lesions in skeleton
- •PATIENT CHARACTERISTICS:
- •Under 12 months at diagnosis
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No evidence of liver disease by ultrasound
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供