High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidence of Bacteriemia in a High Dose Busulfan, Melphalan and Thiotepa Chemotherapy Regimen With Autologous Peripheral Blood Stem Cell Rescue in Patients With High Risk and Relapsed or Refractory Pediatric Solid Tumors
研究概览
简要总结
This is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.
详细描述
Autologous stem cell transplant (ASCT) permits chemotherapy dose-escalation to exploit the steep dose-response of solid tumors to alkylating agents. Although ASCT regimens have activity in some high risk pediatric solid tumors, non-hematological regimen-related morbidity and mortality are major barriers to additional dose escalation. We hypothesized that the chemoprotectant amifostine (Ethyol®) would reduce the toxicity of ASCT without compromising anti-tumor efficacy. This is a study of amifostine at 1125 mg/m2 to determine the efficacy of it's chemoprotection in the reduction of bacteremia in a high dose busulfan, melphalan and thiotepa chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.
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
- •High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's tumor, peripheral PNET
- •High risk desmoplastic small round cell tumors (DSRCT)
- •Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor
- •High risk brain tumors including PNET/Medulloblastomas/germinomas
- •Relapsed germ cell tumors
- •Metastatic or relapsed rhabdoid tumors
- •Other relapsed/refractory pediatric embryonal tumors
- •Less than 30 years of age
- •Performance >= 50%
- •Cancer Diagnosis verification and staging
- •Disease Response and Recovery
- •Adequate Organ Function (Renal, Liver, Cardiac)
排除标准
- •Uncontrolled Infection
- •Pregnancy or Breastfeeding (For Females)
- •Disease Progression
- •Uncontrolled Intercurrent Illness
- •HIV Positive
- •Receiving other Investigational Agents
- •Amifostine Allergy
研究组 & 干预措施
Amifostine
干预措施: Amifostine (Drug)
结局指标
主要结局
Incidence of Bacteriemia in a High Dose Busulfan, Melphalan and Thiotepa Chemotherapy Regimen With Autologous Peripheral Blood Stem Cell Rescue in Patients With High Risk and Relapsed or Refractory Pediatric Solid Tumors
时间窗: 3 months
次要结局
未报告次要终点