NCT00003657已完成2 期
High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Percentage of Participants with Grade 2 or higher renal toxicities
研究概览
简要总结
The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.
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
- 18 Years 至 55 Years（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
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: filgrastim (Biological)
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: Amifostine (Drug)
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: Carboplatin (Drug)
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: Etoposide (Drug)
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: Ifosfamide (Drug)
High Dose ICF with Amifostine
Experimental
- Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
- ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
- Patients receive amifostine IV twice a day on days -7 to -3.
- PBSCs are reinfused on day 0.
- Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
- Patients are followed monthly for the first 2 months and then for survival.
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Percentage of Participants with Grade 2 or higher renal toxicities
时间窗: 2 Months
次要结局
- Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine(2 Months)
研究者
Paul G. Richardson, MD
Richardson, Paul MD
Dana-Farber Cancer Institute
研究点 (3)
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