Pilot Study of High-Dose Chemotherapy With Busulfan, Melphalan, and Topotecan Followed by Autologous Hematopoietic Stem Cell Transplant in Advanced Stage and Recurrent Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Treatment feasibility in terms of investigational agent-related adverse events of a novel treatment combination followed by peripheral blood stem cell rescue
研究概览
简要总结
RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying how well giving busulfan, melphalan, and topotecan hydrochloride together with a stem cell transplant works in treating patients with newly diagnosed or relapsed solid tumor.
详细描述
OBJECTIVES:
I. To assess the feasibility of a novel combination conditioning therapy with busulfan/melphalan and topotecan followed by autologous hematopoietic stem cell transplantation (HSCT) in patients with relapsed, refractory and/or poor risk pediatric solid tumors.
II. To determine within the confines of this pilot study, myeloid and platelet engraftment, overall survival and disease-free survival in patients with relapsed, refractory pediatric solid tumors and in patients who have solid tumors with poor risk factors at the time of diagnosis.
III. To determine the pharmacokinetics of topotecan.
OUTLINE:
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
- 6 Months 至 40 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: autologous bone marrow transplantation (Procedure)
Arm I
See Detailed Description
干预措施: busulfan (Drug)
Arm I
See Detailed Description
干预措施: melphalan (Drug)
Arm I
See Detailed Description
干预措施: topotecan hydrochloride (Drug)
Arm I
See Detailed Description
干预措施: laboratory biomarker analysis (Other)
Arm I
See Detailed Description
干预措施: filgrastim (Biological)
Arm I
See Detailed Description
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
Arm I
See Detailed Description
干预措施: pharmacological study (Other)
结局指标
主要结局
Treatment feasibility in terms of investigational agent-related adverse events of a novel treatment combination followed by peripheral blood stem cell rescue
时间窗: Day 100 post stem cell rescue
次要结局
- Incidence of myeloid and platelet engraftment(Day 100 post stem cell rescue)
- Pharmacokinetics and pharmacodynamics of topotecan hydrochloride and busulfan(Baseline through day 4 of investigational agent treatment)
- Overall survival(1 year post stem cell rescue)
- Disease-free survival(1 year post stem cell rescue)