A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Development of Grade 3-4 GVHD
研究概览
简要总结
The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:
- The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
- The incidence of transplant related mortality at 100 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
- •Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.
排除标准
- •Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:
- •Cardiac: Ejection Fraction less than 50 percent
- •Renal: Est. Creatinine Clearance less than 50
- •Hepatic: Bilirubin greater than 3.0
- •Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 percent on room air.
- •Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
- •Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.
- •As part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2 and HIV. Subjects testing positive for HI may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.
研究组 & 干预措施
allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
干预措施: allogeneic stem cell transplantation (Biological)
allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
干预措施: Busulfan (Drug)
allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
干预措施: Melphalan (Drug)
allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
干预措施: allogeneic stem cell transplantation (Biological)
allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
干预措施: Clyclophosphamide (Drug)
allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
干预措施: Fludarabina (Drug)
结局指标
主要结局
Development of Grade 3-4 GVHD
时间窗: 12 months
次要结局
未报告次要终点