A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma (ASCT)
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.
Biological: allogeneic stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma|
- Development of Grade 3-4 GVHD [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Study Completion Date:||October 2016|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
|Biological: allogeneic stem cell transplantation Drug: Busulfan Drug: Melphalan|
Experimental: 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.
|Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969942
|United States, Kentucky|
|Pediatric Hematology/Oncology University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Kenneth Lucas, M.D.||University of Louisville|