NCT01969942

A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ewing Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	allogeneic stem cell transplantation
DRUG	Clyclophosphamide
DRUG	Fludarabina
DRUG	Busulfan
DRUG	Melphalan

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-10-25
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States