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

Ewing Sarcoma Clinical Trial

— ASCT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01969942
• Other study ID #: 13.0176
• Status: Withdrawn
• Phase: Phase 1
• First received: October 21, 2013
• Last updated: May 8, 2017
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Ewing Sarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Biological:
• allogeneic stem cell transplantation

Drug:
• Clyclophosphamide

• Fludarabina

• Busulfan

• Melphalan

Locations

Country	Name	City	State
United States	Pediatric Hematology/Oncology University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Grade 3-4 GVHD		12 months

External Links

•   University of Louisville Peds--Heme/Onc