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

Primary Purpose

Ewing Sarcoma

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

allogeneic stem cell transplantation

Clyclophosphamide

Fludarabina

Busulfan

Melphalan

About this trial

This is an interventional treatment trial for Ewing Sarcoma focused on measuring Ewings sarcoma

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pediatric Hematology/Oncology University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

allogeneic stem cell transplantation Plan A

allogeneic stem cell transplantation Plan B

Arm Description

Subjects will receive the vaccine, Busulfan and Melphalan.

If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.

Outcomes

Primary Outcome Measures

Development of Grade 3-4 GVHD

Secondary Outcome Measures

Full Information

NCT ID

NCT01969942

First Posted

October 21, 2013

Last Updated

May 8, 2017

Sponsor

University of Louisville

1. Study Identification

Unique Protocol Identification Number

NCT01969942

Brief Title

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

Acronym

ASCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Withdrawn

Why Stopped

No subjects meeting study inclusion were enrolled.

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Louisville

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ewing Sarcoma

Keywords

Ewings sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

allogeneic stem cell transplantation Plan A

Arm Type

Experimental

Arm Description

Subjects will receive the vaccine, Busulfan and Melphalan.

Arm Title

allogeneic stem cell transplantation Plan B

Arm Type

Experimental

Arm Description

If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.

Intervention Type

Biological

Intervention Name(s)

allogeneic stem cell transplantation

Intervention Type

Drug

Intervention Name(s)

Clyclophosphamide

Intervention Type

Drug

Intervention Name(s)

Fludarabina

Intervention Type

Drug

Intervention Name(s)

Busulfan

Intervention Type

Drug

Intervention Name(s)

Melphalan

Primary Outcome Measure Information:

Title

Development of Grade 3-4 GVHD

Time Frame

12 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Lucas, M.D.

Organizational Affiliation

University of Louisville

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Hematology/Oncology University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Links:

URL

https://louisville.edu/medschool/pediatrics/clinical/sections-divisions/hem-onc

Description

University of Louisville Peds--Heme/Onc

Learn more about this trial

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

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