NCT01969942

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.5 years

First QC Date

October 21, 2013

Last Update Submit

May 8, 2017

Conditions

Ewing Sarcoma

Keywords

Ewings sarcoma

Outcome Measures

Primary Outcomes (1)

  • Development of Grade 3-4 GVHD

    12 months

Study Arms (2)

allogeneic stem cell transplantation Plan A

EXPERIMENTAL

Subjects will receive the vaccine, Busulfan and Melphalan.

Biological: allogeneic stem cell transplantationDrug: BusulfanDrug: Melphalan

allogeneic stem cell transplantation Plan B

EXPERIMENTAL

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

Biological: allogeneic stem cell transplantationDrug: ClyclophosphamideDrug: Fludarabina

Interventions

allogeneic stem cell transplantationBIOLOGICAL
allogeneic stem cell transplantation Plan Aallogeneic stem cell transplantation Plan B
ClyclophosphamideDRUG
allogeneic stem cell transplantation Plan B
FludarabinaDRUG
allogeneic stem cell transplantation Plan B
BusulfanDRUG
allogeneic stem cell transplantation Plan A
MelphalanDRUG
allogeneic stem cell transplantation Plan A

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology/Oncology University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

fludarabine phosphateBusulfanMelphalan

Condition Hierarchy (Ancestors)

OsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Kenneth Lucas, M.D.

    University of Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 25, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

US(1)