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

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 1

Conditions: Ewing Sarcoma

Treatments: Drug: Busulfan; Drug: Fludarabina; Drug: Clyclophosphamide; Biological: allogeneic stem cell transplantation; Drug: Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT01969942

13.0176

Details and patient eligibility

About

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.

Sex: All

Ages: Under 30 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

allogeneic stem cell transplantation Plan A

Experimental group

Description:

Subjects will receive the vaccine, Busulfan and Melphalan.

Treatment:

Drug: Busulfan

Biological: allogeneic stem cell transplantation

Drug: Melphalan

allogeneic stem cell transplantation Plan B

Experimental group

Description:

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

Treatment:

Drug: Fludarabina

Biological: allogeneic stem cell transplantation

Drug: Clyclophosphamide