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No subjects meeting study inclusion were enrolled.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allogeneic stem cell transplantation Plan A | Experimental | Subjects will receive the vaccine, Busulfan and 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic stem cell transplantation | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Development of Grade 3-4 GVHD | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Lucas, M.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Hematology/Oncology University of Louisville | Louisville | Kentucky | 40202 | United States |
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| Clyclophosphamide |
| Drug |
|
| Fludarabina | Drug |
|
| Busulfan | Drug |
|
| Melphalan | Drug |
|
| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D002066 | Busulfan |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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