Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors
NCT00357396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2015-11-25
Summary
RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate mofetil may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewing's tumors.
Conditions
- Sarcoma
Interventions
- BIOLOGICAL
-
graft versus host disease prophylaxis/therapy
- DRUG
-
busulfan
- DRUG
-
melphalan
- DRUG
-
thiotepa
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
- PROCEDURE
-
peripheral blood stem cell transplantation
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Susan Prockop, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- United States
Study Locations
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