Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors
NCT00436761 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2013-12-18
Summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methylprednisolone after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors.
Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
- BIOLOGICAL
-
anti-thymocyte globulin
- BIOLOGICAL
-
graft-versus-tumor induction therapy
- BIOLOGICAL
-
sargramostim
- DRUG
-
busulfan
- DRUG
-
cyclosporine
- DRUG
-
melphalan
- DRUG
-
methylprednisolone
- OTHER
-
flow cytometry
- OTHER
-
immunologic technique
- OTHER
-
laboratory biomarker analysis
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
- PROCEDURE
-
umbilical cord blood transplantation
Sponsors & Collaborators
-
Milton S. Hershey Medical Center
lead OTHER
Principal Investigators
-
Kenneth G. Lucas, MD · Milton S. Hershey Medical Center
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
Countries
- United States
Study Locations
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