An interventional study of Stem Cell Transplantation and Busulfan, Melphalan in Neuroblastoma, Central Nervous System Tumors and Lymphomas, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged Up to 25 Years. Per ClinicalTrials.gov, last updated 2009-02-13.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Treatment
Studies have provided evidence that residual microscopic malignant cells in autologous bone marrow or blood stem cell grafts can contribute to posttransplant relapse. Researchers are currently exploring different methods in an attempt to purify or "purge" the stem cell product to minimize the risk of tumor contamination.
The CD133+ antigen is a protein contained on or "expressed" on numerous cells in the human body including specific hematopoietic progenitor (blood forming) cells. However, this antigen is not expressed on certain cancer cells including neuroblastoma. A technique using the investigational CliniMACS cell sorting device has been developed in an effort to filter out only those stem cells that express this CD133+ antigen in order to infuse a hematopoietic stem cell product with no tumor contamination potential.
The primary objective of this study is to establish safety of treating patients with a high dose chemotherapy regimen of Busulfan and Melphalan followed by autologous CD133+ hematopoietic stem cell support. Transplants recipients are expected to achieve engraftment as defined by an absolute neutrophil count of greater than or equal to 500/mm3 for three consecutive days by day 42-post infusion. Thus, safety of the treatment plan will be evaluated in terms of failure to engraft by this specific time period.
Secondary objectives for this protocol include the following:
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 26 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
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Inclusion Criteria:
Eligibility will be determined separately for Part I and Part II of this study:
Part I ( Part I Eligibility criteria (eligibility for undergoing apheresis procedure)
Part II eligibility criteria (criteria for transplantation of CD133 select stem cell product)
Procedure: Stem Cell Transplantation · Drug: Busulfan, Melphalan
Autologous stem cell transplantation
Transplant recipients will receive high dose Busulfan and Melphalan followed by autologous CD133+ antigen specific hematopoietic stem cell infusion. The autologous graft product will be selected using the investigational CliniMACS device.
Also known as: Autologous stem cell transplant, CD133+ antigen specific selection, Apheresis
To determine the safety of the treatment plan using Busulfan and Melphalan followed by infusion of CD133+ selected hematopoietic cells in patients with high-risk malignancies.
Time frame: August 2005
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital