Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
Summary
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.