Neuroblastoma Clinical Trial
Official title:
Busulfan and Melphalan With Autologous Hematopoietic Stem Cell Support With Positively-Selected CD133+ Hematopoietic Cells for Children With High Risk Solid Tumors and Lymphomas
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:
- To describe CD133+ graft content post-selection and to describe the yield and purity of
CD133+ content of the graft obtained.
- To describe the negative selection efficiency of this strategy by assessing the
processed product for tumor specific markers, when applicable.
- To characterize the proliferation of clonal progeny of CD133+ cells.
- To characterize lymphocyte and hematopoietic reconstitution (including the kinetics of
platelet engraftment) in these patients.
- To estimate one-year disease-free and overall survival in these transplant recipients.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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