Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas
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|ClinicalTrials.gov Identifier: NCT00152126|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : February 13, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Central Nervous System Tumors Lymphomas Wilms Tumor||Procedure: Stem Cell Transplantation Drug: Busulfan, Melphalan||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||February 2009|
Procedure: Stem Cell Transplantation
Autologous stem cell transplantationDrug: Busulfan, Melphalan
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152126
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Gregory Hale, M.D.||St. Jude Children's Research Hospital|