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Sponsors and Collaborators: |
St. Jude Children's Research Hospital University of Miami |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00152126 |
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 | Intervention |
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Neuroblastoma Central Nervous System Tumors Lymphomas Wilms Tumor |
Procedure: Stem Cell Transplantation Drug: Busulfan, Melphalan |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Enrollment: | 26 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Procedure: Stem Cell Transplantation
Autologous stem cell transplantation
Drug: 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.
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Secondary objectives for this protocol include the following:
Ages Eligible for Study: | up to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
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 |
Responsible Party: | St. Jude Children's Research Hospital ( Gregory Hale, MD / Principal Investigator ) |
Study ID Numbers: | ST133 |
Study First Received: | September 7, 2005 |
Last Updated: | February 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00152126 |
Health Authority: | United States: Food and Drug Administration |
Autologous stem cell transplantation CD133 cell selection CliniMACS device Tumor marker Tumor purging |
Melphalan Neuroectodermal Tumors, Primitive Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Kidney cancer Neuroblastoma Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Wilms Tumor Neuroepithelioma Kidney Diseases Lymphoma |
Nervous System Neoplasms Immunoproliferative Disorders Wilms' tumor Renal cancer Lymphatic Diseases Neuroectodermal Tumors Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Busulfan Lymphoproliferative Disorders Neuroectodermal Tumors, Primitive, Peripheral Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Complex and Mixed |