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Sponsored by: |
Nationwide Children's Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00874315 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before a donor stem cell transplant helps stop the growth of tumor cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine, tacrolimus, and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant works in treating young patients with high-risk neuroblastoma that has relapsed or not responded to treatment.
Condition | Intervention | Phase |
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Neuroblastoma |
Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Drug: busulfan Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Genetic: gene expression analysis Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: immunoenzyme technique Other: laboratory biomarker analysis Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Multicenter Pilot Study of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation With in-Vivo T-Cell Depletion to Evaluate the Role of NK Cells and KIR Mis-Matches in Relapsed or Refractory High-Risk Neuroblastoma. |
Estimated Enrollment: | 25 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Reduced-intensity conditioning regimen: Patients receive fludarabine phosphate IV over 1 hour on days -10 to
After completion of study treatment, patients are followed periodically for 1 year.
Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of high-risk neuroblastoma, meeting one of the following criteria:
Achieved a complete remission (CR), very good partial remission (VGPR), or partial remission (PR) after ≤ 2 different salvage regimens, as defined by the following:
In VGPR or PR after salvage therapy
Disease status meeting one of the following criteria:
Donors must meet one of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 43205 | |
Contact: Sandeep Soni, MD 614-722-3582 |
Principal Investigator: | Sandeep Soni, MD | Nationwide Children's Hospital |
Responsible Party: | Nationwide Children's Hospital ( Sandeep Soni ) |
Study ID Numbers: | CDR0000636111, NCH-08-0234, IRB08-00234 |
Study First Received: | April 1, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00874315 History of Changes |
Health Authority: | Unspecified |
recurrent neuroblastoma |
Antimetabolites Anti-Infective Agents Neuroectodermal Tumors, Primitive Cyclosporine Immunologic Factors Fludarabine monophosphate Tacrolimus Immunosuppressive Agents Cyclosporins Neuroblastoma Recurrence Antilymphocyte Serum |
Neuroectodermal Tumors Antifungal Agents Neoplasms, Germ Cell and Embryonal Busulfan Mycophenolate mofetil Neuroepithelioma Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neuroectodermal Tumors, Primitive Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Tacrolimus Cyclosporins Neuroblastoma Antifungal Agents Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Mycophenolate mofetil Dermatologic Agents Alkylating Agents Neoplasms by Histologic Type Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neuroectodermal Tumors Neoplasms Busulfan Myeloablative Agonists Fludarabine |