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Sponsored by: |
Lund University Hospital |
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Information provided by: | Lund University Hospital |
ClinicalTrials.gov Identifier: | NCT00790413 |
Children with primary resistant or relapsed neuroblastoma who do not achieve remission with conventional chemotherapy have extremely dismal prognosis. A novel treatment strategy combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (MIBG) and immunotherapeutic effect of haploidentical stem cell transplantation (haploSCT) followed by low-dose donor lymphocyte infusions will be piloted. The use of the isotope is aimed to decrease pre-transplant tumour burden. Reduced intensity conditioning containing Fludarabine, Thiotepa and Melfalan will enable sustained engraftment as well as will serve as additional anti-tumor treatment.
A prompt natural killer (NK)-cell mediated tumour control may be achieved by haploidentical stem cell transplantation. We hypothesize that tumour cells potentially evading NK-cell mediated immunity may be targeted by infused donor T-cells and eliminated by either MHC-dependent manner or through a bystander effect. The possible graft versus tumor effect will be evaluated in children with therapy resistant neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: iodine I 131 metaiodobenzylguanidine Drug: Fludarabine Drug: Thiotepa Procedure: T-cell depletion Procedure: Haploidentical stem cell transplantation Procedure: Donor Lymphocyte Infusion Drug: Rituximab Procedure: Co-transplantation of mesenchymal stem cells |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma |
Estimated Enrollment: | 15 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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High-dose MIBG with haploidentical stem cell transplantation: Experimental | Drug: iodine I 131 metaiodobenzylguanidine Drug: Fludarabine Drug: Thiotepa Procedure: T-cell depletion Procedure: Haploidentical stem cell transplantation Procedure: Donor Lymphocyte Infusion Drug: Rituximab Procedure: Co-transplantation of mesenchymal stem cells |
Ages Eligible for Study: | 6 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacek Toporski, MD, PhD | 004646178089 | jacek.toporski@med.lu.se |
Contact: Dominik Turkiewicz, MD, PhD | 004646178064 | dominik.turkiewicz@skane.se |
Sweden | |
Lund University Hospital, Department of Pediatric Oncology and Bone Marrow Transplantation | Recruiting |
Lund, Sweden, 221 85 | |
Contact: Jacek Toporski, MD PhD 004646178089 jacek.toporski@med.lu.se | |
Principal Investigator: Jacek Toporski, MD, PhD | |
Sub-Investigator: Albert N Bekassy, MD | |
Sub-Investigator: Dominik Turkiewicz, MD, PhD |
Principal Investigator: | Jacek Toporski, MD, PhD | Lund University Hospital, Department of Pediatric Oncology |
Responsible Party: | Lund University Hospital, Department of Pediatric Oncology ( Jacek Toporski ) |
Study ID Numbers: | 385/2005 |
Study First Received: | November 12, 2008 |
Last Updated: | August 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00790413 History of Changes |
Health Authority: | Sweden: Regional Ethical Review Board |
Radiotherapy Immunotherapy Hematopoietic Stem Cell Transplantation |
Neuroectodermal Tumors, Primitive Rituximab Fludarabine monophosphate Neuroblastoma Thiotepa Neuroectodermal Tumors 3-Iodobenzylguanidine |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Iodine Fludarabine Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Neuroblastoma Neuroectodermal Tumors |
Neoplasms 3-Iodobenzylguanidine Therapeutic Uses Neoplasms, Germ Cell and Embryonal Fludarabine Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |