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Haploidentical Stem Cell Transplantation in Neuroblastoma
This study is ongoing, but not recruiting participants.
Sponsor:
Lund University Hospital
Information provided by (Responsible Party):
Jacek Toporski, Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00790413
First received: November 12, 2008
Last updated: March 11, 2017
Last verified: March 2017
| Tracking Information | ||||
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| First Received Date ICMJE | November 12, 2008 | |||
| Last Updated Date | March 11, 2017 | |||
| Start Date ICMJE | August 2005 | |||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Engraftment rate [ Time Frame: day 100 ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00790413 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Haploidentical Stem Cell Transplantation in Neuroblastoma | |||
| Official Title ICMJE | High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma | |||
| Brief Summary | 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. The investigators 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Early Phase 1 | |||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
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| Condition ICMJE | Neuroblastoma | |||
| Intervention ICMJE |
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| Study Arms | Experimental: High-dose MIBG with haploidentical stem cell transplantation
High-dose MIBG followed by Fludarabine, Thiotepa and Melfalan as conditioning Before haploidentical transplantation of T-cell depleted graft
Interventions:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Active, not recruiting | |||
| Estimated Enrollment ICMJE | 15 | |||
| Completion Date | Not Provided | |||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 6 Months to 21 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Sweden | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00790413 | |||
| Other Study ID Numbers ICMJE | 385/2005 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Jacek Toporski, Lund University Hospital | |||
| Study Sponsor ICMJE | Lund University Hospital | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Lund University Hospital | |||
| Verification Date | March 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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