NCT00790413

Haploidentical Stem Cell Transplantation in Neuroblastoma

High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-08-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2008-11-13
• Last updated: 2021-02-21

Locations

1 site across 1 country: Sweden