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Haploidentical Stem Cell Transplantation in Neuroblastoma

NCT00790413 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-02-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Jacek Toporski, MD, PhD · Lund University Hospital, Department of Pediatric Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790413 on ClinicalTrials.gov