Haploidentical Stem Cell Transplantation in Neuroblastoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jacek Toporski, Lund University Hospital

ClinicalTrials.gov Identifier:

NCT00790413

First received: November 12, 2008

Last updated: March 3, 2016

Last verified: March 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2008

Last Updated Date

March 3, 2016

Start Date ^ICMJE

August 2005

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Engraftment rate [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]

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

Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Immunological reconstitution [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
Incidence of acute graft versus host disease [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]

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

Phase 0

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neuroblastoma

Intervention ^ICMJE

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

Study Arm (s)

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:

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Refractory neuroblastoma (any chemo/radiosensitive stable disease)
Relapse incl. autologous HSCT 3 m earlier
Primary induction failure
Cardiac output SF ≥25%
Creatinine clearance ≥40 cc/min/1.73 m2
Performance score of ≥50% (Lansky or Karnofsky)
Available haploidentical family donor, aged ≥18 yrs, HIV-neg

Exclusion Criteria:

Rapidly progressive disease
Pregnancy

Gender

Both

Ages

6 Months to 21 Years (Child, Adult)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Jacek Toporski, Lund University Hospital

Study Sponsor ^ICMJE

Lund University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jacek Toporski, MD, PhD

Lund University Hospital, Department of Pediatric Oncology

Information Provided By

Lund University Hospital

Verification Date

March 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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