Haploidentical Stem Cell Transplantation in Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Lund University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00790413
First received: November 12, 2008
Last updated: November 17, 2010
Last verified: November 2010

November 12, 2008
November 17, 2010
August 2005
December 2011   (final data collection date for primary outcome measure)
Engraftment rate [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00790413 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Haploidentical Stem Cell Transplantation in Neuroblastoma
High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma

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.

Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: High-dose MIBG with haploidentical stem cell transplantation
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 21 Years
No
Contact: Jacek Toporski, MD, PhD 004646178089 jacek.toporski@med.lu.se
Contact: Dominik Turkiewicz, MD, PhD 004646178064 dominik.turkiewicz@skane.se
Sweden
 
NCT00790413
385/2005
Not Provided
Jacek Toporski, Lund University Hospital, Department of Pediatric Oncology
Lund University Hospital
Not Provided
Principal Investigator: Jacek Toporski, MD, PhD Lund University Hospital, Department of Pediatric Oncology
Lund University Hospital
November 2010

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