Trial Information
High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Engraftment rate
Outcome Time Frame:
day 100
Safety Issue:
Yes
Principal Investigator
Jacek Toporski, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lund University Hospital, Department of Pediatric Oncology
Authority:
Sweden: Regional Ethical Review Board
Study ID:
385/2005
NCT ID:
NCT00790413
Start Date:
August 2005
Completion Date:
Related Keywords:
- Neuroblastoma
- Radiotherapy
- Immunotherapy
- Hematopoietic Stem Cell Transplantation
- Neuroblastoma