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


Phase 0
6 Months
21 Years
Open (Enrolling)
Both
Neuroblastoma

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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

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