Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

Last updated: October 20, 2025
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Active - Recruiting

Phase

2

Condition

Neuroblastoma

Treatment

Melphalan

Thiotepa

Autologous Stem Cell Infusion

Clinical Study ID

NCT02605421
2015LS108
  • Ages < 30
  • All Genders

Study Summary

This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.

Eligibility Criteria

Inclusion

  • Less than 30 years of age at diagnosis of neuroblastoma

  • End of Induction disease evaluation demonstrating CR, PR, MR or SD

  • Hematopoietic Recovery from last induction course of chemotherapy

  • No uncontrolled infection

  • Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must all be collected prior to the initiation of consolidation.

  • Adequate organ function defined as:

  • Hepatic: AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal

  • Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure

  • Pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen

  • Renal: Creatinine clearance or GFR > 60 mL/min/1.73m^2. If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2

  • Recovery from acute toxicities of last cycle of induction chemotherapy

  • Appropriate written consent - adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age

Study Design

Total Participants: 12
Treatment Group(s): 7
Primary Treatment: Melphalan
Phase: 2
Study Start date:
June 01, 2016
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Masonic Cancer Center, University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

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