Actively Recruiting

Phase 2
Age: 0 - 30Years
All Genders
NCT02605421

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

Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-10-21

12

Participants Needed

1

Research Sites

547 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Less than 30 years of age at diagnosis of neuroblastoma
  • End of Induction disease evaluation showing complete, partial, mixed response, or stable disease
  • Hematopoietic recovery from last induction chemotherapy course
  • No uncontrolled infection
  • Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant; 2 x 10^6 CD34 cells/kg for back-up strongly recommended; total at least 6 x 10^6 CD34 cells/kg collected before consolidation
  • Adequate organ function: hepatic (AST and ALT < 3x upper limit normal; total bilirubin ≤1.5x ULN if baseline normal), cardiac (shortening fraction ≥27% or ejection fraction ≥45%, no heart failure), pulmonary (no dyspnea at rest, no oxygen needed), renal (creatinine clearance or GFR > 60 mL/min/1.73m²)
  • Recovery from acute toxicities of last induction chemotherapy
  • Appropriate written consent from adult or parent/guardian if patient is under 18, and minor information sheet if patient is over 8 years old
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

L

Lisa Burke

CONTACT

A

Ashish Gupta, MBBS, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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