Actively Recruiting
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
Eligibility Criteria
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
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
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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