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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 30
Updated:9/28/2018
Start Date:June 2016
End Date:January 2023
Contact:Kim Nelson
Email:knelso62@fairview.org
Phone:612-273-2925

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Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

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.


- 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 ≥ 50%, 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
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Principal Investigator: Heather Stefanski, MD
Phone: 612-273-2925
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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mi
from
Minneapolis, MN
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