High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    20
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 30 May 2021
stem cell transplantation
tretinoin
filgrastim
monoclonal antibodies
granulocyte colony stimulating factor
melphalan
isotretinoin
stem cell infusion
shortening fraction
etoposide
colony stimulating factor
neutrophil count
carboplatin
high dose chemotherapy
monoclonal antibody ch14.18

Summary

This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.

Description

This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14.18) on a COG or New Approaches to Neuroblastoma Therapy (NANT) trial.

Details
Condition Neuroblastoma, neuroblastomas
Treatment radiation therapy, etoposide, melphalan, carboplatin, Granulocyte Colony Stimulating Factor, Autologous stem cell infusion, Isotretinoin (13-cis-retinoic acid)
Clinical Study IdentifierNCT01526603
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Less than 30 years of age at diagnosis of neuroblastoma
No evidence of disease progression: defined as increase in tumor size of >25% or new lesions
Recovery from last induction course of chemotherapy (absolute neutrophil count > 500 and platelet > 20,000)
No uncontrolled infection
Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)
Adequate organ function defined as
Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional normal 8 Cardiac: shortening fraction 27% or ejection fraction 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (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

Exclusion Criteria

Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful
Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria
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