High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

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.

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.