31
Participants
Start Date
August 31, 2001
Primary Completion Date
December 31, 2014
Study Completion Date
April 30, 2016
buthionine sulfoximine
Dose fixed at a bolus of 3 gm/M2 given over 30 minutes followed by a continuous infusion of 1 gm/M2/hour for 72 hours (total 72.5 hours).Total daily infusion dose (minus the initial bolus)will be 24 gm/m2/day.
melphalan
The dose level of melphalan will be assigned at study entry onto protocol. There will be 6 dose levels ranging from 20mg/m2/day x 2 days (dose level 1a) to 62.5 mg/m2/day x 2 days (dose level 6a). The starting dose level will be 1a, with a decrease to level 0a (15mg/m2/day x2 days) if there is unacceptable toxicity.
Peripheral blood stem cell infusion
Stem cells will be infused intravenously on day 0 , 24 hours after BSO continuous infusion is completed.Infused within 1.5 hours of thawing via a central venous catheter over 15-30 minutes.
Filgrastim
5 microgram/kg/day , subcutaneous or intravenous, given daily beginning day 0. First dose to begin 4 hours after completion of stem cell infusion and then to continue till ANC \>/= 1500 mm3 for three consecutive days.
University of Chicago Comer Children's Hospital, Chicago
Cook Children's Medical Center - Fort Worth, Fort Worth
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
Children's Hospital and Regional Medical Center - Seattle, Seattle
Childrens Hospital Los Angeles, Los Angeles
Childrens Hospital Boston, Dana-Farber Cancer Institute., Boston
Cincinnati Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia, Philadelphia
Hospital for Sick Children, Toronto
National Cancer Institute (NCI)
NIH
New Approaches to Neuroblastoma Therapy Consortium
OTHER