31
Participants
Start Date
August 4, 2006
Primary Completion Date
February 26, 2011
Study Completion Date
February 26, 2011
Bortezomib
Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.
Dexamethasone
10 mg/m2/day divided BID, oral administration for 14 days.
PEG-asparaginase
2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22
Doxorubicin
60 mg/m2/day IV over 15 minutes on Day 1
Cytarabine
"Given intrathecally on Day 1 of course 1 at the dose defined by age below.~* 30 mg for patients age 1-1.99~* 50 mg for patients age 2-2.99~* 70 mg for patients \>3 years of age"
Methotrexate
"Given intrathecally to all patients who are CNS 1 at study entry on Day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age"
Vincristine
1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.
Triple IT Therapy
"Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:~Methotrexate-~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg~Cytarabine:~* \<2 years: 16 mg~* 2 - \<3 y: 20 mg~* 3 - \<9 y: 24 mg~* \>=9 y: 30 mg~Hydrocortisone:~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg"
Sydney Children's Hospital, Randwick
The Children's Hospital at Westmead, Westmead
New York University Medical Center, New York
Children's Hospital New York-Presbyterian, New York
Children's National Medical Center, Washington D.C.
Johns Hopkins / Sydney Kimmel Cancer Center, Baltimore
Levine Children's Hospital, Charlotte
Children's Healthcare of Atlanta, Atlanta
University of Miami Cancer Center, Miami
Nationwide Children's Hospital, Columbus
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
Primary Children's Hospital, Salt Lake City
Childrens Hospital Los Angeles, Los Angeles
Miller Children's Hospital, Long Beach
City of Hope, Duarte
Children's Hospital & Research Center Oakland, Oakland
Seattle Children's Hospital, Seattle
Stanford University Medical Center, Palo Alto
UCSF School of Medicine, San Francisco
Dana Farber Cancer Center, Boston
C.S. Mott Children's Hospital, Ann Arbor
Childrens Hospital & Clinics of Minnesota, Minneapolis
Universidade Federale de Sao Paulo/Hospital Sao Paulo, São Paulo
Sick Kids, Toronto
Therapeutic Advances in Childhood Leukemia Consortium
OTHER