9
Participants
Start Date
May 22, 2006
Primary Completion Date
May 19, 2009
Study Completion Date
September 23, 2009
ABT-751
"Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest."
Dexamethasone
"In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14."
PEG-asparaginase
"In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15."
Doxorubicin
"In Treatment Course 1 only:~• 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~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12."
Methotrexate
"In Treatment Course 1:~• Given Intrathecally 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~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 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~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose"
Cyclophosphamide
Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.
6-thioguanine
Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.
Childrens Hospital Los Angeles, Los Angeles
Seattle Children's Hospital, Seattle
Stanford University Medical Center, Palo Alto
UCSF School of Medicine, San Francisco
C.S. Mott Children's Hospital, Ann Arbor
Collaborators (1)
Abbott
INDUSTRY
Therapeutic Advances in Childhood Leukemia Consortium
OTHER