16
Participants
Start Date
July 3, 2015
Primary Completion Date
December 15, 2019
Study Completion Date
September 4, 2020
Temsirolimus
Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.
Etoposide
100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.
Cyclophosphamide
440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
Methotrexate
"PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.~* Age 1 - 1.99 give 8 mg of methotrexate~* Age 2 - 2.99 give10 mg of methotrexate~* Age 3 - 8.99 give 12 mg of methotrexate~* Age ≥ 9 give 15 mg of methotrexate~PATIENTS WITH CNS 2 or 3 DISEASE~-COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 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"
Hydrocortisone
"Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.~COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 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"
Cytarabine
"For Patients who are CNS1 COURSE 1: Give intrathecally to patients with CNS1 disease at the dose defined by age below on day 1 of course 1 if no other IT was given within 1 week of day 1 of course 1~* Age 1 - 1.99 give 30 mg of Cytarabine~* Age 2 - 2.99 give 50mg of Cytarabine~* Age ≥ 3 give 70 mg of Cytabine~For Patients with CNS 2 or 3 Disease COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 1 if no other IT chemotherapy given within 1 week of day 1 of course 1. Then give weekly until the patient is CNS 1 or 2 (investigator discretion). No more than 5 weekly doses to be given in cycle 1.~COURSES 2-8: Give intrathecally to patients who were CNS 2or 3 at study entry on day 1 of each course.~* 16 mg for patients age 1-1.99~* 20 mg for patients age 2-2.99~* 24 mg for patients 3-8.99 years of age~* 30 mg for patients \>9 years of age"
Children's Hospital New York-Presbyterian, New York
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins University, Baltimore
Levine Children's Hospital at Carolinas Medical Center, Charlotte
Children's Healthcare of Atlanta, Emory University, Atlanta
University of Miami Cancer Center, Miami
Rainbow Babies, Cleveland
University of Texas at Southwestern, Dallas
Cook Children's Medical Center, Fort Worth
Texas Children's Hospital, Houston
The Children's Hospital, University of Colorado, Aurora
Childrens Hospital Los Angeles, Los Angeles
Seattle Children's Hospital, Seattle
Children's Hospital Orange County, Orange
Children's National Medical Center, Washington D.C.
Lurie Children's Hospital, Chicago
Nationwide Childrens Hospital, Columbus
Oregon Health and Science University, Portland
Primary Children's, Salt Lake City
Medical College of Wisconsin, Milwaukee
Children's Hospital at Westmead, Westmead
Royal Children's Hospital, Brisbane
Royal Children's Hospital, Melbourne, Melbourne
Sydney Children's Hospital, Sydney
Hospital for Sick Kids, Toronto
Sainte Justine University Hospital, Montreal
British Columbia Children's Hospital, Vancouver
UCSF School of Medicine, San Francisco
Dana Farber, Boston
C.S. Mott Children's Hospital, Ann Arbor
Childrens Hospital & Clinics of Minnesota, Minneapolis
St. Jude, Memphis
Collaborators (1)
Pfizer
INDUSTRY
Therapeutic Advances in Childhood Leukemia Consortium
OTHER