28
Participants
Start Date
August 31, 2012
Primary Completion Date
June 30, 2014
Study Completion Date
June 30, 2014
ch14.18 -NCI
25 mg/m\^2/day IV for four consecutive days
ch14.18-UTC
17.5 mg/m\^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2)
Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4.
Isotretinoin
"Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
Columbia University Medical Center, New York
Children's Hospital of Philadelphia, Philadelphia
Duke University Medical Center, Durham
Children's Healthcare of Atlanta - Egleston, Atlanta
University of Michigan C.S. Mott Children's Hospital, Ann Arbor
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis
The University of Chicago, Chicago
Washington University School of Medicine, St Louis
Children's Mercy Hospital (Kansas), Kansas City
Cook Children's Medical Center, Fort Worth
Children's Hospital of Los Angeles, Los Angeles
Seattle Children's Hospital, Seattle
Dana-Farber Cancer Institute, Boston
Lead Sponsor
United Therapeutics
INDUSTRY