10
Participants
Start Date
December 31, 2001
Primary Completion Date
July 31, 2005
Study Completion Date
April 30, 2007
Gemcitabine
"Schedule~Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses).~In the absence of disease progression or DLT, patients may proceed to consolidation.~Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance.~Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year."
Children's Hospital of Pittsburgh, Pittsburgh
University of Pittsburgh Cancer Institute, Pittsburgh
National Cancer Institute, Bethesda
Texas Children's Hospital, Houston
Seattle Children's Hospital, Seattle
Collaborators (2)
University of Pittsburgh
OTHER
National Cancer Institute (NCI)
NIH
Children's Hospital of Pittsburg
UNKNOWN
Seattle Children's Hospital
OTHER
Mayo Clinic
OTHER
Brown University
OTHER
Baylor College of Medicine
OTHER